A Phase II human clinical trial with the new combination therapy, consisting of DiaKine’s Lisofylline (LSF) and Kinexum’s Islet neogenesis associated protein (INGAP) peptide, is expected to begin in late 2008. The trial will be unique in that patients who are beyond the ‘newly diagnosed’ period will be included in the study.
LSF is a synthetic small molecule with novel anti-inflammatory properties, which has demonstrated that it can effectively prevent type-1 diabetes in preclinical models. INGAP is a member of the Reg3 family of pancreatic proteins. INGAP peptide, the active portion of the larger protein, induces islet regeneration in multiple species including humans. It is currently under development by Kinexum Metabolics.
Jerry Nadler, chief scientific officer for DiaKine said: “We believe these two drugs in combination create a unique and highly-effective treatment that could restore endogenous insulin to people with type 1 diabetes.”