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| |  Phase II Trial Expanded to Include Diarrhea in AIDS Patients SOUTH SAN FRANCISCO, Calif. -- March 26, 1997-- Shaman Pharmaceuticals, Inc. has expanded its Phase II program for Provir, an oral product for the treatment of diarrhea, to conduct a pilot study that tests Provir for diarrhea in patients with AIDS. The double-blind, randomized, placebo-controlled study that will enroll 50 AIDS patients suffering from diarrhea will be conducted at the Veterans Hospital in Palo Alto by Dr. Mark Holodniy, Assistant Professor of Medicine at Stanford University Medical Center. The pilot study is designed to test Provir for decreased time to relief of diarrheal symptoms compared with a placebo group. Shaman also announced today that it has completed the first study in a series of double-blind, placebo-controlled Phase II studies to obtain optimal dose information for Provir for the treatment of watery diarrhea in travelers and of indigenous diarrhea of unknown cause (non-specific diarrhea). The results of this study form the basis for additional studies which the Company intends to initiate in April. Based on patient recruitment to date, Shaman plans to complete its Phase II dose-optimization program in mid 1997. An earlier Phase II study in traveler's and non-specific diarrhea demonstrated that 89% of 75 patients treated with Provir returned to normal after 48 hours of treatment. Moreover, of the 71 patients available for follow-up, no recurrence was experienced during the post-treatment period. "Provir represents a novel and potentially important drug because of its unique non-antimicrobial mechanism and ability to interfere with chloride ion secretion in the small intestine, " according to Dr. Herbert DuPont of the University of Texas Medical Center at Houston and Baylor College of Medicine and a world-recognized expert in travel medicine. Dr. DuPont conducted Shaman’s traveler's and non-specific diarrhea studies. Lisa Conte, Shaman's President and CEO stated, "Because many diarrheal syndromes result from excessive chloride ion secretion, we believe that Provir could provide relief for a broad spectrum of diarrheal diseases. Shaman's pilot study for diarrhea in patients with AIDS is designed to potentially broaden the use of Provir for the symptomatic relief of diarrhea that may be related to multiple causes but is thought to be the result of excessive chloride ion secretion. Obtaining an initial indication of efficacy in this trial could enable Shaman to immediately move forward with pivotal trials." Shaman Pharmaceuticals discovers and develops novel pharmaceutical products for major human diseases by isolating active compounds from tropical plants.
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