COMBINATION DRUG DELIVERY DEVICES

Ineffective drug delivery is caused by problems with systemic drug delivery, lack of sustained release capabilities, poor drug transfer, and downstream complications. In the context of drug delivery, the need for efficient systems remains a challenge. There is as yet no perfect drug delivery platform.

In recent years there has been significant renaissance in the polymer drug delivery field. The ideal parameters for these platforms are dictated by the specific clinical consideration and drug physio/chemical properties.

Interface Biologics’ biomedical polymer enabled drug delivery devices include Epidel™ anti-infective polymers and Kinesyx™ bioactive oligomers. Based on the repertoire of unprecedented properties offered by Epidel and Kinesyx technologies, it is expected that these materials will play a significant role in the development of new combination products and strategies in drug delivery.

Epidel™

Implantable medical devices inherently increase the risk of infection either through the implant procedure itself or as an access point to external microorganisms. Chronic infections place a major burden on the healthcare system with some estimates as high as $12 billion per year for the U.S. alone. This is caused by patients spending more time in the hospital, requiring more doctor and nurse time and the use of expensive systemic antibiotics as more aggressive treatment options are explored.

Infection caused by implantable medical devices is often a result of biofilm development on the device surfaces. Microorganisms adhere to the surface of the device, anchoring themselves and facilitating the attachment of other microbes, which leads to further colonization and formation of a polymicrobial environment with increased pathogenic effect. Once the biofilm is developed, it is increasingly difficult to eliminate and the cells become more antibiotic resistant. Biofilm infections have been estimated to be 1,000 times more resistant to antibiotics than conventional infections.

The current state of the art in infection control devices employ mainly silver based technologies. The challenge is that while effective in the short term, silver coatings have limited duration and may not last long enough to prevent infections in devices that are implanted for more than 7 days. Silver is also non-selective and kills healthy cells as well as the targeted microbes.

Interface Biologics' Epidel™ anti-infective polymers allows for pharmaceuticals to be integrated directly into the medical device providing for long term anti-microbial effectiveness, release of the drugs directly from the device to prevent biofilm development andmaintenance of tissue in-growth properties for porous matrices. The Epidel™ technology is flexible, providing solutions for a myriad of medical devices with different surface characteristics (e.g. mesh, polymeric, metallic), manufacturing processes (e.g. coating, extrusion, heat press) and a broad range of compatible drugs.

The current product focus for the Epidel™ technology is called EpiCuff – a percutaneous infection control device that can be used as a cuff with devices such as dialysis catheters, peritoneal dialysis catheters and LVAD leads in order to provide long term anti-microbial effect while supporting the tissue in-growth properties required to effectively seal the entry wound. The company is currently evaluating various product prototypes in animal models.

Product extensions of the EpiCuff technology include: hernia mesh, incontinence slings, sutures and bandages.

Kinesyx™

Interface Biologics’ Kinesyx™ technology is an extension of the Endexo™ platform. Kinesyx™ molecules are polyurethane oligomers with fluorinated segments, and can be designed to work with a number of different pharmaceuticals and biologics with specific release requirements. It is a versatile technology platform with a broad range of formulations. A sustained or transient release profile can be achieved depending on the formulation selection as well as clinical consideration. Kinesyx™ bioactive surface pacifying oligomers provide an ideal platform for drug delivery due to the benefits of the fluorine chemistry, the flexible small molecular structure, the bio-elimination properties, and the ability to tailor both pharmaceutical release and polymer residency.

Interface Biologics is currently evaluating the Kinesyx™ technology in a drug coated angioplasty balloon for peripheral vascular disease (PVD). PVD afflicts an estimated 20 million people in the US and Europe and the lack of effective current solutions results in over 250,000 amputations per year. Balloon angioplasty is often used to treat restricted vessels due to PVD but suffers from a 40% re-occlusion rate because of the accelerated smooth muscle cell growth caused by the procedure itself. Stents are largely ineffective in the periphery because of the mechanical challenges associated with normal flexing of the leg and other pressures as a result of daily activities. Angioplasty balloons which are coated with cytotoxic or cytostatic drugs would appear to be an ideal solution because of the ability both to remodel the vessels and prevent the immediate smooth muscle cell reaction, but the products on the market in Europe today suffer from a number of challenges that will make US approval difficult.

IBI's Kinesyx™ technology provides a unique solution to the existing problems. Due to its unique structure, the Kinesyx™ coating can be consistently applied to the device (either in wrapped or unwrapped states) and has minimal particulate development – significantly below the FDA limits for particles >10 and >25 microns.