- Cell Genesys
Cell Genesys Inc is a
San Francisco basedbiotechnology company . It develops novel therapies for treatingcancer . Though its leading immunotherapeutic candidate GVAX has yielded promising results in clinical trials, none of its products has been given approval yet by theFood 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 plusprednisone ).GVAX immunotherapy for prostate cancer is currently being studied as a single agent in a Phase 3 clinical trial called "VITAL 1". A second Phase 3 trial called "VITAL 2", which studied GVAX immunotherapy for prostate cancer in combination with docetaxel, was terminated in August 2008 after the Independent Data Monitoring Committee observed an imbalance of deaths in the treatment arms: 67 deaths in the GVAX arm versus 47 deaths in the control arm. A cause for the imbalance has not yet been identified.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
* " [http://www.businessweek.com/magazine/content/07_08/b4022100.htm Will Healthy Lab Data Revive Ailing Cell Genesys?] ", "Business Week".
* " [http://www.seekingalpha.com/article/34661-cell-genesys-the-promise-of-gvax Cell Genesys: The Promise of GVAX] ", seekingalpha.com.External links
* [http://www.cellgenesys.com Cell Genesis]
Wikimedia Foundation. 2010.
