Cell Genesys and Japan-based Takeda's wholly-owned subsidiary Millennium Pharmaceuticals have mutually agreed to suspend their US development agreement of GVAX immunotherapy for prostate cancer.
Under the terms of the deal, Takeda will return all rights to GVAX to Cell Genesys and make certain wind-down payments in connection with the phasing out of remaining clinical development activities.
The news follows the termination of VITAL-2, the second of two Phase III trials for GVAX, due to patient deaths. Testing the product in combination with Taxotere (docetaxel) versus Taxotere plus prednisone in patients with advanced-stage prostate cancer, the study showed "an imbalance in deaths between the two treatment arms," according to the firm. The US drugmaker's shares crashed almost 70% at the time (Marketletter September 1), whereas Takeda fell nearly 10%.
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