For:
Antex Biologics
300 Professional Drive
Gaithersburg, MD 20879
(301) 590-0129
FOR IMMEDIATE RELEASE
Contact:
Theresa M. Smith, Esq.
Vice President, Corporate Development
(301) 590-0129
PHASE II EFFICACY TRIAL OF ANTEX'S CAMPYLOBACTER VACCINE ANNOUNCED
Campylobacter Infection Causes 400-500 Million Cases of Diarrhea
Annually; Diarrheal Diseases are Major Cause of Death Worldwide
Gaithersburg, MD, July 9, 1997 -- Antex Biologics, SmithKline Beecham,
and the United States Navy today jointly announced the start of a Phase
II clinical trial for Antex"šs Campylobacter vaccine consisting of
inactivated Campylobacter whole-cells plus an adjuvant. This
double-blinded, placebo-controlled study will evaluate the potential
protective efficacy of this oral vaccine in healthy adult volunteers
against challenge with infectious Campylobacter. The sequence of
clinical and microbiological events associated with Campylobacter
infections will also be characterized and correlated with immune
response patterns in the vaccinated volunteers.
The trial will consist of approximately 65 healthy adult volunteers in
two phases. The first phase, which is ongoing, will consist of two
groups of approximately 15 volunteers each, to determine the dose of
live organisms needed to give the appropriate incidence of disease.
Once determined, the appropriate dose of live organisms will then be
used as the challenge dose for the second phase of the study.
The second phase of the study, for which recruitment is ongoing, will
consist of approximately 35 individuals who will receive either a
placebo or the Campylobacter vaccine and will be subsequently challenged
with live infectious organisms. The trial is expected to take
approximately 5 months for the clinical portion, including dosing,
challenge and follow-up observations, followed by laboratory analysis of
all samples collected during the clinical phase.
This trial is being conducted at the U.S. Army Medical Research
Institute of Infectious Diseases in Maryland by the U.S. Navy and Army,
and is a continuation of ongoing research under existing Cooperative
Research and Development Agreements between the Navy and Antex or
SmithKline Beecham. A portion of this research is also being supported
by the U.S. Army Medical Material Development Activity.
Two prior Phase I safety and immunogenicity clinical trials have been
successfully completed; the first assessed the inactivated Campylobacter
whole cells alone and the second tested the Campylobacter whole cells in
combination with an adjuvant, which is the vaccine formulation being
evaluated in this Phase II study.
The data from both Phase I trials show that the vaccine is safe and
immunogenic and that the adjuvant both improves and broadens the nature
of the immune responses elicited by the vaccine. Volunteers responded
to the vaccine in a dose-dependent manner. Blood samples from
volunteers were collected and analyzed for both humoral and cellular
immune responses. Data from IgA antibody secreting cell assays (an
indicator of the humoral immune response) show that the vaccine produces
a Campylobacter-specific response. Further, measurements of
interferon-gamma (INF-g) showed that the vaccine group had greatly
increased INF-g levels as compared to placebo recipients. INF-g
production typifies a Th1-type T-cell response, which is predominantly
indicative of active cellular immunity. These data are consistent with
results of preclinical safety and immunogenicity studies in animal
models. Data from animal models also showed that the vaccine provides
protective immunity against live infections and illness.
"Based on the positive results from the two Phase I human clinical
trials and preclinical animal models, we are encouraged to proceed with
the Phase II efficacy trial, which is a major milestone for the
Company," said Dr. Vic Esposito, Chairman and CEO of Antex. Dr.
Esposito continued, "The Campylobacter vaccine, based on our patented
NST (Nutriment Signal Transduction) technology, is the most advanced of
our vaccine products. NST is a highly innovative and proprietary
platform for the development of products to prevent and potentially
treat a range of different diseases. Moreover, this is the first
clinical trial that will provide a unique opportunity to more thoroughly
assess the humoral and cellular immune factors contributing to
protection against Campylobacter infections in humans, and should
confirm results from similar preclinical studies."
"We share Antex"šs enthusiasm for proceeding with the Phase II trial of
this vaccine based on promising results of the prior preclinical and
Phase I human studies," said Capt. A.L. Bourgeois, Director of the
Enteric Diseases Program at the Naval Medical Research Institute in
Maryland. Capt. Bourgeois continued, "In my view, the rapid progress of
this project has clearly demonstrated the benefits that can accrue from
Department of Defense and industry partnerships to solve common medical
problems. This Campylobacter vaccine is hoped to greatly reduce the
threat of acute diarrheal disease among soldiers, sailors, and marines
deployed overseas."
Over 2.5 million cases of Campylobacter diarrhea are estimated to occur
in the U.S. annually, with outbreaks and sporadic cases of Campylobacter
gastroenteritis and diarrhea occurring frequently among military
personnel stationed in the U.S. and overseas. Diarrheal diseases are
considered a major cause of death globally, and 400-500 million cases of
Campylobacter diarrhea occur throughout the world each year.
Campylobacter infection is also considered to cause one of the most
severe forms of traveler"šs diarrhea among visitors to less developed
countries.
Antex Biologics Inc. is a biopharmaceutical company committed to
improving human health by developing new products to prevent and treat
infectious diseases and related disorders. The Company has two other
vaccines in clinical development: one is for Helicobacter pylori, the
causative agent of peptic ulcers; and the other is directed against
Haemophilus influenzae, a leading cause of otitis media. The Company"šs
common stock is quoted on the NASDAQ OTC Bulletin Board under the ticker
symbol ANTX.
# # #
Statements contained herein that are not historical facts may be
forward-looking statements that are subject to a variety of risks and
uncertainties. There are a number of important factors that could cause
actual results to differ materially from those expressed in any
forward-looking statements made by the Company. These factors include,
but are not limited to: (i) the Company"šs ability to successfully
complete product research and development, including preclinical and
clinical studies and commercialization; (ii) the Company"šs ability to
obtain required governmental approvals; (iii) the Company"šs ability to
attract and/or maintain manufacturing, sales, distribution and marketing
partners; and (iv) the Company"šs ability to develop and commercialize
its products before its competitors.
RSS