To: MARK TANAKA who wrote (652 ) 2/18/1999 7:34:00 AM From: sylvan Respond to of 900
Company Press Release SOURCE: The Liposome Company Liposome Initiates Phase I Clinical Trial of TLC ELL-12 PRINCETON, N.J., Feb. 18 /PRNewswire/ -- The Liposome Company (Nasdaq: LIPO - news) today announced the initiation of a Phase I clinical trial with TLC ELL-12, a novel anticancer agent. TLC ELL-12 is a liposomal ether lipid, developed from the Company's research efforts into bioactive lipids. The goal of this study is to test the safety of the product in patients with advanced solid tumors, including non-small-cell lung, prostate and melanoma. The Phase I clinical trial was recently initiated at Duke University. ''We are always concerned that something unexpected might happen when giving a novel anticancer agent for the first time,'' said Dr. Michael R. Cooper, Director of Experimental Therapeutics Program, Division of Medical Oncology at Duke University. ''Fundamentally, there were no surprises with the first patient treated.'' ''Ether lipids have been shown to be active in treating cancer in humans, but can be highly toxic to red blood cells. In developing a liposomal formulation we have been able to mitigate this hemolytic toxicity while enhancing the activity of the parent compound,'' according to Dr. Andrew Janoff, Vice President of Research and Development for The Liposome Company. ''We have demonstrated anticancer activity in experimental animal models of non-small cell lung cancer, melanoma, leukemia and human prostate cancer, as well as in multiple-drug resistant cell lines. TLC ELL-12 does not interact with DNA either, so it is not myelosuppressive, which is quite unusual for a cytotoxic agent.'' Dr. Janoff noted that although anticancer products, including those in The Liposome Company's preclinical pipeline, may perform well in animal models, a degree of caution is warranted. The true potential of a product will not be evident until after the product has performed in controlled human studies. The Liposome Company is a biopharmaceutical company developing, manufacturing and marketing therapeutic products to treat cancer and related diseases. ABELCET® is marketed in the U.S. and 22 other countries for the treatment of severe, systemic fungal infections in patients who are refractory to or intolerant of conventional therapy and is the leading lipid-based formulation of amphotericin B in this country. The Company's product pipeline includes EVACET(TM), TLC ELL-12 and bromotaxol for the treatment of various cancers and programs focused on the development of new cancer therapies and vehicles for the delivery of gene therapy. Except for historical information, this press release contains forward- looking statements that involve risks and uncertainties, including but not limited to statements regarding future sales growth prospects for ABELCET®, the ability of ABELCET® to maintain its position as the leading lipid-based formulation of amphotericin B in the U.S., the likelihood that EVACET(TM) or any other product in the research pipeline can receive regulatory approval in the U.S. or abroad or be successfully developed, manufactured and marketed and the uncertainty of future profitability. While these statements reflect the Company's best current judgment, they are subject to risks and uncertainties that could cause actual results to vary, including the risk factors identified in the Registration Statement on Form S-3 dated October 29, 1997 and from time to time in the Company's other SEC filings. This press release and other information are available at LIPO.COM®. SOURCE: The Liposome Company