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Biotech / Medical : AVANT Immunotherapeutics Inc. (Nasdaq: AVAN) -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (404)	5/16/2002 8:23:03 PM
From: SemiBull	Read Replies (1) \| Respond to of 513

AVANT Commences Second Phase II Study of Its Cholera Vaccine NEEDHAM, Mass.--(BW HealthWire)--May 16, 2002--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - News) announced today the start of a placebo-controlled dose-ranging Phase II study of its cholera vaccine in approximately 120 adult volunteers. The objectives of this second Phase II study are to evaluate the safety, immunogenicity and dose-response relationship of the vaccine with the aim of evaluating a new buffer system and optimizing vaccine dosage prior to conducting pivotal Phase III studies. The study is being conducted by Pharmaceutical Research Associates /Dr. Casey Johnson at their clinical pharmacology facility in Overland Park, Kansas. "Our goal is to identify a dose of cholera vaccine that will produce an optimal immune response combined with an optimal safety profile prior to initiating pivotal Phase III clinical trials," said Alistair Wheeler, MD, Vice President, Medical Affairs of AVANT Immunotherapeutics, Inc. "At the same time we will be evaluating a new buffer system that will be commercially superior to the ones previously studied." He noted that the primary endpoints for the trial are immunogenicity and the incidence of adverse events in each treatment group. Development of a safe, effective cholera vaccine is the first step in establishing AVANT's travelers' vaccine franchise. During 2002, AVANT also plans to initiate Phase II clinical studies aimed at demonstrating clinical proof-of-principle for the second product in our vaccine portfolio, Ty800. AVANT has designed the Ty800 vaccine to offer rapid, single-dose protection against Salmonella typhi, the cause of typhoid fever. With the acquisition of Megan, AVANT gained access to technologies for developing vaccines against Shigella, Campylobacter and enterotoxigenic E. coli, three additional causes of serious diarrheal diseases worldwide. These three vaccine programs are in pre-clinical development. AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune system 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. 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 vaccine, vaccines to combat threats of biological warfare, 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: 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 CholeraGarde(TM) and other products;(2) the cost, timing, scope and results of safety and efficacy trials of CholeraGarde(TM) and other preclinical and clinical testing; (3) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of CholeraGarde(TM) and other products, and the adaptation of our attenuated vaccine technology to different infectious diseases; (4) the ability of the company to manage multiple late stage clinical trials for a variety of product candidates; (5) the volume and profitability of product sales of Megan® Vac 1 and other future products; (6) changes in existing and potential relationships with corporate collaborators; (7) the cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers (8) the timing, cost and uncertainty of obtaining regulatory approvals to use CholeraGarde, among other purposes, as a travelers' vaccine and for other products; (9) the ability to obtain substantial additional funding; (10) the ability to develop and commercialize products before competitors; (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. -------------------------------------------------------------------------------- Contact: AVANT Immunotherapeutics, Inc. Una S. Ryan, Ph.D. (781) 433-0771 or Alistair Wheeler MD MFPM (781) 433-0771 info@avantimmune.com or For Media: Kureczka/Martin Associates Joan Kureczka/Jesse Fisher (415) 821-2413 jkureczka@aol.com