Talk:Progress and Prospects in Parkinson's Research/Therapy/Neuroprotection/Exendin-4 (EX-4)
In July 2013 the Michael J. Fox Foundation for Parkinson’s Research awarded a grant of $1.98 million to Dr. T Foltynie of University College, London to pursue this avenue of research. This was to facilitate a double-blind, placebo-controlled trial of Exenatide, self-administered by patients by subcutaneous injection, over a 12 month period at the UCL Institute of Neurology.
In July 2013 Intarcia Therapeutics. the manufacturer of Exanatide, appointed Dr. Eddie Li as Vice President and Global Head of Regulatory Affairs. Dr. Li was charged with the task of conducting Phase 3 Clinical Trials of ITCA 650. This is a product which replaces the requirement to make sub-cutneous injections of Exanatide twice a day with an annual or 6-monthly procedure.
The investigational therapy employs Intarcia's proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time.
Data from Intarcia's ITCA 650 Phase 2 program have demonstrated significant and sustained reductions in HbA1c and body weight over 48 weeks of treatment with a marked reduction in the GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement.
Source Intarcia press release.