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.
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.
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