BUSINESS WIRE; Monday, March 30, 1998
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.
-0-
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.
--30--cmf/sf*
CONTACT: Shaman Pharmaceuticals, Inc. Corporate Communications, 650/952-7070 ext. 480
Copyright (c) 1998/BUSINESS WIRE. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854.
980330
BW980310
Copyright © 1998 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.
AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1998. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .