AVAN Company Press Release
SOURCE: AVANT Immunotherapeutics, Inc.
AVANT Announces Preliminary Results From Phase I/II Study of TP10
- Selects CRO Partner for Phase III Study of TP10 In Infants Undergoing Cardiac Surgery -
NEEDHAM, Mass., March 27 /PRNewswire/ -- AVANT Immunotherapeutics (Nasdaq: AVAN - news) today announced that the recently completed Phase I/II study of AVANT's lead complement inhibitor TP10 met its objectives in infants undergoing cardiac surgery. TP10 was well tolerated by the treated infants and this study will enable AVANT to assess the effect of the investigational drug on complement inhibition and to validate the endpoints for a planned pivotal Phase III study. In addition to the plan study, preliminary comparison of case matched controls from one of the clinical sites indicated promising results in terms of cardiac function, time in intensive care unit and time in hospital. AVANT also announced the selection of Pharmaceutical Product Development International, Inc. (PPDI) as its Clinical Research Organization (CRO) partner for the Phase III study.
``Initial data from the Phase I/II study confirm that TP10 is well tolerated in this very important patient population, and investigators reported no drug-related serious adverse events,' said Alistair Wheeler M.D., Vice President, Medical Affairs at AVANT. ``Moreover, we demonstrated an inhibition of complement activation following cardiopulmonary bypass. Thus, we believe this study met all of its objectives and represents a solid basis for future development of TP10 in this indication. We expect to initiate a pivotal Phase III trial around the end of this year, after we have completed discussions with the FDA.' AVANT additionally plans to refine the TP10 dosing regimen in additional infants prior to starting the Phase III study.
Final results of the Phase I/II study will be presented by Paula Bokesch, M.D., principal investigator at the Cleveland Clinic, at the Society of Cardiovascular Anesthesiologists Annual Meeting in Orlando, Florida on May 8, 2000.
AVANT's lead complement inhibitor, TP10, is a potential treatment to reduce the consequences of reperfusion injury and 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. Activation of complement is caused by blood contact with the heart- lung machine and by the reperfusion injury resulting from blood flow being reestablished to the heart during surgery. As a consequence, heart function is diminished and the body retains excess fluid which can impair oxygen transfer in the lungs. 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 lead therapeutic program 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(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 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.
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