PolyMedix initiates dosing for Phase I systemic infections study

PolyMedix received a notice of no objection from Health Canada for the company’s clinical trial application for PMX-30063 in May 2008.

This first Phase I clinical trial will assess the safety of PMX-30063. The protocol for the trial involves a dose-escalation study in healthy volunteers in which each subject will receive a single dose of PMX-30063.

The subjects are grouped into different cohorts with different dosage levels which will allow for the study of the effects of increased dosages. PolyMedix expects to enroll a total of 30 to 50 subjects in this clinical trial. Upon successful completion of the first clinical study, PolyMedix plans to initiate a second clinical trial to mimic the expected clinical dosing regimen.

The second trial, also to be conducted in healthy volunteers, will involve repeat dosing of two intravenous infusions per day, for up 14 days. Following these clinical trials, significant additional clinical studies and regulatory submissions will be required to obtain regulatory approval from the FDA and other regulatory bodies before PMX-30063 could be commercially sold.

Nicholas Landekic, CEO of PolyMedix, said: “This novel antibiotic compound signals a fundamental potential breakthrough in treating infectious diseases. PMX-30063 is the first and only small molecule defensin mimetic to commence clinical development for the treatment of systemic infections, and the first and only such compound whose mechanism of action is intended to directly address the major problem of bacterial drug resistance.”