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LIPOSOME COMPANY'S FOURTH DRUG ENTERS CLINICAL TRIALS; BEING DEVELOPED TO TREAT OFT-FATAL LUNG DISEASE

 LIPOSOME COMPANY'S FOURTH DRUG ENTERS CLINICAL TRIALS;
 BEING DEVELOPED TO TREAT OFT-FATAL LUNG DISEASE
 PRINCETON, N.J., Aug. 20 /PRNewswire/ -- A new drug for the treatment of Adult Respiratory Distress Syndrome (ARDS) has entered clinical trials. The Liposome Company, Inc. (NASDAQ: LIPO) today began giving its TLC C-53 to human volunteers in a Phase I study. The purpose of the Phase I study is to confirm the drug's safety in healthy human volunteers and to determine an appropriate dosing regimen based on the drug's action upon certain cellular functions. If Phase I is successfully completed, the drug would then be tested for efficacy and safety in Phase II in patients with ARDS.
 TLC C-53 consists of liposome-encapsulated prostaglandin E1 (PGE1). Because of its postulated unique mechanism of action, it may have utility in a broad range of inflammatory and vaso-occlusive diseases.
 ARDS is a condition stemming from a variety of insults, including trauma, burns, sepsis, aspiration, and hyperoxia. The condition is characterized by the lungs filling with fluid that leaks out of injured blood vessels. The blood vessels are injured by certain chemicals that are released as part of an inflammatory response triggered by these insults.
 Once the lungs fill with fluid, breathing becomes difficult, and 50-60 percent of patients die. Patients die because the lungs are so full of fluid that oxygen can no longer get into the blood. There are currently no effective drugs for this condition, which results in over 100,000 deaths per year in the U.S.
 In a preclinical model of ARDS tested at the Webb-Waring Lung Institute, one of the country's leading ARDS research centers, it was shown that TLC C-53 could dramatically reduce the inflammatory response in the lung and significantly prevent the leakage of fluid into the lung. Based on these positive preclinical results, the drug will now be tested in people.
 TLC C-53 is believed to be able to inactivate neutrophils, platelets, and endothelial cells, and to prevent them from adhering or sticking together. Neutrophils and platelets are cells that circulate in the blood. Endothelial cells line the walls of the blood vessels, including veins and arteries. When neutrophils and endothelial cells become activated and adhere to each other, a series of cellular and biochemical reactions is triggered, which can lead to tissue and organ damage, known as inflammation. This type of inflammation is thought to be one of the prime culprits in many serious illnesses, including ARDS. It has been hypothesized that by preventing neutrophil activation and migration, it may be possible to reduce ARDS lung injury.
 The results of the Webb-Waring study were presented in May at the annual meeting of the American Society for Clinical Investigation and at the annual meeting of the American Lung Association.
 "While free PGE1 has been effective in some animal models, it has proved disappointing in patients with ARDS," said John Repine, M.D., director of the Webb-Waring Lung Institute and Professor of Medicine at the University of Colorado. "Our study demonstrates that liposomal PGE1 works much better than free PGE1 to decrease neutrophil-medicated lung injury. We have hypothesized that this may be because liposomal PGE1 has an affinity for neutrophils."
 "There is considerable evidence that activated neutrophils are involved in the development of ARDS," said Repine. "They also may be the culprit in a number of serious inflammatory conditions, including reperfusion injury after heart attacks and other disorders. Accordingly, an agent that could inactivate many of the functions of neutrophils has the potential for limiting the development or extent of these diseases."
 TLC C-53 is being studied preclinically for the treatment of a variety of inflammatory and vaso-occlusive disease conditions, including sepsis syndrome and reperfusion injury following acute myocardial infarction, as well as for the prevention of restenosis after angioplasty.
 The Liposome Company filed an IND (Investigational New Drug) application with the U.S. Food and Drug Administration in July, and this week received permission to initiate the human trials.
 The Phase I study will be conducted by Edward A. Kelly, M.D., of Pharmaceutical Product Development, Inc. at their North Carolina clinical research unit.
 A leading company dedicated exclusively to the development of liposome and lipid-based pharmaceuticals, The Liposome Company selectively develops proprietary parenteral pharmaceuticals for the treatment, prevention and diagnosis of life-threatening illnesses. TLC C-53 is the company's fourth drug in clinical trials. TLC ABLC is in Phase II/III studies for the treatment of systemic fungal infections; TLC G-65 is in Phase II trials in the U.S. and Phase III in Europe for the treatment of Mycobacterium avium-intracellulare (MAI) infections in AIDS patients; and TLC D-99 is in Phase II for treatment of metastatic breast cancer.
 -0- 8/20/92
 /CONTACT: Anne M. Van Lent, senior vice president of The Liposome Company, 609-452-7060/
 (LIPO) CO: Liposome Company, Inc. ST: New Jersey IN: MTC SU:


TS-OS -- NY006 -- 1621 08/20/92 10:10 EDT
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Date:Aug 20, 1992
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