Liposome Technology Inc. reported encouraging preliminaryresults from its NDA-track clinical study to determine themaximum tolerated dose (MTD) of Doxil.
An understanding of the MTD of Doxil, LTI's proprietary Stealthliposome formulation of the anti-cancer agent doxorubicin, isrequired for Phase III efficacy studies in cancer patients withsolid tumors.
No dose-limiting side effects were observed followingtreatment of the first cohort of three patients with 60mg/m2,and indications are that Doxil is at least as well-tolerated asdoxorubicin, the Menlo Park, Calif., company (NASDAQ:LTIZ)said. One more dose is required at this level to confirm initialobservations. Dose levels will then be escalated in 20mg/m2increments until the MTD is reached.
In earlier clinical studies of 15 cancer patients designed todemonstrate Doxil localization in solid tumors, also conducted atHadassah Medical Center in Jerusalem, Stealth liposomesdelivered four to 10 times more doxorubicin to tumors than anidentical dose of "free," or unencapsulated, doxorubicin.
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