I pulled out some interesting parts of the press release from CEGE today and wrote comments after each (marked "****"). Comments are based off my experience working in the pharmaceutical industry and I am a current holder of CEGE shares.
It was reported that a patient with advanced non small-cell lung cancer who had failed standard treatments including chemotherapy, has experienced a complete response to vaccine treatment with the disappearance of all previously detected tumors based on standard radiologic studies.
****non-small cell lung cancer will be huge. Single largest cancer killer worldwide. Advanced non-small cell lung cancer has a 5 year survival rate of 2-5%.
``It is important to note that the CBS news report described the results in only one patient. Any definitive conclusions regarding the therapeutic value of GVAX® vaccines for lung cancer must await the completion of further human clinical trials,''
****results are very preliminary. Nothing is guaranteed.
An earlier Phase I/II trial of GVAX® lung cancer vaccine in patients with advanced non small-cell lung cancer was recently reported at the Ninth World Conference on Lung Cancer in Tokyo, Japan and demonstrated antitumor immunity in 18 of 25 patients.
****anti-tumor activity in 18 of 25 patients (72%). Most chemo combinations given to chemo naive patients in NSCLC has a response of mid-40%s. Chemo given to refractory patients has an even smaller response.
GVAX® vaccines have previously been reported to demonstrate encouraging results in initial clinical trials in prostate cancer and pancreatic cancer.
****Prostate and pancreatic cancers have no current effective chemotherapy treatments. Prostate has surgery if caught early and hormone treatment with certain tumors but advanced stages are really hard/impossible to treat. Pancreatic cancer is a death sentence. If there are no current therapies that are effective, GVAX would fly through the FDA. With great data (I stress the word "great"), Phase III trials can be skipped.
The company's lead GVAX® cancer vaccine program targets patients with recurrent prostate cancer and is currently being evaluated in two multicenter Phase II trials. Additionally, a Phase II trial of GVAX® pancreatic cancer vaccine
Cell Genesys is also developing large scale manufacturing capabilities as well as higher potency GVAX® products for prostate and other cancers that could allow for more efficient vaccine administration.
****new improvements such as higher potency could extend patent life.
Thursday November 16, 7:30 am Eastern Time
Press Release
SOURCE: Cell Genesys, Inc.
Cell Genesys Comments on CBS Segment Highlighting Preliminary Clinical Result In GVAX(R) Lung Cancer Vaccine Trial
FOSTER CITY, Calif., Nov. 16 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE <http://finance.yahoo.com/q?s=cege&d=t> - news </n/c/cege.html>) today confirmed that a news segment aired Wednesday evening on CBS television highlighting an early positive result from Cell Genesys' ongoing Phase I/II GVAX® lung cancer vaccine clinical trial. It was reported that a patient with advanced non small-cell lung cancer who had failed standard treatments including chemotherapy, has experienced a complete response to vaccine treatment with the disappearance of all previously detected tumors based on standard radiologic studies. The patient was treated by John Nemunaitis, M.D., at U.S. Oncology in Dallas, Texas, which is one of eight clinical trial sites participating in this cancer vaccine trial. Cell Genesys had planned to enroll up to 40 patients in the Phase I/II clinical trial but has recently expanded the trial to include up to 80 patients of which more than 60 patients have been enrolled to date. The overall results of this clinical trial are expected to be available in mid-2001.
``It is important to note that the CBS news report described the results in only one patient. Any definitive conclusions regarding the therapeutic value of GVAX® vaccines for lung cancer must await the completion of further human clinical trials,'' cautioned Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. ``We have chosen to issue our comments in order to provide a context for the information contained in the CBS report and otherwise plan to present the results of this clinical trial at a future scientific meeting.''
The currently ongoing multicenter Phase I/II trial of GVAX® lung cancer vaccine is evaluating both early stage lung cancer patients at high risk for recurrence and advanced stage patients who have failed other therapies. An earlier Phase I/II trial of GVAX® lung cancer vaccine in patients with advanced non small-cell lung cancer was recently reported at the Ninth World Conference on Lung Cancer in Tokyo, Japan and demonstrated antitumor immunity in 18 of 25 patients. These two trials have employed a patient-specific product format in which the vaccine is prepared from the patient's own tumor cells in an overnight process that could be carried out at the hospital where the patient is treated. Cell Genesys plans to develop a non patient-specific GVAX® product for lung cancer since other non patient-specific GVAX® vaccines have previously been reported to demonstrate encouraging results in initial clinical trials in prostate cancer and pancreatic cancer.
GVAX® cancer vaccines are comprised of tumor cells which have been 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 then irradiated for safety and used to vaccinate patients to stimulate an immune response against their tumor. The company's lead GVAX® cancer vaccine program targets patients with recurrent prostate cancer and is currently being evaluated in two multicenter Phase II trials. Additionally, a Phase II trial of GVAX® pancreatic cancer vaccine and Phase I trials of GVAX® vaccine for myeloma and leukemia are expected to commence by early 2001. In addition to advancing clinical trials, Cell Genesys is also developing large scale manufacturing capabilities as well as higher potency GVAX® products for prostate and other cancers that could allow for more efficient vaccine administration. |
