Liposome Technology Inc. said Wednesday that it submittedmarketing authorization applications (MAA) for its liposomeformulation of doxorubicin, DOX-SL, in the 12 European Unioncountries.
The MAA seeks approval of DOX-SL as a first-line therapy in thetreatment of AIDS-related Kaposi's sarcoma (KS). The Menlo Park,Calif., company filed a new drug application for DOX-SL in the U.S.in September. That filing differed in that it seeks approval of DOX-SL in KS patients who cannot tolerate or who have failedconventional chemotherapy.
DOX-SL is Liposome Technology's long-circulating Stealthformulation of doxorubicin hydrochloride, the world's most widelyprescribed chemotherapeutic agent, a company official said. Thetechnology enables liposomes, coated with polyethylene glycol, toelude the body's immune system and remain in circulation longer.
The European filing was made under the EU's Committee onProprietary and Medicinal Products (CPMP) "high technology" ListB regulatory procedure.
Under that procedure, Peter Leigh, Liposome Technology's vicepresident and chief financial officer, said it generally takes 11 to 18months for a drug to get through the CPMP. If the CPMPrecommends approval, the drug would be approved for all countriesthat don't decline the recommendation, he told BioWorld.
The company has two ongoing Phase III trials of DOX-SL in theU.S. and Europe, comparing it to standard two- and three-drugchemotherapy regimens. "Our DOX-SL product also is in Phase IItrials in a variety of solid tumors, which is the beginning of what weanticipate will be a fairly lengthy clinical development program forthe drug."
Liposome Technology's stock (NASDAQ:LTIZ) was up 25 cents pershare Wednesday, closing at $7.63. _ Jim Shrine
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