Cell Genesys Launches Phase 1/2 Trial of CG7870 Plus Radiation Therapy in Early-Stage Prostate Cancer
Tuesday April 22, 7:03 am ET
SOUTH SAN FRANCISCO, Calif., April 22 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced the initiation of a multicenter Phase 1/2 clinical trial of CG7870, an oncolytic virus therapy for the treatment of early-stage prostate cancer, administered in combination with radiation therapy. This trial, which was prompted by encouraging results from a previous Phase 1/2 clinical trial evaluating CG7870 as a single agent, is designed to evaluate various treatment regimens combining intraprostatically administered CG7870 with external beam radiation therapy. The trial is expected to enroll up to approximately 25 newly diagnosed patients who have not received any prior treatment for their prostate cancer and will be conducted at up to five medical centers in the United States. Depending on the results of this initial combination therapy trial, Cell Genesys expects to develop CG7870 as a less toxic alternative to radiation seed therapy in newly diagnosed, intermediate to high-risk prostate cancer patients.
"Initial clinical trials of CG7870 as a single agent demonstrated antitumor activity in recurrent prostate cancer by both intraprostatic and intravenous administration. In addition, preclinical studies of oncolytic viruses have demonstrated synergistic antitumor activity in combination with other cancer therapies such as radiation or chemotherapy, and so we are optimistic about the prospects for the combination therapy study we initiated today," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "CG7870 is one of our six clinical programs from two distinct product platforms -- GVAX® cancer vaccines and oncolytic virus therapies. Our lead product candidate, GVAX® prostate cancer vaccine, is expected to enter Phase 3 clinical trials later this year."
In December 2002, encouraging data from a Phase 1/2 trial of CG7870 in patients with localized, recurrent prostate cancer were presented at the International Conference on Gene Therapy of Cancer. The trial enrolled 20 patients who had recurrent prostate cancer following radiation therapy but had not yet received hormone treatment. CG7870 was administered directly into the prostate using techniques similar to those used to implant radiation seed therapy for prostate cancer. Ten patients were treated at the lowest dose level, five at the middle dose level and five at the highest dose level, all with a single administration of the oncolytic virus therapy. Twelve patients were deemed evaluable due to elevated prostate-specific antigen (PSA) levels at baseline. The data demonstrated antitumor activity as measured by reductions in serum levels of PSA in 75 percent (9/12) of patients with elevated PSA levels at baseline. In the nine responders, PSA levels decreased by 25-50 percent, and all patients remained progression-free at a median follow-up time of six months. Treatment with CG7870 was safe and well tolerated.
CG8840, an oncolytic virus therapy for recurrent bladder cancer has been selected as the next oncolytic virus therapy product candidate to enter clinical trials, and the company expects to file an investigational new drug (IND) application to initiate a Phase 1/2 study for this product by late 2003. In addition to CG8840, Cell Genesys is also currently conducting preclinical studies of CG8900 for liver cancer and CG7980 for colon cancer.
Oncolytic (cancer cell killing) virus therapies represent a new approach in the treatment of patients with cancer. This novel therapy is comprised of viruses that are engineered to preferentially replicate in and destroy cancer cells. The engineered viruses are delivered either by direct injection into tumors or by injection into a body cavity containing cancer 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 cancer 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 is cleared by the body's immune system after destroying the cancer cells.
Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is pursuing three cancer product platforms -- GVAX® cancer vaccines, oncolytic virus therapies and cancer gene therapies. Clinical trials of GVAX® vaccines are under way in prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Clinical programs of oncolytic virus therapies include CG7870 for prostate cancer. Preclinical studies are in progress for additional GVAX® cancer vaccines, oncolytic virus therapies and cancer gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, Inc., is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately 8.7 million shares of common stock in its former subsidiary, Abgenix, Inc., an antibody products company. Cell Genesys is headquartered in South San Francisco, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at www.cellgenesys.com.
Clinical Trial Enrollment Information
Patients seeking information about how to participate in the clinical trial of CG7870 can obtain information by visiting the company's website at www.cellgenesys.com or by calling 650-266-3200.
Statements made herein about the company and its subsidiaries, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and preclinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated March 31, 2003 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.
CONTACT: Jennifer Cook Williams, Director of Corporate Communications and Investor Relations of Cell Genesys, +1-650-266-3200.
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Source: Cell Genesys |
