PolyMedix Inc. is an emerging biotechnology company focused on therapeutic drugs to treat serious acute cardiovascular disorders and infectious diseases. The company today announced that it has initiated a phase II clinical trial in Canada for its novel defensin-mimetic antibiotic PMX-30063. Designed to mimic the activity of the body’s natural defense against bacterial infections, PMX-30063 is the first and only systemic antibiotic of its kind.
The phase II trial will enroll up to 200 patients at multiple sites in Canada with a desired end-point to determine the safety and efficacy of PMX-30063 for the treatment of acute bacterial skin and skin structure infections caused by Staph.
“We appreciate Health Canada granting us approval to initiate this phase II clinical trial and look forward to continuing to work with Health Canada and other regulatory bodies for the clinical development of PMX-30063,” Bozena Korczak, Ph.D., senior vice president of Drug Development and chief development officer at PolyMedix stated in the press release. “We have incorporated recommendations from Health Canada as well as the recently released FDA draft guidance for development of drugs for the treatment of acute bacterial skin and skin structure infections into the design of this phase II clinical trial.”
PMX-30063 will be administered to patients once daily intravenously for five days, followed by two days of once daily placebo; Daptomycin will be administered once daily for seven days. Patients will be re-evaluated at day 10 to 15 for test of cure and again for safety at four weeks. PolyMedix said the full study results are expected in mid-2011.
The phase II testing follows two phase II clinical trials in which PMX-30063 was safely administered in single or multiple doses without serious adverse effects.
“In our completed phase I clinical trials, PMX-30063 was safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the trial. This phase II trial is intended to build upon these observations with this study in patients with ABSSSI. We are very proud to be developing the first and only systemic antibiotic drug with this mechanism of action, a defensin-mimetic with less likelihood of resistance than other antibiotics. We look forward to the continued development of PMX-30063 and being able to offer this critically needed new treatment for the major and growing problem of drug-resistant bacterial infections,” Nicholas Landekic, PolyMedix’s president and CEO stated.
For more information visit www.polymedix.com
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