The Liposome Company to Commence Phase I Trial for TLC ELL-12
PRINCETON, N.J., Oct. 27 /PRNewswire/ -- The Liposome Company, Inc. (Nasdaq: LIPO - news) is pleased to announce the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for the Company's third product, TLC ELL-12, an anticancer agent.
This novel drug acts against tumor cells by a mechanism not shared by any currently available anticancer drug. TLC ELL-12 is a formulation of an ether lipid, L-ET-18-OCH3, which acts as a signal transduction modulator. In the 1980's this molecule was shown to selectively inhibit the growth of cancer cells in vitro as well as in a few patients. However, development of L-ET-18- OCH3 was prohibited by hemolytic, gastrointestinal and other toxicities. Liposome Company scientists have developed a liposomal formulation, which reduces these toxicities yet retains, and in some cases enhances, the tumor- specific killing properties seen in the free ether lipid.
In Vitro, TLC ELL-12 has shown potent anticancer activity against drug sensitive and drug resistant cell lines. In Vivo, TLC ELL-12 has shown anticancer activity in mouse models of lung metastasis, primary lung tumors, leukemia and a human prostate tumor. Importantly, unlike most other anticancer drugs, TLC ELL-12 does not cause bone marrow suppression and has shown no negative effects on the gastrointestinal tract.
A Phase I clinical trial has been designed to enroll adult patients with advanced solid tumors, including non-small-cell lung, prostate and melanoma. The Company expects to commence this trial by the end of the year.
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