Four Avant Vaccines Highlighted at 3rd International Conference on Vaccines for Enteric Diseases.Business Editors/High-Tech Writers BIOWIRE2K NEEDHAM, Mass.--(BUSINESS WIRE)--April 28, 2004 Progress in four of AVANT Immunotherapeutics' (Nasdaq: AVAN) vaccines programs is a highlight this week at the 3rd International Conference on Vaccines for Enteric enteric /en·ter·ic/ (en-ter´ik) within or pertaining to the small intestine. en·ter·ic adj. 1. Of, relating to, or within the intestine. 2. Diseases, being held in Montego Bay, Jamaica from April 28 - 30. AVANT scientists and their collaborators will present updates on the development of the company's oral cholera vaccine, oral combination vaccine 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 and oral campylobacter Campylobacter Genus of gram-negative spiral-shaped bacteria infecting mammals. Many species, especially C. fetus, cause miscarriage in sheep and cattle. C. jejuni is a common cause of food poisoning. Sources include meats (particularly chicken) and unpasteurized milk. vaccine. In addition, GlaxoSmithKline and several of that company's academic collaborators will present a special symposium on the Rotarix(R) 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 and its worldwide development, including reports on experience with that investigational vaccine in Europe, the United States, Singapore and Latin America. Phase II Study Results with AVANT Oral Cholera Vaccine Detailed results of the adult portion of an ongoing Phase II study of AVANT's CholeraGarde(TM) live, attenuated Attenuated Alive but weakened; an attenuated microorganism can no longer produce disease. Mentioned in: Tuberculin Skin Test attenuated having undergone a process of attenuation. cholera vaccine will be presented at the Conference by Firdausi Qadri, Ph.D., of the International Center for Diarrhoeal Disease Research, Bangladesh (ICDDR ICDDR International Centre for Diarrhoeal Disease Research (Bangladesh) ,B). Seventy adult volunteers were given a single oral dose of CholeraGarde(TM) or placebo and monitored for adverse events for 21 days after the dosing. The vaccine was well tolerated and there were no reports of diarrhea. Moreover, as announced by AVANT in January 2004, over 70% of the vaccinated adults responded with a favorable immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. . The investigators have now completed the toddler portion of the study, and have reported no safety concerns. They have not yet broken the study code to determine the dose-related immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. in this age group. The investigators are currently vaccinating infants aged 9 to 23 months, and expect to complete the study in the second half of 2004. "Evidence to date indicates that the Peru 15 oral cholera vaccine - AVANT's CholeraGarde(TM) - is safe and acceptable in the age groups tested to date and induces a strong serum immune response in Bangladeshi people. Thus, it shows promise of being highly protective, although future efficacy studies will be needed to prove this protection in this cholera endemic country," said David A. Sack, M.D., director of ICDDR, B. "The live attenuated Peru-15 strain of Vibrio cholerae Vibrio chol·er·ae n. A bacterium that causes Asiatic cholera in humans; Koch's bacillus. Vibrio cholerae Infectious disease The Vibrio and the live attenuated Salmonella enterica used in our oral typhoid fever typhoid fever acute, generalized infection caused by Salmonella typhi. The main sources of infection are contaminated water or milk and, especially in urban communities, food handlers who are carriers. vaccine have both to date shown a good profile of safety and immunogenicity," said Una S. Ryan, Ph.D. AVANT President and Chief Executive Officer. "These organisms can also serve as efficient vectors for the delivery of other disease antigens, thus enabling the creation of a wide range of oral, rapid-acting vaccines. AVANT is currently developing an oral vaccine combining protection against two potential agents of bioterrorism, anthrax and plague." Vectored Vaccines Against Anthrax and Plague AVANT scientist Kevin P. Killeen, Ph.D. will present the company's efforts to develop a live, attenuated vaccine against anthrax and plague based on AVANT's proprietary VibrioVec(TM) and SalmoVec(TM) bacterial vector technology. "The Peru-15 live attenuated cholera vaccine and the live attenuated Salmonella used as AVANT's typhoid vaccine typhoid vaccine n. A vaccine containing a suspension of inactivated Salmonella typhi, used to immunize against typhoid fever. have been well-tolerated in humans and serve as the platform for vectoring antigens from other pathogens to create oral, rapid-acting vaccines against important diseases," Dr. Killeen said. He will describe the status of VibrioVec(TM) strains that vector protective antigen (PA) from Bacillus anthracis Bacillus anthracis Infectious disease A gram-positive organism which causes often fatal infections when its endospores–resistant to heat, drying, UV light, gamma radiation, and many disinfectants–enter the body and cause septicemia Military medicine , the anthrax organism, and SalmoVec(TM) strains that vector a fusion of protective antigens (F1- V) from the plague organism, Yersinia pestis Yersinia pes·tis n. A bacterium that causes plague and is transmitted from rats to humans by the rat flea Xenopsylla cheopis. Also called Pasteurella pestis. . Dr. Killeen will also present pre-clinical data from a plague-directed bacterial vaccine candidate showing that it was well tolerated in mice and elicited high antibody titers against plague antigens. "We believe this oral vaccine technology offers considerable potential for the creation of an effective vaccine against plague, due to its potential ability to rapidly elicit both mucosal and systemic immunity," said Dr. Killeen. "This differs from injectable vaccines which typically take longer to confer immunity, and do not stimulate mucosal immunity - the first line of defense against pathogens like pneumonic plague pneumonic plague n. A frequently fatal form of bubonic plague in which the lungs are infected and the disease is transmissible by coughing. that are inhaled." Additionally, AVANT scientist Donata R. Sizemore will make a poster presentation featuring preclinical data of salmonella-vectored campylobacter vaccine candidates that elicit antibody titers against PEB PEB Physical Evaluation Board PEB Presidential Emergency Board PEB Post Exposure Bake PEB Professional Engineers Board (Singapore) PEB Pre-Engineered Building PEB Personal Electronic Ballot PEB Performance Evaluation Board 1, a key campylobacter antigen. About AVANT AVANT Immunotherapeutics, Inc. discovers, develops and sells innovative vaccines and therapeutics 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 has developed a broad, well-staged pipeline of vaccines and therapeutics for large, high-value, under-served markets. Six of AVANT's products are in clinical development. These include an oral human rotavirus vaccine, a treatment to reduce complement-mediated tissue damage associated with cardiac by-pass surgery, and a novel vaccine for cholesterol management. AVANT has also assembled a technology platform that enables the creation of rapid-protecting, single-dose, oral vaccines that remain stable without refrigeration refrigeration, process for drawing heat from substances to lower their temperature, often for purposes of preservation. Refrigeration in its modern, portable form also depends on insulating materials that are thin yet effective. . The company is developing applications of this vaccine technology in four areas: biodefense, travelers' vaccines, global health needs, and human food safety. AVANT's goal is to demonstrate proof-of-concept for its products before leveraging further development through both traditional pharmaceutical partnerships and collaborations with governmental and other organizations. 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 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 and plague or other bioterrorism threats or emerging health care threats; (3) the ability to successfully complete development and commercialization of TP10, CETi-1, CholeraGarde(TM) (Peru-15), Ty800 and other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of TP10, 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 TP10, 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, Megan(R)Egg 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 TP10, CETi-1, CholeraGarde(TM) (Peru-15) and Ty800, among other purposes, for adults undergoing cardiac surgery, 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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