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Blood Services Company to Test AIDS Treatment : Research: HemaCare’s background was just what a medical company was looking for to try out an experimental therapy for those with the deadly virus.

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TIMES STAFF WRITER

As HemaCare Corp., a tiny medical services company in Sherman Oaks, struggled through much of the 1980s to make a profit on specialized blood services and products, it was unwittingly converging paths with an English scientist looking for a new way to treat AIDS.

Now HemaCare--thanks to its background in those specialized services--is on the verge of testing the little-known therapy, which it hopes will be a breakthrough in treating acquired immune deficiency syndrome.

HemaCare is one of the few companies in the business of performing hemapheresis, a medical procedure in which blood is taken from a patient or a donor, separated into components, recombined and then returned. The process can be used to remove harmful elements from a patient’s blood or beneficial parts from a donor’s.

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On its own, HemaCare wasn’t destined to get involved in AIDS research. But in 1985, Abraham Karpas, a scientist at the University of Cambridge in England, developed a treatment for AIDS relying on a similar blood-separating technique, giving patients specially treated blood plasma from donors who have been infected with the virus that causes AIDS, but who haven’t yet come down with the symptoms of the disease. The idea was to boost the patients’ immune systems with the virus-fighting antibodies in the donors’ plasma.

Medicorp, a Montreal company, soon bought rights to Karpas’ AIDS treatment--called passive hyperimmune therapy, or PHT--and then approached HemaCare to perform a clinical trial because of HemaCare’s network of three specialized plasma centers and background in hemapheresis.

So last week, Karpas and HemaCare’s medical director, Joshua Levy, traveled to the Sixth International Conference on AIDS in San Francisco to announce the company’s plans to conduct the largest trial to date of Karpas’ PHT (sometimes also called passive immunotherapy), involving 225 people in California and lasting one year.

In return for funding the trial, HemaCare received from Medicorp the exclusive rights to provide the treatment in California. If PHT proves effective, that could be a boon to the company, which had $5.8 million in revenue last year.

At least that’s what some investors--apparently caught up in enthusiasm for companies that may be poised to make money on AIDS treatment and prevention--seem to think.

Since HemaCare announced June 7 that the state of California approved the company’s plan to run the trial, the company’s stock has risen sharply. As recently as June 1, the stock traded around $2.88 a share. Last Friday it closed at $4, or 39% higher, although it closed at $3.50 on Monday. HemaCare Chairman Thomas Asher said investors’ calls have about doubled since the announcement.

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In addition, San Francisco investor John Lee acquired 82,000 common stock purchase warrants of HemaCare on June 13-14, which if exercised would give him an 11.7% stake in the company, according to a filing he made Monday with the Securities and Exchange Commission.

Asher is frank about why HemaCare is prepared to spend as much as $1.5 million--basically all the money it has in the bank--on the clinical trial. “I assure you, we wouldn’t be doing it unless we thought we could” make money on the treatment, he said.

But Asher said it’s too early to make any predictions about profiting from the potential AIDS treatment. For one thing, a Utah company, Dimension Laboratories, has already challenged the patent under which HemaCare obtained exclusive rights to the treatment in California. Jack Snyder, a vice president of Dimension, said the company claimed in a suit filed earlier this month in federal court in Salt Lake City that PHT wasn’t unique enough to be patented. He also said Dimension plans its own smaller trial of the therapy involving 40 patients.

Also, PHT is just one of many unapproved AIDS treatments that were discussed at last week’s international AIDS conference. It hasn’t been tested enough to be anything but an experimental treatment.

The broad idea behind PHT is nothing new. Active immunization--using vaccines that stimulate the body to defend itself--isn’t always possible. So doctors have often used passive immunization to guard against disease.

For example, tetanus--an infectious disease that usually enters the body through open wounds, causing severe muscle contractions--is treated by giving victims antibodies against the disease from people who have contracted tetanus and battled it successfully.

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After watching the progress of AIDS in people who are infected with HIV--the virus that causes it--Karpas theorized that the same kind of treatment might work for AIDS.

When people first are infected with HIV, the body creates antibodies to fight it and mounts a temporarily successful battle against AIDS. But later, the body’s defenses break down and, by the time the symptoms of AIDS develop, the antibodies are no longer found in the patient’s blood.

So Karpas decided to try infusing the plasma from the infected but not yet sick patients into patients whose condition was diagnosed as AIDS or AIDS-related complex (ARC), which is a less serious illness caused by HIV that often attacks before the onslaught of full-blown AIDS.

Karpas launched one such small study in 1988. The results have not been dramatic for the patients with full-blown AIDS, whose cases were very serious. Karpas said at least six of the seven lived much longer than would have been expected without the treatment, but one of the seven died within five months, and the rest within 17 months. Only one is still alive.

The treatment seemed far more helpful to those with ARC. All three ARC patients have remained without AIDS symptoms for two years since the treatment began.

But “three patients doesn’t prove anything,” Levy said.

HemaCare’s much larger trial should be far more conclusive. Unlike Karpas’ study, HemaCare’s will include a control group of 75 patients who receive a placebo to compare against the group of 150 that will receive the plasma from the HIV-infected donors.

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HemaCare’s study will also be “double-blind,” meaning that neither the patients nor their doctors will know whether they’re receiving PHT or the placebo.

The plasma used in the PHT will be chemically treated to get rid of HIV and other viruses to ensure that the treatment doesn’t make the patients sicker.

Doctors will monitor all the patients to see whether the treatment helps stave off complications that sometimes kill AIDS patients. They will also watch other signs such as how well their immune systems are working and whether the patients lose or gain weight.

The plasma donors will be watched carefully too. In fact, HemaCare’s Levy hopes that their giving plasma improves their health as well as that of the recipients. Although that sounds strange, it is possible: The body often overcompensates for the loss of the virus-fighting agents by making more of them than it normally would.

The best thing that could happen to HemaCare’s study would be for it to be abruptly changed halfway through. That’s because HemaCare will apply for permission from the state of California to give the treatment to all the patients in the trial if the people receiving PHT are clearly helped by it.

Reporters at HemaCare’s press conference in San Francisco jumped when Karpas said he believed that PHT would be proved “by far the most effective treatment for ARC and AIDS.” But under questioning, he acknowledged that his optimism was based on the fact that alternatives, like the drug AZT, have serious side effects.

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For now, he said, “there is nothing else.”

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