RADNOR, Pa., June 4, 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 that preclinical data presented at the American Society of Clinical Oncology (ASCO) annual meeting suggest that PMX-30063 has encouraging potential as a topical treatment for oral mucositis, a common and often debilitating complication from radiation and chemotherapy treatment. PMX-30063 is PolyMedix's first-in-class defensin-mimetic which recently demonstrated positive results in a Phase 2 clinical study as an intravenous treatment in patients with acute bacterial skin and skin structure Staphylococcus infections.
The data were presented on Saturday, June 2nd by Dr. Richard Scott, Vice President of Research at PolyMedix, in a poster titled, "Evaluation of a Non-Peptidic Mimic of Host Defense Proteins, PMX-30063 in an Animal Model of Oral Mucositis". The data summarized preclinical studies where PMX-30063 was administered to animals as a topical rinse in models of acute and fractionated radiation. In each of the two controlled studies, PMX-30063 substantially reduced the peak mean mucositis scores and the duration of ulcerative mucositis by a statistically significant margin compared to vehicle-treated animals.
Study Details
In the acute radiation study, PMX-30063 was applied as a topical rinse three times daily, at 0.03, 1, 3 or 10 mg/ml over a 28 day treatment regimen (n=10), following a single dose of radiation to the buccal cheek pouch (40 Gy).
In a separate study in a fractionated radiation model, 7.5 Gy/dose of radiation was administered on days 0, 1, 2, 3, 6, 7, 8 and 9, targeting the left buccal pouch mucosa. PMX-30063 was given topically three times a day at 3 mg/ml over a 35- day regimen.
Results
In the acute radiation model, PMX-30063 exhibited efficacy in a dose-dependent manner. At the three highest doses, PMX-30063 significantly reduced peak mucositis scores and daily mucositis scores on 9 to 10 of the 10 evaluation days when mucositis was evident ( p<0.001). PMX-30063 also reduced the number of animal days with ulceration from 42% in vehicle treated animals, to <5% in the three highest dose groups (p<0.001), a reduction of approximately 90%.
In the fractionated radiation model, PMX-30063 significantly reduced the daily mucositis scores prior to peak mucositis and throughout the remaining course of treatment (p<0.001), and reduced the number of animal days with ulcerations from 55% in vehicle treated hamsters to 3.3% (P<0.001), a reduction of approximately 94%.
In both studies, no significant changes in weight gain or adverse clinical signs were detected in any of the animals in the PMX-30063 treatment groups.
"These are among the most compelling results we have ever observed in an animal model of oral mucositis with an experimental therapy," 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. "The rapid effect observed suggests that anti-inflammatory activities may be playing an important role in efficacy. This compound should be rapidly moved into clinical studies in patients with oral mucositis where there is significant need for improved treatments."
Oral Mucositis
Oral mucositis is a common and often debilitating inflammation and ulceration that occurs in the mouth as a side-effect of certain cancer treatments. It afflicts approximately 450,000 patients each year in the United States, and can affect the course and outcome of cancer therapy. In addition to increasing the risk of infection and patient discomfort and ability to eat, oral mucositis is also associated with increased treatment costs of up to $25,000 per patient. Despite these issues, there are no broadly effective pharmacological therapeutic options for this condition, and treatment today is mostly focused on pain management.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company developing a novel class of antimicrobial agents, 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 this new class of antibiotics which imitates the mechanism of natural human immunity, and exploits a method of bacterial cell killing which has not shown bacterial resistance in multiple preclinical studies. 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 safely administered.
PolyMedix also has developed PolyCides®, polymer antimicrobial additives to create self-sterilizing products, surfaces, and materials, such as cosmetics, plastics, and medical devices, and PMX-60056 anticoagulant reversing agent. PolyMedix is seeking strategic alliances to further develop these compounds. PolyMedix's compounds have been internally discovered using a proprietary drug design technology.
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.