Phase I Study of Oral Insulin Film to Commence Before the Start of 2012
Warren, NJ (November 15, 2011) – MonoSol Rx, the developer of PharmFilm® drug delivery technology, and its collaboration partner Midatech Ltd., a global leader and centre of excellence for the design, development, synthesis and manufacture of nanomedicines, announced today that is has received authorization from the Swissmedic, the Swiss regulatory agency for therapeutic products, to initiate a Phase I clinical trial in Switzerland of gold nanoparticle/insulin incorporated into PharmFilm in healthy volunteers.
The first in human clinical trial is designed to assess the safety profile of gold nanoparticle bound insulin when administered transbuccally to healthy volunteers. The study is a single, ascending dose, double blind study in 27 male volunteers using a eu-glycemic clamp. This Phase 1 study will be performed in a clinical research unit near Basel, Switzerland and results of the trial are expected during Q1 2012.
"This trial represents a major advancement in the treatment of diabetes and for the millions of patients worldwide who have been waiting for an easy-to-administer oral insulin formulation that eliminates the need for injection,” stated A. Mark Schobel, President and CEO of MonoSol Rx. "We are very excited that our extensive preclinical work has satisfied the Swissmedic and to be part of a groundbreaking study that could pave the way for developing an effective transbuccal insulin therapy for this significant unmet medical need.”
The two companies are developing methodologies for the delivery of nanoparticle therapeutics under a partnership that leverages MonoSol Rx’s PharmFilm and Midatech’s biocompatible nanoparticles to develop transbuccal bioavailable formulations.
In addition, MonoSol Rx and Midatech are also evaluating additional peptides, including GLP-1, for oral buccal delivery. The first GLP-1 porcine study received positive results and the groups are now moving towards completing pre-clinical testing.
Diabetes is a disease associated with high levels of blood glucose resulting from defects in insulin production, insulin action, or both. It is the seventh leading cause of death in the United States and can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations. According to the Centers for Disease Control, nearly 24 million people in the United States are currently living with diabetes. Globally, more than 230 million people are living with the disease and this number is expected to rise to 350 million within 20 years.
Insulin is a hormone that allows blood sugar to move from a person's bloodstream into cells, giving them energy. Type 1 diabetes results from the body's failure to produce insulin. In type 2 diabetes, the body does not produce enough insulin and/or not using the insulin produced adequately. Among adults with diagnosed diabetes – type 1 or type 2 – nearly 30 percent require daily insulin injections to manage their blood sugar.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence.
MonoSol Rx’s commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. For press releases and other company information visit www.monosolrx.com