HemaCare Corp. reported Monday that initial data from PhaseI/II clinical trials of its plasma-based AIDS therapy showedpositive results based on surrogate markers.
The stock (NASDAQ:HEMA) jumped $1.75 to $12.25 on theannouncement.
The Passive Hyperimmune Therapy (PHT) involves theharvesting of human plasma, rich in antibodies against HIV,from healthy HIV-positive donors. The plasma is sterilized,pooled and infused into patients with symptomatic AIDS.
Although the trial data did not show statistically significantresults on end points such as survival and decreased infection,the company said the study "suggested" enhanced survival andreduced chances of initial opportunistic infections in some AIDSpatients.
On surrogate measures, the company said T4 cell countsimplying immune system rebound had increased significantlyby six months compared with a placebo. As an indicator ofdeteriorating health, beta2 microglobulin blood levels ofpatients receiving a full dose changed little and werestatistically significant compared with a rising level in theplacebo group over seven months.
After 1,300 infusions in more than 200 patients, no trialparticipant has dropped out because of toxicity problems saidDr. Joshua Levy, HemaCare medical director.
The Sherman Oaks, Calif., company has an exclusive licensefrom Medicorp Sciences Inc. of Montreal, which holds thepatent on PHT, to commercialize the technology in California."We hope that California will be the first market, althougheventually we will apply for an investigative new drugapplication from the FDA," said Levy. The target for treatmentin California is the 30,000 to 35,000 patients who test positivefor HIV and have T4 cell counts of 50 to 200, Levy toldBioWorld. -- Kris Herbst
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