PolyMedix Successfully Completes Phase 1B Clinical Study With
Novel Antibiotic PMX-30063
Study showed multiple doses of PMX-30063 to be safe and well-tolerated
Phase 2 clinical trial in Staph patients planned for 2Q 2010
Radnor, PA (March 30, 2010) - PolyMedix, Inc. (OTC BB: PYMX), an emerging bio-technology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B clinical study with its novel defensin-mimetic antibiotic, PMX-30063. The data from the study demonstrate that administration of multiple doses of PMX-30063 are safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the study. PMX-30063, a small-molecule mimetic of host defense proteins, has a novel mechanism of action distinct from other antibiotics, which is believed to make bacterial resistance unlikely to develop. PolyMedix is planning to initiate a Phase 2 clinical trial with PMX-30063 in patients with Staph infections in the second quarter of 2010.
PolyMedix will host a webcast on Tuesday, April 6, 2010 at 10:00 A.M. ET. The webcast will be available at http://www.investorcalendar.com/ClientPage.asp?ID=156938.
Top-line results from this study demonstrated:
- The dose-limiting total daily dose of PMX-30063 in healthy subjects was the same regardless of whether PMX-30063 was administered every 12 or 24 hours.
- Doses of PMX-30063 below the dose-limiting total daily dose killed Staph bacteria, including MRSA, in human serum in blood samples drawn from subjects in the study.
- Dose-limiting effects were generally seen at levels higher than anticipated therapeutic levels.
- Doses administered in the study exceeded theoretical efficacious levels predicted by animal models as well as dose levels which demonstrated bactericidal activity in blood drawn from healthy subjects.
"These data are promising and support the encouraging safety and tolerability profile of our novel antibiotic compound," commented Dr. Eric McAllister, Vice President, Clinical Development and Chief Medical Officer of PolyMedix. "Based upon preclinical and clinical findings to date, we believe we should be able to achieve effective therapeutic levels of PMX-30063 that will be well-tolerated with multiple dose administrations. The results from this Phase 1B clinical study will be used to determine the doses in our upcoming Phase 2 clinical study."
The Phase 1B clinical study was designed as a blinded, randomized, placebo-controlled, ascending, multiple-dose study. A total of 77 healthy subjects were enrolled with 55 receiving PMX-30063 and 22 receiving placebo. The study contained three parts, each of which utilized different dosing durations including every 12, 24 or 48 hours, over five or ten days, for a planned total of five to ten doses. Doses in each part ranged from 0.08 to 0.60 mg/kg per day. The primary endpoints of the study were to further delineate the pharmacokinetics and to find the dose-limiting dose for PMX-30063 when administered as multiple doses over five days.
The results from the entire study showed no difference in tolerability or dose-limiting effects when PMX-30063 was administered every 12 or 24 hours. In addition, the dose-limiting total dose for healthy subjects was 3.0 mg/kg (0.6 mg/kg every 24 hours or 0.3 mg/kg every 12 hours). The dose-limiting effect was paresthesias (abnormal sensations of numbness and tingling) which were mild and non-disabling. There were no other clinically significant adverse effects reported.
To test the antimicrobial activity of PMX-30063, blood samples were drawn from healthy subjects in the study after they had been dosed with PMX-30063. Four different strains of Staphylococcus aureus bacteria, including two MRSA strains, were added to the blood samples. The results showed that PMX-30063 was bactericidal against both MSSA (methicillin-sensitive Staphylococcus aureus) and MRSA (methicillin-resistant Staphylococcus aureus, or drug-resistant Staph) starting at doses as low as 0.1 to 0.3 mg/kg. These data suggest that multiple administrations of PMX-30063 below the identified limiting-dose may have a bactericidal effect on MSSA and MRSA in human subjects.
"Drug-resistant bacterial infections are one of the most serious problems facing the world," commented Nicholas Landekic, President & C.E.O. of PolyMedix. "PMX-30063 is the first and only small molecule defensin-mimetic in clinical development for the treatment of systemic infections, and the first and only such compound whose mechanism of action is intended to make bacterial drug resistance unlikely to develop. We believe these unique characteristics may allow PMX-30063 to address a major unmet medical need and large market opportunity."
PolyMedix plans to initiate a Phase 2 clinical efficacy study in the United States with PMX-30063 by the end of the second quarter of 2010. The trial will be conducted in patients with any type of Staph infection, including both MSSA and MRSA strains. Patients are expected to receive multiple doses of PMX-30063 or an active comparator. The clinical target is expected to be Acute Bacterial Skin and Skin Structure Infections (ABSSSI). It is anticipated that results from this trial could be available by the end of the first quarter of 2011.
About PMX-30063
PolyMedix's antibiotic compound, PMX-30063, is a small molecule mimetic of human host-defense proteins, one of the oldest and most effective antimicrobial defense systems found in virtually all living creatures. PMX-30063 has unique properties including:
- A novel mechanism of action, the direct biophysical disruption of bacterial cell membranes, which we believe makes development of bacterial resistance unlikely to occur;
- Activity against both Gram-positive and Gram- negative bacteria, and in particular, activity against 146 different strains of Staphylococcus bacteria, including 89 drug-resistant strains of Staph bacteria (MRSA);
- Bactericidal activity, meaning it kills bacteria directly, rather than simply stopping reproduction (bacteriostatic) as do many current antibiotics;
- Faster acting than many antibiotics; and
- Activity against drug-resistant bacteria, including clinical isolates of multiple vancomycin-, methicillin-, and daptomycin-resistant strains.
About PolyMedix, Inc.
PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs and biomaterials for the treatment of acute cardiovascular disorders and infectious diseases. PolyMedix's compounds are based on biomimetics: non-peptide small molecule drug candidates and polymers that mimic the activity of proteins. PMX-60056, PolyMedix's heptagonist compound, is being developed to reverse the activity of both heparin and low molecular weight heparins. PolyMedix plans to develop an antagonist drug that is safer and easier to use than currently approved therapy. PMX-30063, PolyMedix's antibiotic compound is a small molecule that mimics human host-defense proteins and has a completely different mechanism of action distinct from those of current antibiotic drugs, a mechanism which is intended to make bacterial resistance unlikely to develop. PolyMedix's goal is to develop this compound as a rapidly acting antibiotic for serious systemic and local infections. Both PMX-60056 heptagonist and PMX-30063 antibiotic are currently undergoing clinical testing. PolyMedix also plans to continue the development of polymeric formulations as antimicrobial biomaterials, which can be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit PolyMedix on its 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, PolyMedix's compounds may not enter or successfully complete 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.
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