NEEDHAM, Mass., Aug 22, 2000 /PRNewswire via COMTEX/ -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced today the signing of a cross-licensing agreement with Megan Health Inc. for exclusive rights to a patent portfolio supportive of AVANT's single-dose, oral vaccine candidate against typhoid fever, called Ty800. The agreement allows AVANT to further its clinical development of Ty800 in expanded Phase II studies, while Megan Health gains non-exclusive rights to use AVANT's high-level expression system for human and non-human vaccines.
"We are delighted to strengthen our patent position in this area of vaccine technology," said Fritz Casselman, Senior Vice President, Strategy and Corporate Development of AVANT Immunotherapeutics, Inc. "We believe that Ty800 has strong potential to be an effective typhoid fever vaccine. If successfully developed, it could be an excellent companion product to our cholera vaccine candidate, possibly as part of a travelers vaccine 'cocktail'." AVANT expects to begin a Phase IIb clinical trial of its cholera vaccine in Q3 2000.
Previously, Ty800 was evaluated in Phase I/II dose escalation studies at the Massachusetts General Hospital (MGH) under the direction of Samuel Miller, M.D. The vaccine was well tolerated and immunogenic over a wide range of doses, eliciting the type of antibodies that correlate with protection against typhoid fever. Dr. Miller, currently Professor of Medicine at the University of Washington, Division of Infectious Disease, stated, "Ty800's clinical profile thus far, demonstrating safety and immunogenicity following one oral dose, is perfectly aligned with the World Health Organization and the International Vaccine Institute (Gates Foundation) attributes for the ideal typhoid fever vaccine. I am very excited about watching Ty800 advance to the next stage of clinical development." In additional Phase I/II studies at MGH under the direction of Dr. Libby Hohmann, Ty800 was evaluated for its capacity as a live vaccine delivery system. The vaccine candidate was well tolerated at all dose levels tested, further supporting its safety profile in humans.
A recent Frost and Sullivan report concludes that typhoid fever is endemic to Africa, Asia (except Japan), and Latin America (including the Caribbean). An estimated 33 million people worldwide contract typhoid fever each year, resulting in about 500,000 deaths. The target market for typhoid vaccines includes both residents of endemic areas and persons traveling to those areas. Frost and Sullivan estimate that worldwide sales of typhoid vaccines to the travel market only were $70 MM in 1998 and are expected to grow to $240 MM by 2005. Two injectable vaccines and a multi-dose oral vaccine currently serve this market. Thus, an oral, single-dose efficacious vaccine is expected to have a significant impact on the travelers vaccine market as well as the developing world market.
AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune response to prevent and treat disease. The company's most advanced therapeutic program focuses on compounds with the potential to inhibit inappropriate activation of the complement cascade, a vital part of the body's immune defense system. AVANT is also developing on its own a proprietary therapeutic vaccine for the management of cholesterol, and Therapore(TM), a novel system for the delivery of immunotherapeutics for chronic viral infections and certain cancers. The company and its collaborators are developing vaccines using the proprietary adjuvants, Adjumer(R) and Micromer(R), for the prevention of Lyme disease and respiratory syncytial virus (RSV). Through additional collaborations, AVANT is also developing an oral human rotavirus vaccine and an oral cholera vaccine.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: www.avantimmune.com
Safe Harbor Statement Under the Private Securities Litigation Reform Act 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 Ty800, the cholera vaccine and other products, including the cost, scope and results of preclinical and clinical testing; (2) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies; (3) changes in existing and potential relationships with Megan Health and other corporate collaborators; (4) the time, cost and uncertainty of obtaining regulatory approvals; (5) the ability to obtain substantial additional funding; (6) the ability to develop and commercialize products before competitors; (7) the ability to retain certain members of management; and (8) other factors detailed from time to time in filings with the Securities and Exchange Commission.
SOURCE AVANT Immunotherapeutics, Inc.
CONTACT: Una S. Ryan, Ph.D., President and CEO, or Fritz Casselman,
Senior Vice President, 781-433-0771, info@avantimmune.com, both of AVANT
Immunotherapeutics, Inc.; or Joan Kureczka, jkureczka@aol.com, or Jesse
Fisher, of J. Kureczka Associates, 415-821-2413, for AVANT
URL: avantimmune.com
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