NOXXON Initiates Phase IIa of Anti-Hepcidin Spiegelmer NOX-H94
Anemia of Chronic Disease Study is Fourth Phase II Initiated by NOXXON in 2012
NOXXON Pharma announced the treatment of the first patients in a Phase IIa clinical trial of its anti-hepcidin Spiegelmer® NOX-H94 to treat anemia associated with chronic disease. This Phase IIa study was initiated following the successful completion of the clinical Phase I program, data from which will be presented at the upcoming ASH (American Society of Hematology) meeting in Atlanta. The Phase I program consisted of a comprehensive single and multiple ascending dose study in healthy volunteers and a subsequent human pharmacodynamic study to assess the ability of NOX-H94 to prevent endotoxin-induced hypoferremia in healthy subjects. This endotoxemia study delivered the first clinical evidence that NOX-H94 is capable of neutralizing high levels of hepcidin in humans and maintaining higher serum iron concentrations relative to subjects receiving placebo.
The NOX-H94 Phase IIa study is being conducted to investigate the hypothesis that inhibition of hepcidin can raise hemoglobin levels in patients with anemia of chronic disease. The four-week repeated-dose multi-center study will be conducted in Europe in anemic patients with cancer. An open-label pilot phase will be followed by a 3-arm randomized, double-blind, placebo-controlled main phase comparing two different dose-regimens of NOX-H94 with placebo.
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