Multi-Center Phase III trial planned for 2019
WEST CALDWELL, NJ and TORONTO, ON /NEWMEDIAWIRE/ May 15, 2019/ Eastgate Biotech Corp. (OTC: PINK: ETBI), a pharmaceutical company, that focuses on innovative technological developments specifically in insulin drug delivery for the treatment of Type 2 diabetes, announced today its plans to take the next steps to initiate Phase III of its innovative liquid insulin mouth rinse solution, Insugin, for Type 2 diabetes patients in Pakistan.
The Phase III study will be a multicenter, randomized, double-blind, placebo-controlled, parallel group study. After the appropriate screening, approximately 200 male and female patients from up to 10 study centers will be treated in this study. Patients with Type 2 diabetes mellitus who are being treated by diet, exercise, untreated with antidiabetic medications or treated with and Metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin) will be eligible for enrollment.
Earlier, Insugin, had met its primary endpoints in Phase II clinical study in Pakistan demonstrating glucose management and lowering of 90-day HbA1c levels.
The Phase II studies were completed in Pakistan by the company’s Joint Venture Partner, Genome Pharma/Origin Pharma. The JV partner will continue to be responsible for providing support, both in financial terms and operational activities, to conduct and carry out the Phase III studies in Pakistan.
“We are very pleased with the progress our Joint Venture partner in Pakistan is taking to advance our innovative liquid insulin mouth rinse to larger Phase III studies straight up to regulatory approval and commercialization”, says Anna Gluskin, Chief Executive Officer of Eastgate Biotech Corp. The successful Phase II study demonstrated that Insugin was safe, effective and lowered HbA1c levels over a 90-day period. Patients reported satisfaction with Insugin, particularly, with its easy-to-use factor. We look forward to expanding on this feedback and look forward to continued positive results with a larger pool of Type 2 diabetes patients that will lend to the potential of Insugin to bring about a treatment paradigm shift, ended Anna Gluskin.
“The positive Phase II human clinical trial of Insugin has encouraged our team to move forward to a larger patient study”, stated Nasir Irfat, Director of Genome Pharma/Origin Pharma, Eastgate's Joint Venture partner. “Over the next weeks we look forward to cooperating with Eastgate in order to get the necessary requirements together in order to get the green light to move into the Phase III study with Insugin, and plan for another successful round, Nasir Irfat continued
About Eastgate Biotech
Eastgate Biotech focuses on innovative technological developments and produces and distributes innovative drug compounds and healthy nutraceuticals that are based on natural therapies absorbed by the body. We utilize advanced nanotechnologies and alternative delivery systems that take difficult to deliver compounds and deliver them using our nanotechnology platform which ultimately increases the bioavailability to the body. Using our methods of delivery provides healthy alternatives to conventional pharmaceuticals that all-too-often create dangerous side-effects and unexpected consequences for those trying to attain and maintain a healthy lifestyle. Eastgate's wholly owned subsidiary Omni Surgery and Anti-Aging Centre is the first of many surgery centers to come under the Omni umbrella as we plan to roll up existing business under the Omni brand and expand our footprint globally.
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SOURCE: Eastgate Biotech Corp.