RADNOR, Pa., Sept. 12, 2011 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and life-threatening infectious diseases, today provided an update for its two lead programs, heptagonist PMX-60056 and defensin-mimetic antibiotic PMX-30063.
"We are excited to be reporting important clinical data in both of our two clinical development programs over the coming months," said Nicholas Landekic, President and Chief Executive Officer of PolyMedix. "I am proud of the tenacious efforts of our research and development team and very much look forward to creating long-term shareholder value for our investors by progressing PMX-60056 and PMX-30063 into more advanced clinical studies."
PMX-60056 Heptagonist
In the upcoming months, PolyMedix anticipates conducting a Phase 1B/2 dose-ranging clinical trial designed to evaluate the reversal of the low molecular weight heparin (LMWH) enoxaparin (Lovenox®) in healthy subjects. Data from this dose-ranging trial will be used to establish a dose-response correlation for enoxaparin and guide dosing for future trials. Results from this trial are expected by the end of this year.
Earlier this year PolyMedix initiated a Phase 2 clinical trial to evaluate the safety and efficacy of PMX-60056 in reversing heparin in patients undergoing Percutaneous Coronary Intervention (PCI) procedures. This multi-center trial is designed to enroll up to 40 patients in the United States. All patients in the trial will receive PMX-60056 by intravenous infusion. Enrollment is on-going and the trial is expected to be completed by the end of this year.
PMX-30063 Defensin-Mimetic Antibiotic
In September 2010, PolyMedix initiated a Phase 2 clinical trial to evaluate the safety and efficacy of PMX-30063 in treating patients with acute bacterial skin and skin structure infections (ABSSSI). This multi-national trial is expected to enroll 200 patients that have ABSSSI due to either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) Staph aureus. Patients are being randomized to receive one of three doses of PMX-30063 or daptomycin, which is the active control. Following the treatment period, patients are assessed for clinical and microbiologic response at both 48 and 72 hours then re-evaluated at day 10 to 15 for test of cure, and at four weeks for safety follow up. Results from an interim analysis will be released once data are analyzed from the first 80 patients enrolled in the trial. PolyMedix recently received clearances from European regulatory agencies which has enabled adding multiple new clinical sites in Russia and Ukraine to accelerate enrollment. Additional sites in Europe may be added later this year. As a result of longer than expected time to receive European regulatory clearances, PolyMedix anticipates announcing the interim results later this year, and expects to complete the full trial in the first half of next year.
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 novel cardiovascular and infectious disease product candidates, all of which were internally developed using proprietary computational drug design technologies. The lead compound in PolyMedix's cardiovascular program is PMX-60056, which is designed to modulate coagulation and mitigate bleeding in certain interventional cardiology procedures, such as Percutaneous Coronary Intervention (PCI), and emergency situations. PMX-60056 has met safety and efficacy endpoints in four clinical trials conducted to date demonstrating clinical proof of concept. PMX-60056 is currently in a Phase 2 clinical trial in patients undergoing PCI. The lead compound in PolyMedix's infectious disease program is PMX-30063, a new class of antibiotic – a defensin-mimetic - designed to mimic first-line human innate immunity, or host defense proteins. This innovative approach utilizes the same mechanism of action that evolved in nature which higher life forms use to protect themselves from bacteria. Having the same mechanism of action as the host defense proteins, PMX-30063 is designed to directly address one of the most significant issues in infectious disease today - drug resistance, which is believed to be much less likely to develop with PMX-30063. PMX-30063 is currently 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. For more information, please visit our website at www.polymedix.com.
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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.