Data Gathered from a Larger Patient Population with Ten-Year Follow-Up Consistent with Previously Reported Data
New Findings Suggest Improved Survival Even After Patient Relapse
Data Presented at the Annual Meeting of the American Society of Clinical Oncology
AVAX Technologies, Inc. (NASDAQ: AVXT) today announced the presentation of data at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO)(May 20-23) in New Orleans on the company's autologous cell vaccine (AC Vaccine™) M-Vax™ for the treatment of metastatic melanoma. The data from additional studies confirm and expand the results of a study published in 1997 showing that M-Vax increases the survival rate of patients with advanced Stage III melanoma, even after disease recurrence.
The trials, which began in 1989, include 214 patients. All had melanoma with large (at least 3 cm diameter) regional lymph node metastases. Following removal of the lymph node masses, patients were treated with M-Vax by one of four dosage-schedules. The median follow-up time for these patients is 4.4 years, and the longest is over 10 years. Fifty-four patients have been observed for five years or more. M-Vax caused no major side effects.
The overall five-year survival rate from all these trials for patients with spread of melanoma to one nodal area was 50%, versus historical five-year survival rates of approximately 20-25% for patients treated with surgery alone. Of note, this group included high-risk patients with clinical features usually associated with poor prognosis, such as in-transit metastases, tumor masses that spread to the skin between the primary site and the lymph node. Another high-risk group treated in this study included patients with spread of melanoma to two nodal areas. In this group, the five-year survival was 35%, versus a 10% five-year survival rate when patients are treated with lymph node surgery alone.
A second major finding of these studies was that patients who developed an immune response against their melanoma following administration of M-Vax had a far better outcome: 65% survived five years, compared to 32% who did not develop immunity. The response was measured by performing a delayed-type hypersensitivity (DTH) skin test using the patients' own melanoma cells. A positive DTH reaction was also associated with increased overall survival even in patients who had relapsed: 38% of relapsed patients survived five years if they had developed anti-melanoma immunity as a result of vaccine treatment. These findings highlight the immunologic activity of M-Vax, suggesting that the vaccine is training the patient's immune system to attack their own cancer. In addition, the ability to produce positive immunologic endpoints is viewed as an advantage by many researchers, since achieving such endpoints not only validates the immunologic activity of the therapy, but may also provide an early indication of whether such therapy will be clinically active.
The studies were conducted by David Berd, M.D., principal investigator, inventor of the AC Vaccine, and Professor of Medicine, Kimmel Cancer Center, Thomas Jefferson University. Dr. Berd commented, "This study has allowed us to determine the dose and injection schedule of M-Vax that was most effective in inducing a DTH skin test response. We have utilized that dosage schedule for AVAX's pivotal trial, in which we are prospectively comparing M-Vax™ with the standard post-surgical treatment for Stage III melanoma, alpha interferon." Berd added, "It is important to note that even patients who develop recurrent melanoma following administration of M-Vax may enjoy prolonged survival if they develop immunity to their cancer."
Jeffrey M. Jonas, M.D., President and CEO of AVAX Technologies, stated, "These data, which suggest enhanced survival even after patients experience a relapse, corroborate our initial published reports and provide strong rationale for the ongoing multi-center randomized trial comparing M-Vax with alpha interferon. We believe that the confirmation of our earlier findings, showing the relationship between the ability of M-Vax to produce a positive DTH skin test and patient survival, serves to illustrate the robust immunologic activity of the AC Vaccine™ technology. It is our belief that autologous vaccines, which are made from a patient's own tumor cells, provide potential therapies for patients with a wide variety of cancers. Therefore, we are also currently conducting several studies in patients with other types of tumors."
To date, more than 350 patients have been treated with M-Vax™ with no serious adverse events having been found. M-Vax™ has received orphan drug status in the U.S., and is expected to become commercially available to patients in Australia in mid-2000. The AC Vaccine technology is also being evaluated in a multi-center Phase 2 trial in ovarian cancer (O-Vax™), a Phase 1/2 equivalent trial in breast cancer with The University of Tokyo, and a Phase 1/2 trial in acute myelogenous leukemia (L-Vax™) at the MD Anderson Cancer Center.
AVAX Technologies, Inc. specializes in the development and commercialization of novel biotechnologies, immunotherapies and pharmaceuticals for cancer and other life-threatening diseases using three core technologies: autologous cell (AC) vaccines, topoisomerase inhibitors and anti-estrogens.