BUSINESS WIRE; Thursday, July 30, 1998
Both studies were double-blind, randomized, placebo-controlled.
The first study further validated Provir's ability to treat traveler's diarrhea in Americans traveling in Jamaica and Mexico. The study involved 184 patients treated for two days on an outpatient basis with either placebo or one of the three Provir doses given four times per day: 125mg, 250mg, or 500mg.
In the key efficacy endpoint, time to last unformed stool (TLUS) over 48 hours (the standard for measurement in acute watery diarrhea studies), all doses reached a highly statistically significant (p less than or equal to 0.01) result versus placebo. The study showed Provir to be well tolerated. More than 35 million individuals travel annually to countries that present the risk of traveler's diarrhea.
The second study evaluated Provir in Venezuelan nationals who locally contracted acute watery diarrhea. A total of 140 patients were enrolled in the trial, which took place in a hospital setting. Provir treatment with 125mg four times per day for two days resulted in statistically significantly earlier resolution of diarrhea as compared to placebo, as measured by TLUS over 48 hours.
Results for patients treated with 250mg and 500mg doses did not achieve statistical significance. This study also showed Provir to be well tolerated.
The principal investigator in the traveler's study, Dr. Herbert DuPont of the University of Texas Medical School at Houston and Baylor College of Medicine commented, "Based upon my twenty-five years of experience testing antidiarrheal agents, these results indicate Provir may be the most potent antisecretory agent available to treat diarrhea."
Dr. James Pennington, Shaman's senior vice-president of clinical research and chief medical officer said, "We are gratified by these confirmatory results, and feel they are consistent with previous results indicating Provir's ability to reduce diarrhea in many patient types.
"We are also pleased by the fact that we have exceeded the Company's enrollment expectations for our Phase III pivotal trial of diarrhea in people with AIDS, which is now over 75% enrolled and on track to support an NDA filing in the first quarter of 1999. We have already received 'fast-track' designation from the FDA for this indication."
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 its collaboration with Lipha s.a., a wholly owned subsidiary of Merck KGaA, Darmstadt, Germany.
Note to Editors: 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.
CONTACT: Shaman Pharmaceuticals, Inc. Corporate Communications, 650/952-7070 ext. 480
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