EastGate Biotech Corp. announced that it has filed an application with the Drug Regulatory Authority of Pakistan (DRAP) and Ministry of National Health Services to initiate a Phase III clinical study for Insugin.  The company recently completed a positive Phase II clinical trial of its innovative liquid insulin mouth rinse solution, Insugin, for Type 2 diabetes patients.  The Phase III trial design is consistent with the 90-day Phase II study that recently met its endpoints. The application requests the dosing of 200 Type 2 diabetic patients in order to achieve statistically significant results for regulatory approval of Insugin in Pakistan. The company is considering dosing as many as 500 patients for inclusion in the Phase III clinical study.  The larger patient population gives the Company greater flexibility in dealing with submissions to surrounding territories for regulatory and marketing purposes. The company completed its Phase II clinical trial in Pakistan in May and met its primary endpoints of demonstrating the safety and efficacy of Insugin.  The Phase II study was designed to assess the safety, tolerability, pharmacokinetics and efficacy against a placebo arm.  There were no Severe Adverse Events (SAE’s) and the drug was well tolerated.  The HbA1c levels decreased by 0.39% after only 1 week of treatment in combination with Metformin versus placebo.  The patients enrolled in the study were Type 2 diabetes patients currently on Metformin treatment who took a regiment of 25 IU of Insugin, a recombinant human liquid insulin mouth rinse twice a day at mealtime along with 500 mg of Metformin. Insugin offers unique benefits and the product’s goal is to slow down progression of Type 2 diabetes mellitus and reduce complications; Insugin displayed a good safety and tolerability profile; Observed a statistically significant decrease in A1c levels after 1 week of treatment in combination with Metformin versus placebo; Observed that the most significant HbA1c reduction resulted from administration of a single dose of Insugin (25 IU) two times a day; Observed improvements in insulin secretion in Type 2 diabetes patients during hyperglycemic clamp; Observed that clinical efficacy of Insugin was non-inferior to Metformin, while its effect on HOMA-IR and fasting insulin level was superior compared to Metformin; Prevents the first step of apoptotic cascade (cytochrome C release) and protects cells from dying when submitted to an oxidative stress level (high glucose levels); Prevents endothelial dysfunction, which is well correlated to an improvement of atherosclerosis and cardiovascular complications and Preserves beta cell mass and beta cell function over time, leading to a potential delay of the disease’s progression.