Liposome Technology Inc. (LTI) said Wednesday that it is startingthree additional Phase II trials of DOX-SL in patients with solidtumors, bringing to five the number of cancer indications being testedby LTI in Phase II trials.LTI, of Menlo Park, Calif., is starting the trials in ovarian cancer, breastcancer and soft tissue sarcomas. In May, the company started Phase IItrials in hepatocellular (primary liver) cancer patients and expanded itsstudy in non-small cell lung cancer.DOX-SL is LTI's proprietary long-circulating Stealth liposomeformulation of the anti-cancer compound doxorubicin hydrochloride.The technology enables liposomes, coated with polyethylene glycol, toelude the body's immune system and remain in circulation longer thatconventional liposomes.The company also said it expects to file a new drug application thisquarter for the use of DOX-SL in treating AIDS patients with Kaposi'ssarcoma (KS) who cannot tolerate or have failed conventionalchemotherapy. Peter Leigh, LPI's vice president finance, toldBioWorld that enrollment has been completed in a Phase III trialcomparing DOX-SL with the standard three-drug regimen for KS. Thattrial is meant to demonstrate the efficacy of DOS-SL as a primarytherapy."This is part of the implementation of a strategy chosen by thiscompany as long as four years ago," Leigh said. "It was to develop thedrug first in an AIDS-related indication, where we saw promisingresponses in early clinical trials, to get the drug approved in the earliesttimeline and simultaneously expand the clinical development of thedrug."The ovarian cancer study will be held in Southern California andinclude up to 30 patients who have failed both platinum- and taxol-based regimens. The first of up to 40 patients have been dosed in thePhase II soft tissue sarcoma study being conducted in Marin County,Calif. And the breast cancer trial, being performed in the U.K., willinclude up to 60 patients with metastatic cancer.Leigh said there likely will be additional Phase II studies, with one goalbeing to "give us the appropriate information on which to design PhaseIII trials in one or more of these cancers based on what we see in theselimited-size Phase II trials."Liposome (NASDAQ:LPIZ) stock was down 25 cents per shareWednesday, closing at $5.50. n
-- Jim Shrine
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