Trials of New AIDS Therapy Show Promise, Company Says : Health care: Researchers hope that HemaCare’s plasma treatment will be able to put patients into remission. But the test results are still inconclusive.
HemaCare Corp., a Sherman Oaks company that makes blood-related products, said Monday that results so far from clinical trials of its plasma therapy for AIDS are “promising,” and that it plans to use the results to press the state for approval of more widespread testing.
The company said results after six months of its one-year, 219-patient trials showed some encouraging differences between patients given the plasma treatment and those who received a placebo.
However, the company also said there was no statistically significant evidence to show improvement in survival rates and a decrease in AIDS infections. Still, HemaCare said there were enough favorable results to expand the plasma therapy to more patients.
While the trial results were a hopeful sign for HemaCare, they represent just one step in the lengthy process of winning approval to market its AIDS therapy. Joshua Levy, HemaCare’s medical director, said the current trials are due to be completed in July.
The idea behind HemaCare’s treatment, called passive hyperimmune therapy (PHT), is essentially like that of passive vaccines: to treat victims of a disease by giving them antibodies from people who have already contracted the disease and have battled it successfully. The hope, still far from being proven in medical tests, is to put AIDS patients into remission.
When first infected with HIV--the virus that causes acquired immune deficiency syndrome--the body creates antibodies to fight it and mounts a temporarily successful battle against the onset of AIDS. Later, the body’s defenses break down and, by the time AIDS symptoms develop, the antibodies are no longer found in a patient’s blood.
PHT involves harvesting human plasma from healthy HIV-positive donors. The plasma is then sterilized, pooled and infused into patients with the symptoms of AIDS.
Based on the six-month results, Levy said, the company plans to ask the California Department of Health Services, under whose auspices the trials are being conducted, to expand the testing to 1,000 patients. That would put the company closer to its eventual goal of marketing the treatment in California under the state’s new drug approval program.
“When you have something that looks this good at six months, we feel that it should be made available to a wider group of patients,” Levy said.
If HemaCare’s AIDS treatment ever proves effective and is eventually approved for marketing in California, it could be a boon for the company. HemaCare has an exclusive license to market the treatment in California. In 1991, HemaCare lost $231,000 on $8.99 million in revenue.
Investors are apparently betting that HemaCare’s efforts will pay off. The company’s stock has more than doubled in the past three months, closing Monday at $12.25 bid per share, up $1.75 for the day.
The clinical trials of PHT were “double-blind,” meaning that neither the patients nor their doctors knew whether they were receiving a full-strength dose of PHT, half-strength PHT or a placebo. All the patients in the study had conditions that were diagnosed as AIDS or AIDS-related complex (ARC), a group of less-serious ailments caused by HIV that often attack before the onslaught of full-blown AIDS.
Levy said PHT infusions seemed to help patients who had somewhat diminished levels of the disease-fighting cells that the human immunodeficiency virus attacks. However, PHT didn’t help those patients whose levels of the disease-fighting cells were critically low.
PHT also appeared to halt the development of a chemical in the blood that generally rises as an AIDS patient’s health deteriorates, Levy said.
Another encouraging sign was that none of the patients were forced to drop out of the study because of problems with toxicity, HemaCare said.
PHT was developed by Abraham Karpas, a scientist at Cambridge University in Britain. A Montreal company, Medicorp, bought the rights to PHT, and HemaCare has an exclusive license from Medicorp to provide the treatment in California.
