HemaCare Corp. on Tuesday said the FDA has approved orphandesignation for its Immupath passive hyperimmune therapy,an anti-HIV therapy based on human blood plasma.
Immupath is made from human blood containing largequantities of antibodies to the p24 antigen of the virus,according to company Chairman Thomas Asher. The p24-richblood is taken from asymptomatic patients who have beeninfected with the virus. The blood is then sterilized, pooled andinfused into patients with symptomatic AIDS.
HemaCare is conducting Phase I/II trials of Immupath inCalifornia under the auspices of state regulatory bodies, Ashersaid. HemaCare announced in March interim results after sixmonths of the trials. Although the data did not showstatistically significant results on end points such as survivaland decreased infection, the company said the study"suggested" enhanced survival and reduced chances of initialopportunistic infections in some AIDS patients.
On surrogate measures, the company said T4 cell countsimplying immune system rebound had increased significantlycompared with a placebo. As an indicator of deterioratinghealth, beta 2 microglobulin blood levels of patients receiving afull dose changed little and were statistically insignificantcompared with a rising level in the placebo group over sevenmonths.
The trials will be completed in July, and the company ispreparing an application for Phase III, according to Asher.
HemaCare received an exclusive license to use PHT technologyin California in 1990 from Medicorp Inc. of Montreal, whichholds the rights to a U.S. patent granted in 1989.
HemaCare's stock (NASDAQ:HEMA) closed unchanged Tuesday at$9. -- Steve Usdin
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