Avant Immunotherapeutics Receives NIH Commitments for Ty800 Development and Phase I Clinical Trial
Monday January 13, 8:15 am ET
NIAID Phase I SBIR Grant to Support Preclinical Development; Separately NIAID to Conduct Phase I Clinical Trial
NEEDHAM, Mass.--(BUSINESS WIRE)--Jan. 13, 2003-- AVANT Immunotherapeutics, Inc. (NASDAQ: AVAN - News) announced today it has been awarded a Phase I Small Business Innovation Research (SBIR) grant to support further preclinical development of Ty800, the company's single dose, oral typhoid vaccine. The National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health (NIH) awarded this grant titled "Feasibility Evaluation of an Oral Typhoid Fever Vaccine", which provides approximately $127,000 in funding to AVANT over a six-month period. In addition, the NIAID and AVANT have entered into a cooperative agreement for the NIAID to conduct a Phase I in-patient dose ranging clinical trial aimed at demonstrating the safety and immunogenicity of the Ty800 oral vaccine. The trial is planned for the second half of 2003 at an NIAID funded clinical site. The NIAID trial seeks to confirm the safety and immunogenicity of the Ty800 oral vaccine observed in an earlier physician sponsored Ty800 vaccine study.
"We are very pleased to receive this new SBIR grant and the NIAID's commitment to conduct the Phase I clinical development of Ty800," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics, Inc. "This funding allows us to move the Ty800 program forward using outside sources to help support the cost of Ty800 vaccine development." This is the second SBIR grant awarded to AVANT in the past seven months.
AVANT has designed the Ty800 vaccine to offer rapid, oral, single-dose protection against Salmonella typhi, the cause of typhoid fever. The company developed the Ty800 vaccine by using genetic techniques to delete specific genes known to be essential to the virulence of S. typhi. The oral Ty800 vaccine is expected to be well tolerated in humans and may rapidly elicit strong immune responses.
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 addressing a wide range of applications including bacterial and viral diseases, chronic human diseases, 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 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. 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 proposed acquisition of UPT and related transactions may not be consummated on the terms currently anticipated or at all; (2) the ability to adapt AVANT's vectoring systems to develop new, safe and effective orally administered vaccines against anthrax and plague or any other microbes used as bioweapons; (3) the ability to successfully complete development and commercialization of CholeraGarde(TM) (Peru-15), Ty800 and of other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of 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 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®Vac 1 and other future products; (8) changes in existing and potential relationships with corporate collaborators; (9) the 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 CholeraGarde(TM) (Peru-15) and Ty800, among other purposes, to protect travelers and people in endemic regions from diarrhea causing diseases and for other products; (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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Contact:
For Media:
Kureczka/Martin Associates
Joan Kureczka, 415/821-2413
jkureczka@aol.com
or
AVANT Immunotherapeutics, Inc.
Una S. Ryan, Ph.D., 781/433-0771
or
AVANT Immunotherapeutics, Inc.
Avery W. Catlin, 781/433-0771
info@avantimmune.com
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Source: AVANT Immunotherapeutics, Inc |
