A Medical Device Daily

PolyMedix (Radnor, Pennsylvania), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has received patent protection for certain exclusively licensed intellectual property by the issuance to the University of Pennsylvania (Philadelphia) of U.S. patent number 7,590,517, "Methods, Systems, and Computer Program Products for Computational Design of Amphiphilic Polymers."

This patent claims the underlying process and implementation of two proprietary computational methodologies: PACE (Proteomic Assisted Computational Engine) and GOLDYN (Global Optimization of Long-time Dynamics force field), useful for the de novo design of small molecule mimetics. It relates to the identification of stable conformations of polymers and polymer fragments (oligomers) by computing force fields for the target compounds, and then predicting their conformations using molecular dynamics and configurational-biased simulations. This methodology enables the design of small amphiphilic polymers or oligomers, taking into account backbone structures, side-chain architectures and solvent effects, and improves the likelihood of synthesizing compounds with desired properties.

These computational methods were used in the design of PolyMedix's defensin mimetic antibiotic compounds, which represent a new class of antibiotic drugs and antimicrobial biomaterials that are believed to work in such a way that makes bacterial resistance unlikely to develop. PolyMedix's lead defensin-mimetic antibiotic compound is PMX-30063, currently in Phase I clinical development. On December 10, 2008, PolyMedix reported the results of the first Phase I human clinical study with PMX-30063. The results of that study suggest that it should be possible to achieve clinically therapeutic levels with daily doses of PMX-30063 which are lower than those associated with any adverse effects seen in the single dose study. On May 15, 2009, PolyMedix reported that it had received regulatory clearance from Health Canada to initiate a second Phase I clinical study with PMX-30063. This Phase IB clinical study will assess the safety of PMX-30063 given repeatedly over a period of several days. The initial indication planned for PMX-30063 is as a treatment for pan-Staphylococcal infections, including MRSA (methicillin-resistant Staphylococcus aureus).