Unexpected Positive Finding Expands Potential for Quigley QR333 Drug for Diabetic Neuropathy; Findings Suggest Possible Disease Modification
The positive findings were detected in compliant patients (approximately 50% of the original intent to treat population) who had measurable nerve activity at both the beginning and end of the study. A more conservative analysis involving approximately 65% of the randomized subjects showed a strong, but non-significant, trend toward benefit for the QR333 treated group. Other nerves evaluated for safety purposes were unaffected. The electrophysiology testing was done as a safety measure and was of interest because of the topical application of the study drug to the area of the sural nerve.
These findings necessitate a change in the potential outlook for this investigational new drug. The Diabetic Peripheral Neuropathy market has significant unmet need for rational, mechanism-based drugs. These clinically significant findings suggest disease modification in this (12 week) phase II (b) study. The Company is aware that this is a finding in a subset of the patient population.
Since the observations obtained from the study relate to positive effect on nerve functioning, we may, in the future, be focusing on a broader therapeutic area.
About The Quigley Corporation
The Quigley Corporation (Nasdaq: QGLY, http://www.Quigleyco.com) is a diversified natural health medical science company. Its Cold Remedy segment is a leading marketer and manufacturer of the COLD-EEZE(R) family of lozenges, gums and sugar free tablets clinically proven to cut the common cold nearly in half. COLD-EEZE customers include leading national wholesalers and distributors, as well as independent and chain food, drug and mass merchandise stores and pharmacies. The Quigley Corporation has several wholly owned subsidiaries; Quigley Manufacturing Inc. consists of an FDA approved facility to manufacture COLD- EEZE(R) lozenges as well as fulfill other contract manufacturing opportunities. Quigley Pharma Inc. (http://www.QuigleyPharma.com) conducts research in order to develop and commercialize a pipeline of patented botanical and naturally derived potential prescription drugs.
Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve known and unknown risk, uncertainties and other factors that may cause the Company’s actual performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statement. Factors that impact such forward-looking statements include, among others, changes in worldwide general economic conditions, changes in interest rates, government regulations, and worldwide competition.
Important Additional Information
The Quigley Corporation (“Quigley” or the “Company”) filed a definitive proxy statement with the Securities and Exchange Commission (the “SEC”) on
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