GAITHERSBURG, Md., Dec. 16 /PRNewswire-FirstCall/ --
Antex Biologics Inc. (Amex: ANX) today announced that it has completed the
required laboratory analysis for its Phase I human clinical trial of the
Company's vaccine to prevent Shigella sonnei infection. The results of the
trial demonstrate that the vaccine is well tolerated, and no serious adverse
events were reported. The trial was carried out at the Johns Hopkins
University Vaccine Testing Unit in Baltimore, and was designed to test the
safety of the vaccine and to generate initial immunogenicity data. The
vaccine was developed using the Company's proprietary Nutriment Signal
Transduction (NST) technology.
The Phase I trial was funded under a U.S. Army contract. The U.S. Army's
interest in a Shigella vaccine is to protect its troops deployed in endemic
regions overseas, such as the Middle East. The Shigella vaccine is one of
three components of the Company's combination ACTIVAX vaccine to prevent
diseases caused by the consumption of contaminated food and water. ACTIVAX is
a multi-component vaccine designed to prevent and eradicate travelers'
diseases caused by Shigella, Campylobacter jejuni and enterotoxigenic E. coli
(ETEC) bacteria. The Company is also developing each of the three vaccine
components as potential individual pathogen-specific vaccines.
The Shigella trial consisted of three groups of subjects treated with two
different dosing regimens of the vaccine, and a placebo. Preliminary
serological data indicated that the vaccine elicited IgA and IgG antibodies,
the primary immunogenicity endpoints of the trial, specifically against
Lipopolysaccharide or LPS, the bacteria's dominant immunogen.
"We are extremely excited about the results of this trial," said Dr. Alan
Liss, Antex's Vice President and Product Development. "We have now taken all
three of the ACTIVAX components into human trials and have gathered safety and
immunogencity data sufficient to proceed into clinical trials with the
combination vaccine."
Diseases caused by the consumption of contaminated food and water are the
most prevalent illnesses afflicting travelers and are serious problems for
military troops deployed overseas. Enteric bacteria, including Campylobacter,
Shigella and ETEC, are the leading causes of these diseases, which can include
gastritis, acute diarrhea, high fever, dehydration, severe dysentery and often
death. There are currently no vaccines on the market for travelers' diseases,
which are responsible for more than three million deaths a year worldwide.
Campylobacter is the number one food-borne pathogen in the U.S.
International public health officials estimate that it causes 400 to
500 million cases of diarrhea worldwide each year. ETEC is estimated to cause
more than 600 million cases of mild to severe diarrhea annually. Shigella is
estimated to add more than 200 million cases annually worldwide and is an
unusually virulent bacterium that causes endemic or epidemic dysentery and
often death. Together, these bacteria are responsible for more than one
billion cases of travelers' diseases each year. Infections occur most
frequently in overcrowded areas with poor sanitation and sub-standard hygiene,
and can be transmitted through person-to-person contact and through
contaminated food and unsafe water supplies. There are no vaccines on the
market against travelers' diseases.
About Antex Biologics
Antex Biologics, and its wholly owned subsidiary, AntexPharma, is a
biopharmaceutical company committed to developing and marketing new products
to prevent and treat infections and related diseases. The Company maintains
strategic alliances with GlaxoSmithKline, Aventis Pasteur, and the US
Department of Defense. The Company currently has two products in human
clinical trials and expects to have three additional products in clinical
trials within the next six months. Based on the Company's operating cash
requirements expected for the remainder of 2002, including costs for clinical
trials, the Company will require additional funding.
Statements contained herein that relate to future events or results are
forward-looking statements. Without limiting the foregoing, the words "may,"
"will," "should," "intends," "estimates," "predicts," "potential," "continue,"
"believes," "anticipates," "plans," "expects," the negative of these terms or
other comparable terminology are intended to identify forward-looking
statements. These statements are only predictions. A number of factors could
cause actual results to differ materially from those indicated by
forward-looking statements. In evaluating forward-looking statements, you
should consider: (i) the Company's ability to fund its future operations; (ii)
the Company's ability to successfully complete product research and
development, including pre-clinical and clinical studies and
commercialization; (iii) the Company's ability to obtain required governmental
approvals; (iv) the Company's ability to attract and/or maintain
manufacturing, sales, distribution and marketing partners; and (v) the
Company's ability to develop and commercialize its products before its
competitors.
SOURCE Antex Biologics Inc.
 back to top
Related links:
http://www.antexbiologics.com
CONTACT:
Jeffrey V. Pirone of Antex Biologics Inc.,
+1-301-590-0129; Media - Andria Pilo of Wolfe Axelrod Weinberger
Assoc. LLC, +1-212-370-4500, fax - +1-212-370-4505,
don@wolfeaxelrod.com, for Antex Biologics Inc.
|
