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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Showing posts with label trial oncology drugs. Show all posts
Showing posts with label trial oncology drugs. Show all posts
Monday, October 25, 2010
Saturday, October 16, 2010
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.
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."
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."
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