Cell Genesys Reports Encouraging Follow-Up Data From Phase I/II Trial of GVAX(R) Lung Cancer Vaccine
Company Updates Plans for Phase III Trials of GVAX(R) Vaccines
FOSTER CITY, Calif., June 27 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced encouraging follow-up data from the company's multicenter Phase I/II clinical trial of GVAX® lung cancer vaccine. The trial, which was last updated in December 2001, evaluated a patient-specific form of the vaccine made directly from patient tumor biopsies and enrolled non small-cell lung cancer patients with either advanced, heavily pretreated disease or early stage disease with high risk of relapse after surgery. The new findings included survival data for 33 advanced disease patients which demonstrated a median survival of 8.0 months, as compared to the reported 5.7 to 7.0 months for the approved second-line chemotherapy for such patients (docetaxel) or 4.6 months for best supportive care. In addition, of the three patients with advanced disease who achieved durable complete responses (with a median response duration of at least 16 months) two were noted to have a subtype of lung cancer referred to as bronchoalveolar carcinoma (BAC), a diagnosis which was found to be the only identifiable predictor of increased survival in the advanced patient group. Finally, follow-up data for the early stage patients who received the vaccine after surgery to prevent recurrent cancer revealed that seven of 10 patients now remain free of disease with median follow-up time of 16 months. These data were reported today at the Third International Lung Cancer Congress by Kristen Hege, M.D., senior director of clinical research at Cell Genesys.
"We are pleased with these updated results from our multicenter Phase I/II trial of GVAX® lung cancer vaccine, particularly with respect to the encouraging complete response rate and survival data for patients with BAC. In view of these findings, we plan to focus the next clinical trials of GVAX® lung cancer vaccine on BAC rather than immediately initiating a Phase III trial in all subtypes of non small-cell lung cancer," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "Given our new plans for GVAX® lung cancer vaccine, we will now prioritize GVAX® prostate cancer vaccine as our lead Phase III clinical program. This decision reflects both the strength of the recently presented GVAX® prostate cancer vaccine clinical data as well as the advantages of the non patient-specific format of this product. GVAX® prostate cancer vaccine is expected to enter a Phase III trial in the first half of 2003."
Future Plans for GVAX® Lung Cancer Vaccine Program
In view of the response rate and survival data for the BAC patients in Cell Genesys' Phase I/II trial of GVAX® lung cancer vaccine, the company has decided to focus its near term clinical trial strategy for this vaccine program on patients with BAC, one of four principal subtypes of non small-cell lung cancer. Instead of proceeding to initiate a Phase III trial for all types of non small-cell lung cancer, two Phase II trials in BAC are now being planned. One of these trials is expected to be sponsored and partially funded by the Southwest Oncology Group (SWOG), a cooperative clinical trials group of the National Cancer Institute (NCI), and the other trial will be sponsored by Cell Genesys. While the specific study designs are currently under discussion, the two trials will include approximately 100 patients total and are targeted to begin in the late 2002 to early 2003 timeframe. Data from these trials could be part of future regulatory filings for product approval.
In order to develop an acceptable product approval strategy, Cell Genesys recently met with the FDA (Food and Drug Administration) to discuss the company's future plans for the GVAX® lung cancer vaccine program. The FDA indicated that the company's proposed design of Phase III trials, as well as the design of its manufacturing facility in Memphis, TN, for the production of patient-specific lung cancer vaccines were generally acceptable. Additional information was requested by the FDA on product testing related in part to the company's plan to use a semiautomated closed manufacturing system designed to facilitate the commercialization of patient-specific vaccines. The requested information will be derived in part from the BAC clinical trials mentioned above as well as from additional laboratory studies. Based on these plans, a Phase III trial in all types of non small-cell lung cancer could be targeted for late 2003.
Future Plans for GVAX® Prostate Cancer Vaccine
Cell Genesys is currently developing a non patient-specific GVAX® vaccine for prostate cancer, which is being formatted as an "off-the-shelf" pharmaceutical product. Recently reported clinical data for this product are also encouraging. At the American Society of Clinical Oncology (ASCO) meeting in May 2002, long-term survival data from a Phase II multicenter clinical trial of GVAX® prostate cancer vaccine were presented demonstrating a dose-dependent trend toward prolonged survival in patients with hormone refractory prostate cancer metastatic to bone. In the 34-patient study, seven of 10 (70 percent) patients receiving the higher dose level of the vaccine were reported to be alive 2.5 years after treatment (median survival greater than 30 months). Of the 24 patients receiving the lower dose of the vaccine, nine of 22 patients (41 percent) were reported to be alive 2.5 years after treatment (median survival 22 months), and two were lost to follow-up. These results compare favorably to the reported median survival of seven to 11 months for hormone refractory prostate cancer patients with bone metastases who are treated with mitoxantrone chemotherapy, the currently approved treatment for this patient group. Based on the survival data in the Phase II trial, GVAX® prostate cancer vaccine is now being prioritized as the company's lead program for advancement into a Phase III trial, which is targeted to begin in the first half of 2003.
About GVAX® Cancer Vaccines
Cell Genesys' 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, and the company is currently evaluating these products in five types of cancer -- prostate, lung, pancreatic, leukemia and myeloma. Currently, Cell Genesys is evaluating non patient-specific, off-the-shelf GVAX® vaccines for prostate cancer and pancreatic cancer and patient-specific, individualized vaccines for lung cancer, leukemia and myeloma. With all tumor types and vaccine formats tested, GVAX® cancer vaccines have demonstrated a favorable side effect profile and have been safely administered to over 400 patients to date.
About Cell Genesys
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 prostate cancer, lung 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.
Statements made herein about Cell Genesys and its subsidiaries, other than statements of historical fact, including statements about the progress and reports of clinical trials, timelines and future plans for clinical programs, marketability and success of potential products and nature of product pipelines, licensing agreements and intellectual property 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 success and results of clinical trials, the regulatory approval process, competitive technologies and products, patents and 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 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.
CONTACT: Jennifer Cook Williams, Associate Director of Corporate Communications of Cell Genesys, Inc., +1-650-425-4542.
SOURCE: Cell Genesys, Inc. |
