Knobias Clip Report (01-14-2008)
Submitted By Knobias ClipReport
CEGE: CEO Discusses Recommendation of Committee to Continue Ph III Trial
Shares of Cell Genesys Inc (CEGE) opened higher in Monday’s session following an Independent Data Monitoring Committee’s (IDMC) completion of a pre-planned interim analysis of the Company’s VITAL-1 Phase 3 clinical trials of GVAX immunotherapy for prostate cancer. The IDMC recommended that the study continue.
Dr. Stephen A. Sherwin, MD, commented in a conference call today, “This interim analysis occurred within the estimated time frame. We are fully blinded from the interim results, so we did not receive any efficacy data. All they said was continue the trial. The final analysis is expected in the second half of 2009.”
GVAX cancer immunotherapy is designed to stimulate the patient’s immune system to effectively fight cancer. It is comprised of tumor cells that are genetically modified to secrete an immune-stimulating hormone known as granulocyte macrophage-colony stimulating factor, or GM-CSF, and are then irradiated in order to prevent them from multiplying. The basic idea is that once the body’s immune system encounters those GVAX cells, the GM-CSF will stimulate the immune cells to recognize those cells as a threat and initiate an immune response directed at them. GVAX is designed to be administered through intradermal injections on an outpatient basis.
The VITAL-1 trial is designed to compare the GVAX cancer immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone in hormone refractory prostate cancer (HRPC) patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. VITAL-1 was initiated in July 2004 and completed recruitment of 626 patients in July 2007. Patients were enrolled at approximately 130 sites in North America and Europe.
“Our shareholders have shouldered the burden for the VITAL-1 trial so far. A partner could obviously provide strategic help, so there is a strategic imperative behind our discussions. Any prospective partner that we seek would have to be one in which we could significantly share in the downstream benefits,” noted Dr. Sherwin.
A second Phase 3 trial, VITAL-2, is a multi-center, randomized, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in HRPC patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial is also an improvement in survival. VITAL-2 was initiated in June 2005 and is currently enrolling patients at approximately 90 sites in North America and Europe. The company expects to complete enrollment of approximately 600 patients in the first half of 2009 and if this is achieved, to have a sufficient number of events for a pre-planned interim analysis at that time.
The safety profile of GVAX immunotherapy for prostate cancer in Phase 2 clinical trials compared favorably with that reported for chemotherapy. Results from both studies also compare favorably to the previously published median survival of 18.9 months for metastatic HRPC patients treated with Taxotere chemotherapy plus prednisone, the current standard of care.
The Company currently competes with other biotechnology companies, which have prostate cancer immunotherapy products in various stages of clinical development, such as Dendreon Corporation (DNDN) and Onyvax, Ltd.
The Company’s ongoing clinical trials also include Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. CG0070 is “armed” with GM-CSF and is designed to potentially destroy cancer cells by two different mechanisms: direct cell-killing by the virus and immune-mediated cell-killing stimulated by GM-CSF.
Dr. Sherwin added, “We expect to present additional important analysis at several upcoming investor conferences. we are also continuing to benefit from our collaboration with John Hopkins. We expect important news this year.”
“This announcement today is a milestone of progress. We are encouraged by what we are able to report. We firmly believe in the potential of this product for prostate cancer. That is why I am still here after all these years.”
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