Vestar Inc. announced Wednesday that it has filed a new drugapplication (NDA) with the FDA for DaunoXome, its liposomalformulation of the anti-cancer drug daunorubicin, for treatingAIDS-related Kaposi's sarcoma (KS).
This is the first NDA filed in the U.S. on a liposomal drug, theSan Dimas, Calif., company (NASDAQ:VSTR) said.
It may also be one of the few NDAs filed in the U.S. on the basisof Phase II clinical trial data. "We believe the data will beacceptable to FDA and see no reason to wait" for Phase III data,Roger Crossley, Vestar's president and chief executive officer,told BioWorld.
Analyst David Webber, who follows Vestar for Alex. Brown &Sons, added that filing for approval on Phase II data is "in linewith FDA's willingness to review and potentially approve drugsfor AIDS-associated illnesses."
Still, the filing came nine to 12 months earlier than Webberhad expected. Extrapolating that the filing would translate intoaccelerated revenues from DaunoXome, Webber raised hisrevenue and earnings estimates on Vestar and reiterated hisinvestment rating of "strong buy" on Wednesday.
Clinical trial data are available on about 150 patients withadvanced KS who have been treated with DaunoXome. Morethan 60 percent of the evaluable patients had a partialresponse to the drug, and many others had their diseasearrested.
"Over 90 percent of the patients get a benefit from the drug.The 60 percent who met the clinical trial group criteria had aresponse; that is, a certain percentage of their lesions eithershrank or disappeared. And about 30 percent benefited,although they didn't meet the criteria," Crossley told BioWorld.
KS is the most common cancer in AIDS patients, affecting atleast 15 percent of them (120,000 according to The Centers forDisease Control). Kaposi's sarcoma is characterized by lesions ofthe skin, mucous membranes and lymph nodes, and oftenprogresses rapidly to internal organs, including the lungs andgastrointestinal tract.
Vestar announced in mid-January that it had started a limitedprogram to provide DaunoXome free to AIDS patients sufferingfrom KS who had failed at least one other cytotoxic therapy.
DaunoXome is currently in Phase III trials comparing theliposomal drug with standard combination chemotherapy.
Liposome Technology Inc. (NASDAQ:LTIZ) of Menlo Park, Calif.,is also developing a liposome-formulated anti-cancer drug fortreating KS, but has chosen to focus on doxorubicin. Theproduct, Doxil, is currently in Phase III trials for KS. The firstPhase III trial, which began earlier this month, is designed tocompare Doxil with the standard chemotherapy drugcombination bleomycin and vincristine, said Nick Arvanitidis,LTI's chief executive officer.
Vestar is already marketing its first liposome-based drug,AmBisome (a formulation of amphotericin B to fight systemicfungal infections) in Europe.
The stock (NASDAQ:VSTR) closed Wednesday at $12.25, up$2.13.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.