Monday March 30, 4:57 pm Eastern Time
Company Press Release
Shaman Begins Enrollment in its Pivotal Phase
III Trial for Provir
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--March 30, 1998-- Shaman Pharmaceuticals, Inc. (NASDAQ:SHMN - news) announced today it has begun enrollment in its pivotal Phase III clinical trial for SP-303/Provir(tm), for the treatment of diarrhea in patients with AIDS.
This double-blind, placebo controlled study is planned to include approximately 300 patients at more than 20 sites throughout the United States and Puerto Rico.
The study includes both an in-patient and out-patient phase, for a total of four weeks of treatment, significantly longer than studied in the Phase II trial. Results are targeted to be announced in early 1999. With success, an NDA filing is planned to follow shortly thereafter.
Since Shaman released positive results from its Phase II study in October 1997, it has been working closely with the FDA to speed the development of Provir to address this unmet medical need. Diarrhea in patients with AIDS continues despite advances in anti-viral therapy. This problem affects daily functioning and patient quality of life.
Dr. James Pennington, Shaman's Senior Vice President of Clinical Research and Chief Medical Officer said, ''This is a significant study and its purpose is two-fold:
To confirm the value of Provir for this important indication, and to do it in a timely fashion in order to get this product approved for patients in need as soon as possible.''
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: Provir, 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.
Note: 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. 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. These filings are available upon request at 650/952-7070.
Contact:
Shaman Pharmaceuticals, Inc.
Corporate Communications, 650/952-7070 ext. 480
|
