AVANT's Complement Inhibitor, TP10, Granted Orphan Drug Status as Treatment for Infants Undergoing Cardiac Surgery
NEEDHAM, Mass., March 14 /PRNewswire/ -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - news) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to AVANT's lead complement inhibitor, TP10, as a potential treatment to reduce the consequences of reperfusion injury and to improve post-operative outcomes in infants undergoing cardiac surgery. Products designated as Orphan Drugs gain seven years of marketing exclusivity for the designated indications once they receive FDA approval, according to the Orphan Drug Act of 1983. AVANT recently completed enrollment in an open-label, Phase I/II safety and efficacy trial of TP10 in infants undergoing cardiac surgery requiring cardiopulmonary bypass (CPB).
``Receiving orphan drug designation for TP10 further strengthens the competitive position of this product,' said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT. ``We plan to report results from our Phase I/II trial during the second quarter and expect to initiate a pivotal Phase III trial in infants undergoing cardiac surgery by the end of the year.'
During cardiac surgery on CPB, complement becomes activated when the heart is stopped and circulation is subsequently restored, causing reperfusion injury, and by the exposure of blood to the heart-lung machine. Complement activation can impair the functions of the heart, lungs and other organs and can contribute significantly to postoperative complications that prolong hospital stays, increase medical expenses and impair patient recovery. Approximately 15,000 infants in the United States undergo cardiac surgery to correct congenital heart defects each year.
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, now in late stage clinical trials, focuses on compounds that inhibit the inappropriate activity 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 atherosclerosis and Therapore?, a novel system for the delivery of immunotherapeutics for chronic viral infections and certain cancers. The Company and its collaborators are developing vaccines using its proprietary adjuvants, Adjumer© and Micromer©, for the prevention of influenza, respiratory syncytial virus (RSV), Lyme disease, and several other vaccine targets. Through additional collaborations, AVANT is also developing an oral human rotavirus vaccine and a cholera vaccine.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through the Company's site on the World Wide Web: avantimmune.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements which reflect AVANT's current views with respect to future events and financial performance. The words ``believe,' ``expect,' ``anticipate,' and similar expressions identify forward-looking statements. Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: (1) the ability to successfully complete development and commercialization of TP10 for use in infants undergoing cardiac surgery and other purposes and of other products; (2) the cost, scope and results of ongoing safety and efficacy trials of TP10 and other preclinical and clinical testing; (3) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of TP10 and other products; (4) changes in existing and potential relationships with corporate collaborators; (5) the time, cost and uncertainty of obtaining regulatory approvals to use TP10, among other purposes, for infants undergoing cardiac surgery and for other products; (6) the ability to obtain substantial additional funding; (7) the ability to develop and commercialize products before competitors; and (8) other factors detailed from time to time in filings with the Securities and Exchange Commission.
SOURCE: AVANT Immunotherapeutics, Inc. |
