AVANT Signs Cholera Vaccine Agreement With International Vaccine Institute.Business Editors and Health/Medical Writers BIOWIRE2K NEEDHAM, Mass.--(BW HealthWire)--Feb. 21, 2002 AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced today the signing of a clinical research agreement with the International Vaccine Institute ("IVI IVI Intelligent Vehicle Initiative IVI International Vaccine Institute IVI Interchangeable Virtual Instrument IVI Intravenous Infusion IVI Interactive Video Instruction IVI Intra Venous Injection IVI Institute for Vision Improvement IVI Interactive Video Initiative ") aimed at conducting clinical trials of AVANT's Peru-15 cholera vaccine in Bangladesh. IVI, through its Diseases of the Most Impoverished ("DOMI") Program, seeks to accelerate the development and introduction of vaccines against cholera, 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. and shigellosis Shigellosis Definition Shigellosis is an infection of the intestinal tract by a group of bacteria called Shigella. The bacteria is named in honor of Shiga, a Japanese researcher, who discovered the organism in 1897. . IVI is founded on the belief that the health of children in developing countries can be dramatically improved by the development, introduction and use of new and improved vaccines and these vaccines should be developed through a dynamic interaction among science, public health and business. The DOMI Program has been funded by the Bill and Melinda Gates Foundation Bill and Melinda Gates Foundation, philanthropic institution founded in 1994 by Microsoft chairman Bill Gates and his wife, Melinda, to improve the lives of the poor throughout the world, primarily through grants for projects relating to global health care, . Under the direction of John D. Clemens, M.D., IVI plans to begin conducting clinical trials of Peru-15 in Bangladesh during 2002. AVANT recently announced results from a Phase IIb human challenge study of Peru-15 that showed 100% protection against moderate and severe diarrhea and 93% protection against any diarrhea. The study results suggest that, if confirmed by further investigation, Peru-15 may be an excellent candidate as a potential single dose, oral vaccine for travelers going to areas where cholera is endemic. "Cholera is a devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. disease in the developing world," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics, Inc. "We are very pleased to announce this partnership with the IVI and to be donating the vaccine to IVI for clinical studies. The development of a safe and effective cholera vaccine is important for protecting residents, travelers and military personnel from cholera in endemic areas. We see the initiation of this trial as serving the dual role of addressing a significant health issue in the developing world and advancing development of AVANT's travelers' vaccine franchise." "I am pleased to see clinical development of the Peru-15 vaccine moving forward in Bangladesh," stated John D. Clemens, M.D., Director of the International Vaccine Institute. "Our partnership with AVANT underscores IVI's mission of accelerating vaccine development to relieve the burden of disease in developing countries. IVI works with vaccine partners like AVANT to pursue vaccine development that otherwise may not occur." AVANT also announced today that it plans to aggressively move its Ty800 typhoid fever vaccine into the clinic and will be conducting two Phase II trials of this oral, single dose vaccine in 2002. Previously, an investigational clinical study of Ty800 was completed at the Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world . In addition, the company has entered into a manufacturing agreement with Bio Sidus S.A. of Buenos Aires, Argentina for production of the Ty800 vaccine. Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics, Inc. said, "Bio Sidus has been our manufacturing partner for production of the Peru-15 vaccine and it only makes sense to expand the relationship to include production of Ty800 as well. We look forward to utilizing their experience and expertise in scaling-up and manufacturing these vaccines in commercial quantities for worldwide sales." AVANT is developing a series of oral, single dose, genetically 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. , live bacterial vaccines to prevent travelers' diarrhea trav·el·ers' diarrhea or trav·el·er's diarrhea n. Diarrhea and abdominal cramps occurring among travelers to regions where sanitation is poor, commonly caused by a toxin-producing strain of the bacterium Escherichia coli. and dysentery dysentery (dĭs`əntĕr'ē), inflammation of the intestine characterized by the frequent passage of feces, usually with blood and mucus. . Frost & Sullivan, a leading market research firm, estimated in a 1999 report that the worldwide market for travelers' vaccines for diarrheal diseases would reach almost $1 billion in 2005. In addition to the Peru-15 and Ty800 vaccines, a Shigella sonnei Shigella son·ne·i n. Sonne bacillus. Shigella sonnei Shigella group D Microbiology The most commonly isolated, least virulent Shigella serotype vaccine, aimed at the shigella shigella Any of the rod-shaped bacteria that make up the genus Shigella, which are normal inhabitants of the human intestinal tract and can cause dysentery, or shigellosis. Shigellae are gram-negative (see gram stain), non-spore-forming, stationary bacteria. S. strain most often contracted by travelers, is in preclinical development at AVANT. Also, AVANT plans to expand its 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 research program to include human applications and to use its E. coli E. coli: see Escherichia coli. E. coli in full Escherichia coli Species of bacterium that inhabits the stomach and intestines. E. coli can be transmitted by water, milk, food, or flies and other insects. expertise and patented technology to develop a vaccine against ETEC ETEC enterotoxigenic Escherichia coli. ETEC Enterotoxic Escherichia coli, see there , the most common form of travelers' diarrhea. Many of these vaccines could also meet the healthcare requirements of less developed countries, where the need for cholera vaccines and typhoid fever vaccines is particularly acute. 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 against viral and bacterial diseases, including single-dose oral vaccines aimed at protecting travelers from cholera, typhoid fever and other illnesses. AVANT is also developing compounds with the potential to inhibit harmful complement activation that occurs in response to surgery. In addition, the company is conducting clinical studies of a proprietary vaccine candidate for cholesterol management. AVANT further leverages the value of its technology portfolio through corporate 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 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. The words "believe," "expect," "anticipate," and similar expressions identify forward-looking statements. Investors should not rely 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 ability to successfully complete development and commercialization of the Peru-15, Ty800 and other vaccines and other products, including the cost, timing, scope and results of pre-clinical and clinical testing; (2) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of the Peru-15, Ty800 and other vaccines and other products, and the adaptation of our attenuated vaccine technology to different infectious diseases; (3) the ability of the Company to manage multiple late stage clinical trials for a variety of product candidates; (4) the volume and profitability of product sales of Megan(R) Vac 1 and other future products; (5) changes in existing and potential relationships with corporate collaborators; (6) the cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers (7) the timing, cost and uncertainty of obtaining regulatory approvals for the Peru-15, Ty800 and other vaccines and for other products; (8) the ability to obtain substantial additional funding; (9) the ability to develop and commercialize products before competitors; (10) the integration of Megan Health's business and programs; (11) the ability to retain certain members of management; and (12) other factors detailed from time to time in filings with the Securities and Exchange Commission. |
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