PolyMedix Initiates Dosing in Phase I Clinical Study of Novel Systemic Antibiotic Compound
News Aug 22, 2008
PolyMedix, Inc. has initiated dosing and commenced a Phase I clinical study in Canada for its defensin mimetic antibiotic compound, PMX-30063.
PolyMedix received a notice of no objection from Health Canada for the Company’s Clinical Trial Application (CTA) for PMX-30063 in May 2008. PMX-30063 is the first and only defensin mimetic antibiotic compound to enter human clinical trials for systemic use, and represents an entirely new class of antibiotic drugs.
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 thirty to fifty 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 fourteen 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.
“The start of the clinical study for PMX-30063 represents a major milestone for PolyMedix, and we believe, for the entire medical community,” said Nicholas Landekic, CEO of PolyMedix.
“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. We are proud to be the first company to bring this completely new type of antibiotic to clinical trials, and to address a major clinical need and market opportunity.”