Cell Genesys news out of ASCO. And Cell Genesys market cap still below the their book value (i.e., the value of their
cash and equity position in ABGX).
biz.yahoo.com
Cell Genesys Reports Positive Results in Initial Clinical Trial of GVAX(R)
Vaccine for Pancreatic Cancer
Prolonged Disease-Free Survival Correlates With Vaccine-Induced Immunity
FOSTER CITY, Calif., May 20 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today reported prolongation of disease-free survival in a Phase I trial of a pancreatic
cancer vaccine in patients who received the vaccine following surgery and adjuvant radiation and chemotherapy. In a trial in fourteen patients conducted at the Johns Hopkins
Oncology Center, three of eight patients receiving the two highest doses of the vaccine are alive and free of disease for more than two years following treatment, while the six patients
receiving the two lowest doses have relapsed. Additionally, all three of the patients with prolonged disease-free survival have biopsy-proven vaccine-induced antitumor immunity, a
finding which was absent in all of the patients who relapsed. 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. These data were presented on May
20, 2000 at the American Society of Clinical Oncology (ASCO) meeting in New Orleans by Elizabeth M. Jaffee, M.D. and colleagues at Johns Hopkins University School of
Medicine. Based on these results, a Phase II clinical trial of pancreatic cancer GVAX© in approximately 60 patients is planned to begin later this year.
``The findings in our initial trial are very encouraging, particularly with respect to the correlation between the vaccine-induced antitumor response and the prolongation of
disease-free survival,'' stated Dr. Jaffee, associate professor of oncology and immunology at Johns Hopkins University School of Medicine. ``Survival rates in pancreatic cancer
patients are extremely poor despite aggressive surgery, chemotherapy and radiation, which is only available to approximately 40 percent of pancreatic cancer patients. We believe that
our results strongly support advancing this vaccine strategy into Phase II trials in pancreatic cancer.''
The Phase I clinical trial in pancreatic cancer conducted at Johns Hopkins University School of Medicine included fourteen patients who underwent surgical resection of the
pancreas and a portion of the small intestine followed by adjuvant chemotherapy and radiation treatment. The vaccine evaluated in this trial is comprised of allogeneic (nonpatient
specific) pancreatic cancer cells genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), an immune stimulatory hormone, and then irradiated
for safety. The vaccine was administered before and after the adjuvant therapy as an intradermal (under the skin) injection. Up to four vaccine treatments were administered. As with
other GVAX© clinical trials, vaccine treatment was safe and generally well tolerated.
In related news at the ASCO meeting, Jonathan W. Simons, M.D. of Johns Hopkins Oncology Center, presented additional data from the first Phase I/II clinical trial for GVAX©
prostate cancer vaccine. Previous reports on this trial demonstrated antitumor activity as measured by prostate-specific antigen (PSA) and antitumor immunity as measured by the
detection of novel anti-prostate cancer antibodies in the vaccinated patients. The new findings reported this week at ASCO indicate a strong correlation between the antitumor effects
induced by GVAX© prostate cancer vaccine and the induction of antitumor immunity as demonstrated by the specific immune cell components of the antitumor immune response
detected on biopsy of the vaccination site. Based on encouraging data from this initial trial, prostate cancer GVAX© is currently being evaluated in two multicenter Phase II trials
which are evaluating higher doses and longer vaccination schedules. The results of these trials are expected to be reported late this year.
GVAX© cancer vaccines are comprised of tumor cells which have been irradiated and genetically modified to secrete 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
vaccine has demonstrated antitumor effects in each of the human clinical trials it has been tested in to date -- prostate cancer, pancreatic cancer, lung cancer, renal cancer and
melanoma. 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. As noted above, a non-patient specific format is also being evaluated in the clinical trials in pancreatic cancer. 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. |
