Quigley gets IND number, will begin testing drug for diabetic peripheral neuropathy

By Lisa Kerner

Erie, Pa., April 10 - Quigley Pharma, a wholly owned subsidiary of The Quigley Corp., said it will begin human studies on its investigational new topical drug, QR-333, for diabetic peripheral neuropathy.

Patient screening and enrollment will begin immediately for the first of two human trials designed to determine the pharmacokinetics of QR-333, according to a company news release.

A phase 2b dose-ranging study will begin once the pharmacokinetic study is completed.

Quigley said it has already held its investigators meeting to organize the multi-center phase 2b trials and will begin the trials as soon as the study drug is available.

"We are anxious to start clinical trials for QR-333 within the Food and Drug Administration Investigational New Drug program," chief executive officer and executive vice president Richard Rosenbloom said in the release.

"The granting of this IND number is a significant milestone for this company and the result of a significant coordinated effort."

In the original proof-of-concept study, subjects using the QR-333 compound had 67% of their symptoms improve, suggesting efficacy, the company said. QR-333 has also been evaluated in animal model toxicity experiments.

Quigley Pharma, based in Doylestown, Pa., conducts research in order to develop and commercialize patented botanical and naturally derived prescription drugs.

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