NEW YORK – Cardior Pharmaceuticals announced Thursday that its CardiorHealth miR-132 Plasma PCR kit received CE marking.
The kit measures circulating microRNA-132 (miR-132) levels in the blood of patients receiving CDR132L, the company's synthetic antisense oligonucleotide-based miR-132 inhibitor, used in patients with heart failure and reduced left ventricular ejection fraction after a myocardial infarction.
Excess miR-132 in cardiac tissue of heart failure patients alters the expression of genes involved in cardiac function and leads to pathological cardiac remodeling.
CDR132L, which aims to restore normal cardiac function by selectively blocking aberrant miR-132 levels, is currently undergoing testing in the randomized and placebo-controlled Phase II HF-REVERT study. Blocking abnormal miR-132 levels by CDR132L is an exploratory parameter in that study.
CE mark approval followed clinical evaluation of the miR-132 PCR kit in patients receiving various doses of CDR132L or placebo. The kit demonstrated results comparable to those of a similar testing protocol in Cardior's Phase 1b study.
"Receiving the CE mark for our CardiorHealth miR-132 Plasma PCR kit is another demonstration of our ongoing commitment to pioneering a paradigm shift in the treatment of cardiac disease," Thomas Thum, CSO and founder of Cardior, said in a statement. "The kit allows us to monitor the effect of our lead candidate in patients and provides us and participating clinicians with valuable information at a high level of certainty."