# Shaman Reports Positive Interim Results For Anti-Diarrhea Therapy in HIV Patients



## Jeffrey Roberts (Apr 15, 1987)

Shaman Reports Positive Interim Results ForAnti-Diarrhea Therapy in HIV Patients NEW YORK, Jul 10 (Reuters Health) - Interim results from a clinical study ofShaman Pharmaceuticals' Normal Stool Formula suggest that the dietarysupplement is a safe and effective long-term treatment of chronic diarrhea inHIV patients, according to the South San Francisco-based company. Shaman said that it will present the data as a poster at the 13th InternationalAIDS Conference in Durban, South Africa, this week. The interim results are based in part on about 10 months of treatment of 11 HIVpatients who suffered from chronic diarrhea. One to two 350 mg Normal StoolFormula tablets taken two to four times daily appear to have producedstatistically significant decreases in stool weight, Shaman reported. The ongoing study is being conducted at San Francisco General Hospital at theUniversity of California, San Francisco Medical Center. A final analysis ofsafety and efficacy data from the full, 12-month trial will be conducted later thissummer. Normal Stool Formula contains SP-303, a patented standardized extract fromthe sap of the Croton lechleri tree. The sap has been "used for centuries bytraditional healers in the Amazon rainforest to control diarrhea," the companyclaims. Previous clinical studies suggest that the standardized extract"normalizes excess water flow in the intestinal tract and promotes normal stoolformation, without causing constipation," Shaman said. According to Shaman, diarrhea is the most common gastrointestinal complaintin people infected with HIV and is reported as a side effect in up to 40% ofpatients taking protease inhibitors. None of the subjects in the current study have experienced adverse eventsattributable to the supplement, Shaman said. In addition, the company reportedthat the product appears to cause "no interference with...other medications," afact of particular significance for HIV/AIDS patients, who are often beingtreated with a number of concurrent therapies. As previously reported by Reuters Health, Shaman had originally planned tomarket SP-303 as a pharmaceutical. However, conversations with the US Foodand Drug Administration (FDA) suggested that the company might encounterdifficulties in bringing the therapy to market as an approved drug. As a result,Shaman chose to sell Normal Stool Formula as a dietary supplement, a tacticthat sidesteps the need for pre-approval from the FDA. During an interview with Reuters Health, a spokesperson for Shaman suggestedthat the reason for the shift was that the relatively small company could notafford the "very expensive" research that the FDA had said would be necessaryfor a successful New Drug Application. Shaman announced in late June that, due to the expiration of an exclusiveagreement with Cardinal Distribution, the company plans to expand the retailavailability of the supplement. Previously, the product had been available onlyon Shaman's Web site and in Cardinal's Medicine Shoppe International retailoutlets. The company also recently said that it would expand its targeted marketingefforts from a nearly exclusive focus on HIV/AIDS patients to include othergroups that commonly experience diarrhea, such as patients undergoingchemotherapy or radiation treatment and certain transplant patients.


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## JeanG (Oct 20, 1999)

Thanks, Jeff!







JeanG


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