Kansas City, MO, July 18, 2000 -- AVAX Technologies, Inc. (NASDAQ: AVXT) today announced that its autologous cancer vaccine (AC Vaccine™) for melanoma, M-Vax™, is now commercially available in Australia, for administration to individuals with Stage III melanoma metastatic to the lymph node. This marks the first time a centrally produced autologous cancer vaccine for melanoma, custom-made from the patient's own tumor cells, has been made commercially available anywhere. AVAX Australia Pty. Ltd., a joint venture between AVAX Technologies and Australian Vaccine Technologies Ltd. (AVT), will market the vaccine and conduct day-to-day operations. Although M-Vax is only available in Australia, AVAX is exploring options for providing the vaccine to patients in a number of European countries. In the United States, a multi-center pivotal registration trial of M-Vax for Stage III melanoma is currently underway to meet U.S. regulatory requirements. A Phase 2 trial using M-Vax for the treatment of Stage IV melanoma is also being conducted. The company's AC Vaccine technology is also in human clinical trials for ovarian cancer, acute myelogenous leukemia (AML) and breast cancer.
Jeffrey M. Jonas, M.D., president and chief executive officer of AVAX Technologies, Inc., stated, "This is an important milestone not only for AVAX, but for cancer patients, the physicians who treat them and cancer researchers worldwide. Our quest has always been to develop a cancer vaccine with therapeutic potential that is essentially non-toxic. M-Vax is a valuable treatment option for people in Australia with melanoma metastatic to the lymph node, who currently have few treatment options. In hundreds of U.S. patients with Stage III melanoma treated in clinical trials, M-Vax has been associated with up to 50-55% five-year survival with no serious side effects. We are now able to provide this treatment option to the Australian market, which has the highest melanoma incidence in the world.
"Given the strength of our clinical data and the safety profile of this product, our ultimate objective is to offer this treatment option to melanoma patients worldwide, as quickly as possible. Australian commercialization is a significant achievement in reaching this goal as it allows AVAX the opportunity to validate its business model."
Melanoma is the most serious form of skin cancer and afflicts approximately 400,000 people worldwide. Australia has the highest melanoma incidence per capita in the world, with a 1999-projected incidence of 8,500 new cases [Source: Australian Institute for Health and Welfare]. The current approved treatment for Stage III melanoma (metastasis to regional lymph nodes) in the United States is surgical removal of the tumor mass (debulking), followed by high-doses of alpha interferon.
"This has been a very exciting time for AVAX. Recently, we gathered 10-year long-term survival data in 214 patients, with Stage III melanoma," continued Dr. Jonas. "In this study, we had a median follow-up of 4.4 years, with the longest follow-up obtained for over 10 years. Remarkably, in this analysis, the overall five-year survival rate for patients with spread of melanoma to one nodal area was 50% compared to the 20%-22% survival historically associated with surgery alone. The five-year survival rate in patients with metastases to two nodal areas was 35%, demonstrating meaningful improvement over historical results. These additional data encourage us to continue the development of our technology, not only in melanoma but in other cancers as well. As we cultivate commercial opportunities abroad, we have four additional clinical trials in progress in the U.S. that are evaluating our AC Vaccine technology's potential in treating solid tumors, such as ovarian cancer, as well as liquid tumors such as AML."
AVAX Technologies currently owns a 65% interest in the AVAX Australia joint venture, which is marketing M-Vax. To date, AVAX Australia has received a total of $7.0 million (AUD) from Australian Vaccine Technologies (AVT), formerly Neptunus International Holdings, for a 35% interest in the joint venture entity. AVT also has the option to purchase an additional 15% interest for $3.0 million (AUD). Under the terms of the agreement, AVAX Technologies has been granted an option to purchase common stock equivalent to 5% of AVT's fully diluted shares. AVT trades on the Australian Stock Exchange (ASX) under the symbol "AVT".
To date, more than 400 patients have been treated with M-Vax, under U.S. clinical trials, with no serious side effects. M-Vax has received orphan drug status in the U.S. 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. The AC Vaccine technology was invented by David Berd, M.D., professor of medicine at the Kimmel Cancer Center at Thomas Jefferson University in Philadelphia.
M-Vax is produced in Australia through a contract manufacturing agreement with Bioenterprises Pty. Ltd.
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: the AC Vaccine technology, topoisomerase inhibitors and anti-estrogens.