Thursday October 30 8:30 AM EST
Company Press Release
Shaman Announces Positive Results and Continuation of Development of
Provir for Treatment of AIDS Diarrhea and Status of Provir Acute Watery
Diarrhea Studies
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Oct. 30, 1997--Shaman
Pharmaceuticals, Inc. (NASDAQ:SHMN) announced today the results of a
Phase II double-blind, randomized, placebo-controlled pilot study that
examined Provir's ability to treat diarrhea in patients with AIDS. The
study was a five-day, in-hospital trial that required a 24-hour baseline
observation period and four days of treatment with either Provir or a
placebo.
The trial was conducted at San Francisco General Hospital and at the
Veterans Administration Hospital of Palo Alto which is closely
affiliated with the Stanford University School of Medicine. The data
from the study will be submitted for presentation at the Twelfth World
AIDS Conference in June 1998.
Dr. James Pennington, Shaman's senior vice president and chief medical
officer, who recently joined the Company from Bayer Corporation, stated,
''The data from this study show a statistically significant treatment
effect over the four days of the study period and suggest that there may
be additional benefit to be gained by a longer treatment period. We
intend to work with the FDA in an expedited program to design and
conduct trials that test Provir for longer treatment periods with larger
patient populations.'' Specific data from this trial are attached.
Dr. Pennington also commented, ''Diarrhea remains a major problem in
patients suffering from AIDS. We are convinced that Provir can have a
substantial impact on decreasing this devastating syndrome for which no
satisfactory treatment currently exists.''
Shaman also announced today conclusions derived from an interim analysis
from one of its ongoing Phase II dose-optimization studies of Provir in
acute watery diarrhea, which includes mild non-specific diarrhea,
moderate to severe traveler's diarrhea, and moderate to severe
non-specific diarrhea. This interim analysis involved 166 Mexican
national patients in a double-blind, placebo-controlled, mild diarrhea
study of non-specific causes in Mexico. Although the analysis provides
additional evidence that Provir is safe, well-tolerated, and not
systemically absorbed, it did not support further studies in this
particular mild diarrhea indication. The Company instead will continue
its efforts involving the use of Provir in moderate to severe diarrhea,
such as traveler's diarrhea.
Lisa Conte, Shaman's president and CEO stated, ''The data from this
interim analysis, together with our very positive results in diarrhea in
patients with AIDS, provide supporting information for the ongoing and
upcoming studies of Provir in traveler's diarrhea and other more serious
diarrheas, including an in-hospital study that we have recently
initiated in Venezuela.''
Shaman Pharmaceuticals discovers and develops novel pharmaceutical
products for major human diseases by isolating active compounds from
tropical plants. The Company has three compounds in clinical
development: Provir, an oral product for the treatment of watery
diarrhea; Virend, a topical antiviral for the treatment of herpes; and
nikkomycin Z, an oral antifungal for the treatment of endemic mycoses.
Shaman also has an active Type II diabetes program which served as the
basis for its collaborations for the development of its diabetes drugs
with Lipha s.a., a wholly owned subsidiary of Merck KGaA, Darmstadt,
Germany and with Ono Pharmaceutical Co., Ltd. of Japan.
Note: Virend(r) and Provir(TM) are trademarks 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/A for the year ended
December 31, 1996 and Quarterly Report on Form 10-Q for the quarter
ended June 30, 1997. These filings are available upon request at
650/952-7070.
-- Data to Follow --
DATA FROM SHAMAN'S PHASE II DOUBLE-BLIND, PLACEBO-CONTROLLED
AIDS DIARRHEA STUDY
Data from 51 evaluable patients indicate that Provir showed improvement
in treating AIDS-related diarrhea in the primary variables of reduction
in stool weight and abnormal stool frequency. A multivariate analysis of
the treatment effect over four days based on evaluation of daily
measurements indicated that patients treated with Provir experienced a
statistically significant reduction in stool weight (p=0.018), and a
reduction in abnormal stool frequency (p=0.047) when compared with a
placebo.
The Provir treated group (26/51 evaluable patients) experienced a mean
reduction from baseline stool weight of 451.3 grams by day four of
treatment versus a mean reduction from baseline stool weight of 150.7
grams for the same measurement period (p = 0.14) in patients receiving
placebo (25/51 evaluable patients). Provir-treated patients also
experienced a reduction in abnormal stool frequency from a mean of 5.2
abnormal stools in 24 hours to a mean of 2.2 abnormal stools at day four
compared with a reduction in abnormal stool frequency from 5.2 abnormal
stools in 24 hours to 3.1 abnormal stools at day four in placebo treated
patients (p = 0.26).
The study did not achieve statistical significance for Provir in
subjective patient assessments of gastrointestinal symptoms associated
with diarrhea. However, the study did achieve statistically significant
results (p=0.035) for a measurement of relief, defined as the maximum
time between abnormal stools.
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Contact:
Shaman Pharmaceuticals, Inc.
Lisa A. Conte, 650/952-7070, x465
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