HemaCare Expects to Expand PHT Testing : Medicine: The AIDS treatment showed promising results in a yearlong trial. But several steps remain in the lengthy process of bringing the therapy to market.
HemaCare Corp. said that results from a yearlong clinical trial of its plasma therapy for AIDS showed that patients who were not critically ill and received the therapy maintained stable immune systems and had improved survival rates.
The findings were encouraging enough that the Sherman Oaks company now expects to win state approval to begin more widespread testing in January. If those trials show statistically significant results, in what may be a two-year program, HemaCare said it would then apply to the state for approval to sell the treatment.
The clinical trial that ended in July began with 219 patients and finished with about 65 patients. The number of people in the study declined over time as patients died or dropped out. HemaCare has applied to the California Department of Health Services, under whose auspices the trials were conducted, to expand the testing to up to 1,000 patients in a 24-month study.
“We are pretty confident that we will get approval to start in January,” said Joshua Levy, HemaCare’s medical director.
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 contracted the HIV virus but remain healthy. The hope is to put AIDS patients into remission--a result that so far is supported by the tests, HemaCare said.
However, while the recent trial results were promising, they represent just one step in the lengthy process of winning approval to market the therapy for acquired immune deficiency syndrome. Although HemaCare hopes the next phase of testing will provide enough positive results for it to apply for marketing approval, there is certainly no guarantee that its treatment will work as planned in future tests.
When first infected with human immunodeficiency virus--the virus that causes AIDS--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.
“The basic concept here is that normally AIDS patients, as they decline, lose their own antibodies to fight the virus,” Levy said. “What we’re doing is giving them antibodies.”
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.
HemaCare, which sells blood-related products and services, lost $636,413 on $5.93 million in revenue in the six months ended June 30.
After gaining $2 a share to close at $8 on Thursday, when HemaCare announced the trial results, its stock fell back to $7 as of Monday’s close.
All the patients in the HemaCare study had AIDS, but they had varying levels of T4 lymphocytes, which are disease-fighting cells that HIV attacks. HemaCare’s PHT did not help those patients whose T4 levels had fallen to critically low levels.
But the treatment did appear to maintain the immune systems of patients whose T4 counts had not fallen below a certain threshold. Levy also said that there were no toxicity problems associated with the PHT treatment.
In applying for expanded testing of PHT, HemaCare also hopes to receive approval to begin charging for the treatment, Levy said. He expects that monthly doses will be priced at $500 to $800 if it is eventually commercialized, although during the testing phase the price would probably be less.
