Some AVAN news... ===================== Tuesday January 18, 8:29 am Eastern Time Company Press Release SOURCE: AVANT Immunotherapeutics, Inc.
WRAIR and NIH Annouce Phase II Trial of AVANT Cholera Vaccine
NEEDHAM, Mass., Jan. 18 /PRNewswire/ -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - news) today announced the collaboration on a Phase IIB clinical trial of its cholera vaccine candidate, Peru-15, with the Walter Reed Army Institute of Research (WRAIR) and the National Institutes of Health (NIH). AVANT and the National Institute of Allergy and Infectious Disease (NIAID) of the NIH have recently signed a Clinical Trial Agreement that allows for the clinical evaluation of the novel Peru-15 cholera vaccine formulation at the Children's Hospital in Cincinnati. The Phase IIB trial will test the safety, immunogenicity, and protective capacity of the vaccine against a challenge with live virulent cholera. The trial is scheduled to be initiated and completed this year. AVANT and WRAIR have successfully manufactured clinical supplies of the candidate vaccine at the WRAIR Forest Glenn facility for use in the study.
Colonel David Taylor of the Division of Communicable Disease and Immunology, WRAIR said ''The development of a safe and effective cholera vaccine is important for protecting both military personnel and U.S. travelers from cholera in endemic regions. We are very pleased to provide clinical lots of this vaccine for advanced human testing with the NIH.'' The manufacture of the cholera vaccine was executed under a Collaborative Research and Development Agreement (CRADA) between AVANT and WRAIR.
NIAID research is focused on global health and recognizes that cholera is a serious public health threat in many areas of the world. Development of an effective cholera vaccine would be useful in protecting populations where the disease is endemic is a goal of the NIAID research program.
Earlier Phase I/II studies of AVANT's ''Peru-15'' vaccine candidate were conducted in collaboration with clinicians at WRAIR, the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and The Johns Hopkins University. Results of those previous studies demonstrated that a single, oral dose of Peru-15 was safe, immunogenic, and protective against a cholera challenge.
''We are delighted that WRAIR and the NIH are moving forward with advanced clinical testing of our recombinant cholera vaccine,'' said Una Ryan, Ph.D., president and chief executive officer of AVANT Immunotherapeutics. ''This collaboration further validates our company's vaccine technology base and its broad applicability to a range of important infectious disease indications.''
AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune response to prevent and treat disease. The Company's lead therapeutic program is focused on compounds that inhibit the inappropriate activity of the complement cascade that is a vital part of the body's immune defense system. The Company is also engaged in the development of Therapore(TM), a novel system for the delivery of immunotherapeutics for chronic viral infections and certain cancers. The Company and its collaborators are developing vaccines using the proprietary adjuvants, Adjumer® and Micromer®, for the prevention of respiratory syncytial virus (RSV), Lyme disease, and several other vaccine targets. In a further collaboration, the Company is developing an oral human rotavirus vaccine, and is developing its own proprietary vaccine for the management of atherosclerosis.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through the Company's site on the World Wide Web: avantimmune.com. |