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Quigley says QR-333 data promising for diabetic neuropathy
By E. Janene Geiss
Philadelphia, Sept. 26 - Quigley Pharma, a wholly owned subsidiary of The Quigley Corp., said Tuesday results from a clinical study demonstrated that QR-333 can be administered safely to patients suffering from diabetic peripheral neuropathy.
The Doylestown, Pa., pharmaceutical company said it will proceed to phase 2b clinical trials, which will include about 200 patients, according to a news release.
The pharmacokinetics trial was the first study in the United States conducted under the Food and Drug Administration-issued Investigational New Drug application. The positive data showed that QR-333 is safe, it is not systemically absorbed and it is well-tolerated after multiple doses. These findings are consistent with prior animal toxicity data and the human proof-of-concept study performed in France.
Based on this positive patient experience, the company said it already has manufactured the first large commercial scale-up quantity of the QR-333 compound, a topical cream designed to reduce oxidative stress, inflammation and treat symptoms of diabetic peripheral neuropathy.
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