SALT LAKE CITY and TORONTO, June 25, 2014 /PRNewswire/– EastGate Acquisitions Corporation (OTCBB: ESAQ), an emerging pharmaceutical company exploring drug delivery innovations in the development of improved novel formulations and alternative dosage forms of existing biologically active molecules announces today that it has received a research grant from the Ontario Brain Institute for its Lorazepam Spray development.
The grant was issued for the purpose to study the administration of a transmucosal Lorazepam Spray for the treatment epileptic seizures in the outpatient settings. As previously announced the company has entered into a collaboration with a leading neurologist, Dr. Peter Carlen, at the Toronto Western Hospital who will serve as a principal investigator on this trial. The grant represents a continued funding of a two-year budget as submitted to the Ontario Brain Institute under the Epilepsy Discovery Project 2013 Continuing Research Study Proposal.
The intraoral Lorazepam Spray is a new transmucosal non-invasive solution for the treatment of acute and repetitive seizures. This spray is a low volume, oral anti-convulsant formulation of Lorazepam designed to be a quick and effective treatment of acute seizures in hospital, home or ambulatory settings. This delivery form of the most potent anticonvulsant is an exceptionally convenient alternative to injectable benzodiazepines that efficiently control epileptic emergencies. The transmucosal oral spray formulation can be used by the patient, paramedics, or any other available non-trained person, even during an ongoing seizure.
The primary goal of this project is to provide a safe and effective anti-seizure medication to a patient to stop seizures in the shortest period of time. Utilising company’s proprietary delivery system, the Lorazepam Spray delivers the drug through the mucosal lining of the mouth directly into the blood stream. This direct buccal and sublingual absorption of Lorazepam into the blood stream provides the desired rapid delivery of the drug to the brain. The spray combines fast absorption, substantial transmucosal penetration and efficient seizure suppression. In addition to being self-administered, an oral administration provides the flexibility to any available person on the scene, be it family members, caregivers or paramedics. Another key benefit of the Lorazepam Spray is that it can be used at any point during a seizure, even if the patient’s mouth is clenched shut as it can be applied directly to the gum or lip mucosa.
To date, experimental results, also supported by the Ontario Brain Institute (OBI) grants, clearly demonstrated the possibility of preparing a highly loaded low volume spray formulation of Lorazepam. Several formulations were tested for anticonvulsant activity in the animal model and some of them revealed a high level of protection against chemically induced seizures. The anticonvulsive action, achieved after Lorazepam spray administration, was practically on par with effect of the same drug dose, delivered via injection. Further development of the oral spray of Lorazepam will focus on speeding up the onset of the anticonvulsive effect.
As part of its clinical and regulatory plan the company will focus on the following highlights of the transmucosal Lorazepam Spray to present to regulatory agencies and to use for future marketing purposes:
- Formulation is based on approved pharmaceutical excipients only
- Easy, convenient, non-invasive administration
- Fast onset of action, comparable to injection
- Can be administered in any setting
- Easy and convenient control of delivered dose
- Can be applied to mucosa of lips or gums even when teeth clenched during a seizure
- May satisfy requirement of 505 (b)(2) regulatory pathway in the USA
“We are excited about this development as the Ontario Brain Institute grant serves as a significant jump-start for the company’s overall financing plans for the technology’s platform” says Anna Gluskin, EastGate’s CEO. “Our innovative technology platform based on a self-nanoemulsion formulation will directly address patient needs for fast onset of treatment and encourage self-administration with the goal of minimizing hospital care and have a positive impact on massive health care costs facing today’s healthcare system”, concludes Gluskin.
STATISTICS ON EPILEPTIC SEIZURES
The rate of prolonged epileptic seizures (status epilepticus) in the USA is estimated at around 150,000 cases per year. Additionally, about 400,000 patients per year suffer from repetitive (cluster) seizures. These critical conditions lead to over 40,000 deaths each year in the US. Treatment of status epilpeticus and repetitive seizures normally requires hospitalization, and emergency treatment involves the intravenous administration of anticonvulsant drugs. Any delay in proper treatment can increase the mortality rate.
About EastGate Acquisitions Corporation
EastGate Acquisitions Corporation with locations in Salt Lake City, Utah and Toronto, Canada, is a pharmaceutical company aimed at utilizing drug delivery innovations for developing of improved novel formulations and alternative dosage forms of existing biologically active molecules. The Company’s model is based on a two-tier business approach that includes development of novel pharmaceutical products and innovative dietary supplements. Both pharmaceutical products and natural supplements are developed using highly effective contemporary technologies and demonstrated already proven usefulness in improvement of bioavailability and biological action of incorporated molecules. The Company’s product candidates address various pharmaceutical markets, including neurological disorders, such as epilepsy and panic attacks, infectious diseases and diabetes. Our natural dietary supplements, also an integral part of our R&D program, include compositions for glucose regulations, urinary tract health improvement, enhanced vitamin delivery and skin conditions. EastGate is working to expand its current product portfolio through targeted investments in pharmaceutical research and development. We are working closely with clinicians and patient advocate groups worldwide to identify existing health issues where EastGate’s approach will be most beneficial for patient care. For more information, please visit the company’s website at www.EastGatePharmaceuticals.com.
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, while considered reasonable by EastGate as of the date of such statements, 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 news release, include those identified from time to time in the reports filed by EastGate with the Securities and Exchange Commission, 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.
SOURCE EASTGATE ACQUISITIONS CORPORATION
CONTACT: Rose Perri 1-647-692-0652
Text: ESAQ to 87804