RADNOR, Pa., Jan. 4, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat serious acute-care conditions, announced that it has completed enrollment of 215 patients in its multinational Phase 2 clinical trial designed to evaluate PMX-30063 defensin-mimetic antibiotic in treating patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staphylococcus aureus, including methicillin-resistant Staph aureus (MRSA). This is the first clinical efficacy study conducted in patients with this new defensin-mimetic antibiotic class. In December 2011, PolyMedix reported encouraging efficacy and safety data from an interim analysis of this study, and expects to report data from the full study in the first half of 2012.
"Completing enrollment in this study is a key milestone in our development of this novel antibiotic which is designed to directly address the global problem of bacterial drug resistance," commented Nicholas Landekic, President and Chief Executive Officer of PolyMedix. "We are gratified to have completed enrollment so soon after the encouraging interim efficacy and safety results last month. I would like to thank our enthusiastic investigators and our dedicated clinical team for their efforts in achieving this important milestone. We look forward to analyzing the final results of the study and sharing the outcomes in the first half of this year."
In December 2011, PolyMedix announced interim analysis of results from the first 80 patients enrolled in this Phase 2 clinical trial with PMX-30063. Pooled blinded results from all patients enrolled in the four dosing arms showed a combined clinical success rate of 92%, with each of the four dosing arms (approximately 20 patients in each arm) having clinical success rates ranging from 87% to 100%. In addition, all dose groups were safe with no clinically important differences observed between the groups.
About PMX-30063
PolyMedix's novel antibiotic compound, PMX-30063, is the first of a new class of antibiotics – defensin-mimetics. PMX-30063 is a small molecule designed to mimic the activity of human host-defense proteins (HDPs), the body's natural defense against bacterial infections. HDPs kill bacteria by directly targeting bacterial membranes and disrupting them. Widespread resistance to this mechanism of action has not developed despite millions of years of evolution. With PMX-30063 designed to mimic HDPs, we believe that resistance is also unlikely to evolve to this innovative antibiotic, making PMX-30063 a novel potential solution to the growing problem of bacterial resistance. PMX-30063 has been successfully tested in three Phase 1 clinical studies and has now completed enrollment in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections caused by Staph aureus bacteria.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company developing first-in-class, small-molecule drugs for the treatment of serious acute care conditions. PolyMedix has a pipeline of innovative infectious disease and cardiovascular product candidates, all of which were internally developed using a proprietary drug discovery technology platform.
PolyMedix's lead infectious disease compound is PMX-30063, the first drug of a completely new class of antibiotics, the defensin-mimetics. Our defensin-mimetic antibiotics are designed to imitate the mechanism of natural human immunity – the host defense proteins. By mimicking the mechanism of action of the host defense proteins, PMX-30063 works completely differently from known biochemical antibiotics, and exploits a method of bacterial cell killing that significantly reduces the risk of bacterial resistance. PMX-30063 has completed enrollment in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph aureus bacteria, including methicillin-resistant Staph aureus (MRSA). PolyMedix is also leveraging its antimicrobial expertise with the PolyCides®, antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces.
PolyMedix's lead cardiovascular compound is PMX-60056, which is designed to normalize blood clotting and reduce bleeding in certain interventional cardiology procedures, as well as treat bleeding in emergency situations, where heparin and low molecular weight heparins (LMWHs) are used. PMX-60056 has met safety and efficacy endpoints in four clinical trials conducted to date demonstrating proof of concept. PMX-60056 is currently in a Phase 2 clinical trial in patients undergoing PCI, and in a Phase 1B/2 dose ranging clinical trial with the LMWH enoxaparin.
For more information, please visit our website at www.polymedix.com.
The PolyMedix, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10449
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are PolyMedix's need for, and the availability of, substantial capital in the future to fund its operations and research and development, and the fact that PolyMedix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.