SAN DIEGO, Feb. 11, 2013 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that it has initiated dosing in a thorough QT/QTc study (TQT study) of ANX-188.
Brian M. Culley, Chief Executive Officer, said: "Consistent with our guidance from October 2011 and our commitment to FDA, we have initiated this study before the end of the first quarter. We were pleased with the discussion we had with the Agency on the study protocol and our agreement on the supra-therapeutic dose."
Santosh Vetticaden, Chief Medical Officer, said: "The FDA requires an assessment of cardiac repolarization for most new drugs having systemic bioavailability. This study will assess whether or not ANX-188 has an effect on QT prolongation. The study should complete dosing in the first quarter, and we expect to announce results in the second quarter of 2013."
The objective of the TQT study is to evaluate the effect of therapeutic and supra-therapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically the QT-interval, in healthy volunteers. The study is a single center, four-period, four-way cross-over, placebo- and positive-controlled, double-blind, randomized trial. Sixty subjects will be enrolled. Each subject will receive each of four treatments (placebo, active control, ANX-188 therapeutic dose, ANX-188 supra-therapeutic dose) during each of the four treatment periods.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company developing proprietary product candidates to treat various diseases and conditions. The Company's lead product candidate, ANX-188, has potential to reduce ischemic tissue injury and end-organ damage by restoring microvascular function, which is compromised in a wide range of serious and life-threatening diseases and conditions. The Company is recruiting subjects in EPIC, a randomized, double-blind, placebo-controlled phase 3 study of ANX-188 in patients with sickle cell disease. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the timing of completion and announcement of results of the TQT study. Among the factors that could cause or contribute to material differences between ADVENTRX's actual results and expectations indicated by the forward-looking statements are risks and uncertainties inherent in ADVENTRX's business, including, but not limited to: the potential for delays in the commencement or completion of clinical studies, including as a result of difficulties with opening trial sites or enrolling study subjects or being subject to a "clinical hold"; the risk of suspension or termination of a clinical study, including due to lack of adequate funding or patient safety concerns; ADVENTRX's reliance on contract research organizations (CROs) to conduct its clinical studies and on other third parties to assist with important aspects of its development and regulatory activities for ANX-188 and the potential for such third parties to fail to perform as expected or required; the risk that clinical studies, including EPIC and the TQT study, are not successfully executed and/or do not successfully demonstrate the safety or efficacy of the investigational drug; the risk that, even if clinical studies are successful, the FDA determines they are not sufficient to support a new drug application; the risk that even if clinical studies of an investigational drug in one indication are successful, clinical studies of the same investigational drug in another indication may not be successful; ADVENTRX's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for ADVENTRX to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk and/or lower-return development paths if it is unable to raise sufficient additional capital as needed; the risk that the FDA does not grant marketing approval of ADVENTRX's product candidates, including ANX-188, on a timely basis, or at all; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.