Cell Genesys, Inc. (Nasdaq: CEGE) today announced follow-up data from a Phase 2 clinical trial of GVAX immunotherapy for pancreatic cancer which was conducted by the Johns Hopkins Sidney Kimmel Cancer Center. The trial enrolled 60 patients with operable pancreatic cancer who received GVAX after surgical resection of their tumor and adjuvant radiation and chemotherapy. The median overall survival for these patients was previously reported to be 26.8 months, a result which compares favorably to the 17 to 22 months median survival results published from multiple studies in patients undergoing pancreatic cancer surgery and adjuvant therapy. Of note, 53 of the 60 patients were considered high risk, based on the unfavorable finding that their cancer had spread to regional lymph nodes. The new data reported today included a median disease-free survival of approximately 16 months which compares favorably to the 13 months disease-free survival recently reported for gemcitabine adjuvant therapy. Moreover, a comparison of the median overall survival of 60 patients from this trial with patients at Johns Hopkins with operable pancreatic cancer who underwent surgery and adjuvant therapy without receiving GVAX indicated that the median overall survival of the latter group was approximately 21 months or nearly six months shorter than the patients in the Phase 2 trial. The analysis of survival data further showed that the potential additive benefit of GVAX following surgery and adjuvant therapy was present during the first three years of the study although GVAX dosing did not continue beyond 18 months, suggesting that ongoing booster administrations of GVAX should be evaluated. Immunologic findings showed that there was an association between disease-free survival and treatment-associated antitumor immunity as measured by the induction of T cell responses to the pancreatic cancer-associated antigen, mesothelin (p=.01). The new findings were presented over the weekend by Daniel Lahe
ru, M.D., assistant professor of medical oncology at Johns Hopkins Kimmel Cancer Center, and colleagues, at the 2007 American Society of Clinical Oncology (ASCO) annual meeting being held in Chicago, IL.
"We continue to be encouraged by the survival data analysis, as well as the immunologic data reported today in this Phase 2 study of GVAX immunotherapy for pancreatic cancer in patients with operable disease," said Kristen Hege, M.D., vice president of Clinical Research at Cell Genesys. "We look forward to the results of ongoing studies conducted by Johns Hopkins which include a study of booster administrations to patients in the completed Phase 2 trial as well as a second 60-patient Phase 2 trial of GVAX immunotherapy with booster administrations following pancreatic cancer surgery and adjuvant radiation and chemotherapy. In addition, we are also looking forward to the results of a third ongoing Phase 2 trial in patients with metastatic pancreatic cancer also being conducted by Johns Hopkins, which is evaluating GVAX immunotherapy in combination with Erbitux(R), an antibody to the EGF receptor.
"The Phase 2 study reported today was designed to evaluate the safety and efficacy of GVAX immunotherapy for pancreatic cancer which is being developed as a non patient-specific "off-the-shelf" pharmaceutical product. All patients underwent extensive surgical resection of their tumors. The immunotherapy was administered as an intradermal (under the skin) injection before and after standard post-operative adjuvant radiation therapy and 5- flourouracil chemotherapy. Patients received up to five doses -- the first prior to adjuvant chemoradiotherapy, the next three following adjuvant therapy at approximately one-month intervals and the fifth as a booster injection six months later. Patients were monitored for evidence of relapse and survival, as well as the occurrence of adverse events and induction of immune response.
An earlier Phase 1 trial o
f GVAX immunotherapy for pancreatic cancer was conducted by the Johns Hopkins Sidney Kimmel Cancer Center in 14 patients who also received the immunotherapy following surgical resection of their tumor and standard adjuvant radiation and chemotherapy. As first reported in the Journal of Clinical Oncology in January 2001, three of eight patients who received the therapeutic dose levels of the immunotherapy had prolonged disease-free survival for a period of at least eight years. This outcome is considered particularly significant since all three long-term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of residual pancreatic tumor following surgery and two patients had metastatic tumor in regional lymph nodes. In addition, the three patients with prolonged disease-free survival -- but not the five who progressed and died -- showed evidence of treatment-associated antitumor immunity, including induction of T cell responses to the candidate tumor-associated antigen, mesothelin.
Pancreatic cancer is the fourth leading cause of cancer death in the United States. According to the American Cancer Society, approximately 37,170 Americans will be diagnosed with pancreatic cancer in 2007, and 33,370 are expected to die from the disease in 2007. 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 median survival of patients with operable cancer of the pancreas with currently available therapies is approximately 17 to 22 months.
Cell Genesys 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 include Phase 3 trials of GVAX immunot
herapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy 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 its principal manufacturing operation in Hayward, CA.
Statements made herein about the company, 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 for the year ended December 31, 2006 filed on March 1, 2007 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.
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