PipelineReview.com - Biotech News & Online Store - Quigley Submits Investigational New Drug Application to the FDA for Its QR-333 Diabetic Peripheral Neuropathy Compound; Filing Allows Quigley to Begin Human Clinical Trials Following a 30-Day Review Period

Quigley Submits Investigational New Drug Application to the FDA for Its QR-333 Diabetic Peripheral Neuropathy Compound; Filing Allows Quigley to Begin Human Clinical Trials Following a 30-Day Review Period

07 Mar 2006

DOYLESTOWN, PA, USA | March 07, 2006 | The Quigley Corporation (Nasdaq: QGLY) and Quigley Pharma Inc., its wholly-owned subsidiary, announced today their filing of an IND (Investigational New Drug) application with the FDA for QR-333, a topical compound for the treatment of Diabetic Peripheral Neuropathy. Today's filing allows Quigley Pharma to begin human clinical trials following a 30-day review period. If the FDA has no further comments, studies with human subjects will commence as soon as possible pending the availability of study drug.

This Application includes a compilation of all of the supporting development data and regulatory documentation required to file an IND application with the FDA. Included within the approximate 3800 page IND application are protocols for two studies including a Phase IIb human study designed to evaluate the efficacious dose range of the compound and a Phase II pharmacokinetic study evaluating safety. To this effect, a human clinical trial protocol has been filed with the Central Institutional Review Board overseeing the first IND study.

"The filing of this IND is a milestone in the drug development process as well as for Quigley Pharma," stated Dr. Richard Rosenbloom, COO of Quigley Pharma. "As we have already received FDA's comments on our IND program during Pre-IND meetings and teleconferences, we are prepared to begin these clinical trials as soon as possible."

In keeping with previous instructions given by the FDA at the Pre-IND meeting, previously announced in March 2004, the Company has completed a series of toxicity studies in animals that include the following:

  Pre-clinical             Completed in      Showed no irritation, photo
    hairless guinea pig*     October 2005      toxicity, contact
    toxicological study                        hypersensitivity or photo
                                               allergy when applied topically
                                               to hairless guinea pigs.

    Pre-Clinical             Completed in      Showed no difference in the
    Gottingen Minipig*       October 2005      dermal response of the compound
    dermal response                            or placebo.
    study

    Gottingen Minipig        Completed in      Support a Phase II human
    pharmacokinetic study    February 2006     pharmacokinetic study
                                               proposed in the IND
                                               application.

* The FDA suggests both animal models for the evaluation of topical drugs According to estimates from the American Diabetes

Association, 7.0 percent of US adults or 20.8 million people have diabetes. While 6.2 million remain undiagnosed an additional 41 million Americans are estimated to have Pre-Diabetes. Longstanding diabetes increases the risk for an array of chronic health problems, and diabetic neuropathy is the most common form of peripheral nerve damage, affecting approximately 53 percent of patients who have had Type II diabetes.

QR-333 is designed and formulated to decrease oxidative stress that contributes to peripheral diabetic neuropathy and thus alleviate its symptoms.
A Proof of concept study was completed in France showed that the topical compound improved the quality of life as well as improved key symptoms associated with this complication of diabetes. The subjects using the compound had 67% of their symptoms improve, suggesting efficacy. The study authors published their findings in the peer reviewed Journal of Diabetes and Its Complications.**

Quality of Life:
After four weeks of treatment, the active group substantially outperformed the placebo group in thirteen out of fourteen Quality of Life parameters.

Symptom Assessment:
Out of a total of 28 Symptom Assessment parameters, patients receiving the active formula fared substantially better than those on placebo. Certain key symptoms showed a substantially wider improvement ratio, suggesting that the active formula was particularly effective for the following symptoms:
- Irritation of the feet due to socks or sheets.
- Numbness of the feet
- Tingling of the feet.

** Valensi, P., Devehat, C. L., Richard, J.L., Farez, C., Khodabandehlou, T., Rosenbloom, R.A.& LeFante, C. (2005). A multicenter, double-blind, safety study of QR-333 for the treatment of symptomatic diabetic peripheral neuropathy A preliminary report. Journal of Diabetes and Its Complications, 19, 247-253.

Timeline

April 2003: Patent No. 6,55,573 B2 "Method and Composition for the Topical Treatment of Diabetic Neuropathy," was awarded.

March 2006: IND Application for QR-333 was filed. Approximately 3800 pages in 13 volumes.

The Quigley Corporation makes no representation that the U.S. Food and
Drug Administration or any other regulatory agency will grant an IND or take any other action to allow the aforementioned compound to be studied or marketed. Furthermore, no claim is made that the potential medicine discussed here is safe, effective, or approved by the Food and Drug Administration.

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 other wholly owned subsidiaries. Darius International markets health and wellness products through its wholly owned subsidiary, InnerLight Inc. Quigley Manufacturing Inc. consists of two FDA approved facilities 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 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.

SOURCE The Quigley Corporation

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