NEEDHAM, Mass., Sept. 15 /PRNewswire/ -- AVANT Immunotherapeutics, Inc.
(Nasdaq: AVAN - news) announced today its plans to initiate a controlled Phase IIb study of AVANT's lead complement inhibitor, TP10 in infants undergoing cardiac surgery. After consulting with the United States Food and Drug Administration (FDA) earlier this week, AVANT expects to initiate a double-blind, placebo controlled Phase IIb study in this patient population before the end of the year to further evaluate the clinical endpoints in the program.
``We continue to be pleased with the success of this program which has shown the activity and tolerability of TP10 in this population,'' said Alistair Wheeler, Vice President, Medical Affairs of AVANT Immunotherapeutics, Inc. ``We are delighted that the FDA is working with us towards our mutual goal of reducing the overall size of the clinical program and increasing the likelihood of a successful outcome. This new study will allow us to further define our clinical endpoints before starting a larger pivotal Phase III study next year.''
AVANT's complement inhibitor, TP10, is under investigation as a potential treatment to improve post-operative outcomes in infants undergoing cardiac surgery. Approximately 15,000 surgeries are performed annually in the United States on children with congenital heart defects, aged one year or less, requiring cardiopulmonary bypass. The activation of complement is believed to be the result of reperfusion (the injury caused by re-establishing blood supply to tissues and organs) and exposure of the blood to the foreign surfaces of the heart-lung machine. It is thought that this activation causes a series of downstream inflammatory events that diminish heart function and cause microvascular leak, resulting in the body retaining excess fluid. These effects can impair oxygen transfer in the lungs as well as delayed closure of the chest. The combination of these factors results in babies requiring assisted ventilation for some period after surgery. Complement activation may be associated with longer term health problems as well as the short term medical and economic consequences of prolonged ventilation.
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 most advanced therapeutic program focuses on compounds with the potential to inhibit inappropriate activation of the complement cascade, a vital part of the body's immune defense system. AVANT is also developing on its own a proprietary therapeutic vaccine for the management of cholesterol, and 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 Lyme disease and respiratory syncytial virus (RSV). Through additional collaborations, AVANT is also developing an oral human rotavirus vaccine and an oral cholera vaccine.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: avantimmune.com. |
