BUSINESS WIRE; Tuesday, February 17, 1998
The side effects were reported for the first time publicly at the Fifth Conference on Retroviruses and Opportunistic Infections earlier this month. They most often take the form of disfiguring fat deposits with nicknames such as the "buffalo hump" and "protease paunch."
Doctors from four countries presented findings on the problem, and reported that up to 60 percent of HIV patients taking protease inhibitors develop the manifestations. As a result, patients are increasingly abandoning treatment with protease inhibitors, even when the therapy proves otherwise beneficial.
According to Alfred T. Sapse, M.D., president of Steroidogenesis Inhibitors International (Nasdaq BB OTC:STGI), these symptoms match Cushing's Syndrome, a disorder whose sole cause is an overproduction of cortisol. Backed by years of published research on cortisol's immunosuppressive effects, Sapse spearheads a growing number of scientists who believe that the adrenal gland hormone plays a major destructive role in many deadly conditions.
Sapse has presented evidence that HIV stimulation induces the adrenal gland to manufacture elevated levels of cortisol. This overproduction can destroy the immune system, thus leading to full- blown AIDS. He has also reported that elevated cortisol is, all by itself, capable of inducing all of the symptoms and opportunistic infections encountered in AIDS. These include a decrease in the level of CD4, increase of CD8 (cytotoxic), P. carinii pneumonia (PCP), Kaposi Sarcoma (KS) and others (Sapse, A.T., Cortisol. High Cortisol Diseases and Anti-cortisol Therapy -- Psychoneuroendocrinology. 22(1) S3-510. Oxford. UK. September 1997).
"It is possible that the protease inhibitors further stimulate the production of cortisol that causes Cushing's-like symptoms in so many AIDS patients," said Sapse. "We are currently taking the first steps to verify the extent of cortisol's role."
While researchers at the Fifth Conference on Retroviruses and Opportunistic Infections linked the problems associated with protease inhibitors to an overproduction of adrenal gland hormones, they stopped short of identifying cortisol as the specific cause. Sapse attributes this hesitancy to what he describes as "a massive blindfold" in current laboratory reporting of cortisol levels.
This "blindfolding" occurs because labs routinely measure cortisol levels only twice daily, at 8 a.m. and 5 p.m. If the hormone is present in normal ranges at these two intervals, the patient is reported to have "normal" cortisol. The problem is that cortisol levels follow a circadian rhythm that can fluctuate dramatically throughout the day and night, reaching dangerous immunosuppresive levels while escaping detection.
To correct such laboratory shortcomings, Sapse has developed a Circadian (24 Hour) Cortisol Rhythm Chart that measures hormone levels over a 24-hour period. Unveiled at the Second International Conference on Cortisol/Anti-Cortisols (held Nov. 9-12, 1997, in Las Vegas), this diagnostic chart enables doctors to accurately measure cortisol levels.
"Thanks to the new chart, we can finally unmask cortisol as a major component of many diseases and conditions, and thus open the door to anti-cortisol therapies," said Sapse.
Steroidogenesis Inhibitors International is a leader in the emerging anti-cortisol industry. In addition to the Circadian Cortisol Rhythm Chart, the company developed and is now producing ANTICORT, an anti-cortisol drug for the treatment of HIV and AIDS. ANTICORT is approved for clinical testing by the FDA (IND 52,663) under a Phase IB/IIA setting. The company has headquarters at 2001 East Flamingo Blvd., Suite 100B, Las Vegas, Nev. 89119; Tel. 702/ 735-7001; Fax 702/737-7016; www.cortisol.com.
CONTACT: Tellem Inc., Los Angeles Erik Deutsch, 213/935-1725 tellempr2@aol.com
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