AVAN Avant Immunotherapeutics (MM)

AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today announced that the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), has initiated a Phase 1 safety study of AVANT�s investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic Escherichia coli (ETEC) and cholera. ETEC infection is a major cause of travelers� diarrhea. The study, a randomized double-blind, placebo-controlled, in-patient Phase 1 trial conducted in up to 64 adult volunteers, will examine the safety and immunogenicity of a single dose of the ETEC-Cholera vaccine, designated Peru-15 pCTB, at up to four escalating dose levels compared against placebo. The Principal Investigator, Dr. Mitchell B. Cohen, M.D., will conduct the study at the Cincinnati Children�s Hospital Medical Center. �We are very pleased that NIAID has chosen to fund this initial study of our combination ETEC-cholera vaccine,� said Anthony S. Marucci, AVANT Immunotherapeutics Interim President and Chief Executive Officer. �This vaccine builds on the clinical successes to date of our single-dose, oral typhoid fever and cholera vaccines, and represents the next important milestone towards our goal of developing a safe, oral, rapid-acting �super enteric� vaccine that combines protection against multiple diseases in a single product.� The Peru-15 pCTB vaccine is derived from the same cholera strain (Peru-15) as AVANT�s cholera vaccine, CholeraGarde�. CholeraGarde has been shown to be well tolerated and provide protective levels of immunity in studies involving over 400 vaccinees. The Peru-15 pCTB vaccine re-engineers the Peru-15 strain to produce additional, key antigens that provide protection against the ETEC bacterium, thus potentially adding protection against travelers� diarrhea. Preclinical animal studies with the investigational combination vaccine have shown it to be highly immunogenic. ETEC is a major cause of enteric disease among travelers, military personnel and those who live in developing countries where the disease is endemic. Market research studies conducted with travel medicine clinics have shown a strong preference for a combined vaccine compared to either ETEC or cholera vaccines given separately. About AVANT Immunotherapeutics, Inc. AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company discovering and developing innovative vaccines and targeted immunotherapeutics for the treatment of cancer, infectious and inflammatory diseases. AVANT focuses on the use of tumor-specific targets and human monoclonal antibodies (mAbs) to precisely deliver therapeutic agents through its novel �targeted immunization� approach. AVANT also possesses innovative bacterial vector delivery technologies with unique manufacturing and preservation processes that offer the potential for a new generation of infectious disease vaccines. AVANT�s deep product pipeline consists of products in varying stages of development, with its lead candidate, CDX-110, partnered with Pfizer, Inc., currently undergoing evaluation in a Phase 2b/3 clinical trial in newly diagnosed glioblastoma multiforme, one of the most aggressive forms of brain cancer. AVANT also has five product candidates in its development pipeline including: CDX-1307, a product based on its proprietary APC Targeting Technology�, which is in two Phase 1 clinical trials for patients with advanced pancreatic, bladder, breast and colon cancer; TP10, a complement inhibitor, in development for transplantation and other indications; 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. AVANT has three commercialized products, including Rotarix� for the prevention of rotavirus infection and two human food safety vaccines for reducing salmonella infection in chickens and eggs. Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: http://www.avantimmune.com. About NIAID and the NIH NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies. The National Institutes of Health (NIH)�The Nation's Medical Research Agency�includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov 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 successful integration of the businesses, multiple technologies and programs of AVANT and Celldex; (2)the ability to adopt AVANT�s APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; (3) the ability to adapt AVANT�s vectoring systems to develop new, safe and effective orally administered vaccines against disease causing agents; (4) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies, and commercialization of CDX-110, CDX-1307, CholeraGarde� (Peru-15), Ty800, ETEC E. coli vaccine, and other products and AVANT�s expectations regarding market growth; (5) the cost, timing, scope and results of ongoing safety and efficacy trials of CDX-110, CDX-1307, CholeraGarde� (Peru-15), Ty800, ETEC E. coli vaccine and other preclinical and clinical testing; (6) the ability to negotiate strategic partnerships or other disposition transactions for AVANT�s cardiovascular programs, including TP10 and CETi; (7) the ability of AVANT to manage multiple clinical trials for a variety of product candidates; (8)�the volume and profitability of product sales of Megan�Vac 1, Megan�Egg and other future products; (9)�the process of obtaining regulatory approval for the sale of Rotarix� in major commercial markets, as well as the timing and success of worldwide commercialization of Rotarix� by our partner, GlaxoSmithKline or Glaxo; (10)�Glaxo�s strategy and business plans to launch and supply Rotarix� worldwide, including in the U.S. and other major markets and its payment of royalties to AVANT; (11) Pfizer�s and our strategy and business plans concerning the continued development and commercialization of CDX-110; (12) AVANT�s expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (13) changes in existing and potential relationships with corporate collaborators; (14) the availability, cost, delivery and quality of clinical and commercial grade materials produced at AVANT�s own manufacturing facility or supplied by contract manufacturers and partners; (15) the timing, cost and uncertainty of obtaining regulatory approvals; (16) AVANT�s ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; (17) AVANT�s ability to retain certain members of management;(18) AVANT�s expectations regarding research and development expenses and general and administrative expenses; (19) AVANT�s expectations regarding cash balances, capital requirements, anticipated royalty payments (including those from Paul Royalty Fund), revenues and expenses, including infrastructure expenses; (20)�the ability to obtain substantial additional funding; (21) AVANT�s belief regarding the validity of our patents and potential litigation; and (22) certain other factors that might cause AVANT�s actual results to differ materially from those in the forward-looking statements including 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 current 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 AVANT does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.