BUSINESS WIRE; May 7, 1998
According to Lisa A. Conte, president and chief executive officer, "The FDA's decision to fast-track SP-303/Provir(TM) represents another important regulatory milestone in the clinical development of this product. Earlier in the year, the FDA agreed with the Company's proposal to submit a New Drug Application (NDA) filing based on the data from the Phase III trial now in process and corroborative information from the previously completed Phase II trial. With these communications, we look forward to continuing to work closely with the FDA to attain rapid approval for a compound that we believe has the potential to meet a critical unmet need, namely, a safe and effective anti-diarrheal product for AIDS patients who suffer from this debilitating syndrome. Final approval, will, of course, be subject to the results obtained in the pending Phase III study and the FDA's analysis of the full NDA package."
Chronic diarrhea is a devastating syndrome that afflicts 20 to 60 percent of patients with AIDS. The syndrome not only compromises their quality of life, it can dramatically impact their health and significantly increase the cost of their care. Despite the treatment breakthroughs of protease inhibitors and highly active antiretroviral therapy (HAART), diarrhea is a persistent problem among patients with AIDS. Furthermore, symptomatic therapies for diarrhea have proven limited in efficacy and frequently resulted in undesirable side effects.
SP-303/Provir(TM) is currently being evaluated in a Phase III human clinical trial which began in late March. This double-blind, placebo-controlled study is planned to include approximately 300 patients at more than 20 sites throughout the United States. The study includes both an in-patient and an out-patient phase for a total of four weeks of treatment. Conte indicated that the Company believes that the results of the study, if successful, will support an NDA filing as soon as early 1999.
In October, 1997, Shaman reported results of an earlier Phase II study, also evaluating the efficacy of SP-303/Provir(TM) in patients with AIDS suffering from diarrhea. The study showed that treatment with SP-303/Provir(TM) was effective in reducing stool weight and abnormal frequency in patients with AIDS, and that the study drug was well tolerated.
Shaman Pharmaceuticals discovers and develops novel pharmaceutical products for major human diseases by isolating active compounds from tropical plants with a history of medicinal use. The Company has three compounds in clinical development: SP-303/Provir(TM), an oral product for the treatment of diarrhea in patients with AIDS, and other watery diarrhea indications; nikkomycin Z, an oral antifungal for the treatment of systemic fungal infections; and SP-134101, an oral product for the treatment of Type II diabetes. Shaman maintains an active Type II diabetes research program which serves as the basis for its collaborations with Lipha s.a., a wholly-owned subsidiary of Merck KGaA, Darmstadt, Germany and with Ono Pharmaceutical Co., Ltd. of Japan.
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Note to Editors: Provir(TM) is a trademark of Shaman Pharmaceuticals, Inc.
This press release contains, among other things, certain statements of a forward-looking nature relating to Shaman's ability to advance its clinical development and research programs and obtain regulatory review and approval thereof. Such statements involve a number of risks and uncertainties including the timing and results of preclinical and clinical studies and determinations by the U.S. Food and Drug Administration, as well as the Risk Factors listed in the Company's SEC filings including, but not limited to, those contained in Shaman Pharmaceuticals, Inc.'s Annual Report on Form 10-K for the fiscal year ended December 31, 1997. These filings are available upon request at (650) 952-7070.
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CONTACT: Shaman Pharmaceuticals, Inc. Corporate Communications, 650/952-7070 ext. 480
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