NEUCARDIN^TM is a genetically engineered recombinant peptide fragment of neuregulin-1 (β2a isoform). It is expressed in E.coli , lyophilized for storage and used for the treatment of moderate to severe heart failure.

Mechanisms

In addition, in vivo administration of NEUCARDIN^TM greatly reduced myocardial cell damage induced by ischemia, hypoxia or viral infection, allowing repair of sarcomere structure, with improvement in cardiac performance, hemodynamics and survival.

Indications

Pharmacological Action

Using various animal models, including (1) rat sub-acute and chronic heart failure, (2) mouse viral myocarditis, (3) rat toxic myocarditis induced by adriamycin, and (4) dog congestive heart failure caused by constriction of inferior venue cava, it has been demonstrated that NEUCARDIN^TM improves impaired myocardial structure, decreases the extent of ischemia injury, and improves heart function and hemodynamics. This results in enhanced survival in these animal models.

Safety pharmacology studies indicate that NEUCARDIN^TM has no adverse effects on cardiovascular or respiratory system function in normal monkeys. Acute toxicity studies in mice showed that the minimum fatal dose was 3000 times the clinical equivalent dose. Safety evaluations in monkeys after administration of multiple doses of NEUCARDIN^TM revealed that a high dosage (above the therapeutic dose) could cause some local microcapillary vessel leakage, but no significant side effects had been found with doses in low to moderate ranges, indicating a safe therapeutic dosage range.