The Super Bowl Kick off time for the 2012 Super Bowl will be around 6:35pm EST. This year's TV network, NBC, invites you to begin watching the Super bowl pregame show between 5pm EST - 6pm EST. At 6pm, the starting players will be announced followed by the singing of the star spangled banner. I expect the kick off time to be around 6:35am between the New England Patriots and the New York Giants.
The 2012 super bowl should get very high ratings due to the two teams that will be playing.
Commercial Ad Rates 2012 - During the 2012 super bowl, commercials will cost 3.5 million per 30 seconds.
Tuesday, January 31, 2012
Thursday, July 7, 2011
Taylor Swift Philadelphia Concert Time - August 6, 2011 - 08/06/2011
Taylor Swift will be playing at Lincoln Financial Field in Philadelphia, PA on Saturday, August 6, 2011. The show is schedule to start at 7:00 PM EST, however; without 3 opening acts, Taylor will come on to the set around 8:30-9:00 PM based on the concert in Pittsburgh, PA on June 18, 2011.
For Taylor Swift Cupcakes which make great tail-gating food, check out: Taylor Swift Decorated Cupcakes
For Taylor Swift Cupcakes which make great tail-gating food, check out: Taylor Swift Decorated Cupcakes
Taylor Swift Philadelphia Concert Date
Taylor Swift will be playing at Lincoln Financial Field in Philadelphia, PA on Saturday, August 6, 2011. The show is schedule to start at 7:00 PM EST, however; without 3 opening acts, Taylor will come on to the set around 8:30-9:00 PM based on the concert in Pittsburgh, PA on June 18, 2011.
For Taylor Swift Cupcakes which make great tail-gating food, check out: Taylor Swift Decorated Cupcakes
For Taylor Swift Cupcakes which make great tail-gating food, check out: Taylor Swift Decorated Cupcakes
Casey Anthony Sentence - July 7, 2011 - 07/07/2011
Judge Perry sentenced Casey Anthony today, July 7, 2011. Casey Anthony was sentenced to the maximum of 1 year of jail time and a $1000 fine for each of 4 consecutive accounts of providing false information to law enforcement officers. However, due to jail time already served and good behavior, she may be released within the next 2-3 months. Judge Perry denied the defense's motion to combine all 4 accounts into 1 account. Judge Perry may also decide to fine Casey Anthony for the money and time spent by law enforcement officers who were searching for a child, based on Casey Anthony's lies. Casey Anthony and her team have not yet decided if they will appeal the sentence, they have 30 days to do so.
Wednesday, July 6, 2011
Casey Anthony Sentencing Time - July 7, 2011
After being charged NOT GUILTY on the accounts of Murder in the 1st Degree, Manslaughter, and aggravated child abuse of her daughter Caylee Anthony, Casey Anthony will be sentenced on 4 accounts of providing false information to law enforcement officers (i.e. lying to police officers.
Her sentencing will take place on July 7, 2011 at 9 AM eastern time.
She faces up to 4 years in prison, minus the 2.5 years already served.
Her sentencing will take place on July 7, 2011 at 9 AM eastern time.
She faces up to 4 years in prison, minus the 2.5 years already served.
Casey Anthony Sentencing Date - July 7, 2011
After being charged NOT GUILTY on the accounts of Murder in the 1st Degree, Manslaughter, and aggravated child abuse of her daughter Caylee Anthony, Casey Anthony will be sentenced on 4 accounts of providing false information to law enforcement officers (i.e. lying to police officers.
Her sentencing will take place on July 7, 2011 at 9 AM eastern time.
She faces up to 4 years in prison, minus the 2.5 years already served.
Her sentencing will take place on July 7, 2011 at 9 AM eastern time.
She faces up to 4 years in prison, minus the 2.5 years already served.
Tuesday, July 5, 2011
Casey Anthony: Verdict - Not Guilty: July 5, 2011
Today, July 5, 2011, the judicial court system failed Caylee Marie Anthony by finding Casey Marie Anthony not guilty for 1st Degree Murder, Manslaughter and Aggravated child abuse. I am personally appalled and disappointed that our court system failed this young child and leaves a murderer out on the streets.
Thursday, June 23, 2011
Stock Market 6-23-11 June 23, 2011, DOW Jones
The stock market is in the red today with the DOW jones dropping over 210 points at one point. Aside from the Greece debt crisis, initial jobless claims were once again disappointing. The stock market also took a tumble due to the Department of Energy releasing oil from the strategic petroleum reserves.
One positive in the stock market today was the housing data. New home sales for May, 2011 were 319,000 which is better than the 290,000 forecast.
Stock market events 6-24-11, June 24, 2011:
Economic Data - GDP Q1 estimate 8:30 AM and durable orders for May, 2011 due out at 8:30 AM.
One positive in the stock market today was the housing data. New home sales for May, 2011 were 319,000 which is better than the 290,000 forecast.
Stock market events 6-24-11, June 24, 2011:
Economic Data - GDP Q1 estimate 8:30 AM and durable orders for May, 2011 due out at 8:30 AM.
Wednesday, December 22, 2010
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.
Monday, November 1, 2010
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.
For more cancer updates, visit: http://astopnews.blogspot.com
For more stock updates, visit: http://daytradingstockblog.blogspot.com
Sunday, October 31, 2010
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.
For more cancer updates, visit: http://www.astopnews.blogspot.com
For more stock updates, visit: http://daytradingstockblog.blogspot.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.
For more cancer updates, visit: http://www.astopnews.blogspot.com
For more stock updates, visit: http://daytradingstockblog.blogspot.com
Monday, October 25, 2010
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.
For more stock updates, visit: http://daytradingstockblog.blogspot.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.
For more stock updates, visit: http://daytradingstockblog.blogspot.com
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.
For more stock updates, visit: http://daytradingstockblog.blogspot.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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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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Sunday, October 24, 2010
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.
For more stock updates, visit: http://daytradingstockblog.blogspot.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.
For more stock updates, visit: http://daytradingstockblog.blogspot.com
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.
For more stock updates, visit: http://daytradingstockblog.blogspot.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.
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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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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Wednesday, October 20, 2010
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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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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