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New Data on Infectious Disease Drug Suggest Potential as Treatment for Oral Mucositis

Posted on June 5, 2012

 

RADNOR, Pa., June 4, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc., a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, has 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 June 2 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."