ParinGenix heart drug approved for clinic

ParinGenix is developing PGX-100 to ameliorate cardiac ischemia-reperfusion injury following myocardial infarction (heart attack), including both ST-elevated and non-Q-wave myocardial infarctions.

Evaluation of PGX-100 in animal models shows PGX-100 significantly reduces damage to the heart following myocardial infarction. The drug is also in preclinical development for other critical-care indications.

With the approval of ParinGenix’s investigational new drug application (IND), which was submitted in December 2004, the company will begin the first of three US phase I clinical trials in mid-February. The studies will examine safety, pharmacokinetics and dosing regimens in healthy volunteers.

Broad inflammation is a major contributor to myocardial damage following reperfusion. ParinGenix researchers have found that high doses of the widely used anticoagulant, heparin, decrease this inflammation. At such high doses, however, the anticoagulant properties of heparin preclude its use as an anti-inflammatory.

ParinGenix researchers have developed a safer, nearly non-anticoagulant heparin derivative that retains its anti-inflammatory activity. This heparin derivative is the drug substance in the PGX-100 intravenous dosage formulation.