RADNOR, Pa., May 10, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX.OB - News), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today announced an update on the development status of its anticoagulant reversing agent, PMX-60056. PolyMedix has stopped enrollment in two clinical trials for PMX-60056: a Phase 2 clinical trial for reversing the anticoagulant activity of unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention procedures, and a Phase 1B/2 clinical trial for reversing the anticoagulant activity of the low molecular weight heparin enoxaparin in healthy volunteers.
In these clinical studies, PMX-60056 showed activity in neutralizing both UFH and enoxaparin, as measured by activated clotting time (ACT) and anti-factor Xa activity, respectively. PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure. PolyMedix believes these side effects could be addressed with PMX-60056 being delivered in a larger volume over a longer infusion time. Furthermore, given the Company's limited resources and current capital market conditions, PolyMedix has made the strategic decision to not incur additional expenses relating to the PMX-60056 program and instead focus its development efforts and resources on PMX-30063.
Nicholas Landekic, President and Chief Executive Officer of PolyMedix, commented, "I am disappointed that we will not continue to fund the development of PMX-60056. We believe in the medical needs and commercial opportunities for an anticoagulant reversing agent such as PMX-60056, and plan to seek strategic partnerships to further develop the program. Given the recent positive results from our Phase 2 clinical trial with our defensin-mimetic antibiotic PMX-30063, and what we consider to be significant unmet medical needs and attractive commercial potential for the program, we are prioritizing our efforts based on available capital. We believe it is in the best interests of PolyMedix and our shareholders to dedicate resources and focus our future development efforts on our promising defensin-mimetic franchise."
PolyMedix will continue to focus its development efforts on PMX-30063 and its infectious disease franchise in more advanced clinical trials and for additional potential uses, such as oral mucositis. PolyMedix recently announced positive results from its first Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI). A Phase 2B dose optimization study in ABSSSI is planned to commence later this year.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company developing first-in-class, small-molecule defensin mimetics for the treatment of serious acute care conditions. PolyMedix's lead infectious disease drug candidate is PMX-30063, the first of a new class of antibiotics, the defensin-mimetics, which imitates the natural human immunity and exploits a method of bacterial cell killing which should significantly reduce the risk of bacterial resistance. PMX-30063 has completed a Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staph aureus bacteria, including methicillin-resistant Staph aureus (MRSA). In the study, all evaluated doses of PMX-30063 showed efficacy comparable to the active control and were safe and generally well-tolerated.
PolyMedix is seeking strategic alliances to develop its PolyCides(R), antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces, and anticoagulant reversing agents.
Specifically the clinical response in ITT population doesn't seem to show a dose response (slide 14). Moreover the sustained efficacy at days 10 and 28 clearly seem to favor daptomycin (slide 16).
Moreover the side effect profile, albeit mild, doesn't seem that impressive when compared to daptomycin (slide 19).
All in all, while the mechanism of action is novel and slide 21 lists the advantages 30063 has over its competitors, is the data from the current phase 2 impressive enough to land a meaningful partnership?
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