SAN DIEGO, CA, USA I February 11, 2013 I 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.
SOURCE: Adventrx Pharmaceuticals
Post Views: 293
SAN DIEGO, CA, USA I February 11, 2013 I 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.
SOURCE: Adventrx Pharmaceuticals
Post Views: 293
