Preclinical Studies on Antex's Traveler's Diarrhea Vaccine Show 100 Percent Effectiveness in Animals

Human Clinical Trials to Begin Later This Year



Apr 04, 2001, 01:00 ET from Antex Biologics Inc.

    GAITHERSBURG, Md., April 4 /PRNewswire/ -- Antex Biologics Inc.
 (Amex:   ANX) today announced that preclinical studies have been completed on a
 vaccine to prevent diarrhea caused by Shigella sonnei, and the first human
 clinical trial will be initiated in 2001.  The vaccine protected 100 percent
 of animals against infection and disease.  These preclinical studies mark a
 significant step in the development of a multivalent vaccine to prevent
 Traveler's Diarrhea, caused by Shigella, Campylobacter and enterotoxigenic E.
 coli (ETEC).  No vaccines are currently available to prevent Traveler's
 Diarrhea.  The worldwide market for a vaccine to prevent Traveler's Diarrhea
 is estimated to exceed $750 million.
     "Completion of the preclinical studies on our Shigella vaccine represents
 a significant accomplishment for Antex, and moves us further along the
 development path of ACTIVAX, our multivalent vaccine for the prevention of
 Traveler's Diarrhea," remarked Stephen Keith, MD, MSPH, President.  "The
 Campylobacter component of ACTIVAX has already completed two Phase II clinical
 trials.  Clinical trials of the multivalent formulation will be initiated upon
 completion of trials of each of the components.  We consider ACTIVAX to have
 considerable commercial potential and look forward to continuing its clinical
 development."
     The Shigella vaccine was developed using the Company's proprietary
 Nutriment Signal Transduction technology.  Efficacy was evaluated in animals
 that were vaccinated orally with four doses of the vaccine alone, the vaccine
 plus a mucosal adjuvant, or a placebo.  Following vaccination, the animals
 were inoculated with live Shigella sonnei bacteria.  One hundred percent of
 the animals vaccinated with the vaccine alone or the vaccine plus a mucosal
 adjuvant were protected against disease.  None of the animals given the
 placebo was protected.  These results indicate that mucosal immunization with
 the Shigella vaccine confers protective immunity against infection and
 disease, and that an adjuvant is not required to elicit protection.
     Antex has already achieved several significant milestones in the
 development of ACTIVAX, an orally administered, multivalent vaccine to prevent
 diarrhea caused by Shigella flexneri, Shigella sonnei, Campylobacter jejuni,
 and ETEC.  The Company has completed two Phase II clinical trials on CAMPYVAX,
 an orally administered vaccine to prevent gastrointestinal disease, including
 diarrhea, caused by Campylobacter jejuni.  And a Phase II Small Business
 Technology Transfer Research (STTR) contract from the U.S. Department of the
 Army was awarded in 2000 to continue the development of ACTIVAX.  The Company
 has also been awarded a grant for the development of an oral microbead
 formulation of ACTIVAX under the U.S. Army Small Business Innovation Research
 (SBIR) Program. The SBIR grant specifically funds studies on the encapsulation
 of inactivated Campylobacter jejuni bacteria into microbeads, and
 determination of their immune responses in preclinical studies.
     Diarrheal diseases are a major cause of morbidity in developed countries
 and are a major cause of both morbidity and mortality in developing countries.
 In the U.S., diarrhea is the second most common infectious illness, accounting
 for one out of every six infectious disease episodes.  The most common
 causative organisms are bacteria, such as E. coli, Shigella and Campylobacter.
 Diarrhea is by far the most frequent health problem encountered by travelers
 to developing countries.  Of the millions of international travelers who will
 cross the world's frontiers this year, including 25 million U.S. residents,
 approximately one-third will contract diarrhea.  The economic impact of
 Traveler's Diarrhea is substantial, because fear of sickness is one of the
 major deterrents to tourism.  ETEC, with an estimated 630 million cases
 reported, is the most common causative agent of Traveler's Diarrhea in all
 countries where surveys have been conducted.  Shigella is a well-known cause
 of bacillary dysentery, with over 200 million cases reported.  Campylobacter
 jejuni is the number one food-borne pathogen in the U.S., with over 2.5
 million cases of Campylobacter diarrhea in the U.S. annually.  Worldwide, 400-
 500 million cases of Campylobacter diarrhea occur each year.
     AntexBiologics, together with 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 has three
 vaccine products in clinical development and has strategic alliances with
 GlaxoSmithKline, Aventis Pasteur, and the U.S. Department of Defense.
 
     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 preclinical 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.
    GAITHERSBURG, Md., April 4 /PRNewswire/ -- Antex Biologics Inc.
 (Amex:   ANX) today announced that preclinical studies have been completed on a
 vaccine to prevent diarrhea caused by Shigella sonnei, and the first human
 clinical trial will be initiated in 2001.  The vaccine protected 100 percent
 of animals against infection and disease.  These preclinical studies mark a
 significant step in the development of a multivalent vaccine to prevent
 Traveler's Diarrhea, caused by Shigella, Campylobacter and enterotoxigenic E.
 coli (ETEC).  No vaccines are currently available to prevent Traveler's
 Diarrhea.  The worldwide market for a vaccine to prevent Traveler's Diarrhea
 is estimated to exceed $750 million.
     "Completion of the preclinical studies on our Shigella vaccine represents
 a significant accomplishment for Antex, and moves us further along the
 development path of ACTIVAX, our multivalent vaccine for the prevention of
 Traveler's Diarrhea," remarked Stephen Keith, MD, MSPH, President.  "The
 Campylobacter component of ACTIVAX has already completed two Phase II clinical
 trials.  Clinical trials of the multivalent formulation will be initiated upon
 completion of trials of each of the components.  We consider ACTIVAX to have
 considerable commercial potential and look forward to continuing its clinical
 development."
     The Shigella vaccine was developed using the Company's proprietary
 Nutriment Signal Transduction technology.  Efficacy was evaluated in animals
 that were vaccinated orally with four doses of the vaccine alone, the vaccine
 plus a mucosal adjuvant, or a placebo.  Following vaccination, the animals
 were inoculated with live Shigella sonnei bacteria.  One hundred percent of
 the animals vaccinated with the vaccine alone or the vaccine plus a mucosal
 adjuvant were protected against disease.  None of the animals given the
 placebo was protected.  These results indicate that mucosal immunization with
 the Shigella vaccine confers protective immunity against infection and
 disease, and that an adjuvant is not required to elicit protection.
     Antex has already achieved several significant milestones in the
 development of ACTIVAX, an orally administered, multivalent vaccine to prevent
 diarrhea caused by Shigella flexneri, Shigella sonnei, Campylobacter jejuni,
 and ETEC.  The Company has completed two Phase II clinical trials on CAMPYVAX,
 an orally administered vaccine to prevent gastrointestinal disease, including
 diarrhea, caused by Campylobacter jejuni.  And a Phase II Small Business
 Technology Transfer Research (STTR) contract from the U.S. Department of the
 Army was awarded in 2000 to continue the development of ACTIVAX.  The Company
 has also been awarded a grant for the development of an oral microbead
 formulation of ACTIVAX under the U.S. Army Small Business Innovation Research
 (SBIR) Program. The SBIR grant specifically funds studies on the encapsulation
 of inactivated Campylobacter jejuni bacteria into microbeads, and
 determination of their immune responses in preclinical studies.
     Diarrheal diseases are a major cause of morbidity in developed countries
 and are a major cause of both morbidity and mortality in developing countries.
 In the U.S., diarrhea is the second most common infectious illness, accounting
 for one out of every six infectious disease episodes.  The most common
 causative organisms are bacteria, such as E. coli, Shigella and Campylobacter.
 Diarrhea is by far the most frequent health problem encountered by travelers
 to developing countries.  Of the millions of international travelers who will
 cross the world's frontiers this year, including 25 million U.S. residents,
 approximately one-third will contract diarrhea.  The economic impact of
 Traveler's Diarrhea is substantial, because fear of sickness is one of the
 major deterrents to tourism.  ETEC, with an estimated 630 million cases
 reported, is the most common causative agent of Traveler's Diarrhea in all
 countries where surveys have been conducted.  Shigella is a well-known cause
 of bacillary dysentery, with over 200 million cases reported.  Campylobacter
 jejuni is the number one food-borne pathogen in the U.S., with over 2.5
 million cases of Campylobacter diarrhea in the U.S. annually.  Worldwide, 400-
 500 million cases of Campylobacter diarrhea occur each year.
     AntexBiologics, together with 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 has three
 vaccine products in clinical development and has strategic alliances with
 GlaxoSmithKline, Aventis Pasteur, and the U.S. Department of Defense.
 
     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 preclinical 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.