Following a 3-month treatment, significant Hb1c Reduction was observed with administration of a single dose of Insugin two times a day
WEST CALDWELL, NJ and TORONTO, ON, April 24, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- 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 positive Phase II Clinical Results of its innovative liquid insulin mouth rinse solution for Type 2 diabetes patients.
The 90-day Phase II clinical study was conducted in Pakistan at the Sharif Medical City Hospital (http://www.sharifmedicalcity.org/). Dr. Ayub Latif Khawaja is the Principal Investigator (PI). This ongoing Phase II human clinical trial is estimated to enroll 50 Type 2 patients currently on metformin treatment. Interim results are based on the first 30 patients 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. The Phase II study assessed safety, tolerability, pharmacokinetics and efficacy. A placebo arm was also incorporated in the clinical protocol.
The study summary and conclusions included:
-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;
-Preserves beta cell mass and beta cell function over time, leading to a potential delay of the disease’s progression;
“While we are excited about all of the findings of this Phase II study with our innovative liquid insulin mouth rinse, we met our primary goal which was to demonstrate the safety and efficacy of Insugin,” says Anna Gluskin, CEO of EastGate Biotech. “My position has always been that insulin is one of the best, if not, the most effective diabetes treatment. A non-injectable formulation of insulin encourages greater patient compliance, and ultimately leads to better maintenance of glucose control. Our liquid insulin mouth rinse may have the ability to maintain better glucose control among Type 2 patients which will slow down the progression of the disease and reduce the incidence of debilitating conditions such as strokes, heart attacks, kidney disease,” concludes Anna Gluskin.
“We are very proud to have conducted the first human Phase II trial in Pakistan,” stated Nasir Irfat, Director of Genome Pharma/Origin Pharma, EastGate’s Joint Venture partner. “The patients in the Phase II trial were very pleased with the results and found the product easy to administer and expressed an overall satisfaction with Insugin.” Nasir Irfat continued, “The actual reduction of HbA1c is key to the regulatory path but the acceptance and demand from diabetes patients will play a role in the marketing plan going forward.”
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 increase 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.