University of Michigan Cancer Center receives Millions for Cancer Research

The University of Michigan Comprehensive Cancer Center has received a five-year $10.7 million grant from the National Cancer Institute to study colorectal and pancreatic cancer.

The Specialized Program in Research Excellence or SPORE, grant in gastrointestinal cancers brings together basic and clinical researchers to test new approaches for cancer prevention, early detection, diagnosis and treatment.

"This grant represents a major effort to bridge the basic science to the clinic. You have to have very good science, but it also has to translate: How are we going to use this information to help patients? The depth of expertise at the University of Michigan allows us to pursue this work," says Dean Brenner, MD principal investigator of the new grant and a professor of internal medicine and pharmacology at the U-M Medical School and the Ann Arbor VA Healthcare System.

Researchers from nine different departments from the U-M Medical School and School of Public Health will collaborate on the grant.

The Gastrointestinal SPORE grant is centered on four major projects, all of which will be tested in both laboratory research and clinical trials:

1. Preventing colorectal cancer. Researchers will study whether substituting omega-3 fatty acids for omega-6 fatty acids could help prevent colorectal cancer. Omega-3 fatty acids are found in fish and are believed to improve heart health.

2. Early detection of pancreatic cancer. Researchers will look for markers found in blood and plasma that are associated with pancreatic cancer. By using proteomics technology, researchers will analyze the changes in proteins in people with pancreatic cancer, non-cancerous pancreatic conditions and healthy pancreases. They hope to identify a marker or panel of markers that could be used to detect pancreatic cancer before it spreads to the rest of the body.

3. Improving pancreatic cancer treatment. Researchers will look at whether blocking a certain protein could make pancreas tumors more sensitive to chemotherapy and radiation therapy. By doing this, researchers hope to improve the effectiveness of current treatments.

4. Developing new pancreatic cancer treatments. Most pancreatic cancers express a gene called ATDC. Researchers will look at new therapies designed to target ATDC as a way of treating pancreatic cancer.

The grant also allows for training of young cancer researchers to encourage the next generation of scientists.

Colorectal cancer statistics: 142,570 Americans will be diagnosed with colorectal cancer this year and 51,370 will die from the disease.

Pancreatic cancer statistics: 43,140 Americans will be diagnosed with pancreatic cancer this year, and 36,800 will die from the disease. Pancreatic cancer is one of the most deadly cancer types, with more than 70% of patients dying within six months of diagnosis.

McKesson Corp. (MCK) acquires US Oncology for $2.16 Billion

By Andrea: http://nursingoncologyjob.com

McKesson Corporation (MCK), a leading healthcare services and information technology company, and US Oncology, a leading integrated oncology company, recently announced that the two companies have signed a definitive agreement under which McKesson will purchase all outstanding shares of US Oncology for cash. The total transaction, including the assumption of US Oncology's outstanding debt, is valued at approximately $2.16 billion. The combined organization will focus on providing a comprehensive offering of solutions for the oncology industry, one of the fastest-growing segments in healthcare.

The parties are targeting a closing by the end of McKesson's third fiscal quarter, ending December 31, 2010, subject to customary conditions, including all necessary regulatory clearances. Excluding transaction and integration costs, the acquisition is expected to be neutral to McKesson's diluted earnings per share in its current fiscal year, and modestly accretive beginning in McKesson's fiscal year 2012. In connection with the acquisition, it is anticipated that substantially all of US Oncology's debt will be repaid or refinanced, including the Senior Floating Rate PIK Toggle Notes due 2012 issued by US Oncology Holdings, Inc., and the 9.125% Senior Secured Notes due 2017 and 10.75% Senior Subordinated Notes due 2014, both issued by US Oncology, Inc.

The unified organization will bring together the collective capabilities of McKesson and US Oncology to provide oncology customers access to:

• Leading evidence-based medicine offerings that drive continued improvements in clinical outcomes and enable value-based reimbursement;
• Expanded clinical expertise, clinical research and personalized medicine offerings;
• Integrated, efficiency-enabling healthcare information technology, including the iKnowMed(TM) and Lynx^(R) technology platforms, facilitating outcomes measurement, reporting, and advanced product and inventory management;
• Innovative practice-management solutions and consultative capabilities that allow independent community specialists to thrive in a changing healthcare environment; and
• Superior distribution capabilities and supply-chain expertise.

These solutions will help community oncologists improve the care experience for patients and drive business and clinical innovations that address the increasing demand for high-quality, cost-effective, personalized cancer care.

"McKesson is committed to improving the health and vitality of our customers, with the ultimate goal of improving the health of patients," said John H. Hammergren, chairman and chief executive officer, McKesson. "The combination of US Oncology and McKesson will enhance our ability to achieve these goals in one of the most important segments in healthcare. Community oncology practices need strategic support that offers not only technology and distribution solutions, but also value-added clinical and reimbursement management services that enable them to provide the highest-quality, most efficient care to their patients. With this acquisition, McKesson will offer a compelling suite of services and solutions to community oncologists and other partners in the rapidly evolving specialty business."

The combined McKesson Specialty Care Solutions business will be led by Bruce Broussard, chairman and chief executive officer of US Oncology, and will be headquartered in The Woodlands, Texas, with continuing operations in the San Francisco Bay Area and other locations throughout the country. Broussard will report to Paul Julian, executive vice president and group president, McKesson Corporation. McKesson will continue to operate the United Network of US Oncology, including US Oncology's Comprehensive Strategic Alliance offering, US Oncology Research and other services under the US Oncology brand name.

Strategic Acquisition Creates Broader, Deeper Oncology Offering

The unified company will deliver a best-in-class oncology program, clinical tools, guidelines and care pathways that will create a leader in evidence-based medicine backed by a deep team of clinical experts. With approximately 3,000 total physician customers, the new organization's expanded breadth will accelerate investments in integrated systems, process excellence, and clinical programs that will help drive productivity, efficient care delivery, and the best possible care experience for patients.

"With the healthcare marketplace moving rapidly toward reimbursement based on quality and cost-effectiveness, our physician customers need access to deep clinical, operational and information technology capabilities to create integrated networks that continually enhance the quality of care in a cost-efficient manner," said Bruce Broussard. "In joining McKesson, we are building the scale and expertise necessary to empower our customer base to shape the future of healthcare."

"The addition of US Oncology's physician-centric business model and clinical expertise to the McKesson portfolio advances our strategy and significantly strengthens our offering for community oncology and other partners in the specialty segment," said Paul Julian. "McKesson and US Oncology's businesses are highly complementary, providing our collective customers access to more services and solutions that will enhance their ability to deliver advanced cancer care."

Unified Organization Creates More Choices for Community Oncology

Together, McKesson and US Oncology will provide oncology practices with a robust suite of practice-support options and services, which can be tailored to meet each customer's specific needs. US Oncology's existing Comprehensive Strategic Alliance (CSA) practice-management offering and core services will remain intact, while the combined organization will offer a broad array of a la carte technology, practice-management, reimbursement and clinical services to the community oncology segment. US Oncology does not employ the physicians or own the practices affiliated with the company, and all customers will retain the flexibility to select the business-relationship model that best suits their individual needs.

"This strategic acquisition is a logical next step in our commitment to ensure the continued vitality of community oncology, while creating value for our shareholders," concluded Hammergren. "We look forward to welcoming US Oncology's innovative, experienced employees to McKesson and to working together with our customers to create better health for our customers and the patients they serve."

About US Oncology

US Oncology, Inc. is the nation's leading integrated oncology company. By uniting the largest community-based cancer treatment and research network in America, US Oncology expands patient access to high-quality care and advances the science of cancer care. Headquartered in The Woodlands, Texas, US Oncology is affiliated with more than 1,300 community-based oncologists, and works with patients, hospitals, payors and the medical industry across all phases of the cancer research and delivery continuum. By promoting the use of innovative technology, clinical research, evidence-based medicine and shared best practices, US Oncology improves patient outcomes and offers a better patient experience.

About McKesson

McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to helping its customers deliver high-quality healthcare by reducing costs, streamlining processes, and improving the quality and safety of patient care. Over the course of its 177-year history, McKesson has grown by providing pharmaceutical and medical-surgical supply management across the spectrum of care; healthcare information technology for hospitals, physicians, homecare and payors; hospital and retail pharmacy automation; and services for manufacturers and payors designed to improve outcomes for patients.

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Cellceutix Corp. (CTIX) - Kevetrin: Breast Cancer Drug

By Andrea: http://nursingoncologyjob.com

Recently, Cellceutix Corp. (CTIX) made an exciting announcement on their trial cancer drug: Kevetrin. Kevetrin in early studies, has demonstrated significant delay of Tumor growth in drug resistant cancer:

Cellceutix Corporation (CTIX) today announced that it has completed its second and final species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations. This is the last safety study required for an Investigational New Drug (IND) filing. In the study, animals were administered five doses of Kevetrin™ weekly over a 29 day period. Three groups of 14 animals were administered 5 mg/kg, 25 mg/kg and 60 mg/kg respectively while a fourth group acted as controls. There was a 14 day recovery period after the dosing. Parameters measured were hematology, clinical chemistries, weight change, food consumption, survival, urinalysis, ophthalmic examination and histopathology. This study, as well as the earlier toxicity and safety pharmacology studies, were performed by Toxikon, in Bedford, Massachusetts.

"This is the last safety study we had to complete prior to IND filing and we are extremely pleased with the results," said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Having now seen the data from all the required studies, I am very excited about the future of this compound in development for cancers that are resistant to standard therapies."

"This is an extraordinary milestone for a young company like ours," said George Evans, CEO of Cellceutix. "We would like to acknowledge our partner for these studies, Toxikon Corporation, who provided us with high quality work and excellent customer service. We believe we are now well on our way to an IND filing later this year or early next."

"We are proud to have led these important toxicology studies and help Cellceutix achieve its goal of getting Kevetrin to human trials and, ultimately, to market," said Dr. Laxman Desai, president and CEO of Toxikon, adding that "Toxikon is equipped to meet the industry's anticancer and antiviral drug discovery demands."

About Cellceutix

Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, and KM-391, which it is developing for the treatment of autism.

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BioSante Pharmaceuticals (BPAX): LibiGel Phase III

By Andrea: http://nursingoncologyjob.com

BioSante Pharmaceuticals, Inc. (BPAX) recently announced enrollment of the 2,500th woman in the LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. This important enrollment milestone triggers the first unblinded statistical analysis of cardiovascular events by the independent Data Monitoring Committee (DMC), which coincides with their fourth unblinded review of all adverse events. LibiGel is being developed for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.

The DMC's unblinded statistical analysis will determine whether the current study enrollment of 2,500 is sufficient to prove statistically the relative safety of LibiGel compared to placebo after an average of 12 months of exposure is reached, or if enrollment will continue. To date, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, and only seven diagnoses of breast cancer, a rate of approximately 0.32 percent, after approximately 2,300 women-years of exposure in the study. BioSante will remain blinded as to the distribution of the reported safety events between the active and placebo study arms.

If enrollment continues beyond 2,500 women, an additional unblinded statistical analysis will be conducted by the DMC each time a new cardiovascular event is adjudicated. At each of these analyses the trial potentially could be fully enrolled. If enrollment is not completed sooner, enrollment will continue until the study reaches its predetermined maximum of 4,000 women.

"This milestone gives BioSante our first opportunity potentially to declare completion of enrollment in the safety study," stated Michael Snabes, M.D., Ph.D., BioSante's senior vice president of medical affairs. "We have had an extremely low number of cardiovascular and breast cancer events to date, as well as three previous favorable DMC recommendations. We expect the study to demonstrate the safety of LibiGel in the treated population, regardless of whether the DMC stops enrollment at 2,500 women or we need to continue enrollment."

About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 month exposure to LibiGel or placebo. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.

The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.

About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.

In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

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Apricus Biosciences, Inc. (APRI) - PrevOnco: hepatocellular carcinoma drug

By Andrea: http://nursingoncologyjob.com

Apricus Biosciences, Inc., (APRI) today announced the formation of a Clinical Advisory Board focused on the development of its investigational oncology compound, PrevOnco(TM). The Clinical Advisory Board is chaired by Stephen B. Howell, who also serves as Chairman of the Company's Scientific Advisory Board ("SAB"). Additional members of the Clinical Advisory Board include, Drs. Ghassan K. Abou-Alfa, Melanie Thomas, Robert G. Gish and Yehuda Patt.

Apricus Bio is developing PrevOnco, a marketed anti-ulcer compound, lansoprazole, to treat patients with advanced, unresectable hepatocellular carcinoma, or liver cancer. The Company is finalizing the Special Protocol Assessment ("SPA") Phase 3 registration protocol for a comparator study against doxorubicin in patients who have failed treatment with Nexavar(R) (the currently marketed first-line anti-cancer treatment for patients with either hepatocellular carcinoma , or advanced renal cell carcinoma). Subject to positive data, the Phase 3 study would be expected to support the filing of a New Drug Application for marketing approval in the U.S. and Europe. Management expects to submit the SPA Phase 3 protocol to the U.S. Food & Drug Administration ("FDA") before year-end 2010.

In the U.S., Nexavar is marketed by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., and is approved in more than 90 countries for the treatment of patients with liver cancer.

Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are pleased to be able to, once more, tap the extraordinary expertise of Dr. Howell. Additionally, we are delighted to welcome Drs. Abou-Alfa, Thomas, Gish and Patt. Together, they will be instrumental in helping us move this important clinical program forward."

Dr. Howell, Chairman of the Company's SAB, commented, "We have assembled an impressive group of key opinion leaders. Having been involved in the clinical development of Nexavar, their experience in developing new hepatocellular carcinoma therapies will be invaluable to us as we finalize the SPA for submission to the FDA."

Dr. Howell is a medical oncologist and Professor of Medicine at the University of California, San Diego. He also serves as Associate Director for Clinical Research and Director of the Cancer Therapeutics Training Program at the Moores Comprehensive Cancer Center at the University of California, San Diego, and runs the Clayton Foundation Drug Resistance Laboratory at the Cancer Center. During his career, Dr. Howell has co-founded three pharmaceutical companies, including DepoTech (1989), Beacon Laboratories (1995), and Targa Pharmaceuticals (2003), serving as Medical Director of each. He holds a number of patents for his innovative work in chemotherapeutics, drug-delivery systems, and diagnostic assays and is the recipient of numerous awards. He is currently one of the main organizers of the American Association of Cancer Research.

Dr. Ghassan K. Abou-Alfa is a board-certified medical oncologist at Memorial Sloan-Kettering Cancer Center, specializing in primary liver cancer (hepatocellular carcinoma), pancreas, gallbladder, and bile duct tumors. He is involved in research focusing on improving the effectiveness of cancer therapy by incorporating small, novel biological molecules that target cancer into the treatment of chemotherapy-resistant gastrointestinal malignancies, particularly hepatobiliary and pancreatic cancers. Dr. Abou-Alfa received his M.D. from American University of Beirut, and completed residencies and fellowships at Yale University School of Medicine.

Dr. Melanie Thomas, M.S., is an Associate Professor and Associate Director of Clinical Investigations and the Grace E. DeWolf Chair of Medical Oncology at MUSC Hollings Cancer Center in Charleston, South Carolina. She earned her M.D. from Boston University School of Medicine and her M.S. from Harvard University. Dr. Thomas' professional interests include, hepatocellular, pancreatic, gallbladder, biliary and colorectal cancer.

Dr. Robert G. Gish serves as Chief of Clinical Hepatology, Professor of Clinical Medicine and co-director of the Center for Hepatobiliary Disease and Abdominal Transplantation (CHAT) at the University of California, San Diego School of Medicine. He is a NIH-funded researcher whose work focuses on the epidemiology of liver disease, biomarkers for liver disease and multi-targeted therapies for liver cancer. Dr. Gish received his medical degree from the University of Kansas in Kansas City. He completed his internship and residency in internal medicine at the University of California, San Diego School of Medicine and a fellowship in Gastroenterology and Hepatology at the University of California, Los Angeles. He is board certified in Internal Medicine and Gastroenterology and has the advance Certificate of Added Qualification (CAQ) in Liver Transplantation and is a UNOS certified Liver Transplant Physician.

Dr. Yehuda Patt is a Professor of Internal Medicine and the Director of Gastrointestinal Oncology Research at the University of New Mexico Cancer Center in Albuquerque, NM. He attended the Hebrew University and Hadassah Medical School, and completed his residency at Sheba Medical Center in Tel Aviv, Israel, and fellowship at the Anderson Hospital and Tumor Institute in Houston, Texas.

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Seattle Genetics, Inc. (SGEN): brentuximab vedotin (SGN-35) Hodgkin Lymphoma Drug Update

By Andrea: http://nursingoncologyjob.com

Seattle Genetics, Inc.(SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited , today announced that brentuximab vedotin (SGN-35) will be featured in three poster presentations at the 8th International Symposium on Hodgkin Lymphoma (ISHL) being held October 23-26, 2010 in Cologne, Germany.

The following posters will be presented on Tuesday, October 26, 2010:

Objective responses with SGN-35 retreatment in CD30-positive hematologic malignancies: a case series (Abstract #113) Activity, safety and tolerability of antibody-drug conjugate (ADC) SGN-35 in relapsed/refractory Hodgkin lymphoma and CD30+ hematologic malignancies (Abstract #74) Activity of SGN-35 in preclinical models of combination therapy and relapse prevention (Abstract #49)

"These presentations complement the recent positive results from our pivotal Hodgkin lymphoma and phase II systemic anaplastic large cell lymphoma (ALCL) trials, both in the relapsed or refractory setting, and describe the additional opportunities we are pursuing to meet the needs of patients with CD30-positive malignancies," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "In addition, we are preparing our brentuximab vedotin Biologics License Application (BLA) for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011."

"The acceptance of these presentations at ISHL underscores the scientific community's continued interest in brentuximab vedotin," said Nancy Simonian, M.D., Chief Medical Officer of Millennium. "We maintain our focus on meeting with regulators in Europe to discuss filing strategies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory ALCL."

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.

Seattle Genetics and Millennium recently reported top-line data from a pivotal trial of brentuximab vedotin for relapsed or refractory Hodgkin lymphoma and a phase II trial for relapsed or refractory ALCL. In the pivotal Hodgkin lymphoma trial, 75 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response was greater than six months. In the phase II ALCL trial, 86 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response has not yet been reached at a median follow up on study of approximately six months. The safety profile of brentuximab vedotin in these trials was generally consistent with prior clinical trial experience. More complete data sets from both trials will be presented in oral sessions at the American Society of Hematology (ASH) annual meeting, December 4-7, 2010, in Orlando, FL.

The companies are also conducting a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for the front-line treatment of Hodgkin lymphoma.

About the Seattle Genetics/Millennium Collaboration

Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond autologous stem cell transplant.

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Eli Lilly and Co. (LLY) - Teplizumab: Autoimmune Drug Update

By Andrea: http://nursingoncologyjob.com

MacroGenics, Inc. and Eli Lilly and Company (LLY) today announced that the Protege Data Monitoring Committee (DMC), composed of independent experts in the fields of diabetes and biostatistics, has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab, an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.

The DMC concluded that the primary efficacy endpoint of the study, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. The DMC, noting that all administration of experimental drug had been completed, commented that appropriate safety monitoring is warranted. No unanticipated safety issues were identified in the DMC's review.

"We will comply with the DMC's recommendations," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer, MacroGenics. "We remain committed to discovering and developing novel biologics for the treatment of autoimmune disorders like type 1 diabetes."

Following careful evaluation of the DMC's recommendations for Protege, based on the lack of efficacy, the companies have decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes: the Protege Encore Trial, a second Phase 3 trial of the same design as Protege, and the SUBCUE trial, a Phase 1b trial that is exploring the subcutaneous administration in patients with type 1 diabetes.

"The failure to meet the primary endpoint is obviously disappointing for the millions of people who live with and treat type 1 diabetes," said Gwen Krivi, Vice President, Product Development, Lilly Diabetes. "Lilly and MacroGenics will be considering all options for teplizumab in type 1 diabetes as well as the impact of the DMC's recommendations on other potential indications."

About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Insulin is a hormone that is needed to convert sugar (glucose), starches and other food into energy needed for daily life. People with type 1 diabetes must take multiple injections of insulin daily or continually infuse insulin through a pump to manage their blood glucose levels.

Type 1 diabetes, previously known as juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. Of the nearly 24 million Americans who have diabetes, as many as 3 million may have type 1.(i)

About Teplizumab

Teplizumab, also called MGA031 and hOKT31 (Ala-Ala), is a humanized, anti-CD3 monoclonal antibody. Teplizumab binds to an epitope of the CD3-epsilon chain expressed on mature T lymphocytes and, by doing so, may modulate the pathological immunologic responses underlying multiple autoimmune diseases. Specifically, teplizumab may inhibit unwanted effector T cells and enhance beneficial regulatory T cell functions, thus promoting immune tolerance.

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Genentech: Avastin Breast Cancer Drug

By Andrea: http://nursingoncologyjob.com

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),recently announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin® (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment. In accordance with FDA guidelines, the agency has extended the review period for the sBLAs by an additional 90 days. The company now anticipates FDA action on the sBLAs by December 17, 2010.


At this time, Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The FDA is currently reviewing two sBLAs that Genentech submitted in November 2009 for Avastin in combination with taxane-based, anthracycline-based and capecitabine chemotherapies based on the results of the AVADO and RIBBON1 studies. Data from AVADO and RIBBON1 were submitted as part of Genentech's effort to convert the accelerated approval to a full approval.


"We are pleased by the FDA's decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period," said Hal Barron, M.D., executive vice president, Product Development and chief medical officer.


Today's announcement does not impact Avastin's availability for its approved uses for other cancer types in the U.S. or approved uses, including breast cancer, in other countries. Doctors with questions about the use of Avastin for advanced breast cancer can call Genentech's Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage or doctors with questions about reimbursement can call Genentech's Access Solutions Group at (866) 4 ACCESS.


In February 2008, FDA granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. The approval was based on an improvement in progression-free survival (PFS). Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. There are no data available showing that Avastin improves disease-related symptoms or survival in advanced HER2-negative breast cancer.


About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF (vascular endothelial growth factor) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.


Avastin is approved for first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.

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Neoprobe Corp (NEOP.ob) - RIGScan: Solid Tumor Cancer Technology

By Andrea: http://nursingoncologyjob.com

Neoprobe Corporation (NEOP.ob), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has submitted a response letter to the U.S. Food and Drug Administration (FDA) regarding its RIGScan™ technology Biologic License Application (BLA). The filing of the BLA response letter is the initial step in Neoprobe’s efforts to commercialize the RIGS technology designed to enhance the surgical treatment of solid tumor cancers. The review responsibility for the RIGS BLA was recently transferred from CBER to the Division of Medical Imaging Products in CDER at FDA.

“The submission of the BLA response letter is the first of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology,” said Rodger Brown, Neoprobe’s Vice President of Regulatory Affairs and Quality Assurance. “We intend to file a request for an Investigational New Drug (IND) for the biologic component of the RIGS technology. The IND request will be accompanied by a synopsis of the proposed Phase 3
RIGS technology clinical evaluation. Once FDA has assigned a new IND we will file the complete protocol for FDA evaluation under the provisions of a Special Protocol Assessment (SPA). A SPA review of the prospective protocol will provide a clear development pathway for RIGS in 2011.”

Neoprobe executives will discuss the development activities for both the RIGS and Lymphoseek product initiatives during the third quarter earnings conference call tentatively scheduled for the second week of November.

Dako - HercepTest Stomach Cancer Drug

By Andrea: http://nursingoncologyjob.com

Dako has received approval from the U.S. Food and Drug Administration (FDA) to expand
the intended use for HercepTest(TM) and HER2 FISH pharmDx(TM) Kit to include patients
with metastatic gastric or gastroesophageal junction adenocarcinoma (stomach cancer).
Dako's diagnostic tests are indicated as an aid in the assessment of patients for whom
Herceptin (trastuzumab) treatment is being considered. The FDA has simultaneously
approved the use of Herceptin in combination with chemotherapy for HER2-positive,
metastatic stomach cancer or cancer of the gastroesophageal junction. Results from a
recent clinical study indicate that patients with HER2-positive metastatic stomach
cancer live longer when treated with Herceptin in combination with chemotherapy,
compared to chemotherapy alone.

Sunil S. Badve, MB, BS, FRCPath, professor at the Indiana University, Department of
Pathology & Laboratory Medicine (USA) and diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, states:

"Dako's HercepTest(TM) and HER2 FISH pharmDx(TM)Kit will be a great advance to the
identification of patients with metastatic stomach cancer who are appropriate for HER2
targeted therapy with Herceptin. The diagnostic tests can identify the group of patients having HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma, and are appropriate candidates for receiving the right combination of targeted treatment and chemotherapy. With these diagnostic kits we now have tools to aid in the selection of a therapy for approx. 22% of the estimated 21,130 Americans who are diagnosed with stomach cancer each year."

The FDA approval of Dako's HercepTest(TM) and HER2 FISH pharmDx(TM) Kit for use in
stomach cancer patients in the United States is based on the positive results of an
international Phase III study (ToGA).In the screening phase for assessing HER2-status,
the study involved more than 3,700 patients at 122 sites in 24 countries. The
FDA-approved dataset (N=594) showed that treatment with Herceptin® in combination with
chemotherapy in patients with metastatic HER2-positive stomach cancer found by the use
of Dako's diagnostic tests significantly prolongs the lives of patients with this
aggressive cancer.

"The FDA approval underlines our commitment to develop high quality diagnostic tests to
identify the right cancer patients for specific cancer therapy. We have seen how Dako's
HercepTest(TM) and HER2 FISH pharmDx(TM) Kit combined with Herceptin® treatment have
revolutionized the field of breast cancer. It is our hope that these diagnostic kits
will help patients with HER2-positive stomach cancer just as much," says Lars Holmkvist,CEO of Dako.

Stomach cancer is the second most common cause of cancer-related deaths globally with
over 1,000,000 new cases diagnosed each year. An estimated 21,130 Americans were
diagnosed with stomach cancer and more than 10,600 Americans died from the disease in
2009, according to the American Cancer Society (ACS). More than 64,000 Americans are
currently living with the disease. Early diagnosis is challenging because most patients
do not show symptoms in the early stage. Approximately one in five of all stomach tumors are HER2-positive.

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Arena Pharmaceuticals (ARNA) - Lorcaserin Weight Loss Drug

By Andrea: http://nursingoncologyjob.com

Arena Pharmaceuticals, Inc. (ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena's New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >/= 30) or patients who are overweight (BMI >/= 27) and have at least one weight-related co-morbid condition.

The FDA has completed its review of the NDA and determined that it cannot approve the application in its present form. In the CRL, the FDA outlined the non-clinical and clinical reasons for their decision.

The non-clinical issues identified by the FDA included diagnostic uncertainty in the classification of mammary masses in female rats, unresolved exposure-response relationship for lorcaserin-emergent mammary adenocarcinoma, and unidentified mode of action and unclear safety margin for lorcaserin-emergent brain astrocytoma.

The CRL included the following requests related to the non-clinical issues: provide a detailed accounting of all slides prepared from female rats that contributed to mammary tumor incidence data in each update to the FDA and to the final study report; in consultation with the FDA, identify an independent pathologist or group of pathologists to re-adjudicate all mammary and lung tissues (neoplastic and nonneoplastic lesions) from all female rats; demonstrate that the apparent increase in aggressiveness of adenocarcinoma in rats administered lorcaserin is reasonably irrelevant to human risk assessment; and provide additional data/information regarding the distribution of lorcaserin to the CNS in animals and human subjects that would clarify or provide a better estimate of astrocytoma exposure margins.

With respect to the clinical reasons, the FDA stated in the CRL that the weight loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes is marginal and recommended that Arena submit the final study report of the BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. The FDA also stated in the letter that in the event evidence cannot be provided to alleviate concern regarding clinical relevance of the tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin's benefit-risk profile.

The BLOOM-DM trial evaluated lorcaserin versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes mellitus. The trial is complete, and Arena expects to announce top-line results in the next few weeks and to have a completed study report by the end of the year.

Additionally, the FDA stated in the CRL that it would recommend placement of lorcaserin in Schedule IV of the Controlled Substance Act based on its review of the materials submitted in the NDA. The CRL provided the opportunity to complete preclinical studies that may lead to a different recommendation.

"This is an important step for us toward the FDA's approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline. We will work with the agency to address the issues with our NDA as quickly as possible."

Arena intends to request a Type A meeting with the FDA to clarify its requests, and, if the meeting is granted, the FDA's guidance states that it should occur within 30 days of the request.

Lonnel Coats, President and Chief Executive Officer of Eisai Inc., stated, "Eisai is committed to collaborating with Arena to address the FDA's requests. Obesity is an epidemic in America, and our goal is to bring lorcaserin to physicians and patients who need additional weight loss options."

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Onyx Pharmaceuticals: New Myeloma drug delayed

By Andrea: http://nursingoncologyjob.com

Onyx Pharmaceuticals, Inc. (ONXX) recently released an update on its new drug carfilzomib:

Onyx Pharmaceuticals, Inc. (ONXX) announced that it will delay its New Drug Application (NDA) filing for carfilzomib based on a recent meeting with the Chemistry, Manufacturing and Controls (CMC) review division of the U.S. Food and Drug Administration (FDA). The FDA has requested additional CMC information related to commercial-scale manufacturing of carfilzomib. Onyx had previously anticipated filing an NDA by the end of 2010 for accelerated approval of carfilzomib and now expects that its NDA filing for accelerated approval could occur as early as mid-year 2011.

The clinical profile of carfilzomib has not changed, and no new safety signals have been observed. The Phase 3 trials are on schedule and actively enrolling patients, and this change is not expected to impact any of the carfilzomib trials or other development plans.

In preparation for commercial-scale production, the company made manufacturing process enhancements in the production of carfilzomib, which are customary when migrating from clinical to commercial-scale manufacturing. In a recently completed manufacturing-scale run, the company observed minor variations that are believed to be primarily related to equipment temperature variances. In response to FDA’s request, Onyx is providing the agency with additional CMC information. Onyx has additional data and is generating more information to share as part of the ongoing dialogue with the CMC review division in preparation for an NDA filing.

“We are confident in the clinical and preclinical data package supporting the carfilzomib NDA and in our manufacturing strategy,” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “We believe that by providing this supportive data, we will strengthen our NDA package, thus enabling us to bring carfilzomib to patients with multiple myeloma as quickly as possible.”

The complete data set from the Phase 2b 003-A1 clinical trial of carfilzomib in patients with relapsed and refractory multiple myeloma, along with new data on carfilzomib from additional studies, will be presented at the American Society of Hematology Annual Meeting in December 2010.

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Hologic Inc: Selenia Dimensions 3-D to help Increase Early Detection of Breast Cancer

By Andrea: http://nursingoncologyjob.com

Hologic, Inc. (HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced that the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) today unanimously voted that Hologic's Pre‐Market Approval (PMA) demonstrated both the effectiveness and safety of the Company's Selenia Dimensions three‐dimensional (3‐D) digital mammography tomosynthesis system, "Selenia Dimensions 3‐D." In addition, the Panel voted in favor that the benefits of this new technology outweigh the risks.

Following today's FDA Panel meeting, which was held in Gaithersburg, Maryland, Hologic will work with the FDA on next steps for approval of its 3‐D digital mammography system. While the Panel's favorable vote is advisory in nature, the FDA will consider it in its final review of Hologic's PMA application for the Selenia Dimensions tomosynthesis system.



"Our Selenia Dimensions 3‐D technology marks tremendous progress in the early diagnosis of breast cancer," said Jay A. Stein, Co‐Founder and Chief Technical Officer. "The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions. I speak for all of Hologic in voicing great satisfaction that the FDA Panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality."

Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a two -dimensional (2‐D) image, breast tomosynthesis produces a three‐dimensional image. We believe our multicenter clinical study has demonstrated that compared to 2‐D digital mammography alone, 3‐D digital tomosynthesis used in combination with 2‐D digital mammography has the potential to reduce recall rates and improve cancer detection.

Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is presently commercially available outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional only system that can be upgraded to do breast tomosynthesis (3‐D) imaging when and if the product is approved by the FDA.

"We are extremely pleased with the outcome of today's FDA Panel meeting," said Rob Cascella, President and Chief Executive Officer. "Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2‐D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection ‐ fast, high‐quality 2‐D and 3‐D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women's lives."

Dendrion Corp: Provenge Drug to Prolong life in Patients with Prostate Cancer

By Andrea: http://nursingoncologyjob.com

Dendreon Corporation (DNDN) recently announced the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE(R) (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC). The manuscript is published in the July 29, 2010 issue of the journal.

PROVENGE is the first product in a new therapeutic class known as autologous cellular immunotherapies to be approved by the U.S. Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic mCRPC.

The 512-patient multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study demonstrated that PROVENGE extended median survival by 4.1 months compared to control (25.8 months vs. 21.7 months) and reduced the risk of death by 22.5% compared to control (HR=0.78; P=0.032). Adverse events more commonly reported in the PROVENGE arm in this study included chills, fever, headache, influenza-like illness, muscle aches, hypertension and groin pain.

"These results represent the beginning of a new era in the treatment of cancer, one in which a patient's own immune system is harnessed to fight the disease," said Philip Kantoff, M.D., lead author of the publication, co-principal investigator of IMPACT and Chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place PROVENGE as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC."

Results of the published IMPACT study also showed that:

* The survival benefit associated with PROVENGE was observed consistently across multiple patient subgroups, including those with prognostic factors known to be adversely correlated with overall survival, such as PSA, LDH, alkaline phosphatase, number of bone metastasis, Gleason score, performance status, and presence of pain;
* Of patients that received PROVENGE, 97.1% received at least one infusion and 92.2% received all three infusions. In addition, the median time from the first to the third infusion was 28 days;
* Sensitivity analyses provided no evidence that the use of docetaxel could account for the observed treatment difference with respect to overall survival;
* Results were consistent with and confirmed the findings of D9901, a Phase 3, randomized trial, in which the PROVENGE group had a median increase in survival of 4.5 months, a median survival of 25.9 months, and a 3-year survival rate of 34.1%;
* The time to objective disease progression was similar in the two study groups and consistent with results from other trials in this patient population; and
* Overall, 0.9% of patients in the PROVENGE group were unable to receive all three infusions because of infusion-related adverse events.

"PROVENGE has opened a new door in the treatment of advanced prostate cancer, providing patients with a clear and meaningful survival benefit, as well as a minimal and readily manageable side effect profile, with a short duration of therapy," said Paul Schellhammer, M.D., professor of urology at the Eastern Virginia Medical School and co-principal investigator of the IMPACT study.

PROVENGE Safety

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence > to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

Infinity Pharmaceuticals: Non-small cell lung cancer update

By Andrea: http://nursingoncologyjob.com

Infinity Pharmaceuticals, Inc.(INFI) announced that results from its Phase 2 study of IPI-504, a novel IV-administered Hsp90 chaperone inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) were published in the Journal of Clinical Oncology (Sequist et. al., J Clin Oncol. doi: 10.1200/JCO.2010.30.8338, 2010). These data, presented previously at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), documented for the first time the activity of an Hsp90 inhibitor in a molecularly defined cohort of patients with advanced NSCLC. In the study, IPI-504 was generally well tolerated and demonstrated clinical activity, particularly among patients with oncogenic anaplastic lymphoma kinase (ALK) gene rearrangements.

"These results support molecular analysis as a key tool in clinical trials to determine the signature of the best responding patients, and suggest that patients with NSCLC and ALK rearrangements may preferentially respond to Hsp90 chaperone inhibition," stated Lecia Sequist, M.D., MPH, from the Massachusetts General Hospital Cancer Center and an Assistant Professor of Medicine at Harvard Medical School. "We hope the ongoing study of IPI-504 in NSCLC patients with ALK rearrangements will validate these initial findings."

"We are encouraged that IPI-504 was generally well tolerated and demonstrated clinical activity in NSCLC, further supporting the clinical potential of Hsp90 chaperone inhibition as a targeted approach to treating certain cancers," stated Julian Adams, Ph.D., president of research and development, Infinity. "The results of the ongoing Phase 1b study of IPI-504 in combination with Taxotere(R) in patients with solid tumors, as well as data from Dr. Sequist's study assessing IPI-504 in patients with NSCLC and ALK rearrangements, will help inform the path forward for IPI-504."

Trial Design and Results

The Phase 2 study of IPI-504 was designed to evaluate the safety, tolerability and anti-tumor activity of IPI-504 in patients with stage IIIb/IV NSCLC whose tumors had progressed after treatment with an EGFR tyrosine kinase inhibitor. Seventy-six patients were enrolled and stratified by their EGFR mutation status. A subset of patients also underwent EGFR (n = 25), KRAS (n = 30) and BRAF (n = 5) genotyping analysis, as well as a fluorescent in situ hybridization (FISH) assay to detect ALK gene rearrangements.

The results of the Phase 2 study show an objective response rate of seven percent in the overall study population: ten percent in patients who were EGFR wild-type, four percent in those with EGFR mutations, and 12 percent among KRAS wild-type patients. There was a 67 percent response rate among the patients with ALK rearrangements, with two of three patients experiencing partial responses and the third patient experiencing a 24 percent disease reduction. All three patients with ALK rearrangements received IPI-504 for at least six months.

IPI-504 was generally well-tolerated in this study. Most adverse events were Grade 1 or Grade 2. The most commonly reported adverse events (regardless of relationship to drug) were fatigue, nausea, diarrhea, vomiting and cough.

Molecular Insight Pharmaceuticals: Prostate Cancer Update

By Andrea: http://nursingoncologyjob.com

Molecular Insight Pharmaceuticals, Inc.(MIPI) this week presented positive data from Phase 1 clinical studies comparing Trofex(TM) (123I-MIP-1072), its lead molecular imaging candidate for the diagnosis and monitoring of metastatic prostate cancer, and ProstaScint(R) (111In-capromab pendetide), an imaging radiopharmaceutical for the visualization of metastatic prostate cancer. Data presented at the Annual Congress of the European Association of Nuclear Medicine in Vienna demonstrated that Trofex rapidly detected prostate cancer localized in the prostate bed, soft tissues and bone within four hours post injection. In contrast, ProstaScint required five days before imaging and was unable to detect metastatic disease in bone.

Trofex is a radiolabeled, small-molecule that binds prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer cells, with high affinity and specificity. The high degree of uptake and retention of Trofex in prostate cancer cells allows for non-invasive molecular imaging of prostate cancer.

Data from two completed Phase 1 studies and preliminary data from one ongoing Phase 1 study were presented in an abstract titled: Detection of Metastatic Prostate Cancer (PCa) in Soft Tissue, Bone, and Prostate with 123I-MIP-1072: A Comparison with 111In-Capromab Pendetide. John W. Babich, Ph.D., Molecular Insight Executive Vice President, Chief Scientific Officer and President of Research and Development, senior author of the study, presented the data from these studies.

Study Methodology The two completed Phase 1 studies enrolled a total of 13 subjects (7 prostate cancer patients and 6 healthy volunteers) while in the ongoing study 12 patients have been enrolled. In the first two studies, patients with confirmed metastatic prostate cancer and normal subjects received Trofex (370 MBq), followed by serial whole-body planar imaging, SPECT/CT scanning, and blood and urine analysis. Image analysis from the Trofex scans was used to estimate organ pharmacokinetics and to calculate radiation dosimetry. In the ongoing study, Trofex and ProstaScint images as well as bone scans were compared in the same patient. All images were compared visually and by quantitative image analysis for assessing relative tumor detectability.

Conclusions Molecular Insight reported that in this limited group of patients Trofex visualized lesions in the prostate, lymph nodes and bone at four hours after injection, confirming that targeting the extracellular domain of PSMA with small molecules is a viable approach for imaging metastatic prostate cancer. In comparison to Trofex, which is rapidly cleared from the blood and can detect tumors within a few hours, ProstaScint requires five days for optimal imaging. In this study, ProstaScint was unable to detect bone metastases and required supplementary blood pool imaging for confirmation of lymph node metastases along the normal vasculature.

In the second presentation at the EANM Annual Congress, Molecular Insight reported new preclinical data from its prostate cancer therapy program. Molecular Insight scientists have developed an analog of Trofex that carries the therapeutic iodine radionuclide, I-131, creating a molecularly targeted radiotherapeutic that specifically binds PSMA on prostate cancer cells and offers the potential for treatment of metastatic prostate cancer. In an abstract titled Inhibition of Human Prostate Cancer Growth by Targeting Prostate Specific Membrane Antigen (PSMA) using an I-131 labeled small molecule inhibitor, researchers reported that a Molecular Insight compound, 131I-MIP-1375, was effective at inhibiting, in a dose-related manner, the growth of human PSMA-expressing prostate tumors in a mouse model. The Company said that these preclinical data provide a basis for advancing the development of 131I-MIP-1375 as a targeted radiotherapeutic option in the treatment of prostate cancer.

About Prostate Cancer According to the American Cancer Society, more than 2.5 million men are currently affected by prostate cancer and approximately 200,000 new cases are diagnosed annually. While early diagnosis has improved overall survival rates, prostate cancer is the second leading cause of cancer death among men in the United States. Most prostate cancer mortalities occur when the disease has spread and therefore staging and monitoring the disease accurately is critically important in improving patient outcomes.

Ariad Pharmaceuticals Inc. : Myeloid Leukemia and Lymphoblastic Leukemia Update

By Andrea: http://nursingoncologyjob.com

Ariad Pharmaceuticals Inc. (ARIA) recently announced the initiation of the pivotal Phase 2 clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). The PACE (Ponatinib Ph+ ALL and CML Evaluation) trial is designed to provide definitive clinical data for regulatory approval of ponatinib in this setting. Ponatinib has been granted orphan drug status in both the United States and Europe for the treatment of CML and Ph+ ALL.

"The start of the pivotal PACE trial represents an important step in the development of our second molecularly targeted cancer therapy," stated Harvey J. Berger, M.D., chairman and chief executive officer. "With the strong clinical evidence observed to date of hematologic, cytogenetic and molecular anti-leukemia activity of ponatinib in heavily pretreated patients with CML, including those patients with the T315I mutation for whom no current treatments are available, we are highly optimistic about the likelihood of success for ponatinib in this registration trial. We also believe that the time to full patient enrollment in this study and to potential regulatory approval of ponatinib will be swift."

Trial Design

The PACE trial is a global, single-arm clinical study of oral ponatinib in 320 patients with chronic phase, accelerated phase, or blast phase CML, as well as Ph+ ALL. Patients resistant or intolerant to dasatinib (Sprycel(R)) or nilotinib (Tasigna(R)), or with T315I mutation of BCR-ABL, will be enrolled in the trial. Patients will be grouped into one of six separate cohorts based on their phase of CML (i.e., chronic, accelerated or blast) and BCR-ABL mutation status (i.e., with or without the T315I mutation); Ph+ ALL patients will be grouped with blast phase CML. A total of 160 patients with chronic phase CML will be included. The primary endpoints are major cytogenetic response rate for chronic phase patients and major hematologic response rate for accelerated or blast phase CML patients and Ph+ ALL patients. Secondary endpoints in the trial include major molecular response rate, duration of response, progression-free survival, and overall survival.

Patients will receive ponatinib in tablet form once daily at a dose of 45 mg. The PACE trial will be conducted at approximately sixty centers in North America, Europe, Australia and Asia. Full patient enrollment is anticipated by year-end 2011.

"Clinical results from the ongoing Phase 1 trial of ponatinib, taken together with the preclinical data that characterize ponatinib as a potent, pan-BCR-ABL inhibitor, provide a strong rationale for advancing directly to a pivotal trial of ponatinib in a population of patients who have extremely limited, if any, treatment options," stated Jorge Cortes, M.D., professor and deputy chair, Department of Leukemia, The University of Texas MD Anderson Cancer Center and a leading investigator in the PACE trial. "There is great interest in the PACE trial from clinicians and patients, and I look forward to having this investigational option available for patients with this disease."

Regulatory Agency Agreement on Study Design

The PACE trial protocol was developed in consultation with leading CML experts from around the world. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provided valuable input on the design and analysis of the pivotal trial. Based on these favorable interactions and depending on the actual results of this pivotal trial, ARIAD anticipates that it will be able to submit data from this single-arm trial with six months of follow-up response data.

All patients in the PACE trial will be genotyped in a central laboratory upon enrollment in the study to determine their BCR-ABL mutation status. Direct sequencing for determination of the T315I mutation will be applied rigorously and uniformly throughout the study. In parallel, ARIAD is proceeding with plans to have a companion diagnostic test for the T315I mutation developed and commercialized. The need for a commercialized companion diagnostic test in the United States applies only to the T315I cohorts and not to the larger resistant/intolerant CML patient population.

"We will use the same diagnostic test to determine T315I mutation status in the PACE trial that we used in the Phase 1 clinical trial of ponatinib, performed at a single site and applied uniformly," stated Frank G. Haluska, M.D., Ph.D., vice president and chief medical officer at ARIAD. "We have agreement with the FDA on how to proceed with genotypic evaluation of all patients in the PACE trial and will finalize plans for development and commercialization of the companion diagnostic as the PACE trial moves ahead."

BioFocus to Provide Management Services to the National Cancer Institute (NCI)

 By Andrea: http://nursingoncologyjob.com

BioFocus announced recently that its Compound Focus subsidiary has signed an agreement with the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH).  Under the terms of the agreement, BioFocus will provide compound management services to NCI for a base period of three years for a total of up to $5 million (€3.7 M), with two one-year extension options.
 
BioFocus runs a compound management facility for a number of industrial and U.S. government customers out of its Compound Focus, Inc. subsidiary in South San Francisco.  Under the agreement announced today, Compound Focus will establish a Small Molecule Repository for the NCI Chemical Biology Consortium (CBC).  This repository will form part of the CBC’s drug discovery and development platform for new oncology therapeutics being researched by a consortium of primarily academic institutions.  The base three year contract is funded by American Recovery and Reinvestment Act (ARRA) funds.

“We are pleased to welcome the National Cancer Institute as a new collaborator.  Compound Focus has done very well to expand its long-standing relationship with the NIH into this new project with the NCI,” said Onno van de Stolpe, CEO of Galapagos.  “Our compound management facility has met or exceeded its revenue objectives since we acquired it in 2006, making it a solid contributor to our service division’s revenue stream.”

Charles River and Transposagen Biopharmaceuticals: Joint Venture

By Andrea: http://nursingoncologyjob.com

Charles River Laboratories International, Inc. (CRL), a drug development company, has entered into an exclusive, long-term marketing and distribution agreement with Transposagen Biopharmaceuticals, Inc.

Under this agreement, Charles River has become the exclusive, global provider for Transposagen's p53 and Bcrp TGEM Knockout Rat Models and associated downstream services utilizing these models. The companies have also agreed to a R&D collaboration, whereas scientific management from both companies will hold technical discussions and cooperatively work towards the creation of select, new genetically modified rat models.

The exclusive license for these two research model lines expands Charles River's portfolio of research models and services to offer knockout rat models, an emerging tool in drug discovery and development research, to its pharmaceutical, biotechnology, academic and government clients, the company said.

Transposagen's TGEM model, the p53 TGEM Knockout Rat Model, is expected to be a valuable tool in oncology research as it is believed that the Tp53 gene (tumor protein 53) is the most commonly mutated gene in human cancers. The p53 TGEM Knockout Rat Model is also the only fully phenotyped p53 knockout rat model commercially available, the company added.

Iva Morse, corporate vice president of global research model services at Charles River, said: "Charles River is extremely pleased to offer knockout rat models to our clients for the first time by partnering with Transposagen Biopharmaceuticals, a leader in the creation of genetically modified
rat models. Knockout rat models are a new and emerging tool in drug discovery and development, and Transposagen's p53 and Bcrp TGEM Knockout Rat Models are expected to become widely accepted for research in oncology and other therapeutic areas."

Neogenix Oncology: Pancreatic and Colocrectal Cancer Update

By Andrea: http://nursingoncologyjob.com

Neogenix Oncology, Inc. recently announced that it will present data from its new serum biomarker ELISA utilizing its NPC-1C antibody for patients with colorectal and pancreatic cancers. Results from the study will be presented at the American Society of Clinical Oncology (ASCO)-NCI-EORTC Annual Meeting on Molecular Makers in Cancer, to be held in Hollywood, Florida from October 18-20, 2010.

Neogenix has developed an ELISA serum biomarker using, NPC-1C, its novel, proprietary chimeric antibody that selectively targets pancreatic and colorectal cancer. The prospective study, being conducted at Conemaugh Cancer Center, in Johnstown, PA, provides for the evaluation of blood serum samples from patients confirmed with pancreatic or colon cancer. Preliminary results demonstrate the Neogenix biomarker assay’s ability to differentiate between blood serum of healthy donors and that of patients with colorectal or pancreatic cancer. In addition, the results of the NPC-1C biomarker test indicate superior sensitivity as compared to commercially available CEA and CA19-9 assays. A complete data set will be presented at the ASCO Meeting.

"We are very excited about the study results which hold promise for the early detection of these devastating diseases. These tests could provide a real hope for patients by enabling early intervention and substantially improved clinical outcome,” says Philip M. Arlen, M.D, President and CEO of Neogenix Oncology.

Breast Cancer Awareness Month: Events

By Andrea: http://nursingoncologyjob.com

Today from 9:30am-6pm the staff and teachers at Quiltique will be auctioning off their “blinged” bras to raise money for the Susan G. Komen Foundation.

The idea started with a post on the BERNINA Blog. They invited their blog’s readers to “Bling their Bra” in October, to celebrate Breast Cancer Awareness Month.  Quiltique, a local Henderson quilt shop took the idea one step further. They asked their staff and teachers to create over-the-top lingerie creations to auction, with the auction proceeds going to the Susan G. Komen Foundation. The staff and teachers went wild, creating one-of-a-kind originals, some of which would turn the head of even the most seasoned Las Vegas Stripper.

Though the staff has taken a whimsical approach, the goal is clear – to raise money to fight breast cancer, a disease that has affected far too many mothers, daughters, sisters, aunts, grandmothers, cousins… and dear friends.

For customers interested in a treat for the stomach as well as the eyes, the staff has baked up culinary sensations to sell at their bake sale, also on October 16th, which will also benefit Susan G. Komen.
Quiltique is a boutique quilt shop in Henderson, Nevada that has been family owned and operated since 2003. It is located at 213 N. Stephanie, on the corner of Stephanie and American Pacific.

Seattle Genetics, Inc. (SGEN): Non-Hodgkin Lymphoma Update

By Andrea: http://nursingoncologyjob.com

Seattle Genetics, Inc. recently reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing. SGN-75 is an antibody-drug conjugate (ADC) targeted to CD70. The data were presented at the 35th European Society for Medical Oncology (ESMO) Congress being held in Milan, Italy.

"These preliminary data are encouraging, and show initial evidence of antitumor activity with SGN-75 in patients with relapsed/refractory non-Hodgkin lymphoma or metastatic RCC," said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine of Seattle Genetics. "We are continuing to dose escalate in this trial to further assess the safety and activity of SGN-75, as well as to establish the optimal dosing regimen for future clinical trials."

Data were reported from 16 patients in the open-label phase I clinical trial, including seven with non-Hodgkin lymphoma and nine with RCC. Cohorts of patients received SGN-75 either every three weeks at doses ranging from 0.3 to 2.0 milligrams per kilogram (mg/kg) or on a weekly basis at a dose of 0.3 mg/kg. Enrolled patients in each indication had received a median of three prior systemic therapies.

Best clinical response among non-Hodgkin lymphoma patients included one patient with a complete remission, four patients with stable disease, one patient with progressive disease and one patient who was not evaluable. Best clinical response among RCC patients included one patient with a partial response, three patients with stable disease and five patients with progressive disease. The most common adverse events were fatigue, nausea and peripheral edema (swelling). A maximum tolerated dose has not been established with either dosing schedule and dose escalation continues. (Abstract #532P)

The single-agent phase I study of SGN-75 was initiated in November 2009 and is designed to enroll up to approximately 80 patients at multiple centers in the United States. The trial is evaluating the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75. Patients enrolled in the trial must have received at least one prior therapy and have confirmed CD70 expression.

SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic cell-killing agent, monomethyl auristatin F (MMAF), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, and to release its cell-killing agent upon internalization into CD70-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.

Greenville, SC: Institute for Translational Oncology Research

By Andrea: http://nursingoncologyjob.com

Greenville Hospital System University Medical Center is paving the way for a new wave of Oncology Research through the opening of its new Institute for Translational Oncology Research. The new center will work on the development of new drugs, diagnostic discovery, and advanced cancer care:

ITOR is part of the GHS Cancer Center, a recognized regional multi-disciplinary center. ITOR partners will include leading pharmaceutical companies, research universities, private industry and the government. GHS made the announcement today (Oct. 12).

The new institute, known as ITOR, builds on the success of GHS' Clinical Research Unit and its rapidly-developing biorepository tissue-banking service, which helped make GHS one of the country's prominent players in the development of promising new oncology drugs. Numerous first-in-human studies have been conducted through the CRU, which began in 2004 as part of GHS' long-standing relationship with Cancer Centers of the Carolinas.

The evolving institute is steadily moving into the arena of personalized gene-based cancer therapies, which match the treatment to tumor-specific genetic abnormalities and patient-specific predictors of toxicity. Such translational research helps bring discovery directly from the lab to practical applications in patients. Part of ITOR's strength is its focus on using innovative public and private sector partnerships and initiatives to advance leading-edge cancer care.

"Through ITOR, we will be able to make new therapies accessible to patients far more quickly than traditional models have allowed," said Joe Stephenson, M.D., who serves as the institute's medical director.

To accomplish the goal of speeding-up the delivery of patient-specific therapies, ITOR strives to identify new ways to achieve earlier prediction of drug success, find new applications and patients for existing drugs and integrate advanced molecular and gene-based technologies into diagnostic and treatment protocols.

In practical terms, that means ITOR is focused on developing a more personalized approach to cancer therapy – targeting the right drug to the right patient – by integrating leading-edge technologies such as molecular profiling into an enhanced drug validation process.

Pharmaceutical and industry partners include long-time collaborator U.S. Oncology, Caris Life Sciences and Lab21, as well as Amgen, AstraZeneca, Japanese-based Eisai Pharmaceuticals, Oncolix and Novartis, which recently selected ITOR as one of its newest designated phase 1 clinical trial sites. Early academic partners also include the Cancer Research Center of the University of South Carolina.

Novel Kinase Inhibitors: Oncology Research Update

By Andrea: http://nursingoncologyjob.com

ArQule, Inc. (ARQL) and Daiichi Sankyo Co. recently announced that they will expand on their current research and development to continue the exploration of novel kinase inhibitors in Oncology:

ArQule, Inc. (ARQL) and Daiichi Sankyo Co., Ltd. today announced the expansion of their research, development and license agreement for the discovery of novel kinase inhibitors in the field of oncology. This expanded agreement establishes a third therapeutic target, with an option for a fourth, in the field of oncology, and it includes a two-year extension based on the application of the proprietary ArQule Kinase Inhibitor Platform (AKIP(TM)) technology.

"This technology has provided us with a unique and innovative approach for discovery in the treatment of cancer," said Dr. Hideyuki Haruyama, the Global Head of Research, Daiichi Sankyo. "We expect that the expansion of this collaboration will produce other drug candidates and lay the foundation for future growth in this field."

Consistent with the existing AKIP(TM) collaboration, the economic terms provided for in the expanded agreement include payments for research support, licensing fees for compounds discovered as a result of this research, milestone payments related to clinical development, regulatory review and sales, and tiered royalty payments on net sales of each product. Daiichi Sankyo will have an option to license compounds directed to the targets defined under the agreement following the completion of certain pre-clinical studies. ArQule retains the option to co-commercialize any resulting licensed products in the U.S.

"Our initial drug discovery collaboration has identified a development candidate for one target, and we are optimizing advanced lead compounds for the other target," said Dr. Thomas C.K. Chan, chief scientific officer of ArQule. "The expansion of this collaboration will continue to deploy AKIP technology to discover inhibitors with novel modes of action for additional oncology targets over the next two years."

European Society for Medical Oncology (ESMO) - Portal for Cancer Research

By Andrea: http://www.oncologynursingjob.com

A unique portal, offering oncologists access to the latest information in the field of cancer research, will be launched in 2011 by the European Society for Medical Oncology (ESMO) in association with Thomson Reuters. The announcement was made today at the 35th ESMO Congress taking place from 8 to 12 October, in Milan, Italy.

Prof David J Kerr, President of ESMO, presented the Society's latest project at the Opening Press Conference. "ESMO is the leading European professional organization for oncologists," declared Professor Kerr. "We strive to serve our members and this year we are particularly excited about the launch of OncologyPRO. OncologyPRO stands for Oncology Professional Resources Online and is a unique scientific portal for ESMO members, providing instant access to the highest quality scientific knowledge in one easy-to-access portal. ESMO is proud to announce an exclusive partnership with Thomson Reuters, the world's largest information provider, to create the site, which gives cancer specialists access to the most complete resources in oncology today."

"First-class online resources for members are essential for knowledge-based societies and we are delighted to provide ESMO members with such a resource in OncologyPRO, our new state-of-the-art web site," said Mr. Alan Howard, ESMO CEO. "ESMO has listened to its members and carefully evaluated their needs, both in the clinical and research settings. OncologyPRO provides a variety of services, far beyond the level of service an individual society could provide, thanks to our partnership with the Thomson Reuters organization. We are confident this service will be highly appreciated by our members."

"OncologyPRO is an innovative collaboration between ESMO and Thomson Reuters that gives practicing clinicians an information portal tailored to meet their specific needs," added Jon Brett-Harris, Executive Vice President at Thomson Reuters. "We're delighted that our most up-to-date and clinically relevant content will be offered in a way that enables ESMO members to work more efficiently and ultimately to the benefit of patient outcomes."

Seattle Genetics, Inc. (SGEN): Hodgkin Lymphoma Update

By Andrea: http://www.nursingoncologyjob.com

Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced positive top-line results from the pivotal trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.

Seventy-five percent of patients in the pivotal trial achieved an objective response as assessed by an independent central review, the primary endpoint of the trial. The median duration of response was greater than six months. The safety profile of brentuximab vedotin in this trial was generally consistent with prior clinical trial experience. A more complete data set will be presented at an upcoming scientific meeting.

“We are extremely excited with the top-line results, as they move us one step closer to our goal of bringing brentuximab vedotin to patients with relapsed or refractory Hodgkin lymphoma,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are positioned for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011. In addition, we plan to report top-line data from our phase II trial of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) within the next few weeks.”

“The lack of adequate therapies for the treatment of relapsed and refractory Hodgkin lymphoma represents a substantial unmet medical need worldwide, with almost a third of the 30,000 newly diagnosed patients relapsing or becoming refractory to front-line therapy annually,” said Nancy Simonian, M.D., Chief Medical Officer of Millennium. “These data have the potential to provide an important advance in therapy for Hodgkin lymphoma. We intend to discuss these results with European regulators to support our goal of submitting a Marketing Authorization Application to the European Medicines Agency (EMA) in 2011.”

Pivotal Trial Design
The single-arm pivotal trial assessed efficacy and safety of single-agent brentuximab vedotin in relapsed or refractory, post-autologous stem cell transplant (ASCT) HL patients. Patients received 1.8 milligrams per kilogram of brentuximab vedotin every three weeks for up to 16 total doses. The primary endpoint of the trial was objective response rate as assessed by an independent review facility. Response assessments were based on the rigorous and internationally established Revised Response Criteria for Malignant Lymphoma (Cheson, 2007). Secondary endpoints included complete response rate, duration of response, progression-free survival, overall survival and tolerability. The trial was conducted under a Special Protocol Assessment (SPA) with the FDA and was discussed with the EMA during the process of obtaining EU Centralized Scientific Advice on the brentuximab vedotin development program. Brentuximab vedotin has been granted orphan drug designation by the FDA and EMA for the treatment of HL and ALCL and has been granted fast track designation by the FDA for HL.

About Brentuximab Vedotin
Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics’ proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.

In addition to the pivotal HL trial, Seattle Genetics and Millennium are conducting a phase II trial for relapsed and refractory systemic ALCL, a phase III clinical trial (the AETHERA trial) for patients at high risk of residual HL following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for front-line treatment of HL.

About Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond ASCT.

About the Seattle Genetics/Millennium Collaboration
Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Pfizer: Oncology Research Update

By Andrea: http://www.nursingoncologyjob.com

Pfizer (PFE) Oncology will present new data across its portfolio representing novel approaches to researching treatments for patients with rare and difficult-to-treat cancers. These results will be presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy from October 8-12.

"Pfizer (NYSE: PFE) has focused its oncology research on targeting molecular drivers and pathways in various cancers, such as EGFR, ALK and IGF-1R," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "We are committed to using this approach to seek treatments for well-known, difficult-to-treat and rare tumor types that have few or no therapeutic options and where we can make a big impact in defined patient populations."

At ESMO, Pfizer will present data on key compounds from its portfolio, which includes:

* PF-00299804


Updated results from a global, randomized Phase 2 trial evaluating the anti-tumor activity and safety of PF-00299804 compared to erlotinib in patients with NSCLC following progression on treatment with one or more chemotherapy regimens (Abstract #365PD, October 10).(1) In addition, preliminary efficacy and safety data from a Phase 2 study evaluating PF-00299804 as first-line treatment in patients with advanced NSCLC whose tumors are likely to carry the EGFR mutation will be presented as a late breaker in a Proffered Paper session (Abstract #LBA18, October 11).(2)

PF-00299804 is an investigational, oral, pan-HER (pan-human epidermal growth factor receptor) inhibitor.(2) PF-00299804 is currently being evaluated in the BR.26 clinical trial, a Phase 3, double-blind, placebo-controlled, randomized study in patients with stage IIIB/IV NSCLC who have progressive disease following standard chemotherapy and EGFR inhibitor therapy.(3) BR.26 is led by the NCIC Clinical Trials Group (CTG).(3)

* Crizotinib (PF-02341066)


Updated data on crizotinib (PF-02341066), a first-in-class, oral ALK inhibitor, will also be presented, from the ongoing expansion cohort from the Phase 1 study evaluating the compound in patients with ALK-positive advanced NSCLC (Abstract #366PD, October 10).(4)

* Sunitinib


Pfizer will also present results from SUN 1087, a Phase 3 trial evaluating sunitinib plus erlotinib compared to erlotinib alone in patients with advanced NSCLC who have received at least one previous treatment with a platinum-based regimen (Abstract #LBA6, October 11).(5) In August, Pfizer announced that this study demonstrated a statistically significant improvement in progression-free survival but not in overall survival. Overall survival was the primary endpoint of the study and progression free survival was the secondary endpoint of the study.

Pfizer will also present progression-free survival (PFS) data as determined by blinded independent central review (BICR) from the pivotal, placebo-controlled SUN 1111 Phase 3 trial evaluating sunitinib in patients with progressive, well-differentiated pancreatic neuroendocrine tumor (NET) (Abstract #747P, October 9).(6)

* Figitumumab


Results from a Phase 1/2 study evaluating figitumumab (CP-751,871), a selective fully human IgG2 monoclonal antibody against the IGF-1R (insulin-like growth factor 1 receptor) pathway, in patients with refractory Ewing's sarcoma and other sarcomas will be presented in a Proffered Paper session (Abstract #1344O, October 10).(7)

Pfizer continues to investigate approved therapies within its portfolio, including Aromasin® (exemestane tablets). At the Congress, research findings for the compound will be presented in two key presentations.

- Distant recurrences at median of 5-years among 9,779 postmenopausal women with hormone receptor-positive early breast cancer treated on the TEAM trial of adjuvant endocrine therapy (Abstract #213O, October 11)(8)

- Effects of exemestane or tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial: a meta-analysis (Abstract #225P, October 10)(9)

Data on the following compounds and investigational agents will also be presented: neratinib (HER2 positive breast, solid tumors),(10),(11) axitinib (renal cell carcinoma or RCC),(12) inotuzumab (non-Hodgkin's lymphoma),(13) and Torisel® (temsirolimus) (RCC, solid tumors).(14),(15)