AVANT Immunotherapeutics Achieves Immune Responses Against Cholera, Typhoid and Enterotoxigenic E. coli with a Single-Dose, Oral Combination Vaccine
NEEDHAM, Mass.--(BUSINESS WIRE)--Dec 5, 2007 - AVANT Immunotherapeutics (Nasdaq: AVAN) today reported preclinical data demonstrating positive immunogenicity and lack of immune interference for an experimental single-dose, oral vaccine combining protection from three of the most important causes of severe enteric diseases: typhoid fever, enterotoxigenic E. coli (ETEC) and cholera. The experimental, trivalent vaccine consists of the co-administration of two live-attenuated bacteria: the Peru-15pCTB vaccine candidate that forms the basis of AVANT's investigational combination ETEC/cholera vaccine and AVANT's investigational typhoid fever vaccine, Ty800.The data were presented today as a poster at the United States-Japan Cooperative Medical Science Program 42nd Panel Meeting on Cholera and Other Bacterial Infections, held in Austin, Texas.
"One issue surrounding the development of combination vaccines is the potential for vaccine interference, whereby competition for colonization and/or the immune response against one vaccine organism or antigen may negatively impact the immune response against another," said Lawrence J. Thomas, Ph.D., of AVANT Immunotherapeutics. "We have now demonstrated in a rabbit immunization model that oral dosing of our trivalent vaccine effectively induces the production of specific antibodies against all three disease organisms at titers not significantly different from those elicited by either the Peru-15pCTB or Ty800 vaccines when administered alone."
"Demonstrating a lack of vaccine interference is an important step in the development of a "Super-enteric" vaccine capable of combining rapid protection against multiple disease agents in a single, oral dose," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. "Vaccines that protect against multiple diseases with a single dose are highly valued in all target markets, including travelers, military and people in developing countries where these diseases are widespread."
AVANT Immunotherapeutics recently announced that the National Institutes of Health will be sponsoring a Phase 1 clinical trial of the Peru-15pCTB vaccine combining protection against ETEC and cholera in Q1 2008, and AVANT's Ty800 is currently undergoing Phase 2 clinical testing.
"If the results of these current clinical studies are successful, the preclinical data presented today pave the way for initial human clinical testing of a trivalent Super-enteric vaccine," commented Dr. Ryan.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. is a Massachusetts-based NASDAQ-listed company discovering and developing innovative vaccines and therapeutics that harness the human immune system to prevent and treat disease. AVANT's innovative bacterial vector delivery technologies with unique manufacturing and preservation processes offer the potential for a new generation of vaccines. AVANT has three commercialized products, including Rotarix(R) for the treatment of rotavirus and two human food safety vaccines for reducing salmonella infection in chickens and eggs. AVANT also has four product candidates in its development pipeline, an anti-inflammatory agent, TP10, and three candidates based on its oral, rapidly-protecting, single-dose and temperature-stable vaccine technology, including combination vaccines for travelers, the military and global health needs.
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 of 1995: This release includes forward-looking statements that are subject to a variety of risks and uncertainties and reflect AVANT's current views with respect to future events and financial performance. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by AVANT. These factors include, but are not limited to: (1) the integration of multiple technologies and programs; (2) the ability to adapt AVANT's vectoring systems to develop new, safe and effective orally administered vaccines against anthrax and plague or other any other microbes used as bioweapons and other disease causing agents; (3) the ability to successfully complete development and commercialization of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli vaccine, and other products and AVANT's expectations regarding market growth; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli vaccine 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 TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli vaccine and other products; (6) the ability of AVANT to manage multiple late stage clinical trials for a variety of product candidates; (7) our expectations regarding our technological capabilities and expanding our focus to broader markets for vaccines; (8) our expectations regarding AVANT's ability to develop products through its collaborations; (9) changes in existing and potential relationships with corporate collaborators; (10) the availability, cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers and partners; (11) the timing, cost and uncertainty of obtaining regulatory approvals; (12) the ability to develop and commercialize products before competitors that are superior to the alternatives developed by competitors; (13) the ability to retain certain members of management;(14) AVANT's expectations regarding research and development expenses and general and administrative expenses; (15) AVANT's expectations regarding cash balances, capital requirements, anticipated royalty payments (including those from Glaxo), revenues and expenses, including infrastructure expenses; (16) our belief regarding the validity of our patents and potential litigation; and (17) certain other factors that might cause AVANT's actual results to differ materially from those in the forward-looking statements include those set forth under the headings "Business," "Risk Factors" and Management's Discussion and Analysis of Financial Condition and Results of Operations" in each of AVANT's Annual Report on Form 10-K, its Quarterly Reports on Form 8-K, as well as those described in AVANT's other press releases and filings with the Securities and Exchange Commission, from time to time. You should carefully review all of these factors, and you should be aware that there may be other factors that could cause these differences. These forward-looking statements were based on information, plans and estimates at the date of this press release, and we do not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.
Contact
AVANT Immunotherapeutics, Inc.
Una S. Ryan, Ph.D., 781-433-0771
President and CEO
or
Avery W. Catlin, 781-433-0771
Chief Financial Officer
info@avantimmune.com
or
For Media:
Kureczka/Martin Associates
Joan Kureczka, 415-821-2413
jkureczka@comcast.net
