Cell Genesys
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Cell_Genesys".

Cell Genesys Inc is a San Francisco based biotechnology company . It develops novel therapies for treating cancer. Though its leading immunotherapeutic candidate GVAX has yielded promising results in clinical trials, none of its products has been given approval yet by the Food and Drug Administration.

Development

Cell Genesys's GVAX consists of genetically modifies human tumor cells to secrete an immune-stimulating factor known as granulocyte macrophage colony stimulating factor. When these cells, which have been irradiated to prevent reproduction, are administered they induce an antitumor response which may destroy cancer cells that persist or recur after surgery, radiation or chemotherapy. This kind of treatment avoids many of the toxicities of traditional therapies. The main side effects reported were injection site reactions and mild flu-like symptoms.

GVAX

The company’s lead product, GVAX for prostate cancer, has been tested in five phase 1 and 2 clinical trials. The company announced in April 2007 the final results from its phase 2 trial. A total of 80 patients received escalating doses of GVAX, resulting in the following median survival rates:

• 33 patients received a low dose resulting in a median survival rate of 20 months.

• 25 patients received a medium dose resulting in a medium survival rate of 23.1 months.

• 22 patients received a high dose resulting in a median survival rate of 35 months.

This compared to a median survival of 19.1 months for patients treated with standard therapy ( taxotere plus prednisone). GVAX immunotherapy for prostate cancer is currently being studied both as a single agent and in combination with docetaxel chemotherapy in two Phase 3 clinical trials. Cell Genesys has enrolled approximately 1200 patients with metastatic hormone-refractory prostate cancer for these trials.

GVAX Prostate Partnership

On March 31, 2008 the company announced a partnership with Takeda Pharmaceuticals of Japan for the commercialization of GVAX Prostate. The partnership, which gave Takeda rights to eventually commercialize the drug in the US, Europe, and Japan, included a $50 million upfront payment plus up to $270 million of additional milestone payments. Takeda will also take on external development costs for ongoing Phase III trials. In the event of successful commercialization of GVAX Prostate, Cell Genesys will receive tiered, "double-digit royalties" on sales of the drug.

References

• "Will Healthy Lab Data Revive Ailing Cell Genesys?", Business Week.
• "Cell Genesys: The Promise of GVAX", seekingalpha.com.

External links

• Cell Genesis

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