HemaCare Corp. said Tuesday that it has suspended placebostudies of its Passive Hyperimmune Therapy (PHT) for AIDSand switched all participants in an ongoing California study toPHT, which has shown positive results.

The change was approved by the Food and Drug Branch (FDB)of the California Department of Health Services, which isoverseeing the state study. Its decision was based in part onpositive data from a six-month interim review of dataannounced last March, according to the company.

HemaCare (NASDAQ:HEMA) of Sherman Oaks, Calif., licensedPHT in 1989 from Canada's Medicorp Inc. The treatment usesblood plasma from HIV-positive people who have a largenumber of HIV-neutralizing antibodies in their blood butexhibit no symptoms of the disease. Their donated blood ispurified against other diseases and infused into patients withclinical AIDS.

About 170 of the 219 AIDS patients initially recruited to theCalifornia study are still participating, said Hal Lieberman,HemaCare's president. The study involved three groups of thesame size that received full-strength plasma (500cc), half-strength plasma (250cc and 250cc of 5 percent albumin) or aplacebo once a month.

Data are now being studied from the initial phase of the study,which was completed last month after all of the participantshad been treated for 12 months.

The company has drafted protocols for a Phase IIIinvestigational new drug (IND) application to gain approval fora 1,000-patient study of PHT that could start next month,

If the studies continue to produce positive data, "it'sconceivable that we might file for approval within 1993,"Lieberman said.

The results announced last March found in the PHT-treatedgroup significantly larger T4 cell counts and lower levels of thep24 antigen in the blood. The early results did not show astatistically significant improvement in survival or in thenumber of infections in the PHT group. -- Ray Potter

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