HemaCare Corp. announced Monday that it has filed aninvestigational new drug application with FDA to begin Phase IIIclinical trials of its passive hyperimmune therapeutic Immupath.
According to the company, the proposed study would examine theefficacy of Immupath "to prolong survival and to improve immunecompetency" in AIDS patients with CD4 cell counts of between 50 and400 cells/cubic millimeter. HemaCare (NASDAQ:HEMA) stressed thatImmupath, derived from the plasma of asymptomatic HIV-positiveindividuals, is inherently non-toxic and contains a wide variety ofanti-HIV antibodies that could overcome the difficulty of viralmutation encountered by other agents.
Last September the Los Angeles company received conditionalapproval from the California Department of Health Services, Food andDrug Branch, to begin Phase III testing of Immupath inapproximately 600 patients (see BioWorld, Sept. 16). The companyhas been testing Immupath since 1990.
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