AIDS drug wins approval

Art Nadler

Friday, June 6, 1997 | 5:47 a.m.

Two weeks ago Dr. Alfred Sapse got the news he's been waiting to hear for 13 years. The Food and Drug Administration gave him the green light to begin testing Anticort on HIV-positive patients.

Anticort is the trade name of an anti-cortisol drug manufactured by Sapse's Las Vegas company, Steroidogenesis Inhibititors Inc. Double-blinded testing on 40 people, in which neither doctors nor patients know who is getting Anticort or a placebo, should begin in four to six weeks in San Francisco. Results are expected to be released in 16 months.

Cortisol, which is naturally produced by the adrenal glands, is found to be elevated in HIV-positive and AIDS patients. It's Sapse's belief that if the body's cortisol can be reduced to normal levels, HIV-positive people will not develop AIDS.

Sapse wrote a medical paper in 1984, "Stress, Cortisol, Interferon and Stress Diseases: Cortisol As the Cause of Stress Diseases," in which he proposed that many diseases are brought about by an elevation in cortisol. Besides AIDS, such diseases as Alzheimer's, depression, stress, multiple sclerosis and Lou Gehrig's all have elevated cortisol.

"I said that what we were taught in medical school was wrong," Sapse said. "Cortisol is not the result of these diseases. It's the cause. Cortisol directs all the functions of the body. But when it's elevated, it becomes a killer."

Sapse developed Anticort in 1987. It's been unofficially tested by physicians on approximately 200 people with varying diseases in France, Canada and Brazil.

"The results were spectacular," Sapse, 72, said in his soft Romanian accent. "People with advanced stages of AIDS got better. The virus was there, but they were not sick."

Sapse said the study group will consist of previously untreated HIV-positive patients who have counts of 300-600 CD4 cells and viral counts more than 10,000. People previously treated with AIDS drugs will not be eligible.

In order for the FDA to approve Anticort as a treatment for AIDS patients, Sapse said he will have to prove that it is not harmful and that it actually gets results. He's very confident the results will be positive.

"There are not major side-effects," Sapse said. "Out of 100 people (unofficially tested), only two got dizzy because it lowers blood pressure."

Sapse founded his company in Miami in 1982 and moved to Las Vegas five years ago.

Unlike current AIDS drugs that can run as high as $1,500 a month, Sapse said Anticort will be more affordable at around $80 a month.

In 1978, Sapse successfully treated the late artist Salvador Dali for stress. Dali was so grateful that he created an allegory painting of a tree's roots being poisoned by stress. Its branches depict, in surrealistic fashion, how stress brings about aging, death and heart attacks.

"I gave Dali the precursor of Anticort," Sapse said. "I've known for 30 years that cortisol was the cause of diseases."

Sapse organized the first "Conference on Cortisol and Anti-cortisols in Chateau de Fillervall" near Paris in June 1996. There, for the first time, he learned that doctors from around the world believed as he did and were experimenting with anti-cortisol therapies.

A second conference is scheduled to take place Nov. 9-12 at The Mirage. Leading physicians and representatives of medical organizations from around the world are expected to attend.

Sapse said his study will cost $2.5 million. It is being funded by private offerings. He also plans to take Steroidogenesis Inhibitors Inc. public in January.

"More than 90 percent of the diseases in the world are associated with elevated conditions of cortisol," Sapse said. " Anticort is not just a drug. It's opening a new era of medicine like penicillin did."

Local HIV-positive people, who previously haven't been treated with AIDS drugs, can volunteer for Sapse's Anticort testing.

For information, call Ballard Communications at 836-3000.