PolyMedix completes second successful clinical study of PMX-60056

PolyMedix, Inc. (OTC BB: PYMX, http://polymedix.com), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders, has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056. The Phase 1B clinical study was a pilot proof-of-concept study conducted in the U.S. under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

Highlights from the Phase 1B clinical study include:

• PMX-60056 completely reversed the anticoagulant effects of heparin and normalized blood clotting time in human subjects in less than 10 minutes.
• No serious adverse events occurred during the study of PMX-60056.

“We are very proud and happy to have completed this major step in the development of PMX-60056,” commented Nicholas Landekic, President & Chief Executive Officer of PolyMedix. “PMX-60056 represents a new class of drug, which we call heptagonists, and we believe is the only compound being developed as a reversing agent for heparin and low molecular weight heparins (LMWHs). PMX-60056 may offer important benefits and improvements in treating the potential bleeding complications of heparin, which was targeted in this study, as well as LMWHs which we hope to investigate in future clinical studies. We hope that in the future PMX-60056 will allow physicians to continue to use heparin, the only anticoagulant currently available for open-heart surgery and kidney dialysis, with a new and unique reversing agent, and potentially the first reversing agent for LMWH’s.”

“I am encouraged by the promising results with PMX-60056. This drug could be an important addition to the medical armamentarium, and may address unmet clinical needs in reversing heparin as well as being potentially the first reversal agent for LMWH,” commented Dr. Mark Stafford-Smith, of Duke University Medical Center, a clinical advisor to PolyMedix.

This Phase 1B clinical study evaluated subjects who received heparin followed by PMX-60056 or placebo. Significant additional clinical studies and regulatory submissions, and regulatory approvals from the FDA and other regulatory bodies, will be required before PMX-60056 could be commercially sold as a reversing agent for heparin or for LMWHs. PolyMedix is currently evaluating plans for the continued clinical development of PMX-60056. There can be no assurances that future clinical studies will be successful, that required regulatory approvals will be obtained, or that the company will be able to market and sell any products based on PMX-60056.

Mr. Landekic went on to comment: “This study represents a validation of the capabilities and efficiency of PolyMedix’s structure-based drug design approach. In developing PMX-60056, we went from the very beginning of drug design to attaining a clinical efficacy endpoint while spending less than $10 million in direct costs. We attribute this efficiency realized in developing PMX-60056 to our structure-based drug design approach, and the skill of our seasoned research and development leadership.”

Study Design

The pilot proof-of-concept study was conducted using a double-blind, placebo-controlled, crossover design, with six healthy human volunteer subjects. This study design and low number of subjects were intended to generate meaningful results for a pilot study at minimal cost. Twenty minutes after administration of a 70 U/kg dose of heparin, which is sufficient to produce anticoagulant activity, each of the subjects was administered, in a blinded manner, either a single dose of 0.3 mg/kg of PMX-60056 or a placebo as a 10-minute intravenous infusion. With the crossover design, each subject was dosed twice, initially with heparin and either PMX-60056 or a placebo and then, two days after the first dose, with heparin and whichever (PMX-60056 or a placebo) he did not receive in the first dose. Each subject thus acted as his own control.

The primary endpoint of the clinical study was safety, specifically whether blood pressure decreases would be mitigated by the presence of heparin, and the secondary endpoint was efficacy, as measured by blood clotting time. The desired outcomes were no clinically significant decrease in blood pressure, and rapid reversal of activated clotting time (ACT), a standard bedside blood clotting measurement, and activated partial thromboplastin time (aPTT), a more accurate laboratory measurement of blood clotting time. These blood clotting times are machine-read to ensure objective measurement.