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| |  Clinical Data on Volociximab (M200) Presented at the American Society of Clinical Oncology Annual Meeting Interim Results Presented for Three Phase 2 Clinical Trials of an Anti-angiogenesis Antibody in Kidney Cancer, Pancreatic Cancer and Melanoma FREMONT, CA, and CAMBRIDGE, MA -- June 16, 2006 -- PDL BioPharma, Inc. and Biogen Idec announced that new data on volociximab (M200), a novel, anti-angiogenic, chimeric antibody directed at alpha5-beta1 integrin, were presented at the 2006 American Society of Clinical Oncology (ASCO) meeting, taking place from June 2 to 6 in Atlanta, Ga. Volociximab is being co-developed by PDL BioPharma and Biogen Idec. Interim results were presented from three, Phase 2, open-label clinical trials of volociximab 10mg/kg administered intravenously every two weeks as either a single agent or in combination with chemotherapy as part of the treatment regimens for metastatic renal cell carcinoma, adenocarcinoma of the pancreas and melanoma. Volociximab is a chimeric monoclonal antibody that blocks the alpha5-beta1 receptor and halts the proliferation of endothelial cells that lead to angiogenesis, the formation of new blood vessels that feed a tumor, allowing the cancerous tumor to grow and metastasize. "Based on its proposed mechanism of action, volociximab may inhibit tumor angiogenesis regardless of the pro-angiogenic growth factors that promote tumor growth," said Robert A. Figlin, MD, Professor of Medicine and Urology at the David Geffen School of Medicine at the University of California, Los Angeles. "This could potentially improve the clinical outcome of patients with different types of advanced cancers that may be fueled by a variety of angiogenic stimuli." "We are encouraged by the early signs of tolerability suggested by these exploratory trials," said Steven Benner, MD, Senior Vice President and Chief Medical Officer, PDL. "We look forward to advancing the volociximab clinical development program with our partner, Biogen Idec, with additional Phase 2 studies of volociximab at higher doses, including an early trial in patients with melanoma to further characterize tumor expression of alpha5-beta1." In the poster presentation titled, "Phase II study of volociximab (M200), an alpha5-beta1 anti-integrin antibody in refractory metastatic clear cell renal cell cancer (RCC)" [Abstract 4535 -- Saturday, June 3], a total of 40 patients, 21 (53%) of whom received two or more prior therapies, including anti-angiogenic therapies, were evaluated for safety and measured for objective responses. Volociximab was administered as a single agent in this study. One of 40 patients (3%) achieved a partial response (PR) and 32 of 40 patients (80%) achieved stable disease (SD). Median time to disease progression was 3.8 months (113 days). An estimate of overall survival (OS) had not been reached at a median follow up of 11.2 months (335 days). No detectable immune responses to volociximab and no changes in hematological, renal and hepatic parameters were noted. In patients evaluated to date in this study, volociximab appears to be well tolerated. The most frequently reported adverse events (AE), regardless of relationship to study drug, were fatigue (25 patients; 63%), nausea (13 patients; 33%), dyspnea or shortness of breath (7 patients; 18%), pain in the extremities (7 patients; 18%), arthralgia (6 patients; 15%) and headache (6 patients; 15%). In the poster presentation titled, "Phase II study of volociximab (M200), an alpha5-beta1 anti-integrin antibody in metastatic adenocarcinoma of the pancreas (MPC)" [Abstract 4111 -- Saturday, June 3], volociximab was administered in combination with standard doses of gemcitabine (Gemzar(R); Eli Lilly and Co.). One of 19 efficacy-evaluable patients (5%) achieved a PR and 10 of 19 patients (53%) achieved SD. Median time to disease progression was 4.0 months (121 days) and the median OS was 5.1 months (152 days). In patients evaluated to date in this study, volociximab appears to be well tolerated. The most frequently reported AEs, regardless of relationship to study drug, were nausea (13 patients; 65%), vomiting (12 patients; 60%), constipation (10 patients; 50%), lethargy (9 patients; 45%), diarrhea (8 patients; 40%), peripheral edema (7 patients; 35%), influenza-like illness (6 patients; 30%) and pyrexia (6 patients; 30%). In addition, upper abdominal pain, anorexia and fatigue were each reported in 5 patients (25%), and abdominal pain, dyspepsia and headache were each reported in 4 patients (20%). Anemia, chills, dehydration, dyspnea, myalgia, neutropenia, rash and decreased weight were each reported in 3 patients (15%). The poster presentation titled "Phase II study of volociximab (M200), an alpha5-beta1 anti-integrin antibody in metastatic melanoma" [Abstract 8011] showed that of 37 efficacy-evaluable patients who received a combination of volociximab and dacarbazine, one patient (3%) achieved a PR and 22 patients (60%) achieved SD. Median time to disease progression was 2.4 months (72 days) and the median OS was 8.0 months (237 days). In patients evaluated to date in this study, volociximab appears to be well tolerated. The most frequently reported AEs, regardless of relationship to study drug, were nausea (20 patients; 50%), fatigue (17 patients; 43%), injection site reaction (12 patients; 30%), vomiting (12 patients; 30%), constipation (11 patients; 28%), arthralgia (8 patients; 20%) and diarrhea (8 patients; 20%). Pain in the extremities and pyrexia were each reported in 7 patients (18%) and anorexia and peripheral edema were each reported in 6 patients (15%).
SOURCE: PDL BioPharma, Inc.
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