PolyMedix, Inc. (OTC BB: PYMX), a biotechnology company focused on developing new therapeutic drugs to treat patients with acute infectious diseases and cardiovascular disorders, announced today that its lead defensin-mimetic antibiotic compound, PMX-30063, when administered topically as an oral rinse, has shown activity against oral mucositis in an animal study. Oral mucositis is a common and often debilitating inflammation and ulceration that occurs in the mouth as a complication of cancer treatment. PMX-30063 is currently in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections caused by Staph bacteria. “The ability of PMX-30063 to mitigate ulcerative mucositis in pre-clinical studies is significant and exciting,” commented Stephen T. Sonis, DMD, DMSc, Chief Medical Officer at Biomodels where the studies were performed, and a Professor of Oral Medicine at Harvard’s School of Dental Medicine and world-renowned expert in the clinical treatment and research of cancer related mucosal toxicities. “Radiation and chemotherapy are life-saving treatments for cancer patients, but the development of extensive painful lesions in the mouth, tongue and throat renders many patients unable to eat, speak or tolerate therapy. The results seen with PMX-30063 are extremely promising and support further testing as a new therapeutic agent to address this substantial unmet medical need.” “We continue to be excited by the breadth of therapeutic possibilities for our defensin mimetic compounds,” commented Nicholas Landekic, President and Chief Executive Officer of PolyMedix. “There is a major need for effective treatment options for the hundreds of thousands of patients per year who develop ulcerative lesions as a result of their cancer treatment. A recent study from Northwestern University quantified the cost of additional resource use attributable to the management of patients with mucositis at over $17,000 as well as lengthening hospital stays, making this an expensive and serious medical problem. Having the ability to potentially administer PMX-30063 topically may also provide advantages over systemic approaches.”
PMX-30063 and other PolyMedix defensin-mimetic antibiotic compounds were tested in an animal model of radiation induced oral mucositis and demonstrated a significant reduction in ulcerations after preventively dosing three times a day for twenty days. In addition, no adverse events were noted. PolyMedix has recently presented this data at a prestigious scientific meeting.About PMX-30063 PolyMedix’s novel antibiotic compound, 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 unique 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 novel antibiotic, making PMX-30063 one potential solution to the growing problem of bacterial resistance. PMX-30063 is currently in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections caused by Staph bacteria. About PolyMedix, Inc. PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs for the treatment of serious infectious diseases and acute cardiovascular disorders. PolyMedix uses a rational drug design approach to create non-peptide, small-molecule drug candidates. PolyMedix’s lead antibiotic compound, PMX-30063, is currently in a Phase 2 clinical trial for treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph. PMX-30063 is a small-molecule that mimics the mechanism of action of human host defense proteins, a mechanism that is distinct from currently approved antibiotic drugs and is intended to make bacterial resistance unlikely to develop. PolyMedix’s lead heptagonist compound, PMX-60056, is in a Phase 2 clinical trial in patients undergoing PCI procedures. PMX-60056 is designed to reverse the anticoagulant activity of both heparin and low molecular weight heparins (LMWH). PolyMedix believes that PMX-60056 could potentially be a safer and easier to use anticoagulant reversing agent, with broader activity, than the currently approved therapy for reversing heparin and LMWH. In addition to its small molecule therapeutics, PolyMedix has polymeric formulations with the same mechanism of action as PMX-30063, PolyCides ®. PolyCides are intended for use in antimicrobial biomaterials applications as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit our website at www.polymedix.com. 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.