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Biotech / Medical : Cell Genesys (CEGE) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (1164)	12/14/2001 9:38:02 AM
From: tuck	Read Replies (2) \| Respond to of 1298

>>FOSTER CITY, Calif., Dec. 14 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today reported further results of a Phase I/II clinical trial of CG7870, an oncolytic virus engineered to target and destroy prostate cancer cells which is being evaluated in patients with advanced prostate cancer. The updated findings demonstrated stabilization of PSA (prostate-specific antigen) levels in six of 23 patients (26 percent) for a median duration of four months after just a single intravenous injection in patients with advanced hormone refractory prostate cancer. The Phase I/II trial was conducted at three medical centers under the direction of Eric Small, M.D., clinical professor of medicine and urology at the University of California, San Francisco Comprehensive Cancer Center. These data were reported at the International Conference on Gene Therapy of Cancer currently being held in San Diego, Calif. The Phase I/II trial was a dose escalation study designed to evaluate the safety and efficacy of CG7870 for the treatment of patients with advanced hormone refractory prostate cancer. The 23 patients enrolled to date were divided into eight treatment groups, each of which received one intravenous administration of CG7870 at a progressively higher dose level. Six of the 23 patients demonstrated stabilization of PSA levels for a median duration of four months, and three additional patients had PSA reductions of approximately 20 percent or greater from baseline. Secondary peaks of viral replication in serum were also observed suggesting in vivo replication of CG7870. No serious or unexpected drug-related toxicities have been observed, and a maximum tolerated dose was not defined. ``We are pleased by the results achieved from a just a single injection of CG7870 particularly with respect to the newly-reported findings of response duration,'' stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. ``We are also encouraged by the new results from preclinical studies which show that CG7870 and taxotere may have highly synergistic antitumor effects, and we look forward to initiating a Phase I/II study evaluating CG7870 in combination with taxotere in the second half of 2002.'' Separate Report of Synergistic Antitumor Activity in Preclinical Studies In a separate presentation at this conference, data were reported from a preclinical study that demonstrated significant synergistic antitumor activity when CG7870 was used in combination with chemotherapy currently used to treat prostate cancer. In mouse tumor models of prostate cancer, a single injection of CG7870 in combination with taxotere completely eliminated tumors within four weeks of treatment without dose-limiting toxicity -- a 1000 fold increase in the therapeutic index compared to treatment with CG7870 alone. Also included in this presentation were preclinical data demonstrating that CG7060, an oncolytic virus therapy currently being evaluated in clinical studies of early-stage prostate cancer, demonstrated a 95 percent reduction in tumor volume within six weeks following treatment when used in combination with local tumor radiation. This combination therapy was also observed to have significantly reduced the number of blood vessels supplying the treated tumors. Additionally, 50-fold less CG7060 virus was needed when used with radiation to produce comparable results to that seen with CG7060 alone. Similar preclinical studies demonstrated synergistic antitumor activity when using chemotherapy in combination with CG8900 and CG8840 for liver and bladder cancer, respectively. Cell Genesys expects to initiate a Phase I/II clinical trial in the near future evaluating the combination of CG7060 and external beam radiation therapy in early-stage prostate cancer patients. Background on Oncolytic Virus Therapies CG7870 is currently one of five products based on Cell Genesys' proprietary oncolytic virus technology platform which employs cancer cell killing adenoviruses engineered to selectively replicate in and kill targeted cancer cells. Adenovirus is a commonly occurring virus responsible for the common cold. The engineered viruses are delivered either by direct injection into tumors or by intravenous administration and are thousands of times more specific for killing cancer cells than standard chemotherapeutic drugs. Once the therapy is delivered to the cancer cells, the virus replicates within the cell until it bursts, thereby destroying the cell and spreading the newly created viruses throughout the tumor, repeating the cycle in the neighboring cancer cells. The virus, which specifically targets cancer cells, is cleared by the body's immune system after destroying the cancer cells. In addition to CG7870, other products utilizing this technology are CG7060, currently in clinical trials for early stage prostate cancer; and CG8900, CG7980 and CG8840, preclinical product candidates for liver cancer, colon cancer and bladder cancer, respectively. CG7870 is one of three products targeting prostate cancer currently in clinical development at Cell Genesys. CG7870 and GVAX® prostate cancer vaccine are being evaluated in advanced prostate cancer, whereas CG7060 is being evaluated in patients with early stage disease. During 2001, it is projected that in the United States alone, approximately 198,100 new cases of prostate cancer will be diagnosed, approximately one million men are living with prostate cancer, and about 31,500 men will die of this disease. Prostate cancer is the second leading cause of cancer death in men, exceeded only by lung cancer.<< snip Cheers, Tuck