Treatment of Ovarian Cancer Accepted By FDA
New Phase 2 Clinical Trials of O-VAX Initiated
AVAX's AC Vaccine Technology Applied to a Second Cancer
Indication
KANSAS CITY, Mo., Jan. 18 /PRNewswire/ -- AVAX Technologies, Inc. (Nasdaq:
AVXT - news) today announced that its corporate Investigational New Drug (IND)
Application for O-Vax(TM), the company's proprietary haptenized autologous cell vaccine
(AC Vaccine(TM)) for the treatment of advanced ovarian cancer, was accepted by the U.S.
Food and Drug Administration (FDA). FDA has authorized AVAX to begin Phase 2 clinical
trials. Accordingly, AVAX has initiated recruitment of clinical sites and patients for the first of
three planned multi-center O-Vax studies that are expected to enroll over 400 patients. This
is the second IND opened in the U.S. by AVAX for the use of their proprietary autologous
vaccines for the treatment of metastatic cancers.
This significant program in ovarian cancer follows two pilot studies of advanced ovarian
cancer patients, which were conducted by David Berd, M.D., Professor of Medicine, and
Charles Dunton, M.D., Professor of Obstetrics and Gynecology, both of Thomas Jefferson
University. Data from these studies indicate that O-Vax was found to induce an
immunological (DTH) response to the patient's own tumor cells. O-Vax, prepared from the
patient's own tumor tissue taken at the time of surgical debulking, is administered to patients
following standard chemotherapy. Although up to 80% of women initially respond to
standard chemotherapy, the majority of these women will subsequently develop recurrent
disease. Currently, there are no therapies available for patients who initially respond to
chemotherapy, but are at high risk of having their cancer return.
Jeffrey M. Jonas, M.D., President and CEO of AVAX Technologies, Inc., stated, ``We are
very excited to build upon the data from many years of research, including two positive pilot
O-Vax studies, to further the advancement of this promising technology. Ovarian cancer is
one of the most common gynecologic cancers, affecting more than 26,000 women in the U.S.
each year. This program also represents a very important corporate milestone, since AVAX
will now begin late stage clinical testing in a second cancer indication. We believe that the AC
Vaccine technology is capable of generating favorable results across a broad range of
cancers and are anxious to apply it in the ovarian cancer setting for which there are few
options to the patient.'
Ovarian cancer is the fifth most common cancer among women and the leading cause of
death from gynecologic malignancy in the U.S. It is estimated that one in 70 women will
develop ovarian cancer in her lifetime.
Two pilot trials of O-Vax in 17 women, reported at the annual meeting of the American
Society of Clinical Oncology in 1999, demonstrated that the therapy appeared to induce
immune responses and possibly extended survival in patients with advanced ovarian cancer.
As reported in 1999, in the first trial, nine patients were treated with six weekly intradermal
injections of O-Vax after debulking surgery and standard chemotherapy. Eight out of these
nine patients were alive (median = 25 months) and three were relapse free. Six of the nine
patients had been sub-optimally debulked, indicating a less favorable prognosis. In the
second study, using the same vaccine regimen, five out of eight patients with advanced, bulky
disease who had failed chemotherapy were also alive (median = six months). Patients
continue to be followed from these study |
