Cell Genesys Initiates Phase II Trial of GVAX(R) Cancer Vaccine in Patients With Inoperable Pancreatic Cancer
FOSTER CITY, Calif., May 29 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced the initiation of a Phase II clinical trial of GVAX® pancreatic cancer vaccine in patients with inoperable or metastatic pancreatic cancer. This trial was prompted by compelling results from an initial Phase I clinical trial of GVAX® pancreatic cancer vaccine which demonstrated prolonged, disease-free survival in three of eight patients treated at the higher dose levels. The new Phase II trial is in addition to a second ongoing Phase II trial in patients with operable pancreatic cancer who receive GVAX® pancreatic cancer vaccine in combination with pancreatic cancer surgery and standard adjuvant radiation and chemotherapy. The new trial is expected to enroll approximately 40 patients and will be conducted at medical centers across the United States.
The initial Phase I trial of GVAX® pancreatic cancer vaccine was conducted at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in 14 patients who received the vaccine following surgical resection of their tumor together with standard adjuvant radiation and chemotherapy. The results of this trial which were first reported in the Journal of Clinical Oncology in January 2001, revealed that three of eight patients who received the higher doses of vaccine were alive and disease-free at 38, 35 and 33 months after diagnosis, and this continues to be true at their most recent follow-up. In addition, the three patients with prolonged disease-free survival had biopsy-proven vaccine-induced antitumor immunity, a finding which was absent in the other five patients in the same treatment groups who had progressive pancreatic cancer. The significance of these findings was underscored by the fact that all three long term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of pancreatic tumor following surgery or metastatic tumor in pancreatic lymph nodes. As with other GVAX® clinical trials, vaccine treatment was safe and generally well tolerated.
"We are pleased to be initiating a trial of GVAX® vaccine in patients with inoperable pancreatic cancer, a group of patients with very few treatment options which unfortunately is true for the majority of pancreatic cancer patients," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "We look forward to continuing the clinical development of GVAX® cancer vaccines in multiple indications and advancing GVAX® cancer vaccines into Phase III clinical trials in advanced lung cancer and prostate cancer in late 2002 and the first half of 2003, respectively."
The GVAX® pancreatic cancer vaccine being evaluated in this Phase II trial is comprised of a non patient-specific vaccine which will be developed as an "off-the-shelf" pharmaceutical product. The vaccine will be administered as an intradermal (under the skin) injection. Patients will generally receive six vaccine treatments at 21-day intervals and will then be monitored to determine the safety and clinical efficacy of treatment with GVAX® pancreatic cancer vaccine.
GVAX® cancer vaccines are comprised of tumor cells which have been irradiated and genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body's immune response to vaccines. The genetically modified tumor cells are used to vaccinate patients to stimulate an immune response against their tumor. GVAX® cancer vaccines have demonstrated antitumor effects against every type of human cancer against which they have been tested to date including pancreatic cancer, lung cancer, prostate cancer, renal cancer and melanoma. Cell Genesys is currently evaluating non patient-specific GVAX® cancer vaccines in prostate and pancreatic cancer and patient-specific, individualized vaccines in lung cancer, leukemia and myeloma.
Pancreatic cancer is the fourth leading cause of cancer death in the United States. According to the American Cancer Society, in 2002, an estimated 30,300 Americans will be diagnosed with pancreatic cancer and approximately 29,700 Americans will die from the disease. Because symptoms are non-specific, cancer of the pancreas is rarely diagnosed at an early stage leaving surgical removal of the tumor as a treatment option for only approximately 20 to 30 percent of pancreatic cancer patients. The average survival time following diagnosis of patients with metastatic cancer of the pancreas is three to seven months.
Cell Genesys is focused on the development and commercialization of innovative therapeutic products for cancer based on gene therapy technologies. The company is pursuing three cancer product platforms--GVAX® cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies. Clinical trials of GVAX® vaccines are under way in lung cancer, prostate cancer, pancreatic cancer, leukemia and myeloma. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include oncolytic virus therapies and gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately nine million shares of common stock in its former subsidiary, Abgenix, an antibody products company. Cell Genesys is headquartered in Foster City, 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 GVAX® pancreatic cancer vaccine trial can obtain information by visiting the company's web site at www.cellgenesys.com or by calling 650-425-4542.
Statements made herein about the company and its subsidiaries, other than statements of historical fact, including statements about progress reports and plans for clinical trials, the company's progress and results and timing of clinical trials and preclinical programs, progress and capabilities of manufacturing facility sites 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 research and development programs, clinical trials, 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 filed April 1, 2002 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, Associate Director, Corporate Communications of Cell Genesys, Inc., +1-650-425-4542.
SOURCE: Cell Genesys, Inc. |
