Tanox's Anti-Factor D Antibody Reduces Systemic Inflammation in An Experimental Model of Cardiopulmonary Bypass.
Tanox, Inc. (Nasdaq: TNOX) today reported positive results in using TNX-224, its anti-factor D monoclonal antibody, to reduce inflammatory responses in an experimental model of cardiopulmonary bypass. The study appears in the July issue of the Journal of Thoracic and Cardiovascular Surgery.
Tanox's scientists together with researchers from Baylor College of Medicine, Texas Children's Hospital, and the Texas Heart Institute in Houston reported that TNX-224 (previously known as 166-32) effectively inhibited the activation of complement, neutrophils, and platelets. TNX-224 is a monoclonal antibody specific for factor D, a key element of the alternative complement pathway that controls complement activation. The reported data suggest that inhibition of complement activation by TNX-224 could be useful in reducing systemic inflammation in patients undergoing cardiopulmonary bypass.
In the study, TNX-224 was added to freshly collected blood from five healthy donors and recirculated through a pediatric cardiopulmonary bypass circuit, to mimic the condition of open-heart surgery procedures. An irrelevant monoclonal antibody was used as a negative control with the same donor blood in a parallel bypass circuit on the same day. Blood samples were collected at different time points during recirculation for measurement of activation of complement, neutrophils, and platelets.
TNX-224 effectively inhibited complement activation and blocked the production of the products Bb, C3a, sC5b-9, and C5a. Upregulation of adhesion molecules CD11b on neutrophils and CD62P on platelets was also significantly inhibited by TNX-224, which is consistent with the inhibition of the release of neutrophil-specific myeloperoxidase and elastase and platelet-specific thrombospondin. The antibody also suppressed production of the proinflammatory cytokine interleukin 8. The results suggest that inhibition of complement activation by targeting factor D during cardiopulmonary bypass procedures could prevent the inflammatory responses caused by neutrophils, platelets and cytokines.
"We are pleased with the initial results of TNX-224. This study suggests that TNX-224 represents a potentially important new approach for inhibiting complement activation," said Nancy T. Chang, President and CEO of Tanox, Inc. "Factor D may prove to be a valuable target in blocking complement-induced systemic inflammation. TNX-224 may be useful in preventing inflammation and tissue damage during open-heart surgery involving cardiopulmonary bypass."
The complement system plays a central role in the normal immune response to infectious agents and foreign antigens. However, when activated in an uncontrolled and excessive manner, the complement system may cause inflammation and contribute in a major way to the pathogenesis of autoimmune diseases. Factor D is a key enzyme involved in activation of the alternative pathway and in amplification of the classical and lectin pathways of the complement system.
TNX-224 is being developed for use in patients undergoing coronary artery bypass grafting (CABG) procedures. The majority of these procedures involves the use of cardiopulmonary bypass. There are approximately 600,000 procedures performed each year in the U.S.
Tanox, Inc. is a biopharmaceutical company with demonstrated expertise in monoclonal antibody technology. The Company is engaged in the discovery and development of therapeutic monoclonal antibodies designed to address significant unmet medical needs in the areas of asthma, allergy, inflammation and other diseases affecting the human immune system. Xolair(TM), Tanox's most advanced product in development is an anti-immunoglobulin E, or anti-IgE, antibody which is being developed for allergic asthma, seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis in collaboration with Novartis Pharmaceutical Corporation and Genentech, Inc. Genentech and Novartis are collecting information to respond to the complete response letter received from the U.S. FDA on the marketing application submitted for Xolair for allergic asthma and seasonal allergic rhinitis. The information will also be provided to health authorities in the EU, Switzerland, Australia and New Zealand to support marketing applications filed there.
Statements in this press release about Tanox's products, including Xolair, and their prospects for development and commercialization, other than statements of historical facts, are forward-looking statements and are subject to a number of uncertainties that may cause actual events or results to differ materially from those suggested in the forward-looking statements. Factors that could affect actual events or results include risks associated with obtaining regulatory approval for and market acceptance of Tanox's products, performance by the Company's present and future collaboration partners, the outcome of pending litigation, the uncertainty of preclinical and clinical testing results, the Company's limited experience and capability in manufacturing and marketing the Company's products, the Company's ability to enter into future collaborations, competition and technological change, the strength of the Company's patent portfolio, the Company's ability to manage growth and to attract and retain key personnel, the Company's access to additional financings in the future, and existing and future government regulations. Other risks that may affect Tanox include the variability of royalty, license and other revenues, timelines that are subject to change, and the unpredictability of decisions by the FDA and other regulatory agencies, including decisions regarding whether sufficient data and compliance with other requirements exist to support product licensure.
This release and other information about Tanox, Inc. can be found on the World Wide Web at http://www.tanox.com .
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