Liposome Technology Inc. said Tuesday that its DOX-SL Stealthliposome product qualified for review under the European Union'sCommittee on Proprietary and Medicinal Products' "high technology"List B regulatory procedure.Under List B regulatory procedures, a company can file for marketingapproval simultaneously in all European Union countries, rather thangetting country-by-country approvals. Liposome plans to file forregulatory approval of its DOX-SL product, a long-circulatingformulation of the anti-cancer compound doxorubicin hydrochloride, totreat Kaposi's sarcoma in AIDS patients, by the end of the year inEurope.Peter Leigh, vice president and chief financial officer for the MenloPark, Calif., company, told BioWorld the List B filing "should be amore efficient, and thus more cost-effective way of getting Europeanapproval. The other advantage is speed."Liposome filed a new drug application in the U.S. on Sept. 7 for DOX-SL to treat Kaposi's sarcoma in AIDS patients who cannot tolerate orwho have failed conventional systemic chemotherapy. The Europeanfiling will differ in that it will seek approval of DOX-SL as a first-linetherapy, Leigh said.Liposome has ongoing Phase III trials in the U.S. and Europecomparing DOX-SL against the standard three- and two-drugregimens, respectively, for Kaposi's sarcoma, which are designed toshow the drugs effectiveness as a primary therapy.Liposome's technology allows liposomes, coated with polyethyleneglycol, to elude the body's immune system. The company has Phase IItests ongoing in ovarian, breast, primary liver and non-small cell lungcancers, as well as soft tissue sarcomas.Liposome stock (NASDAQ:LTIZ) gained 63 cents Tuesday, closing at$7.13 per share. _Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.