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Company Profile

Cell Genesys (Nasdaq: CEGE) is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms—GVAX TM cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials of GVAX cancer immunotherapies include two Phase 3 trials of GVAX immunotherapy for prostate cancer (VITAL-1 and VITAL-2), Phase 2 trials of GVAX immunotherapy for leukemia and a Phase 2 trial of GVAX immunotherapy for pancreatic cancer. The oncolytic virus therapy clinical program currently includes a Phase 1 trial of CG0070 for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary — Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has manufacturing operations in Hayward, CA.

Recent Cell Genesys Highlights



In April 2007, Cell Genesys announced final, updated results from its second multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer which evaluated escalating doses of the immunotherapy in 80 patients with metastatic hormone-refractory prostate cancer (HRPC). Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company’s ongoing Phase 3 program indicates that the median survival is 35.0 months. The company previously reported final median survival results from its first multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer in 34 patients with metastatic HRPC that showed an overall median survival of 26.2 months. The survival results from the two, independent multi-center Phase 2 clinical trials compare favorably to the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere ® (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients. GVAX immunotherapy for prostate cancer is being compared to Taxotere chemotherapy in the ongoing Phase 3 trials to evaluate a potential survival benefit.
In February 2007, announced encouraging follow-up data on the first twelve patients with advanced prostate cancer treated on a Phase 1 clinical trial of GVAX immunotherapy for prostate cancer, administered in combination with Medarex’s fully human anti-CTLA-4 antibody, ipilimumab (MDX-010). The twelve patients who have completed treatment to date included six patients who received the combination therapy at the therapeutic doses currently being evaluated in both GVAX and ipilimumab Phase 3 clinical trials. Antitumor activity was observed in five of these six patients, including prostate-specific antigen (PSA) declines of greater than 50% that were maintained in four of these patients for at least six months, with the longest response ongoing at more than 12 months. Moreover, clinical evidence of antitumor activity was observed in three of these five PSA responders, including improvement of multiple lesions on bone scan, resolution of abdominal lymph node disease by CT scan, and improvement in pain due to bone metastases, respectively. All five patients with PSA partial declines have experienced either Grade 2 or 3 immune-mediated endocrine deficiencies similar in type to those previously reported with ipilimumab therapy and were successfully treated with standard hormone replacement therapy.
In January 2007, announced follow-up data from a Phase 2 clinical trial of GVAX immunotherapy for pancreatic cancer in 60 patients with operable pancreatic cancer who received the immunotherapy after surgical resection of their tumor and adjuvant radiation and chemotherapy. The updated results showed a median survival of 26.8 months. This compares favorably with published, historical data from multiple single-arm and randomized studies in patients undergoing pancreatic cancer surgery and adjuvant therapy for whom the median survival has been reported to be in the range of 17 to 22 months, including the most recently reported results for gemcitabine chemotherapy.
The company had approximately $170 million in cash, cash equivalents and short-term investments at the end of the third quarter of 2006.

Company Information (12/01/06)
Nasdaq symbol:
Shares outstanding:
Institutional ownership:
Number of employees:
Company headquarters:
CEGE
Approximately 62 million
Approximately 63%
Approximately 292
South San Francisco, CA
Analyst Coverage
Cantor Fitzgerald
Pamela Bassett
646.734.7694

  Lehman Brothers
Jim Birchenough, M.D.
415.274.5393
Canaccord Adams
Joe Pantginis
646.264.6021
Needham & Company
Mark Monane, Ph.D.
212.705.0346
JPMorgan
Richard Smith, Ph.D.
212.622.6531
Next Generation Equity Research
Liisa Bayko
312.334.4405

Product Platforms


GVAX® Cancer Immunotherapy
GVAX cancer immunotherapy is designed to stimulate the patient’s immune system to effectively fight cancer. It is comprised of tumor cells that are genetically modified to secrete an immune-stimulating hormone known as granulocyte macrophage-colony stimulating factor, or GM-CSF, and are then irradiated for safety. More than 600 patients have received our investigational GVAX immunotherapies through multiple Phase 1 and 2 clinical trials to date, and the immunotherapies have been shown to have a favorable side effect profile that avoids many of the toxicities associated with conventional cancer therapies. We are conducting two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, Phase 2 clinical trials of GVAX immunotherapy for l eukemia (acute and chronic) and a Phase 2 clinical trial of GVAX immunotherapy for pancreatic cancer.

Oncolytic Virus Therapies
Our oncolytic virus therapy program utilizes adenovirus, one of the viruses responsible for the common cold, to create viruses that can kill cancer cells. The virus is engineered to selectively replicate in targeted cancer cells, thereby killing these cells and leaving healthy normal cells largely unharmed. We are developing our oncolytic virus therapy program in part through a global alliance with Novartis AG. We currently have an ongoing Phase 1 clinical trial of CG0070 in recurrent bladder cancer. CG0070 is “armed” with GM-CSF and is designed to potentially destroy cancer cells by two different mechanisms: direct cell-killing by the virus and immune-mediated cell-killing stimulated by GM-CSF.

EXECUTIVE Team
Stephen A. Sherwin, M.D.
Chairman and
Chief Executive Officer

Kristen M. Hedge, M.D.
Vice President, Clinical Research
 
Sharon E. Tetlow
Senior Vice President and Chief Financial Officer

Christine McKinley
Senior Vice President,
Human Resources
 

Robert J. Dow, M.D.
Chief Medical Officer

Michael W. Ramsay
Senior Vice President,
Operations
 

Carol C. Grundfest
Senior Vice President,
Regulatory Affairs &
Portfolio Management

Robert H. Tidwell
Senior Vice President,
Corporate Development
 
Peter K. Working, Ph.D.
Senior Vice President,
Research and Development

 

Cell Genesys, Inc.
500 Forbes Boulevard
South San Francisco, CA 94080
650.266.3000
Fax: 650.266.3010
http://www.cellgenesys.com
E-mail: ir@cellgenesys.com


Statements made herein, other than statements of historical fact, including statements about the company's and its subsidiaries’ progress and results of clinical trials and preclinical programs, timing of clinical trials, marketability of potential products and therapies and 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 research and development programs, the regulatory approval process, competitive technologies and products, patents, 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 for the year ended December 31, 2006 dated March 1, 2007 as well as Cell Genesys' reports on Forms 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission.

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