U.S. Bioscience Inc. (AMEX:UBS) announced Tuesday that it hasfiled a new drug application (NDA) with the FDA for NeuTrexin(trimetrexate) for treating moderate or severe Pneumocystiscarinii pneumonia (PCP) in AIDS patients who are notcandidates for trimethoprim/sulfamethozazole therapy.
The West Coshonocken, Pa., firm licensed the compoundtrimetrexate from Warner-Lambert in August 1991, accordingto Robert Kriebel, senior vice president of finance andadministration. "There are a number of applications for thisproduct," Kriebel told BioWorld, including for solid tumors andpsoriasis, but "it's immediate use is for treating PCP."
Clinical trial results on nearly 900 patients demonstrated thattrimetrexateQwhich interferes with the metabolic pathway offolic acid, a B vitaminQadministered with a generic producttermed leucovorinQwhich acts as a protective agent againstpotential side effectsQhas shown both efficacy and a favorableside effect profile in treating PCP, the most common life-threatening infection in AIDS patients.Although there are effective first-line therapies for acuteepisodes of PCP, about a third of the patients will discontinuetherapies due to intolerable side effects or lack of response. Inthese cases, the firm claims, Neutrexin represents a potentialtherapeutic alternative.
This is the third NDA that U.S. Bioscience has filed with theFDA. The first was approved in December 1991 for an ovariancancer treatment, marketed as Hexalen. The second, on Ethyolas a protective agent for use with cancer chemotherapy, hasn'tfared so well. In February 1992 an FDA advisory panel refusedto recommend approval for the product, stating that it needsmore evidence that Ethyol is effective in protecting healthybone marrow cells from the toxicity of cancer chemotherapy.U.S. Bioscience is waiting for the European Community'scomments on the drug, and expects to receive the EC'sconsolidated questions soon, Kriebel told BioWorld.
-- Jennifer Van Brunt Senior Editor
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