Cell Genesys Provides Update On Clinical Program For GVAX Immunotherapy For Leukemia

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 10 May 2007 - 0:00 PDT

email to a friend   printer friendly   opinions  

Cell Genesys, Inc. (Nasdaq: CEGE) today reported that three new clinical trials for GVAX immunotherapy for leukemia are now under way in collaboration with the Johns Hopkins Sidney Kimmel Cancer Center. The new trials are based on encouraging results in an initial Phase 2 study of the product in patients with chronic myelogenous leukemia (CML) and include:

-- A Phase 2 randomized trial in 56 patients with CML who have persistent molecular evidence of disease following Gleevec(R)(imatinib) therapy that will compare the combination of GVAX plus continued Gleevec to the combination of interferon-alpha, GM-CSF plus continued Gleevec with respect to the levels of bcr-abl, a well-established marker of residual leukemia. The study will also compare the ability of each combination therapy to permit a carefully monitored discontinuation of therapy in those patients who achieve a sustained complete disappearance of bcr-abl in order to determine the potential for disease eradication.

-- An extension study of the initial Phase 2 trial in 19 patients with CML that will evaluate the efficacy of a second course of GVAX with respect to inducing a complete disappearance of bcr-abl in the 11 patients who responded to the first course of GVAX, but failed to achieve a sustained complete response.

-- A Phase 1 trial in 18 patients with poor risk myelodysplastic syndrome (MDS) with or without prior chemotherapy, that will evaluate response to GVAX as measured by blood counts and transfusion requirements, cytogenetics and levels of WT-1, a marker associated with leukemia.

The three new trials are being conducted by Hyam I. Levitsky, M.D., professor of Oncology Medicine and Urology, and colleagues at the Johns Hopkins University School of Medicine and were described yesterday in a presentation by Dr. Levitsky at the Sloan-Kettering Cancer Center in New York City.

"We are encouraged by the results we have seen to date with GVAX immunotherapy for leukemia and are pleased that our collaborators at Johns Hopkins University are expanding the clinical program with these three new important studies," stated Kristen Hege, M.D., vice president of Clinical Research at Cell Genesys. "GVAX immunotherapy for leukemia, like our lead product, GVAX immunotherapy for prostate cancer now in Phase 3 development, is designed to stimulate the immune system as a means of treating cancer. Moreover, GVAX immunotherapy for leukemia may prove to be useful in multiple hematologic malignancies."

Cell Genesys reported at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2006 encouraging long-term follow-up data from a Phase 2 trial of GVAX immunotherapy for leukemia in CML. A total of 19 CML patients with molecular evidence of persistent leukemia following at least one year of Gleevec therapy were treated with GVAX immunotherapy for leukemia while continuing to receive Gleevec. Results showed that the addition of GVAX immunotherapy to Gleevec therapy reduced persistent leukemic disease in 10 of 19 patients as demonstrated by a complete disappearance (five patients) or a greater than one log (90%) reduction (five patients) in bcr-abl. The company also previously reported encouraging clinical data from a Phase 2 trial of GVAX immunotherapy for leukemia in patients with acute myelogenous leukemia (AML). Patients with newly diagnosed leukemia were treated with chemotherapy, and if responsive, subsequently received autologous bone marrow stem cell transplantation and GVAX immunotherapy. The findings in this trial indicate that GVAX immunotherapy was well-tolerated and may reduce residual leukemic cells that persist after chemotherapy as indicated by decreased levels of WT- 1, which is detectable in over 95 percent of patients with active AML.

Clinical trials of GVAX cancer immunotherapies are under way for multiple types of cancer including, in addition to leukemia, prostate cancer and pancreatic cancer. The products are comprised of tumor cells that have been modified to secrete GM-CSF, an immune stimulatory hormone, and then irradiated for safety. GVAX cancer immunotherapies are being developed as non patient- specific "off-the-shelf" pharmaceutical products and have demonstrated a favorable side effect profile in over 600 patients treated in Phase 1 and 2 clinical trials to date.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently developing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy 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. For additional information, please visit the company's website at http://www.cellgenesys.com.

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. The company assumes no obligation to update the forward-looking information in this press release.

Cell Genesys, Inc.
http://www.cellgenesys.com

• Additional
• References
• Citations