AIDS TREATMENT NEWS #138, November 1, 1991
John S. James
Hypericin is an antiviral which has been extensively covered in AIDS TREATMENT NEWS for over three years (starting with issue #63, August 26, 1988). This potential drug is important because it has shown quite promising results in laboratory tests with HIV, including "wild" strains directly taken from patients; in the laboratory, it suppresses HIV infection in freshly-drawn human blood. And in animal tests, it has been found effective in treating diseases caused by other retroviruses (other than HIV, which is difficult to study in animals).
In addition, hypericin has long been in human use as low- dose herbal extracts of the St. John's wort plant; this experience, as well an animal tests with larger doses, suggest that it might be nontoxic in doses large enough to be useful. And if it does prove feasible as a treatment, hypericin might be especially valuable since its mechanism of action appears to be entirely different from that of AZT, ddI, ddC, or any other treatment available, meaning that the drug might provide a new kind of therapeutic option. Animal studies indicate that hypericin can be used orally (although the new trial will administer it intravenously in order to obtain the most precise data), and that it does cross the blood-brain barrier.
Hypericin might also be useful against certain other viruses, possibly including cytomegalovirus (CMV) and hepatitis B.
Previous trials of hypericin have only used the crude St. John's wort preparations which were available, but which contain much less than one percent of the active drug; the results of these trials have been modest at best, and laboratory studies suggest that the doses obtainable this way may be much too low to be effective against HIV. In the animal studies, best results have been obtained with pure hypericin chemically extracted from the plants. But chemically synthesized hypericin, not the plant extract, was chosen for development as a human drug.
Synthetic hypericin is being developed by VIMRx Pharmaceuticals Inc., located in Stamford, Connecticut. In September 1991 U. S. patents were issued to New York University and to Yeda Research and Development Company Ltd., which commercializes inventions from The Weizmann Institute of Science, which in turn has worked with New York University and VIMRx on antiviral uses of hypericin; previous European and U. S. patents had been issued to Yeda. The clinical trial is being supported by the AIDS Clinical Trials Group (ACTG) of the U. S. National Institute of Allergy and Infectious Diseases. The principal investigator is Fred Valentine, M. D., of New York University.
The Trial
The new trial is designed primarily as a safety study, but will also look for evidence of anti-HIV activity. It will test four escalating doses of hypericin, ranging from 0.25 mg per kg of body weight, to 2.0 mg per kg; all doses will be given intravenously, twice per week. Volunteers must have a T-helper count under 300, and five of the eight patients at each dose level must have positive p24 antigen (by the conventional tests).
Volunteers cannot use AZT, ddI, or any other retroviral during the trial, or within one month of starting; also, they cannot use any form of oral hypericin within one month of starting the trial. They cannot have an active opportunistic infection nor require continuous medication (other than pneumocystis prophylaxis) when they enter the trial. Short courses of most medicines are OK; but those which cause photosensitivity (increased sensitivity to sunlight) will not be allowed, because of the possibility that hypericin itself may cause photosensitivity.
For information about volunteering for this trial, contact the AIDS Clinical Trials Unit near you and ask for information about the hypericin trial (protocol #150). Note that the trial is being conducted only at the following three centers; and the waiting list in New York may be full. You can talk with any of the research nurses at the following numbers:
Boston: Beth Israel Hospital, ACTU Clinic, 617/735-4103.
Minneapolis: University of Minnesota, ACTU Clinic, 612/625- 1462.
New York: New York University Medical Center, ACTU Clinic, 212/263-6565.
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