EastGate Biotech Receives Approval to Commence a Phase 2 Trial for Liquid Insulin Mouth Rinse Solution Addressing Patient Compliance in the Type 2 Diabetes Market
DRAP (Drug Regulatory Authority Pakistan) provided approval to commence studies of INSUGIN in Pakistan
WEST CALDWELL, N.J. and TORONTO, ON / ACCESSWIRE / October 3, 2018 / 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 mellitus (T2DM), today announced it received the approval from DRAP ( www.dra.gov.pk ) to commence a Phase 2 clinical trial of its oral mouth rinse. The generic name of the insulin mouth rinse is INSUGIN. The primary objectives of the study are to evaluate the safety and tolerability of INSUGIN in Type 2 patients. Secondary objectives are to assess the pharmacokinetic profile, food effects, and pharmacodynamic effects of INSUGIN.
Rose, President of EastGate said, “We couldn’t be happier with the progress our Joint Venture partner in Pakistan, Origin Pharma/Netris Pharma has made in a short period of time to outline the regulatory path to approval in this market in a succinct matter with a view to mirroring the pathway and protocol to other markets.”
“The initiation of human studies is a major accomplishment as we move forward with our clinical program that has over $40 million in milestone payments committed,” said Anna Gluskin, CEO of EastGate. “As we transition away from proof of concept and into rigorous clinical development, we will be updating our shareholders more frequently and get into more detail about the protocol and recruitment levels as our principal investigator makes the information available. We already have proof of concept and expect this trial to be a substantial springboard to additional licensees once the trial data becomes available. For years patient compliance has been a major hurdle in treating T2DM and we believe INSUGIN has merit, not only in the non-compliant market, but also in the mainstream market where injections currently dominate. This drug could change the market paradigm for the treatment of T2DM.”
Nasir Irfat, Director of Regulatory Foreign Affairs & Relations for Origin Pharma/Netris, said, “It is with satisfaction that we can announce that our first clinical trial application has been submitted to a national authority and BioEthical committee. The start of the clinical trial is planned for Insugin assuming required approvals have been granted. After completion of the Phase 2 studies at the end of 2018, we plan on a follow-up scientific advisory meeting with DRAP. We approach this milestone with continued confidence.”
About Oral Mouth Rinse
EastGate Biotech’s oral insulin mouth rinse is delivered through the buccal mucosa (inner lining of the mouth) and penetrates the blood brain barrier. It is a liquid solution that acts like a mouthwash. It is swirled for less than 60 seconds prior to each meal and delivers 25UI via a 5 ml dosage. It serves to supplement existing Type 2 regimens like Metformin or other anti-diabetes drugs. In Pakistan, the Health Authorities have allowed the testing to include Type 1 Patients as well.
About Type 2 Diabetes
Type 2 diabetes, the most common type of diabetes, is a disease that occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of energy and comes mainly from the food you eat. Insulin, a hormone made by the pancreas, helps glucose get into your cells to be used for energy. In Type 2 diabetes, your body doesn’t make enough insulin or doesn’t use insulin well. Too much glucose then stays in your blood, and not enough reaches your cells. You can develop Type 2 diabetes at any age, even during childhood. However, Type 2 diabetes occurs most often in middle-aged and older people. You are more likely to develop type 2 diabetes if you are age 45 or older, have a family history of diabetes, or are overweight or obese. Diabetes is more common in people who are African American, Hispanic/Latino, American Indian, Asian American, or Pacific Islander.
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.