To: Amigo Mike who wrote (1469 ) 6/29/2000 9:31:00 AM From: R Hamilton Respond to of 1476
Antex Advances to Phase II U.S. Department of Army Funding For Development of a Traveler's Vaccine GAITHERSBURG, Md., June 28 /PRNewswire/ -- Antex Biologics Inc. (OTC Bulletin Board: ANTX) today announced it was awarded a Phase II Small Business Technology Transfer Research (STTR) contract from the U.S. Department of the Army to continue the development of ACTIVAX(TM), an oral multivalent vaccine for Traveler's Diseases. ACTIVAX is being developed using the Company's proprietary NST(TM) (Nutriment Signal Transduction) technology. In granting the Phase II STTR funding to Antex, the Department of the Army is indicating substantial interest in the full development of ACTIVAX. A very low percentage of STTR contracts are advanced to this stage by the Army. ACTIVAX has three components, two of which are the subject of this research project-enterotoxigenic E.coli (ETEC) and Shigella. Assuming continued success in Antex's Phase II research, the company expects to submit Shigella, the second component of the new vaccine for Traveler's Diseases, to the FDA for human clinical trials next year. Campylobacter, the first component of Antex's ACTIVAX, is being funded by the Department of the Navy. This component has already reached human clinical studies. "We are pleased to receive this Phase II funding, which was awarded based on the successful results of our Phase I project," said Dr. Larry Ellingsworth, Vice President, Research and Development at Antex. "The goal of this Phase II research is to evaluate the effectiveness of the vaccine components of Shigella and ETEC in an appropriate animal model. By the end of the funding period, we expect to have the Shigella vaccine component ready for human clinical trials." Diarrhea is the most common cause of ill health in travelers and is a serious problem for military troops deployed overseas. Enteric bacteria, including Campylobacter, Shigella and ETEC, are the most common causes of Traveler's Diseases, which can include gastritis, acute diarrhea, high fever, dehydration, severe dysentery and death. Seemingly mild, diarrheal diseases are responsible for three million deaths a year globally. International public health officials estimate that Campylobacter causes 400 to 500 million cases of diarrhea worldwide each year, and is the number one cause of food-borne illness in the US. ETEC is the leading cause of Traveler's Diseases worldwide, causing an estimated 630 million cases of mild to severe diarrhea annually. Shigella, with over 200 million cases reported annually worldwide, is an unusually virulent bacteria that causes endemic or epidemic dysentery with high death rates. Together, these bacteria are responsible for over 1 billion cases of Traveler's Diseases each year. Infections occur most frequently in overcrowded areas with poor sanitation, sub-standard hygiene, and can be transmitted through person-to-person contact and through contaminated food and unsafe water supplies. Today, there is no vaccine on the market that is capable of conferring general protection against diarrhea. A combined vaccine for the prevention of Traveler's Diseases is a product target uniquely suited to Antex's NST(TM) platform technology. Antex's patented NST technology regulates bacterial cell growth and virulence (pathogenicity) by physiological signal transduction. NST-grown bacteria express a profile of antigens and virulence factors that are more similar to organisms seen in an infected person than the same organism grown using standard laboratory methods. These NST- bacteria have greater biological mimicry and confer more relevant immune responses. Using NST technology, the Company has produced antigenically enhanced Campylobacter and Shigella bacteria, and is using these bacteria in an inactivated whole cell form in ACTIVAX. The Company has six issued US patents and several foreign patents issued and pending claiming compositions and methods of using the Campylobacter and Shigella vaccines. Additional patents will be filed for the ETEC vaccine component. Antex Biologics 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 SmithKline Beecham, Aventis Pasteur, Pfizer and the U.S. Department of Defense. The Company's common stock is quoted on the OTC Bulletin Board under the ticker symbol ANTX. Statements contained herein that are not historical facts regarding the development of ACTIVAX may be forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a variety of risks and uncertainties that may cause actual results to differ materially from those expressed in any forward-looking statements made by the Company. Such factors are fully described in the Company's Form 10-KSB filed with the United States Securities and Exchange Commission, and include, but are not limited to: (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. CO: Antex Biologics Inc.; U.S. Department of the Army ST: Maryland IN: BIO FIN MTC SU: EXE CON 06/28/2000 10:44 EDT prnewswire.com