AVANT Announces Initiation of Cholera Vaccine Trial in Bangladesh
Thursday December 12, 8:00 am ET
NEEDHAM, Mass.--(BUSINESS WIRE)--Dec. 12, 2002--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - News) announced today that the International Vaccine Institute ("IVI"), in collaboration with the International Centre for Diarrhoeal Disease Research, Bangladesh, has initiated a Phase II clinical trial of AVANT's cholera vaccine, CholeraGarde(TM), in approximately 70 adult and 280 pediatric subjects in Bangladesh. Through its Diseases of the Most Impoverished ("DOMI") Program, IVI seeks to accelerate the development and introduction of vaccines against cholera, typhoid fever and shigellosis.
"I am pleased to see clinical development of this cholera 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." 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.
Alistair Wheeler, M.D., Vice President, Medical Affairs of AVANT Immunotherapeutics Inc. commented, "This study will assess the safety and immunogenicity of a higher dose than we have previously tested in the United States in adults. As we review the data, testing will move into progressively younger pediatric populations over the next two years, eventually studying the vaccine in children as young as nine months. Residents of regions where cholera is endemic often require different doses of vaccine as their gastrointestinal system is exposed to different populations of bacteria in everyday life. Therefore, it is important to study vaccine dose levels in these human populations that may be different from dose levels required to protect individuals not living in endemic regions. The data gained from these trials will be enormously helpful to AVANT's overall vaccine development efforts and will also provide a significant body of pediatric data to support worldwide regulatory submissions."
"Cholera is a devastating 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 be donating the vaccine to IVI for this clinical study. 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 bacterial vaccine franchise."
AVANT is developing a series of oral, single dose, genetically attenuated, live bacterial vaccines to prevent travelers' diarrhea and dysentery. In addition to CholeraGarde(TM), AVANT has designed the Ty800 vaccine to offer rapid, single-dose protection against Salmonella typhi, the cause of typhoid fever. In 2003, the company expects to initiate a Phase I in-patient safety and dose ranging clinical study aimed at demonstrating safety and immunogenicity of the Ty800 vaccine. This trial will be followed by a larger Phase II out-patient safety and immunogenicity study. AVANT is currently seeking outside sources to help fund the cost of the Ty800 trials. A Shigella sonnei vaccine, aimed at the shigella strain most often contracted by travelers, is in preclinical development at AVANT. Also, AVANT has expanded its Campylobacter vaccine research program to include human applications and is using its E. coli expertise and patented technology to develop a vaccine against ETEC, the most common form of travelers' diarrhea. Many of these vaccines could also meet the healthcare requirements of developing countries, where the need for vaccines is particularly acute.
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. 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.
--------------------------------------------------------------------------------
Contact:
AVANT Immunotherapeutics, Inc.
Una S. Ryan, Ph.D., 781/433-0771
or
AVANT Immunotherapeutics, Inc.
Avery W. Catlin, 781/433-0771
info@avantimmune.com
or
For Media:
Kureczka/Martin Associates
Joan Kureczka/Jesse Fisher, 415/821-2413
jkureczka@aol.com
--------------------------------------------------------------------------------
Source: AVANT Immunotherapeutics, Inc. |
