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Liquid Shark Cartilage Extract Shows Encouraging Results to Cancer Experts
Date: 98-03-30

NEW ORLEANS, March 30 /PRNewswire/ -- A leading Canadian biotechnology company, AEterna Laboratories, announced very encouraging results from a clinical trial using liquid shark cartilage extract in lung cancer tumors in humans. The results, presented today at the 89th Annual Meeting of the American Association for Cancer Research, confirmed that AE-941 is the first shark cartilage product to show a trend of efficacy without serious side effects related to its administration.

The study was conducted on patients with refractory metastatic lung cancer where they received one of four different doses of AE-941 for a three-month period. The objective of the first part of the study was to establish the safety profile of the product and determine the optimal dose for subsequent studies.

Within the context of the rigorous U.S. and Canadian clinical trial standards, AE-941 displayed no serious adverse events related to the administration of the product. At no time was it necessary to suspend the administration of the product to the patients because of adverse reactions. The study investigators also found that the highest dose of AE-941 produced the greatest efficacy in the patients.

"This trial conducted on late-stage cancer patients is an important milestone in the clinical development of AE-941. More than 300 patients have received the product in the last two years, some of them for more than 18 months," said Dr. Riviere, MD, Vice President of Clinical Affairs at AEterna Laboratories. "The second part of the Phase I/II study started recently in research centers in Canada and the United States."

ANTIANGIOGENESIS LIQUID SHARK CARTILAGE EXTRACT
AE-941 is a liquid shark cartilage extract manufactured under patent, using state-of-the-art cell fractionation and molecular isolation techniques. It is expected to inhibit the growth and spread of cancer tumors by reducing the blood supply to tumor cells in the body. AE-941 has reduced the number of metastases and the growth of the primary tumor in animal studies. Animal models showed a significant 70 per cent reduction in the number of lung metastases and a 60 per cent reduction in the growth of breast primary tumors.

Some new drugs under clinical investigation have serious side effects that limit their further development. Side effects are the primary reason that patients must stop cancer treatments, namely chemotherapy-based treatments. According to the new AE-941 clinical trial results, AE-941 is the first shark cartilage product to show a trend of efficacy without serious side effects related to its oral administration.

"Results obtained to date are very encouraging. An angiogenesis inhibitor has to be administered orally and have minimal or no toxicity in order for the patients to benefit from a long-term administration of a such product," said Dr. Jean Latreille, MD, an oncologist at the Centre Hospitalier de l'Universite de Montreal, Hotel-Dieu Campus and Principal Investigator of this clinical trial. "If the results obtained to date are confirmed while keeping the same type of safety profile, AE-941 could well become a first-line therapeutic weapon to treat cancers."

"We are very pleased with the first results obtained with the collaboration of several university hospitals. These results were well received by the scientific community and enable the company to continue the development of AE-941 as a treatment for lung cancer. The next steps of AE- 941's development will have to confirm the product's efficacy on a larger number of patients," commented Dr. Dupont, Ph.D., President and CEO of AEterna Laboratories.

U.S. CLINICAL TRIAL SITES

U.S. and Canadian cancer researchers are encouraged with recent trial results. Several world-renowned cancer research centers have agreed to participate in clinical trials, including the University of Texas MD Anderson Cancer Center and the North Shore - LIJ Health System in New York. AEterna begun testing AE-941 in the United States after receiving approval of their investigational new drug (IND) application in January, 1997.

The Phase I/II lung cancer results have already been released in Canada under the Timely Disclosure Policy of the Market Surveillance and Disclosure of the Toronto and Montreal Stock Exchanges.

AEterna Laboratories performs research and development activities on drugs that can control diseases complicated by angiogenesis. AEterna is a leading biotechnology company in Canada and is a world leader in the development of anti-angiogenic therapies. All studies on AE-941 have not been completed. Consequently, AE-941 has not been approved yet by competent authorities for its commercialization.


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