Exhibit 99
Contact: Robert A. Hoerr, M.D., Ph.D. Karen L. Bergman (media)
President & CEO Jonathan M. Nugent (investors)
GalaGen Inc. Burns McClellan, Inc.
612/481-2105 212/213-0006
FOR IMMEDIATE RELEASE
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GALAGEN INC. INITIATES PHASE II CLINICAL TRIAL WITH DIFFISTAT-G
FOR ANTIBIOTIC-ASSOCIATED DIARRHEA
Arden Hills, Minn. -- August 14, 1997 -- GalaGen Inc. (Nasdaq: GGEN) today
announced that it has initiated a multi-center Phase II clinical trial of
Diffistat-G,(the Company's polyclonal antibody drug for the treatment of
antibiotic-associated diarrhea, a life-threatening illness caused by the
pathogen, Clostridium difficile (C. difficile). Principal investigators in the
study include Ciaran Kelly, M.D., Assistant Professor of Medicine, and J. Thomas
LaMont, M.D., Professor of Medicine and Chief, Gastroenterology Division, both
of Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston.
Antibiotic-associated diarrhea is a major complication of broad spectrum
antibiotic therapy, in which the normal bacterial flora in the colon are
suppressed, permitting the bacteria C. difficile to colonize the colon. In
antibiotic-associated infections, C. difficile releases toxins that injure the
lining of the colon, causing painful diarrhea. C. difficile affects an estimated
400,000 patients annually in the U.S. and more than one million globally.
"The initiation of this Phase II clinical trial represents a key milestone in
the advancement of Diffistat-G through the clinical development process," said
Robert A. Hoerr, M.D., Ph.D., President and CEO of GalaGen. "We believe that the
results of this trial will further define the therapeutic potential of
Diffistat-G as an effective treatment for antibiotic-associated diarrhea."
Providing an update on the Sporidin-G(TM) clinical development program, GalaGen
announced that it has placed the U.S. Phase II/III clinical trial in HIV/AIDS
patients on hold, citing a continued decline in Cryptosporidium parvum (C.
parvum) infections due to the current success of anti-AIDS therapies.
"We remain very positive about the clinical potential of Sporidin-G in the
treatment of C. parvum infections and will maintain an active IND in case a
clinical need reemerges in the AIDS population or we decide to pursue other
indications for the product," Dr. Hoerr stated. "In the interim, we will focus
the Company's resources on other pharmaceutical and nutritional products in
development. These products offer significant market opportunities and are
receiving substantial interest from potential corporate partners."
-more-
GalaGen Announces Diffistat-G Phase II Trial Initiation
Page Two
GalaGen Inc. is evaluating the commercial potential for Sporidin-G in HIV/AIDS
patients in developing countries where there is an ongoing need for promising
products to address opportunistic infections. The Company is also evaluating
other potential indications, because C. parvum continues to be targeted by
public health officials as a serious emerging pathogen that causes acute
diarrhea in normal individuals, particularly in children.
GalaGen Inc. is developing a portfolio of oral pharmaceutical products derived
from its platform technology that target life-threatening and emerging
pathogens. In addition to Diffistat-G, the Company currently is advancing two
other polyclonal antibody therapeutics. Candistat-G(TM) is an oral antibody
product in early clinical development for the treatment of thrush or infection
of the throat and oral cavity with the fungus Candida. PylorImune-G(TM) is in
preclinical development with the Company's corporate partner, Chiron
Corporation. The Company is utilizing its pharmaceutical and nutritional
expertise to actively develop proprietary dietary supplements and medical foods.
EXCEPT FOR HISTORICAL INFORMATION, MATTERS DISCUSSED IN THIS PRESS RELEASE ARE
FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES, AND ACTUAL
RESULTS MAY BE MATERIALLY DIFFERENT. FACTORS THAT COULD CAUSE ACTUAL RESULTS TO
DIFFER INCLUDE: LEVELS OF RESOURCES DEVOTED BY THE COMPANY TO THE DEVELOPMENT OF
ITS MANUFACTURING AND MARKETING CAPABILITIES, RISKS GENERALLY ASSOCIATED WITH
CONSTRUCTION OF MANUFACTURING FACILITIES, THE ABILITY OF THE COMPANY TO MAKE
TECHNOLOGICAL ADVANCES, THE STATUS OF COMPETITIVE PRODUCTS AND THE ABILITY OF
THE COMPANY TO ESTABLISH STRATEGIC ALLIANCES TO PROVIDE RESEARCH AND DEVELOPMENT
FUNDING TO THE COMPANY.