(BW) (SHAMAN-PHARMACEUTICALS)(SHMN) Favorable Phase III For Shaman's SP-303/Provir For Treatment of Diarrhea in People With AIDS

DonateNow
Print this article

(BW) (SHAMAN-PHARMACEUTICALS)(SHMN) Favorable Phase III For Shaman's SP-303/Provir For Treatment of Diarrhea in People With AIDS

Business Wire - Tuesday, December 22, 1998


SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Dec. 22, 1998-- Shaman Pharmaceuticals, Inc. (Nasdaq:SHMN) announced today favorable results from their single pivotal Phase III study of SP-303/Provir(tm) for the treatment of diarrhea in people with AIDS.

The double-blind, randomized, placebo-controlled trial was divided into two treatment phases: an inpatient phase of six days and an outpatient phase of three weeks. During the inpatient phase, 400 patients were enrolled, and patients were randomized to treatment for six days with either placebo or one of three SP-303 doses/formulations given four times per day: 250mg tablets or 500mg tablets (the intended commercial formulation), or 500mg beads (an older formulation). Responders in the inpatient phase were allowed to continue on their same regimen during the outpatient phase.

In the primary efficacy endpoint, reduction in total daily stool weight during the inpatient phase, the 500mg tablet group achieved a favorable result versus placebo by two different methods of intent-to-treat statistical analysis, both of which were prospectively agreed upon with the FDA. An analysis of the reduction from baseline to the end of treatment yielded a value of p equals 0.075. A random regression analysis (which measures rate of reduction over the course of treatment), yielded a value of p equals 0.033. Due to the four arms in the study, the statistical significance of these values must be discussed with the FDA. Other doses/formulations did not produce a meaningful change during the inpatient phase. In the outpatient phase, the 500mg tablet group saw a sustained effect and the drug was well tolerated throughout the study.

Dr. James Pennington, Shaman's Senior Vice President of Clinical Research and Chief Medical Officer said, "We are pleased with these results, which are consistent with the treatment effect seen in our Phase II study. We are particularly encouraged by the safety and tolerability demonstrated with SP-303 over a four-week treatment period which is so critical due to the chronic nature of this diarrhea syndrome. In addition, the treatment effect demonstrated in the trial was even more pronounced in the patients who entered the trial with the most severe diarrhea. This study represents an important result due to the unmet medical need in people with AIDS whose lives are affected by this devastating syndrome. With this success, we will be meeting with the FDA in January for a pre-NDA meeting, and we remain on track to submit an NDA filing in early 1999. We have already received `fast-track' designation from the FDA for this indication."

Lisa Conte, President and Chief Executive Officer, commented, "We are committed to working with the FDA and the AIDS/HIV Community to make this product commercially available as soon as possible. We are acutely aware of the human suffering which diarrhea creates in the lives of of people living with AIDS, and of the need for new solutions and treatments. We enrolled an additional 25% of patients in this study to meet the needs of the Community. In addition, we are initiating an Extension Study to make SP-303 available to some of the patients from our studies who are most in need. And, we also stand by our commitment to give back to the Community via the Shaman HIV Investment Trust."

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 people 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 it collaboration with Lipha s.a., a wholly-owned subsidiary of Merck KGaA, Darmstadt, Germany.

Note: Provir(tm) is a trademark of Shaman Pharmaceuticals, Inc. Shaman Pharmaceuticals(R) is a registered U.S. trademark of the company.

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/A for the year ended December 31, 1997. These filings are available upon request at 650/952-7070. Also, visit Shaman at http://www.shaman.com.

--30--azs/sf* sd/ba/sf

CONTACT: Shaman Pharmaceuticals, Inc. J.D. Haldeman, 650/952-7070 ext. 409


Keywords: PHARMACEUTICAL BIOTECHNOLOGY MEDICINE PRODUCTKWDpharmaceuticalbiotechnologymedicineproduct
981222
BW981206

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. .