More promising results with the first commercially availableliposomal anti-fungal provided good news for both itsmanufacturer and the competition.
In December, Vestar Inc.'s AmBisome was shown to cure apatient's liver infection. Now, successful use of the drug in 126patients in 43 hospitals worldwide and in a dramatic cure of apremature baby is detailed in letters to The Lancet this week.
The British baby, born at 28 weeks gestation and sufferingfrom bodywide fungal infection, required artificial breathingand showed fungal growth in cultures despite repeatedtreatment with conventional anti-fungals, includingamphotericin B.
When the liposomal form of amphotericin B, made by Vestar(NASDAQ:VSTR), was given, blood cultures became negative.The baby was discharged and remained healthy at 6 months ofage.
Swedish investigators, meanwhile, reported that 37 of 64patients in whom fungal infection could be proved wererelieved of their symptoms, and the fungi could bedemonstrated to have been eradicated by AmBisome in 35others.
The cure rate was better for candida infection that foraspergillus infection (76 vs. 31 percent) perhaps because mostaspergillus infections affected the lung, which may requirehigher doses of the drug, the Swedish researchers said.
"AmBisome is expensive, but it could prove to be abreakthrough in the treatment of invasive fungal infections inimmunocompromised patients," the researchers concluded.
Disguising amphotericin B in the liposomal shells ofphospholipid is allowing far higher doses to be used withoutthe usual kidney toxicity.
The Liposome Co. (NASDAQ:LIPO), which is developing acompeting liposomal, amphotericin B, is pleased to hear thenews on AmBisome, said Marc Ostro, vice chairman and chiefscience officer.
Phase III trials of its agent in multiple indications are about tostart in the United States and Europe, Ostro said. Bristol-MyersSquibb, co-developer and license holder, is conducting thetrials.
The company's patents do not interfere with existing patentson liposomal amphotericin B, said Ostro.
San Dimas, Calif.-based Vestar has approval to market itsproduct in several European countries, but has no U.S. rights tothe drug. In a dissolution of a joint venture last August,Fujisawa USA Inc. of Deerfield, Ill., was assigned marketingrights for AmBisome in the United States, Canada and Asia.Vestar has marketing rights for the rest of the world.
Vestar shares dropped 50 cents to $20.50 on Thursday. LIPOalso was down 50 cents to $20.25.
-- Roberta Friedman, Ph.D. Special to BioWorld
(c) 1997 American Health Consultants. All rights reserved.