DRAP (Drug Regulatory Authority Pakistan) provided approval to commence studies of INSUGIN in Pakistan
WEST CALDWELL, N.J. and TORONTO, ON / ACCESSWIRE /
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
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
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
Cautionary statement on forward-looking information
All statements, other than statements of historical fact, contained or incorporated by reference in this news release constitute "forward-looking information" or "forward-looking statements" within the meaning of certain securities laws, including the provisions for "safe
The words "anticipates,'' "plans,'' "expects,'' "indicate,'' "intend,'' "scheduled,'' "estimates,'' "forecasts,'' "focus,'' "guidance,'' "initiative,'' "model,'' "methodology,'' "outlook,'' "potential,'' "projected,'' "pursue,'' "strategy,'' "study,'' "targets,'' or "believes,'' or variations of or similar such words and phrases or statements that certain actions, events or results "may,'' "could,'' "would,'' or "should,'' "might,'' or "way forward,'' "will be taken,'' "will occur" or "will be achieved" and similar expressions identify forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that are inherently subject to significant business, economic and competitive risks, uncertainties and contingencies. The risks, estimates, models and assumptions contained or incorporated by reference in this release, include those identified from time to time in the reports filed by EastGate with the SEC, which should be considered together with any forward-looking statement. EastGate undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT:
Rose Perri
1-647-692-0652
Email: information@eastgatepharmaceuticals.com
Website: www.EastGateBiotech.com
SOURCE: EastGate Biotech Corp.
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https://www.accesswire.com/513295/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
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