SemiBull,
Let's go ahead and archive the text, as Yahoo! links expire within a few months, and we may want to look back on this for what it says about the trial design. It's usually possible to find the protocols for cancer trials online, so we can hunt for it. If initiated it may already be up; I'll have a look later if no one beats me to it. Busy today. Still has 10.50% of ABGX . . .
>>FOSTER CITY, Calif., Oct. 22 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today announced the initiation of a Phase II clinical trial of GVAX® vaccine in patients with pancreatic cancer who have undergone surgical resection of their tumor. This trial was prompted by compelling results from an initial Phase I clinical trial of GVAX® pancreatic cancer vaccine which demonstrated antitumor immunity and prolonged, ongoing disease-free survival for as long as four years in a subset of patients. The new Phase II trial will evaluate the safety and efficacy of GVAX® cancer vaccine used in combination with surgical resection of pancreatic cancer followed by standard adjuvant radiation and chemotherapy. The study is being conducted at the Johns Hopkins Oncology Center and will enroll up to approximately 60 patients.
The initial Phase I trial of GVAX® pancreatic cancer vaccine was conducted in 14 patients who received the vaccine following surgical resection of their tumor along with standard adjuvant radiation and chemotherapy. It was reported in January 2001, in connection with a report on the trial in the Journal of Clinical Oncology, that three of eight patients who received the higher doses of the vaccine in combination with surgery and standard adjuvant therapy were alive and disease-free at 38, 35 and 33 months after diagnosis. Ten months later, these patients remain disease-free at 48, 45 and 43 months after diagnosis. The three patients with prolonged disease-free survival also had biopsy-proven vaccine-induced antitumor immunity, a finding which was absent in the other five patients in the same treatment groups who had progressive pancreatic cancer. 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. As with other GVAX® clinical trials, vaccine treatment was safe and generally well tolerated.
``We are encouraged by the initial results obtained with GVAX® pancreatic cancer vaccine particularly with respect to the three patients who are disease-free for as long as four years after diagnosis,'' stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. ``As a result of these findings, we are not only supporting this new Phase II trial at Hopkins in patients with pancreatic cancer who can undergo surgery, but also a second Phase II trial in patients with inoperable pancreatic cancer expected to begin in early 2002.''
Pancreatic cancer, a highly lethal cancer, is the fourth leading cause of cancer death in the United States. Because symptoms are non-specific, cancer of the pancreas is rarely diagnosed at an early stage leaving surgical removal of the tumor as a treatment option for approximately 20 to 30 percent of pancreatic cancer patients. The average life expectancy following diagnosis is less than one year.
The GVAX® vaccine being evaluated in this Phase II trial is comprised of a non patient-specific vaccine which will be developed as an ``off the shelf'' pharmaceutical product. The vaccine will be administered before and after the post-operative radiation and chemotherapy as an intradermal (under the skin) injection. Patients will generally receive four vaccine treatments and will then be monitored for treatment effect using standard clinical and radiologic tests.
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 vaccines have demonstrated antitumor effects against every type of human cancer against which they have been tested to date including pancreatic cancer, lung cancer, prostate cancer, renal cancer and melanoma. Cell Genesys is currently evaluating non patient-specific GVAX® cancer vaccines in pancreatic and prostate cancer and patient-specific, individualized vaccines in lung cancer and myeloma.
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 the company's GVAX® vaccines are under way in prostate cancer, lung cancer, pancreatic cancer and myeloma with plans to initiate a trial for acute leukemia in late 2001. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include gene therapies and oncolytic virus therapies for multiple types of cancer as well as gene therapy for hemophilia. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold a 10.5 percent equity interest in its former subsidiary, Abgenix, an antibody products company. For additional information, please visit the company's website at www.cellgenesys.com.
Clinical Trial Enrollment Information
Patients seeking information about how to participate in the GVAX® pancreatic cancer vaccine trial can obtain information by visiting the company's web site at www.cellgenesys.com or by calling 650-425-4542.
Statements made herein, other than statements of historical fact, including statements about the progress, reports and timelines of GVAX® cancer vaccine clinical trials, the company's progress and results of other clinical trials and preclinical programs, and 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 research and development programs, the success and results of clinical trials, successful development of large scale manufacturing capabilities, 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 2, 2001 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.<<
BTW, SB, is your handle a double entendre for partially bullish generally and specifically bullish on the semiconductor conductor, or is it one or the other? This has been keeping me awake nights.
Edit: Actually, not a hard find, that protocol:
>>Trial Number:G-0010
Objectives:
Evaluate safety in patients receiving 2 different doses of GVAX® Prostate Cancer Vaccine.
Evaluate the pharmacokinetics of serum GM-CSF levels after each vaccination
Evaluate the efficacy of GVAX® Prostate Cancer Vaccine.
Eligibility:
Metastatic hormone-refractory prostate cancer with PSA greater than 5 ng/mL
No bone pain or history of bone pain
No previous gene therapy, chemotherapy, biologic therapy or immunotherapy
Treatment:
Patients will receive 6 doses of vaccine at 28-day intervals. There will be a follow-up visit 28 days after the last vaccination and then two follow-up visits at 4 and 7 months after the last treatment. The duration of the study is one year.
In order to assist you and your physician with determining whether this trial may be appropriate for you, major eligibility criteria are listed above. If you live near one of the clinical trial sites and believe you may be a candidate for this clinical trial, please contact the clinical trial site directly. The contacts are listed below.
Participating Clinical Trial Sites:
John Corman, MD
Virginia Mason Medical Center
Seattle, Washington
Contact: Leanne Geddeis
(206) 341-0578
Celestia Higano, MD
University of Washington Medical Center
Seattle, Washington
Contact: Sonja Peterson
(206) 288-1188
Eugene Dula, MD
West Coast Clinical Research
Van Nuys, California
Contact: Brenda Fulham
(818) 901-8546 Ext 124
Jay Young, MD
South Orange County Medical Research
Laguna Woods, California
Contact: Erika Pirtle or Christie Leach
(949) 855-1011
Eric Small, MD
UCSF
San Francisco, California
Contact: Dr. Small
(415) 353-7095
Arturo Centeno, MD
Urology San Antonio Research
San Antonio, Texas
Contact: Roland Enriquez or Yvette Delgado
(210) 477-8839
Jonathan Simons, MD
Emory University
Atlanta, Georgia
Contact: Mitch Gibbs
(404) 778-4302
Marc Gittelman, MD
South Florida Medical Research
Aventura, Florida
Contact: Maya Raismenahem
(305) 931-8080
David C. Smith, MD
University of Michigan
Ann Arbor, Michigan
Contact: Dr. Smith
(734) 936-8906
Christopher Steidle, MD
Northeast Indiana Research
Fort Wayne, Indiana
Contact: Carol Gregory
(219) 434-1939
Additional clinical trial sites are expected to be added over the coming year as the series of GVAX® prostate cancer vaccine studies is expanded.<<
Cheers, Tuck |
