PolyMedix Inc. (PYMX.OB) Obtains Regulatory Clearance for its United States IND Application for PMX-30063 Antibiotic
11/10/2010 11:31:21 AM
RADNOR, Pa.--(BUSINESS WIRE)--PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMX-30063, a synthetic defensin-mimetic antibiotic. As the first step in PolyMedix’s United States clinical development activities with PMX-30063, PolyMedix has initiated a Phase 1 clinical trial. The trial is designed to further evaluate the safety and pharmacokinetic profile of PMX-30063 in female subjects, who have not been previously studied in Phase 1 trials, as well as male subjects, over a longer term treatment regimen. PolyMedix is currently conducting a Phase 2 clinical trial in Canada to evaluate the safety and efficacy of PMX-30063 in patients as an initial treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph bacteria.