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.
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.--(BUSINESS WIRE)--PolyMedix, Inc. (OTC BB: PYMX - News), 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.
•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), generally localized to the oral area and extremities, 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 http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.polymedix.com%2F&esheet=6232663&lan=en_US&anchor=www.polymedix.com&index=2&md5=2900eedffa245e07ac4dac739c6005c6
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