Quigley gets patent covering peripheral neural, vascular complaints for diabetic neuropathy drug QR-333

By E. Janene Geiss

Philadelphia, Aug. 21 - Quigley Pharma, a wholly owned subsidiary of The Quigley Corp., said Monday that the company has been assigned Patent No. US 7,083,813 B2 for its application, "Methods For The Treatment of Peripheral Neural and Vascular Ailments," filed in November 2002.

This adds another degree of intellectual property support to its lead investigational new drug QR-333 currently in phase 2 clinical trials, according to a company news release.

The company said it filed the patent application based upon observations that subjects participating in the proof-of-concept study conducted in France using the QR-333 compound had further improvements over and above the existing protocol.

A significant observation regarding the improved color of study patient's feet led the company to conclude that the topical application of the QR-333 compound may have led to improved peripheral circulation, officials said.

Subsequently, an immediate data search evaluating the active ingredients indicated that they indeed could have the potential to impact upon the human circulation system as vasodilators.

This important new information provided the rationale for the company to file a separate patent application to protect the company's intellectual property and allow it to study this further therapeutic benefit.

"The possibility of developing a drug that not only relieves the symptoms of diabetic peripheral neuropathy, but also improves circulation, would fulfill a significant therapeutic need," Richard Rosenbloom, chief operating officer of Quigley Pharma, said in the release.

Among the 15 claims cited in the patent are "methods of treating patients having diabetic neuropathy with various effective topical formulation options that can be administered for treating peripheral neural ailments, such as decreasing pain, decreasing tingling, normalizing sensitivity to heat or cold, decreasing cramping, decreasing muscle weakness, decreasing numbness and improving peripheral circulation."

These are medically recognized as significant improvements to patients suffering from this disease state, officials said.

The first of two human clinical trials on QR-333 began in May after a FDA review of the Investigational New Drug application for the compound.

QR-333 is designed and formulated to decrease oxidative stress that can contribute to the relief of symptoms associated with diabetic peripheral neuropathy.

The Quigley is a Doylestown, Pa., natural health medical science company.

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