HemaCare Corp. (NASDAQ:HEMA) outlined its plans for Phase IIIclinical trials of Immupath, its passive hyperimmune therapy for AIDS,at a meeting of the American Foundation for Aids Research (AMFAR)community-based clinical trials network in Chicago, Ill. this week.The company, located in Sherman Oaks, Calif., filed an investigationalnew drug (IND) application with the FDA in January. If approval isobtained, the company hopes to begin trials this summer.Joshua Levy, senior vice president and medical director, said thecompany plans to enroll 600 patients.Levy said HemaCare has received FDA approval to obtain plasma fromdonors, and expects to receive approval for its use in recipients soon.Phase I/II trials of Immupath began in January 1991. Hyperimmuneplasma with high-titer antibodies to HIV was harvested from healthyHIV-positive donors, chemically sterilized, pooled, and sterile bottled.The plasma was then administered to the 220 subjects, who weredivided into three groups: placebo, half-strength plasma, and full-strength plasma. In July 1992, with all patients having completed atleast 12 months of placebo or treatment, those who had received half-strength Immupath were given the choice of crossing over to full-strength. Of these subjects, 92 chose to switch to full-strength and werefollowed for an additional 12 months.CD4 cell counts were used as a measure of illness. The lower the count,the more progressive the disease. HemaCare reported that, aftercrossover, the patient group with CD4 cell counts greater than 50 whohad been receiving a placebo showed a decrease in mortality. Noserious toxicity was noted in recipients, and no adverse effects ofrepeated plasma donations were observed in donors. Researchersreported that passive hyperimmune therapy may be a promising adjuncttreatment to other drugs such as anti-virals.
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