85% Survival Rate in High-Risk Melanoma Patients Who Were Tumor-Free at Two Years
New Data Presented at the 26th Annual Scientific Meeting of the Clinical Oncological Society of Australia, the Company's First Commercialization Market
KANSAS CITY, MISSOURI -- NOVEMBER 29, 1999 @ AVAX TECHNOLOGIES, INC. ("AVAX") (Nasdaq: AVXT) today announced nine-year follow-up data of stage III melanoma patients from company-sponsored Phase 2 studies of M-Vax™, an individualized cell-based vaccine for cancer and the company's lead development product. Ernest W. Yankee, Ph.D., the company's Executive Vice President, presented these groundbreaking data at the 26th Annual Scientific Meeting of the Clinical Oncological Society of Australia in Melbourne on November 26, 1999. Australia has the highest per capita incidence of melanoma in the world, three times the U.S. rate. AVAX plans to begin marketing M-Vax in Australia early next year.
David Berd, M.D., Professor of Medicine, Thomas Jefferson University, and the inventor of M-Vax, began studies of M-Vax in 1989 and now has a sufficient number of patients in these studies to conduct this long-term analysis. At the conference, Dr. Yankee highlighted results from 71 patients who were melanoma free for at least two years following treatment with M-Vax and then monitored for up to 9.8 years (median follow-up time 5.3 years). The nine-year overall survival rate was approximately 85% in this group of patients, demonstrating that the clinical response to M-Vax therapy is long lasting. The data also demonstrate a nine-year relapse-free survival rate of 80% in these patients. No serious or long-term toxic effects of M-Vax were observed in any of these patients. Confirming earlier findings, a patient's clinical outcome was strongly influenced by the development of cell-mediated immunity to the patient's own melanoma cells. Cell-mediated immunity is an important factor in determining whether a patient is mounting an immune response against his/her own cancer as a result of treatment with the cancer vaccine. It is measured by a simple skin test called a DTH (delayed-type hypersensitivity) test that is administered to the patient after the vaccine treatment is completed.
Of these 71 patients, all of whom had received M-Vax after surgical debulking of bulky regional lymph node metastases, over half had entered the studies with one or more widely recognized indicators of poor prognosis. These included in-transit metastases (spread of the cancer between the initial lesion and the lymph node group) or spread of the cancer to multiple lymph nodes. -more- AVAX Technologies Announces Long-Term Follow-Up Data of High-Risk Melanoma Patients Treated with M-Vax™ Cancer Vaccine Page 2
"There are several experimental vaccines administered post-surgically that claim prolonged survival rates in stage III melanoma patients," stated Dr. Yankee. "These survival rates are generally calculated on the basis of estimates and not on actual observations. We believe that AVAX is the only cancer vaccine company with strongly positive survival data that extend to five years and beyond in a group of patients that were given very little hope for cure. These data are extremely encouraging, especially since there is a direct correlation between the development of an immune response to the patients' melanoma cells and survival. We believe these findings continue to validate the clinical promise of the company's autologous cell vaccines. We also believe that these vaccines, which are made from a patient's own tumor cells, provide potential therapies for patients with other cancers.
"We anticipate that Australia will be the first country where M-Vax will be made available and are currently exploring other international opportunities to further expand our commercialization efforts. This year, we completed the build-out of a manufacturing facility in the United States and implemented an efficient delivery system, allowing us to deliver vaccines throughout the country, thereby providing custom-made products cost effectively. In fact, we have demonstrated the commercial feasibility of this delivery paradigm by supplying custom-made vaccines to patients around the United States as part of our clinical activities. Once we complete and receive approval for a manufacturing facility in Australia, we believe we will be able to quickly replicate the same delivery paradigm and begin commercialization activities there," added Dr. Yankee.
M-Vax™ is the first of several autologous cell vaccines based on AVAX's proprietary AC Vaccine™ technology. To date, more than 350 patients have been treated with M-Vax on an outpatient basis. M-Vax, which received orphan drug status in the U.S. in February 1999, is currently being evaluated in a multi-center, pivotal registration trial in the United States.
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.
Except for statements that are historical, the statements in this release are "forward-looking" statements that are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements involve significant risks and uncertainties, and in light of the significant uncertainties inherent in such statements, the inclusion of such information should not be regarded as a representation by AVAX that the objectives and plans of the company will be achieved. In fact, actual results could differ materially from those contemplated by such forward-looking statements. Many important factors affect the company's ability to achieve the stated outcomes and to develop successfully and commercialize its product candidates, including, the ability to obtain substantial additional funds, to obtain and maintain all necessary patents or licenses, to demonstrate the safety and efficacy of product candidates at each state of development, to meet applicable regulatory standards and receive required regulatory approvals, to meet obligations and required milestones under its license agreements, to be capable of producing drug candidates in commercial quantities at reasonable costs, to compete successfully against other products, and to market products in a profitable manner, as well as other risks detailed from time to time in AVAX's public disclosure filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31,1998. AVAX does not undertake any obligation to publicly release any revisions to these forward-looking statements or to reflect the occurrence of unanticipated events.