PolyMedix Inc. Stops Studies on Anti-coagulant Reversing Agent
RADNOR, Pa., May 10, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), 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®, antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces, and anticoagulant reversing agents.
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.
CONTACT: Lisa Caperelli
Director, Investor Relations & Corporate Communications
484-598-2406
lcaperelli@polymedix.com
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®, antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces, and anticoagulant reversing agents.
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.
CONTACT: Lisa Caperelli
Director, Investor Relations & Corporate Communications
484-598-2406
lcaperelli@polymedix.com