�PolyMedix, Inc. (OTC BB: PYMX), an emerging biotech company developing new therapeutical drug products to treat infectious diseases and penetrating cardiovascular disorders based on biomimetics, has initiated dosing and commenced a Phase I clinical study in Canada for its defensin mimetic antibiotic compound, PMX-30063. PolyMedix received a notice of no objection from Health Canada for the Company's Clinical Trial Application ("CTA") for PMX-30063 in May 2008. PMX-30063 is the first gear and only defensin mimetic antibiotic compound to enter human clinical trials for systemic habit, and represents an entirely new class of antibiotic drugs.
This first Phase I clinical trial testament assess the safety of PMX-30063. The protocol for the trial involves a dose-escalation written report in healthy volunteers in which each subject testament receive a single dose of PMX-30063. The subjects are grouped into different cohorts with different dosage levels which will admit for the study of the effects of increased dosages. PolyMedix expects to enroll a total of thirty to fifty subjects in this clinical tribulation. Upon successful completion of the first-class honours degree clinical subject area, PolyMedix plans to initiate a second clinical trial run to mimic the expected clinical dosing regimen. The second run, also to be conducted in healthy volunteers, will involve iterate dosing of two endovenous infusions per day, for up fourteen days. Following these clinical trials, meaning additional clinical studies and regulatory submissions will be required to obtain regulative approval from the FDA and other regulatory bodies before PMX-30063 could be commercially sold.
"The commence of the clinical survey for PMX-30063 represents a major milestone for PolyMedix, and we believe, for the full medical community of interests," said Nicholas Landekic, CEO of PolyMedix. "This novel antibiotic combine signals a fundamental potential breakthrough in treating infectious diseases. PMX-30063 is the first and only modest molecule defensin mimetic to commence clinical development for the treatment of systemic infections, and the first and solely such compound whose mechanism of action mechanism is intended to straight address the major problem of bacterial drug resistance. We ar proud to be the first troupe to bring this completely new type of antibiotic drug to clinical trials, and to address a major clinical want and market opportunity."
About PMX-30063
Completely different from other antibiotic drug compounds currently on the market, PMX-30063 is a synthetic chemical mimic of host united States Department of Defense proteins, one of the oldest and most in force antimicrobial defense systems ground in well-nigh all living creatures. PMX-30063 is the first little molecule mimetic of host defense proteins to embark clinical trials intended to treat systemic infections.
PolyMedix has undertaken in vivo studies in animals and in vitro pre-clinical studies to observe compound efficacy and toxicology attributes, and to judge the development of drug resistance. Based on these pre-clinical studies, we believe PMX-30063 has unique properties which sets it apart from traditional antimicrobial molecules and materials, including:
- A novel mechanism of action, the aim biophysical disruption of bacterial cell membranes, that makes development of bacterial resistance unlikely;
- Activity against both Gram-positive and Gram- minus bacteria, and in especial, activity against 146 dissimilar strains of Staphylococcus bacterium, including 89 drug-resistant strains of Staph bacteria;
- 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- and methicillin-resistant strains.
Primitive life sentence forms, such as molds, secrete compounds like penicillin to protect themselves from bacteria. This forms the basis for conventional antibiotics - compounds which act against biochemical targets or pathways in bacterial cells. Multi-cellular organisms, such as insects, animals, and human race, possess a more complex, first-line immune system defence against bacterial infections: the host defence proteins. Host defense proteins are part of the non-humoral (that is, not involving antibodies) response that keep world from speedily succumbing to infections. Biologists have observed many different classes of natural host-defense peptides. Although these molecules possess a diverse array of structures, their physicochemical properties ar similar. All are amphiphilic, meaning they have a combination of positively electrically charged properties, and hydrophobic (water-hating, fat-loving) chemical properties. This amphiphilic structure is believed to be responsible for horde defense peptides' antimicrobial activity and their unique abilities to straight disrupt bacterial cell membranes. Among the most vulgar and well-studied antimicrobial peptides are the defensins, establish in human beings, the magainins, found in frogs, and the cecropins and melitins, found in insects.
PMX-30063 is designed to mimicker the amphiphilic structure of the host defense proteins, but with a completely synthetic, non-peptide, small corpuscle structure. PMX-30063 directly disrupts bacterial electric cell membranes; a mechanism shared with the host defence proteins just is unique among known antibiotic drugs. For this reason, we believe that bacterial opposition is less likely to develop with PMX-30063 than has been experienced with many conventional antibiotic drugs. Multiple serial passage experiments conducted by PolyMedix and others on PMX-30063 and related PolyMedix antibiotic compounds also support our view of a lower likeliness of developing resistance.
About PolyMedix, Inc.
PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs and biomaterials for the treatment of infectious diseases and sharp cardiovascular disorders. PolyMedix's compounds are based on biomimetics: non-peptide small molecule drugs that mimic the activity of proteins. The Company's antibiotic compounds, including PMX-30063 - small molecule mimetics of human host-defense proteins - have a wholly different mechanism of activity from stream antibiotic drugs, a mechanism which is intended to make bacterial resistance improbable to develop. These compounds are organism developed as rapidly performing antibiotics for serious systemic and local infections. The Company plans to go on the development of polymeric formulations as antimicrobial biomaterials, which canful be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. The Company's heptagonist compounds, including PMX-60056, reverse the activity of both heparin and Low Molecular Weight Heparins, with the goal of developing an antagonist drug that is safer and easier to use than currently sanctioned therapy. For more information, please visit PolyMedix on its web site at hTTP://www.polymedix.com.
This press release contains advanced statements made pursuant to the good harbor victuals of the Private Securities Litigation Reform Act of 1995 that involve risks and that could reason PolyMedix's actual results and experience to differ materially from awaited results and expectations expressed in these forward looking for statements. PolyMedix has in some cases identified forward-looking statements by using language such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends" and similar expression.. Among other things, there can buoy be no assurance that PolyMedix's compounds will enter or successfully complete clinical testing or be given regulatory approval to be sold and marketed in the Unites States or elsewhere. A more complete description of these risks, uncertainties and assumptions is included in PolyMedix's filings with the Securities and Exchange Commission. You should t stead undue reliance on any forward-looking statements. PolyMedix undertakes no duty to release publicly the results of any revisions to any such innovative statements that may be made to reflect events or luck after the date of this crusade release or to reflect the occurrence of unforeseen events.
PolyMedix, Inc.
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