One of these days, the street is going to give some value to these sorts of results from CEGE - and we will start to trade above the book value.
Wednesday May 17, 7:30 am Eastern Time
Cell Genesys Reports Encouraging Preclinical Data for GVAX(R) Vaccine in Acute Leukemia Studies Demonstrated Improvement in Tumor-Free Survival
FOSTER CITY, Calif., May 17 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) collaborators at Johns Hopkins University reported today that in animal studies of acute leukemia, GVAX© cancer vaccine, administered following bone marrow transplantation, significantly prevented tumor relapse and increased the therapeutic benefit of transplantation. Tumor-free survival rates were approximately 80 percent in animals receiving the combination of GVAX© vaccine and transplantation, 40 percent in animals receiving vaccination alone and zero percent in animals receiving neither treatment. Additionally, GVAX© vaccination resulted in the sustained production of an expanded population of tumor-specific immune cells, thereby redirecting the immune system to recognize and destroy tumor cells. This study, published by Hyam I. Levitsky, M.D., Ivan Borrello, M.D., and their colleagues at Johns Hopkins University School of Medicine in the May 15, 2000 issue of the journal, ``Blood,'' provides a model for how to use GVAX© cancer vaccine following bone marrow transplantation in humans with hematologic cancers such as acute leukemia and multiple myeloma. Human clinical trials for GVAX© vaccine in leukemia and myeloma are currently planned to start during the next year.
``These preclinical data strongly support the initiation of human clinical trials in GVAX© cancer vaccine following bone marrow transplantation in patients with acute leukemia and other hematologic malignancies,'' stated Dr. Levitsky, associate professor of oncology and medicine at Johns Hopkins University School of Medicine. ``Although autologous bone marrow transplantation is currently employed in the treatment of acute leukemia and multiple myeloma, relapse rates remain unacceptably high. We are encouraged that in these preclinical studies, GVAX© cancer vaccine not only significantly reduced tumor
relapse but also resulted in the generation of a sustained increase in the numbers of antitumor immune cells, increasing the therapeutic benefit of transplantation.''
In the preclinical study described in the ``Blood'' paper, GVAX© cancer vaccine was administered to two groups of mice -- those which received marrow transplants and those which did not. It was observed that post-transplant administration of GVAX© generated more effective antitumor immune responses than vaccination in the non-transplant group in several distinct assays of immune function. It was also reported that GVAX© vaccine resulted in the sustained activation of tumor-specific immune cells and that this effect correlated closely with improved tumor-free survival in the transplant animals.
Autologous (patient-specific) bone marrow transplantation is currently being used to treat hematologic cancers in order to reduce the bone marrow toxicity of high dose chemotherapy. In the human trials of GVAX© vaccine in acute leukemia and multiple myeloma that are currently being planned, patients will be treated with chemotherapy to induce remission and will then be vaccinated before and after autologous bone marrow transplantation. The form of GVAX© vaccines used in these trials will be a mixture of the patient's irradiated tumor cells collected prior to chemotherapy and a non-patient specific GVAX© product produced at Cell Genesys. The goal of GVAX© vaccine therapy in this setting is to stimulate an immune response directed against the patient's tumor cells and prolong the remission induced by chemotherapy and transplantation.
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. The company's lead GVAX© cancer vaccine program employs a non patient-specific form of the vaccine for patients with prostate cancer which will be commercialized as an off-the-shelf pharmaceutical. Prostate cancer GVAX© is currently being evaluated in two multicenter Phase II trials, the results of which are expected to be reported late this year. A non patient-specific form of GVAX© vaccine is also being evaluated in patients with pancreatic cancer. The results of an initial pilot study of pancreatic cancer GVAX© conducted at Johns Hopkins University School of Medicine will be reported at the American Society for Clinical Oncology Meeting this month. Cell Genesys is developing GVAX© cancer vaccines for prostate cancer and lung cancer through a worldwide collaboration with the pharmaceutical division of Japan Tobacco Inc. (JT) and retains worldwide rights to all other cancers including leukemia, myeloma and pancreatic cancer.
Cell Genesys is focused on the development and commercialization of gene therapies to treat cancer and other major, life-threatening diseases. The company is conducting two multicenter Phase II human clinical trials for its GVAX© cancer vaccine in prostate cancer and a multicenter Phase I/II trial of GVAX© vaccine in lung cancer. Preclinical stage programs include gene therapy for hemophilia, cancer, cardiovascular disorders and Parkinson's disease. Cell Genesys' assets outside gene therapy include approximately 12 percent ownership of its former subsidiary, Abgenix, Inc., and the company's licensing program in gene activation technology. For additional information, please visit the company's web site at www.cellgenesys.com. |
