WEST CALDWELL, NJ and TORONTO, ON, Dec. 30, 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, today provides an end of year 2019 Corporate and Development Highlights.
“This year we turned the corner in our pathway toward the clinical development of Insugin. This year the company completed a successful Phase II study dosing approximately 50 Type 2 diabetes patients in Pakistan with the company’s liquid insulin mouth rinse solution,” said Anna Gluskin, EastGate Biotech’s Chief Executive Officer. “The positive results from the Phase II study attracted an influx of inquiries from both diabetes patients and potential partners alike; the latter of which are exploring regulatory requirements for local marketing activities. Most of our effort has been focused on preparing for the Phase III 90-day study. We are in the process of finalizing the CMC and any required Regulatory piece in the new- year. Attaining this Phase III milestone of dosing patients should also help us expand the number of indications in which we can use Insugin. Regulatory bodies look favorable upon drugs that have prior evidence of clinical activity. In addition to the clinical results, there is a large body of research on insulin absorption through the inner lining of the mouth and the buccal mucosa. Completion of the Phase 2 study with Insugin demonstrated, the safe and effective delivery of oral insulin, and has the potential to play a pivotal role in the therapeutic treatment of the ever expansive diabetes market.”
Gluskin added, “We are committed to initiating clinical and regulatory activities that culminate with the submission of Insugin for regulatory approval in 2020. In other markets, we plan to generate Proof of Concept data with Insugin for the Alzheimer’s indication. In retrospect, we feel that all the media attention regarding the high cost of insulin injections and the economic burdens placed on diabetes patients will make regulators and the public more open to our cost-effective and innovative insulin product.”
Rose Perri, President of EastGate Biotech, also commented on the highlights of 2019: “If I was put on the spot, and only allowed to choose one EastGate milestone during the past year, I would highlight the positive results from our Phase II study on Insugin and the fact that there was a decrease in the HbA1c after the 90 day study. To most readers decreasing HbA1c are just words on a paper, but to a diabetic actually suffering with this disease, fighting every day to simply control and stabilize their HbA1c, it represents real hope of reversing their disease progression. The extent of the global diabetes pandemic demonstrates that diabetes patients still do not have access to insulin which is the ultimate therapeutic treatment available to them. If insulin was globally available and in particular a non-injectable insulin and patients complied with the treatment this pandemic would see the number of global cases decline. Instead, the number of global diabetes cases has increased. In my role as a Global Ambassador at the United World Against Diabetes I often hear first hand from diabetes patients that express their concern in maintaining glucose levels and in particular reaching the “ideal” daily glucose readings to maintain a healthy lifestyle. A future of daily insulin injections that lead to insulin injection abscesses around multiple injection sites on the body is not something any of them look forward to experiencing. Insugin, as an add-on therapy or a monotherapy, can be the safe and effective product that will assist in making this chronic disease manageable. I look forward to future Insugin clinical trials in 2020 and provide access of Insugin to more diabetes patients,” concludes Rose Perri.
“My discussions with potential marketing partners over the past year has convinced me that the diabetes pandemic will not go away anytime soon,” said Bill Abajian, EastGate Biotech’s Chief Operating Officer. “Diabetes management impacts patients on an individual basis but collectively the 600-million plus and growing diabetes community creates havoc to the healthcare system and government budgets who need to keep up with the growing healthcare costs related to diabetes and the related diseases such as strokes, heart attacks, kidney disease, amputations. In 2019 I have been encouraged by my discussions with marketing companies that recognize the importance of Insugin with respect to their effectiveness and cost efficiencies. EastGate Biotech’s innovative alternative insulin delivery is not a hard sell for those that realize that the diabetes treatment paradigm needs a product that is well known and patient friendly. We look forward to executing more partnerships in 2020,” stated Bill Abajian.
Clinical and Scientific Highlights in 2019:
- Announced positive Phase II Clinical Results of Insugin, its liquid insulin mouth rinse for Type 2 diabetes patients in Pakistan
- Preparation underway for the Phase III Clinical Study of Insugin in Pakistan
- Signs Strategic Alliance Agreement with MJ Biopharm for Insulin API Supply; the terms include free API insulin to be provided to EastGate Biotech for all clinical studies of Insugin
- Expands and restructures Joint Venture with its partner in Pakistan to focus on EastGate Biotech as a brand. The key products of the Joint Venture to be tested, registered and marketed include Insugin for diabetes application, alternative insulin product for Alzheimer’s application and blood plasma-based products, Human Serum Albumin 20% for the Canadian market
- Initiated plans to expand its alternative insulin delivery portfolio to apply to the treatment of Alzheimer’s Disease with a desired endpoint of delaying the progression of the disease which is measured in terms of memory loss and improvement in the status of self care
Corporate Highlights:
- Announced the appointment of Bill Abajian as Chief Operating Officer to lead licensing and Marketing Phase of the company’s developments
- Filed 2017 and 2018 Financial Reports
Anticipated Milestones:
- Initiation and completion of Phase III study of Insugin in Pakistan
- Execute licensing agreements in other territories aiming to cover continents; plan regulatory and clinical path for each of these markets
- Initiate a Proof of Concept study of an alternative insulin product for Alzheimer’s indication
- Plan registration of Human Serum Albumin 20% and regular recombinant human insulin in Canada
- Consider a secondary public listing
- Explore uplisting to a senior exchange
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.