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.
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 harbor" under the United States Private Securities Litigation Reform Act of 1995 and are based on
expectations, estimates and projections as of the date of this news release.
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.
