Navigation Links
Quigley Corporation Releases Update on Quigley Pharma's Phase IIb Clinical Study of QR-333 in Diabetic Peripheral Neuropathy
Date:9/11/2007

DOYLESTOWN, Pa., Sept. 11 /PRNewswire-FirstCall/ -- The Quigley Corporation (Nasdaq: QGLY) today issued an update on a Phase IIb Clinical Study of QR-333 on Diabetic Peripheral Neuropathy by its wholly owned subsidiary, Quigley Pharma, http://www.QuigleyPharma.com.

The update on the study noted that over 100 subjects have been enrolled, 52 subjects have completed treatment and over 225 subjects have been screened for the Phase IIB study designed to evaluate the safety and efficacy of the topical formulation on subjects with diabetic peripheral neuropathy. Subject screening and enrollment will continue to ensure a 140 evaluable patient study population. Once enrolled, subject treatment time is 12 weeks. To date the in-progress safety profile for this study has been consistent with the findings from the favorable safety results of the previous human proof of concept study conducted in France.

The screening process for enrollment is one of the most crucial aspects of a clinical drug trial, with only the most relevant subject population being selected, thus preventing a compromise of the resultant data and ensuring an accurate measure of the drugs evaluation. Consistent with other diabetic peripheral neuropathy studies, the inclusion/exclusion criteria for this trial are very stringent.

The subjects must:

-- be stable in their diabetes (reflective of their blood glucose levels)

-- have a confirmatory diagnosis of diabetic peripheral neuropathy with a

demonstrated level of pain (40 out of 100 on a visual analogue pain

scale) significant enough to be able to gauge an improvement

-- not have other serious diseases which would confound the data

-- not be on other medications which would confound the data

-- not so advanced in their neuropathy that they are not capable of

improvement

Although the Company believes enrollment should be completed before year end 2007, based on the protocol and stringent criteria submitted to the FDA, it is difficult to predict exactly when the study will be completed.

Currently in the United States, there are approximately 20,000,000 people with Diabetes. Of this population, nearly one half have or will have the symptoms of Peripheral Neuropathy. The company believes that a safe and effective topical product approved by the FDA as a "first line" treatment for diabetic peripheral neuropathy could develop a significant market position in a growing therapeutic category currently dominated by systemic therapies.

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. Additionally, data that demonstrates activity or effectiveness in animals or in vitro tests do not necessarily mean the formula test compound; referenced herein will be effective in humans. Safety and effectiveness in humans will have to be demonstrated by means of adequate and well-controlled clinical studies before the clinical significance of the formula test compound is known. Readers should carefully review the risk factors described in filings the Company files from time to time with the Securities and Exchange Commission.

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 several 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.

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.


'/>"/>
SOURCE The Quigley Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Trouble-shooting: Misincorporation or low fidelity
2. Roche Diagnostics Corporation
3. Roche Diagnostics Corporation
4. Promega Corporation: Wisconsins quiet innovator
5. Giuliani will keynote RedPrairie Corporations user conference
6. Madison Development Corporation makes loans to three area companies
7. Corporations and blogging
8. Metavante acquires Florida banking corporation
9. TriMas Corporations Cequent Group Acquires Chem-Chrome, Inc.
10. Merge eMed releases software upgrade
11. Sony releases tool for Blu-ray disc production
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- Houston Methodist Willowbrook Hospital has signed a ... serve as their official health care provider. As ... provide sponsorship support, athletic training services, and most ... athletes and families. "We are excited ... to bring Houston Methodist quality services and programs ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, ... of the Supplyframe Design Lab . Located in Pasadena, Calif., the Design ... of how hardware projects are designed, built and brought to market. , The ...
(Date:6/23/2016)... , June 23, 2016 ... Review, 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 Published ... the peer-reviewed journal from touchONCOLOGY, Andrew D ... cost of cancer care is placing an increasing ... of expensive biologic therapies. With the patents on ...
(Date:6/23/2016)...  Amgen (NASDAQ: AMGN ) today announced ... life sciences incubator to accelerate the development of new ... at QB3@953 was created to help high-potential life science ... early stage organizations - access to laboratory infrastructure. ... two "Amgen Golden Ticket" awards, providing each winner with ...
Breaking Biology Technology:
(Date:5/24/2016)... facilitates superior patient care by providing unparalleled technology to leaders of the medical imaging ... product recently added to the range of products distributed by Ampronix. Photo ... ... ... News ...
(Date:5/16/2016)... 16, 2016   EyeLock LLC , a market ... opening of an IoT Center of Excellence in ... the development of embedded iris biometric applications. ... convenience and security with unmatched biometric accuracy, making it ... from DNA. EyeLock,s platform uses video technology to deliver ...
(Date:5/9/2016)... , UAE, May 9, 2016 ... it comes to expanding freedom for high net worth ... Even in today,s globally connected world, there is still ... system could ever duplicate sealing your deal with a ... second passports by taking advantage of citizenship via investment ...
Breaking Biology News(10 mins):