Eaton Scientific Systems, Ltd. Completes Its Study Protocol for Its Planned Clinical Trial of Its Patent Pending Non-Hormonal Treatment of Hot Flashes
Published: Sep 07, 2012
BEVERLY HILLS, Calif., Sept. 6, 2012 /PRNewswire/ -- Eaton Scientific Systems, Ltd. ("Eaton" or the "Company") a wholly-owned subsidiary of Pristine Solutions, Inc. (OTCQB: PRTN) is pleased to announce that it has completed the Protocol for the Clinical Trial for Tropine 3, its novel indication of homatropine, in oral suspension to be prescribed to women afflicted with hot flashes during pre-menopause, peri-menopause, and post-menopause.
Eaton CEO, Michael Borkowski, announced today that Eaton has a complete Protocol that is the guideline for Eaton's Clinical Trial. "This is a very important step in the process of seeking FDA Approval for Tropine 3 and illustrates our progress towards the Clinical Trial."
The Protocol and proposed Clinical Trial will be a Phase I/II, Prospective, Randomized, Double Blind, Placebo-Controlled, Dose Escalation, Open Label Study to Test the Efficacy and Safety of Homatropine Methylbromide Oral Suspension on Selected Climacteric Symptoms and Quality of Life in Menopausal Women Not Receiving HRT.
Homatropine methylbromide has been used as a drug in humans for over 50 years. Currently, it is used to discourage overdose in the popular narcotic cough syrup Hycodan.
Due to the long established use of homatropine methylbromide, the usual bench toxicity and animal studies will not be performed for this IND application. Instead, a combined phase I/II design will be used. This design incorporates both dose-finding rules and early stopping rules in terms of response and toxicity, thus combining elements of more typical Phase I and Phase II designs.
About Pristine Solutions, Inc.
Pristine Solutions, Inc., through its wholly-owned subsidiary company, Eaton Scientific Systems, Ltd., holds the intellectual property and global marketing rights to Tropine 3, a patent pending novel indication of an existing FDA approved drug for the non-hormonal treatment of hot flashes in pre-menopausal, peri-menopausal, and post-menopausal women.
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Pristine Solutions' actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Pristine Solutions' filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Pristine Solutions herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Pristine Solutions disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.
SOURCE Eaton Scientific Systems, Ltd.