Navigation Links
Quigley Announces Completion of Phase IIb Clinical Study of QR-333 For Diabetic Peripheral Neuropathy on November 25, 2008; Collection and Evaluation of Study Data to Begin Immediately Thereafter

DOYLESTOWN, Pa., Nov. 12 /PRNewswire-FirstCall/ -- Quigley Pharma Inc., a wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY) announced today that the last subject in the Phase IIb Study is scheduled to complete treatment on November 25, 2008. This will effectively move the study to the final stage of data collection, evaluation and study conclusions. The Company, after collecting all the patient information from 21 Study centers and conferring with its panel of experts on the data, will draft and report study conclusions, as soon they are available.

The Phase IIb study is designed to evaluate the safety and efficacy of QR-333, a unique topical formulation designed to offer physicians and patients an effective, easy to administer, safe treatment for diabetic peripheral neuropathy with little to no side effects. To date there is no fully effective treatment for diabetic neuropathy. Current treatment options are limited to products such as NSAIDs, analgesics, anticonvulsants, antidepressants, etc., which are often not well tolerated by patients.

The Company believes that a safe and efficacious topical product, if approved by the FDA, could be a "first line" treatment for diabetic peripheral neuropathy and possibly could develop a significant market position in a growing therapeutic category currently dominated by systemic therapies.

Currently in the United States, there are approximately 20,000,000 people with diabetes. Of this population, nearly one half has or will develop symptoms of peripheral neuropathy. Diabetic neuropathy is among the most common complications of diabetes, resulting in pain and numbness, which affects the patient's sleep, functioning and well being. The pain is often accompanied by unpleasant sensations of buzzing, burning or jolting.

The Phase IIb trial will evaluate the safety and efficacy of QR-333, applied three times daily as compared to placebo-treated patients over 12 weeks. Efficacy will be determined by Symptom Assessment Scores; a Visual Analogy Scale (VAS); Quality of Life and Sleep Questionnaires. Safety will be determined by medical history; physical examination; vital signs, laboratory tests and nerve conduction studies.

QR333 Investigation Chronology:

-- April 2003; Quigley receives first U.S. patent; "Method and

Composition for the Topical Treatment of Diabetic Neuropathy".

-- April 2003; Quigley announces safety and positive results from proof of

principal, efficacy and safety trial, "A multicenter, double blind

safety study of QR333 for the treatment of symptomatic diabetic

peripheral neuropathy", in France.

-- June 2005; Published results of proof of principal study in Journal of

Diabetes and Its Complications, "A multicenter, double blind safety

study of QR333 for the treatment of symptomatic diabetic peripheral

neuropathy A preliminary report".

-- Sept 2005; Quigley conducts Investigators meeting and prepares for

Pharmacokinetic Study-003 followed by Phase IIb Safety and Efficacy

Study-002 in humans in the U.S., pending issuance of IND number from


-- April 2006; Quigley receives IND No. 67,168 from FDA.

-- August 2006; Quigley receives second U.S. patent; "Method for the

Topical Treatment of Small Fiber Neuropathies".

-- September 2006; Quigley reports positive data from Study-003,




-- December 2006; Quigley announces commencement of Study-002, "PHASE



-- August 2008; Quigley receives third U.S. patent; "Methods for the

Treatment of Peripheral Neural & Vascular Ailments".

About QR333:

Concentrated and standardized nutrient based active compounds dosed in a topical cream designed to reduce oxidative stress and treat symptoms of Diabetic Peripheral Neuropathy, a nerve disorder that can lead to numbness, skin ulcers, constant pain or extreme sensitivity to a stimulus.

The Quigley Corporation makes no representation that the US Food and Drug Administration or any other regulatory agency will allow this Investigational New Drug to be marketed. Furthermore, no claim is made that potential medicine discussed herein is safe, effective, or approved by the Food and Drug Administration.

About The Quigley Corporation

The Quigley Corporation (Nasdaq: QGLY, 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 wholly owned subsidiaries; Quigley Manufacturing Inc. consists of two FDA approved facilities to manufacture COLD- EEZE(R) lozenges as well as fulfill other contract manufacturing opportunities and Quigley Pharma Inc. ( conducts research in order to develop and commercialize a pipeline of patented botanical and naturally derived potential prescription drugs.

Forward-Looking Statements

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.


Media Investor Relations

Karen Pineman Carl Hymans

G.S. Schwartz & Co. G.S. Schwartz & Co.

212.725.4500 212.725.4500

SOURCE Quigley Pharma Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. The Quigley Corporation Reports Third Quarter 2008 Results; Continues Investment in Pharmaceutical R&D Future
2. The Quigley Corporation Names Gerard M. Gleeson to Succeed Retiring George J. Longo as Chief Financial Officer and Director
3. The Quigley Corporation Reports First Quarter 2008 Results - Increases Investment in Pharmaceutical R&D Future
4. The Quigley Corporation Reports Fourth Quarter & 2007 Annual Results; Increases Investment to $6.5 million in Pharmaceutical R&D in 2007
5. The Quigley Corporation Announces Sale of Its Health and Wellness Segment
6. Waterfront Media Announces Everyday Health Network is Number One Online Health Destination : First time in ten years comScore Media Metrix names a new leader in online health
7. Hologic Announces Fourth Quarter and Fiscal 2008 Operating Results
8. Alexza Pharmaceuticals Announces Upcoming Conference Participation and Webcasts
9. International Isotopes Inc. Announces Third Quarter and Nine Months 2008 Financial Results
10. Prime Companies Announces Launch of Consumer Dental Service Software
11. WebMD Announces 2008 Health Heroes
Post Your Comments:
(Date:11/25/2015)... ... ... Dr. John Pierce, Medical Director at the Ageless Forever clinic in Las ... Pro laser therapy cap. FDA cleared for safety and efficacy, the Capillus272 offers men ... surgery, prescription pills, or topical foams. , “Capillus272™ Pro is a home-use device ...
(Date:11/25/2015)... ... 2015 , ... On November 10, 2015, Bohrer Brady, LLC filed a class ... of a home health care worker who provided companionship services for the elderly, ill ... employed by Humana, Inc., Humana at Home, Inc., and SeniorBridge Family Companies (CT), Inc. ...
(Date:11/25/2015)... ... November 25, 2015 , ... According to an article ... being more and more widely heralded as a breakthrough for performing hernia repairs. The ... over traditional laparoscopic surgery is that it can greatly reduce the pain that a ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dental professionals who would like to ... are invited to attend Dr. Mark Iacobelli’s Advanced Implant Mentoring (AIM) CE course. Courses ... , As the co-founders of Advanced Implant Mentoring (AIM), Dr. Iacobelli and Dr. ...
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon ... programs, launches new Wimbledon Athletics Facebook page to educate the public, ... unsuspected cardiac abnormalities. About 2,000 people under the age of 25 die from ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , Nov. 26, 2015 Research and ... the "Advanced Wound Care Market by Type (Dressings, ... End User (In-Patient Facility, Out-Patient Facility), and Geography - ... --> --> ... description, definition and forecast of the global advanced wound ...
(Date:11/26/2015)... 26, 2015 ... adds "Global Repaglinide Industry 2015 ... on China Repaglinide Market, 2010-2019" reports ... and information to its online business ... . --> ...
(Date:11/26/2015)... 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in the ... Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new 247-page ... therapeutic drug monitoring market, including emerging tests, technologies, ...
Breaking Medicine Technology: