Liposome Technology Inc. is taking its DOX-SL product before theFDA's Oncologic Drugs Advisory Committee today, seeking arecommendation that could lead to the first U.S. approval of aliposome-based drug.
DOX-SL is the Menlo Park, Calif., company's long-circulating Stealth formulation of doxorubicin hydrochloride. Thecompany is seeking approval of DOX-SL in those with AIDS-relatedKaposi's sarcoma who cannot tolerate or who have failedconventional chemotherapy.
"This technology has been around a long time, and people arebeginning to wonder if the technology will ever be approved," NickArvanitidis, the company's chairman and CEO, told BioWorld. "[Afavorable recommendation] would give our Stealth technologycredibility, and would allow the company to go to the next step."
A recommendation, followed by approval, also would have a numberof other benefits. One, he said, would be getting to the market firstwith a liposome-encapsulated drug. Approval also would havepositive ramifications for the technology, the industry, the companyand investors, he said.
DOX-SL is being tested in five Phase II trials in various cancers.Liposome Technology filed in December for approval of DOX-SL inEurope as a first-line therapy for Kaposi's sarcoma.
Liposome Technology's stock (NASDAQ:LTIZ) was up $1.06 (13percent) Monday, closing at $9.06 per share. _ Jim Shrine
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