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Oct 16, 2008

Cell Genesys Restructures After Second Clinical Trial Failure with Prostate Cancer Immunotherapy

  • Cell Genesys reported the halt of a second late-stage trial called VITAL-1, because it was determined to have less than a 30% chance of meeting its primary endpoint. As a result, further development is on hold pending a review of the program with its collaborator, Takeda Pharmaceutical.

    Also, the company will reduce its staff of 290 by approximately 75% by year-end. Further reductions are anticipated in the first half of 2009 as additional activities are phased out.

    As of September 30, the company had approximately $150 million in cash and currently estimates that the year-end cash will be approximately $128 million. Personnel-related restructuring charges of approximately $12.8 million are expected this year.

    The other Phase III study, VITAL-2, was nixed in August, because there were more deaths in the treatment arm than in the control arm. At the time, the company lost almost 74% of its value. It dropped another approximately 75% to open today at $0.16. 

    VITAL-1 was comparing GVAX immunotherapy to Taxotere® plus prednisone in patients with asymptomatic metastatic hormone-refractory prostate cancer. VITAL-2, on the other hand, was assessing GVAX immunotherapy with Taxotere as opposed to Taxotere and prednisone in the symptomatic metastatic hormone-refractory prostate cancer setting.

    Once VITAL-2 was cancelled, Cell Genesys asked its independent data monitoring committee to conduct a futility analysis. This revealed the low chance of meeting the endpoint of an improvement in survival.

    Cell Genesys was not immediately available to comment on other GVAX immnunotherapy programs or the future of the company.



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