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PYMX - 2010 Milestones

http://finance.yahoo.com/news/PolyMedix-Announces-Planned-bw-1016870406.html?x=0&.v=1

PolyMedix Announces Planned Milestones for 2010
On-Track to Initiate 4 Clinical Trials

RADNOR, Pa.--(BUSINESS WIRE)--PolyMedix, Inc. (OTC BB: PYMX, www.polymedix.com), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, provided an overview of its 2010 clinical milestones in a presentation by President & C.E.O., Nicholas Landekic at the 2010 BIO CEO & Investor Conference. A replay of the webcast is available at http://www.veracast.com/webcasts/bio/ceoinvestor2010/27101233.cfm.

“PolyMedix has achieved noteworthy accomplishments in 2009 which have paved the way for our planned progress in 2010,” commented Mr. Nicholas Landekic, President & C.E.O. of PolyMedix. “In the fourth quarter of 2009 we completed a $21M financing and announced successful results from two Phase 1B clinical trials for our lead products, PMX-60056 and PMX-30063. With a strengthened balance sheet and proof-of-concept results we are planning to initiate four new clinical trials in 2010.”

PolyMedix anticipates the following plans for its two lead clinical programs in 2010:

PMX-60056 Heptagonist

•In the first quarter of 2010, PolyMedix anticipates initiating a Phase 1B/2 pilot proof-of-concept study in the United States to evaluate the safety and efficacy of a single-dose of PMX-60056 on healthy subjects who have received a low molecular weight heparin (LMWH). The design of this trial will be similar to that which PolyMedix completed in October 2009 which demonstrated that a single dose of PMX-60056 was well tolerated, completely and rapidly reversed heparin and normalized blood clotting time in six healthy subjects. Results from this trial are expected to be available by the end of the second quarter of 2010.
•In the first quarter of 2010, PolyMedix also anticipates initiating a second Phase 1B/2 clinical trial that will be designed as a dose-ranging study for the reversal of heparin in healthy subjects. The objective of this trial will be to study higher doses of heparin than those used in the first heparin reversal study, and more precisely quantify the dose of PMX-60056 needed to reverse a given amount of heparin. Results from this trial are also expected by the end of the second quarter of 2010.
•In the second half of 2010, PolyMedix anticipates initiating a Phase 2 efficacy study. The objective of the study is to evaluate the safety and efficacy of PMX-60056 in reversing heparin in patients undergoing cardiothoracic surgeries. Information gathered from this study will be used to determine the clinical and regulatory path forward, and in particular, the needs and logistics for Phase 3 pivotal trials. Results from this trial are also expected by the end of the first quarter of 2011.

PMX-30063 Antibiotic

•PolyMedix is on schedule to complete the third and final segment of the ongoing Phase 1B study with PMX-30063 by the end of the first quarter of 2010. In this third segment of the study, healthy subjects are receiving PMX-30063 or placebo twice a day for five days. Up to three dose levels are expected to be given in this segment of the study. The results of the entire Phase 1B study will be used to determine the next steps for the development of PMX-30063, and in particular, to select optimal dosing for the planned Phase 2 study.
•By the end of the second quarter of 2010, PolyMedix anticipates initiating a Phase 2 efficacy study in the United States. This study will be in patients with Staph infections. The study is planned to allow enrollment of a broad range of Staph infections, including both drug susceptible and drug resistant strains. The clinical target is expected to be skin and soft tissue infections. IND enabling activities are on-track for the initiation of this clinical trial. Results from this trial are also expected by the end of the first quarter of 2011.

Nicholas Landekic continued, “We expect that 2010 will be a pivotal year for PolyMedix as we undertake Phase 2 clinical trials for our two lead programs, which should yield important results. We believe that both PMX-30063 and PMX-60056, with their unique mechanisms of action and demonstrated clinical proofs-of-concept, have the potential to address major clinical needs and large market opportunities. We look forward to the continued development of both of these programs.”

About PMX-60056

PolyMedix’s heptagonist compound, PMX-60056, is a synthetic, small molecule that reverses the anticoagulant activity of both heparin and Low Molecular Weight Heparins (LMWHs). LMWHs are used in approximately 12 million patients annually for chronic treatment of thrombosis. Up to 20% of patients may experience bleeding complications. There is presently no FDA approved reversing agent available to reverse the anticoagulant activity of LMWHs. Heparin is an i.v. anticoagulant used to prevent clots from forming during certain cardiothoracic and orthopedic surgical procedures. After these procedures, the anticoagulant activity of heparin must be reversed in order to restore normal clot formation. Protamine is presently the only agent available for this use. Protamine has many limitations, and there is a major need for a safer and easier to use heparin reversing agent. PolyMedix is developing PMX-60056 as a safer and easier reversing agent for heparin and LMWHs. A Phase 1B double-blind, placebo controlled pilot efficacy study was successfully completed in October 2009. The results showed that PMX-60056 was well-tolerated with no clinically significant adverse effects, and was able to completely neutralize heparin and normalize blood clotting time. Pre-clinical and clinical data suggest many potential safety and other advantages over protamine, as well as a unique opportunity as the first reversing agent for LMWHs.

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 mechanism of action that is completely different than current antibiotic drugs, and intended to make bacterial resistance unlikely to develop. In addition, it is fast acting and kills bacteria directly rather than simply stopping reproduction. A Phase 1A single dose trial has been successfully completed as well as two segments of a Phase 1B multi-dose clinical trial. The combined results showed that it was possible to safely administer PMX-30063 without any serious side effects at doses which exceeded those associated with full efficacy in animal models of infection. The side effects seen at higher doses were all mild and fully reversible. The third segment of the Phase 1B trial is underway.

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 acute cardiovascular disorders. 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, with the goal of developing 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.