Dose-Ranging Study of AVANT's CholeraGarde Presented at ICAAC; Study Results Confirm Immunogenicity, Dosing and Tolerability of Oral Cholera Vaccine.Business Editors/Health/Medical Writers BIOWIRE2K NEEDHAM, Mass.--(BUSINESS WIRE)--Sept. 16, 2003 AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today presented the full study results of a dose-ranging, immunological study of the company's oral cholera vaccine candidate, CholeraGarde(TM), in healthy volunteers as a poster presentation at the 43rd annual Interscience Conference on Antimicrobial Agents and Chemotherapy Antimicrobial Agents and Chemotherapy (print-ISSN 0066-4804, CODEN AMACCQ; canceled ISSN 0074-9923, canceled CODEN AACHAX) is an academic journal published by the American Society for Microbiology. (ICAAC ICAAC Interscience Conference on Antimicrobial Agents and Chemotherapy ICAAC Iowa Community College Athletic Conference ) in Chicago, IL. The study results demonstrate a dose-response relationship The Dose-response relationship describes the change in effect on an organism caused by differing levels of exposure (or doses) to a stressor (usually a chemical). This may apply to individuals (eg: a small amount has no observable effect, a large amount is fatal), or to populations and showed the vaccine's ability to elicit vibriocidal antibodies without an increased incidence of adverse effects compared to placebo. In a previous Phase IIb double-blind, placebo-controlled challenge study, a single, oral dose of CholeraGarde(TM) demonstrated 100% protection against moderate and severe diarrhea and 93% protection against any diarrhea. Phase II field trials of CholeraGarde(TM) in adults and children are currently being conducted by the International Vaccine Institute in Bangladesh. AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to prevent and treat disease. The company is developing a broad portfolio of vaccines addressing a wide range of applications including bacterial and viral diseases viral diseases Diseases caused by viruses. Long-term immunity usually follows viral childhood diseases (see chickenpox). The common cold recurs into adulthood because many different viruses cause its symptoms, and immunity against one does not protect against others. , chronic human disease, biodefense and food safety. These include single-dose, oral vaccines that protect against important disease-causing agents and a novel, proprietary vaccine candidate for cholesterol management. AVANT's goal is to demonstrate proof-of-concept for its products before leveraging their value through partnerships. Current collaborations encompass the development of an oral human rotavirus rotavirus /ro·ta·vi·rus/ (ro´tah-vi?rus) any member of the genus Rotavirus. ro´taviral Rotavirus /Ro·ta·vi·rus/ (ro´tah-vi?rus vaccine, vaccines to combat threats of biological warfare biological warfare, employment in war of microorganisms to injure or destroy people, animals, or crops; also called germ or bacteriological warfare. Limited attempts have been made in the past to spread disease among the enemy; e.g. , and vaccines addressed to human food safety and animal health. Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: http://www.avantimmune.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: This release includes forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. which reflect AVANT's current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe", "expect", "anticipate", "intend", "estimate", "project" and similar expressions which do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: (1) the integration of multiple technologies and programs; (2) the ability to adapt AVANT's vectoring systems to develop new, safe and effective orally administered vaccines against anthrax anthrax (ăn`thrăks), acute infectious disease of animals that can be secondarily transmitted to humans. It is caused by a bacterium (Bacillus anthracis and plague or other bioterrorism threats or emerging health care threats; (3) the ability to successfully complete development and commercialization of CETi-1, CholeraGarde(TM) (Peru-15), Ty800 and other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of CETi-1, CholeraGarde(TM) (Peru-15), Ty800 and other preclinical and clinical testing; (5) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of CETi-1, CholeraGarde(TM) (Peru-15), Ty800 and other products; (6) the ability of the Company to manage multiple late stage clinical trials for a variety of product candidates; (7) the volume and profitability of product sales of Megan(R)Vac 1 and other future products; (8) changes in existing and potential relationships with corporate collaborators; (9) the availability, cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers; (10) the timing, cost and uncertainty of obtaining regulatory approvals to use CETi-1, CholeraGarde(TM) (Peru-15) and Ty800, among other purposes, to raise serum HDL cholesterol HDL cholesterol n. See high-density lipoprotein. HDL Cholesterol About one-third or one-fourth of all cholesterol is high-density lipoprotein cholesterol. levels and to protect travelers and people in endemic regions from diarrhea causing diseases, respectively; (11) the ability to obtain substantial additional funding; (12) the ability to develop and commercialize products before competitors; (13) the ability to retain certain members of management; and (14) other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements. |
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