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PolyMedix Presents New Data On Its Defensin-Mimetic Antibiotics At 52nd Annual ICAAC

RADNOR, Pa., Sept. 11, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative approaches to transforming the treatment of infectious diseases, today announced that the Company presented data on its defensin-mimetic antimicrobial compounds at the 52 nd Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, CA. The presentations included results of the first Phase 2 clinical study of PolyMedix's lead defensin-mimetic, brilacidin (PMX-30063), which showed high clinical response rates in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus.

"We are excited to present data at ICAAC from our first Phase 2 study with brilacidin and our preclinical studies with other defensin-mimetic compounds," said Dr. Richard Scott, Vice President of Research at PolyMedix. "We are proud to be the pioneers in developing defensin-mimetics, a novel class of antibiotics with a distinct mechanism of action from currently known drugs. We look forward to advancing the development of these innovative compounds and exploring their potential to treat a wide range of infectious diseases."

Brilacidin Phase 2 ABSSSI Data

In a multicenter, double-blind dose-ranging Phase 2 study, 215 patients with ABSSSI (Acute Bacterial Skin and Skin Structure Infections) and evidence of Staph aureus were randomized into three treatment groups and given a low (0.40 mg/kg day 1 + 0.30 mg/kg days 2-5), medium (0.75 mg/kg day 1 + 0.35 mg/kg days 2-5) or high (1.0 mg/kg day 1 + 0.35 mg/kg days 2-5) dose of brilacidin for 5 days followed by 2 days of placebo, or daptomycin for 7 days. Investigators examined response rates at days 2-3, 7-8, 10-14 and 28. A patient met the response criteria if there was a significant reduction in lesion size at all four assessment visits. As indicated in the table below, the results of this study showed that clinical response rates were high across all treatment groups and similar to daptomycin:

Study Visit Low dose n=40 Medium dose n=35 High dose n=39 Daptomycin n=47
Day 2-3 97.5% 91.4% 92.3% 91.5%
Day 7-8 92.5% 94.3% 97.4% 95.7%
Day 10-14 92.5% 91.4% 97.4% 95.7%
Day 28 87.5% 80.0% 97.4% 93.6%
         
 Data based on per protocol patient population.        

In the study, brilacidin was safely administered and adverse events appeared to be exposure-related. Aside from mild, transient numbness and tingling, for which no patient discontinued treatment, the overall adverse event rates were under 10% in each dose group. Rare cases of transient systolic blood pressure elevations occurred in 6 of the 160 (3.8%) patients treated with brilacidin. Of the six patients, three were in the high dose group. The one patient in the low dose group that experienced high blood pressure was reported as having pre-existing hypertension.

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