PolyMedix provides overview of its 2010 clinical milestones

PolyMedix, Inc.Feb 10 2010

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”

“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.”