Clinical testing of Nanoinsulin PharmFilm expected to begin during the second quarter of 2011.
MonoSol Rx and Midatech are establishing a joint venture to develop nanoparticle transbuccal film products for the treatment of diabetes. The initial Nanoinsulin™ PharmFilm product will be commercialized in collaboration with a third party. Phase I trials are projected to start during the second quarter of 2011.
The two firms have been collaborating since 2008 on the development of products utilizing Midatech’s nanoparticle platform and MonoSol’s PharmFilm drug delivery technologies. For the diabetes joint venture the partners are already carrying out preclinical studies evaluating buccally delivered insulin in primate models of diabetes. Previous testing in multiple animal models has confirmed that insulin delivered via the buccal route decreases circulating levels of glucose, while tolerability and acute and chronic toxicity studies have demonstrated the safety of nanoparticles in different animal models, they stress.
“The strength of the data generated so far and the early indications from our primate study give us confidence that our nanoparticle oral film platform is capable of delivering a therapeutic insulin dose into the systemic circulation,” remarks A. Mark Schobel, MonoSol president and CEO. “For the future, it is important to acknowledge that the combination of our respective technologies is applicable to other biologics, and we look forward to exploring additional opportunities together.”
MonoSol has two marketed PharmFilm products. Its PharmFilm ondansetron anti-emetic Zuplenz, and buprenorphine/naloxone opiod dependence product Suboxone, both achieved FDA clearance during mid-2010. The firm’s pipeline includes PharmFilm formulations of existing drugs for the treatment of asthma/allergy, migraine, severe allergic reaction, and depression.
Midatech is focused on developing, synthesizing, and manufacturing nanomedicines based on its proprietary, self-assembling biocompatible nanoparticle technology. The firm’s development programs are focused on metabolic disorders including diabetes and oncology applications. It also aims to produce prophylactic vaccines and immunotherapy products for cancer and chronic viral diseases.