The FDA has ordered HemaCare to conduct an additional virusinactivation study of its anti-HIV hyperimmune plasma, Immupath,before approving the start of Phase III clinical trials for the potentialAIDS treatment.Hal Lieberman, HemaCare's president and CEO, said the study willtake a month. He said the FDA was not satisfied with the results of astudy done by the company four years ago as part of HemaCare'sPhase I/II trials."The study we conducted showed [Immupath] had the ability todestroy HIV," Lieberman said. "But the FDA wants to see it kill morevirus particles."If the FDA approves results of the additional study, the Phase III trialswill begin, Lieberman said.HemaCare Chairman Thomas Asher said the study is an extension ofthe prior trials. "We're looking forward to this last little jump throughthe hoop and getting started on Phase III," Asher said. "Everybody isgetting impatient."The Sherman Oaks, Calif., company filed an investigational new drugapplication with FDA in January and had hoped to begin Phase IIItrials with 600 patients this summer.In the Phase I/II trials, hyperimmune plasma with high-titer antibodiesto HIV was taken from healthy HIV-positive donors. It was thenchemically sterilized, pooled and infused into AIDS patients whodisplayed impaired immunocompetence and who lacked neutralizingantibodies. The trials involved 220 patients and results were reported inearly 1993. The company said the tests showed Immupath improvedimmune competence as measured by CD4 cell counts and improvedsurvival in certain patients.HemaCare has hired Kemper Securities Inc., of Chicago, to explorenew financing sources. Lieberman said the Phase III trials will cost $20million and HemaCare currently has about $1 million to fund thetests._ Charles Craig
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