Vestar Inc. announced that its liposome-formulatedamphotericin B compound may be useful in treating visceralleishmaniasis (VL), an often fatal parasitic infection. ClinicianRobert Davidson of St. Mary's Hospital Medical School inLondon, reported on a multicenter, combined Phase II/IIIclinical trial of Ambisome at the XIII International Congress forTropical Medicine and Malaria held in Pattaya, Thailand.
AmBisome treatment cured all 32 VL-infected patients,including 12 who were immunocompromised (nine with HIV)and five who had a drug-resistant strain of the disease. Aswell, "our results indicate that AmBisome is entirely safe andnon-toxic in visceral leishmaniasis, in contrast to the existingcompounds, all of which have frequent and serious adverseeffects," Davidson said. The conventional treatment for VL isanti-monial drugs, which are toxic to the heart and other bodyorgans, Michael Ross, the San Dimas, Calif., company's(NASDAQ:VSTR) executive vice president, told BioWorld.
Visceral leishmaniasis is usually fatal if not treated, especiallywhen complicated by malaria, pneumonia, tuberculosis, chronicdiarrhea or hemorrhage. Although VL is thought of as"tropical," it also occurs in France, Spain, Portugal and Italy,where infections are now occurring in AIDS patients and inother individuals being given immunosuppressive drugs."Leishmaniasis is a huge problem worldwide, with about400,000 new cases yearly," Ross said.
In addition to the European trials on AmBisome, the WorldHealth Organization is coordinating ongoing trials in the Sudan,Kenya and Brazil, Ross told BioWorld.
Vestar also said AmBisome has received full marketingapproval in Portugal to treat systemic fungal infections.
The drug has been available on a named basis in Portugal since1990. The United Kingdom, Sweden, Mexico, Germany andIreland have also approved AmBisome.
In clinical trials of AmBisome, 85 percent of patients haveshown clinical improvement against a variety of fungalinfections with minimal side effects. The drug is in PhaseIII/IV in Europe for fungal infection.
-- Jennifer Van Brunt Senior Editor
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