�Cell Genesys, Inc. (Nasdaq:CEGE) announced that it has terminated VITAL-2, the s of two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, which compares GVAX immunotherapy in combination with Taxotere� (docetaxel) to Taxotere asset prednisone in patients with advanced-stage prostate cancer. The Company complete the trial as recommended by its Independent Data Monitoring Committee (IDMC) which, in a routine safety review meeting held this week, observed an instability in deaths between the two handling arms of the study. To date, VITAL-2 enrolled 408 patients. The IDMC based its recommendation on 114 deaths of which 67 occurred in the GVAX plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm. At this clock time, a specific cause for the asymmetry in deaths has not been identified and the IDMC reported no modern safety issues for GVAX when administered in combination with Taxotere. The Company plans to fully analyze the clinical data from these patients to attempt to empathise the potentiality cause for the higher rate of deaths ascertained in the GVAX immunotherapy plus Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as early treatment variables. In light-colored of the IDMC's observation with deference to VITAL-2, the Company has requested that the IDMC perform a antecedently unspecified futility analysis of VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer. The Company expects the results of the VITAL-1 futility analysis in approximately one month.
"Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all active clinical test sites and regulatory agencies that registration of new patients into VITAL-2 has been suspended as has treatment with GVAX immunotherapy for prostate cancer of patients enrolled in the study," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "Notwithstanding this disappointing final result, we would like to acknowledge the courage and commitment of the patients and physicians who have participated in this trial."
Dr. Sherwin continued, "The observation in the VITAL-2 trial is very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of VITAL-1 in order to determine the overall prospects for our on-going development platform for this product. Moreover, with the cessation of VITAL-2, we expect to make commensurate adjustments to our business operations and we testament provide further details regarding this in the near future. As a reminder, the party ended the second quarter of 2008 with $166 million in cash."
VITAL-2 was a multi-center, randomized, controlled Phase 3 clinical trial designed to measure the guard and efficaciousness of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the purpose of Taxotere chemotherapy and prednisone in hormone-refractory prostate gland cancer (HRPC) patients with metastatic disease who are symptomatic with cancer-related painful sensation. The primary endpoint of the tribulation was an improvement in survival. VITAL-2 was initiated in June 2005 and to escort had enrolled 408 patients at one hundred fifteen clinical trial sites situated in North America and the European Union. VITAL-1, the other Phase 3 clinical test of GVAX immunotherapy for prostate cancer, is designed to compare GVAX genus Cancer immunotherapy as a monotherapy to Taxotere chemotherapy plus prednisone in earlier microscope stage HRPC patients with metastatic disease wHO are symptomless with respect to cancer-related pain. The primary terminus of the trial is an improvement in survival. In 2007, the VITAL-1 trial completed enrollment with 626 patients. In January 2008, Cell Genesys announced that the IDMC had completed a pre-planned meanwhile analysis for VITAL-1 and recommended that the study continue, providing no further information to the company other than the passport to retain the trial.
Conference Call and Webcast
Members of the Cell Genesys management team testament host a conference call today, Wednesday, August 27, 2008, at 8:30 a.m. ET to discuss the IDMC's good word. Investors crataegus oxycantha listen to the webcast of the conference call live on the investor section of the Cell Genesys website, http://www.cellgenesys.com. Alternatively, investors may heed to a replay of the phone by dialing (800) 475-6701 from locations in the U.S. and (320) 365-3844 from outside the U.S. The call in replay and webcast will be available for at least 72 hours following the send for. Please refer to reservation number 958709.
About GVAX Immunotherapy for Prostate Cancer
GVAX immunotherapy for prostate gland cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine that plays a key function in stimulant the body's immune response, and then irradiated for safety. GVAX immunotherapy for prostate genus Cancer is intentional to be administered through intradermal injections on an outpatient fundament.
About Cell Genesys
Cell Genesys (Nasdaq: CEGE) is focused on the development and commercialisation of novel biological therapies for patients with crab. The company's lead product platform is GVAX� immunotherapy for cancer, which holds the voltage to treat multiple types of cancer including prostate gland cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys continues to confine an equity interest in its former subsidiary, Ceregene, Inc., which is development gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, California, and has manufacturing operations in Hayward, California. For additional information, please
Thursday, 4 September 2008
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