NIH Initiates Phase 1 Safety Study Of AVANT's Oral Combined Enterotoxigenic E. coli-Cholera Vaccine

AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) 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: avantimmune.


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.

National Institutes of Health


View drug information on Rotarix.

Buy Yaz Without Prescription