SALT LAKE CITY, UT and TORONTO, ON--(Marketwired - Sep 29, 2015) - EastGate Biotech Corp. (OTC PINK: ETBI), an emerging pharmaceutical company aimed at utilizing drug delivery innovations in the development of improved novel formulations and alternative dosage forms of existing biologically active molecules, has announced that it has commenced scale-up activities for its proprietary intraoral insulin tablet.
The company is now equipped with all necessary pharmaceutical machinery required for the development and finalization of the scale-up manufacturing process. The developed manufacturing process along with analytical methods will be transferred to a selected contract GMP manufacturing facility wherein a clinical batch will be produced. The transferred technology and preparation processes will also fulfill production requirements for commercial batches in the future after regulatory approval is obtained. The delivery and implementation of the current equipment was facilitated by Proactive Supply Chain Solutions (www.proactivegroup.ca).
To date, the company is successfully advancing in a formulation development of a 25 IU intraoral insulin tablet, designed to manage mealtime glucose levels. The intraoral insulin tablet dissolves under the tongue and delivers insulin to the bloodstream. The tablet is proposed for the treatment of Type 2 diabetes mellitus and pre-diabetic condition. The tablet can also be used as an add-on therapy in combination treatment with other oral anti-diabetic drugs.
"We are ready for this critical next step in the development of our intraoral insulin tablet," says Anna Gluskin, EastGate Biotech's CEO. "The consistent and reproducible glucose lowering activity of this tablet will carry the company through clinical trials leading to the commercial success. An insulin tablet has not yet reached the marketplace and we are pleased to work in this exciting development that will have an important impact on the diabetes treatment paradigm," concludes Ms. Gluskin.
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 harbour" 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.