Proof of Principle Studies (Data on File)
PRx has already amassed considerable data that characterize the performance of its BDEP™ product in a cross section of relevant animal studies. Of the 16 studies performed to date, the following investigations have established Proof of Principle for the intended use of BDEP™ coated sutures. Taken together, these data provide a compelling rationale for commercializing of the Company’s coated suture products as its lead product candidate: (i) Separate mouse palate model and pig in-vivo studies were successfully employed to demonstrate the anti- inflammatory properties of salicylic acid and Diflunisal as the BDEP™, respectively. (ii) Pharmacokinetics of Drug release was validated for both PolySA™ and PolyDF™ over a broad dosage range in a subcutaneous rat model. No “burst effect” or untoward breakdown products of BDEP™ metabolism were observed. (iii) Separate studies demonstrated that PolySA™ inhibits growth of Pseudomonas, E. Coli and S. Aureus in-vitro. (iv) An in-vivo pig model was conducted to examine the effects of PolySA™ coatings on polytetrafluoroethylene vascular graft function in-vivo.
Features and Benefits of PRx Technology
- Novel chemistry: the active drug compound (e.g., SA, DF, etc) is the backbone of the actual polymer product itself; that is, the polymer (PolySA or PolyDF) is also the drug or device.
- Choice of FDA-cleared GRAS agents as the initial therapeutic compounds minimizes regulatory barriers and creates a clear, near term market entry opportunity.
- BDEPs™ can be engineered with high drug loads, up to 90+% by weight, with desirable pharmacokinetic elution profiles lasting from as little as a few days to nearly two years with no burst effect.
- BDEP™ platform technology is scalable and adaptable to numerous device applications:
- Coatings: surgical sutures, staples, clips, meshes, wound care, catheters.
- Fabrication or coatings: orthopedic screws, plates and rods, reparative bone fillers.
- Delivery systems: hydrogels, sheets, tapes, films, microspheres, nanoparticles.
- Ability to formulate BDEPs™ with a wide range of other drug compounds in addition to NSAIDS
Polymer Therapeutics’ SA-medical polymer has passed ISO 10993 testing for pyrogenicity and cytotoxicity while Proof of Concept of SA’s antimicrobial and antibiofilm properties has been established in 19 preclinical studies (data on file). Based on evidence from these studies, and following direct correspondence and dialogue with FDA regarding the appropriate regulatory submission pathway, Management, with guidance from its consultants, has focused on developing products in the surgical space with SA-coated surgical sutures as the leading Indication For Use. The current understanding with FDA is as follows: (i) SA-coated sutures will be a 510(k) submission with the likely indication statement being: antimicrobial surgical suture for soft tissue approximation to reduce incidence of SSI and biofilm production. (ii) SA coated surgical sutures will be viewed as a “combination” medical device. (iii) Two appropriate predicate devices have been identified and accepted. (iv) One additional in-vitro study has been recommended by FDA and is currently being designed. (v) Target submission: early Q2 2013. Strategically, this pathway is important as it will create a “510(k) predicate device” reference for future medical device applications that are developed using PRx’s medical polymers.