DOYLESTOWN, Pa., Jan. 24 /PRNewswire-FirstCall/ -- The Quigley Corporation , the leading developer and marketer of diversified health products today announced a research and development update for its wholly- owned Quigley Pharma (Ethical Pharmaceuticals) subsidiary, which is developing natural-source prescription medicinals for Influenza A, Radiation Dermatitis and Diabetic Neuropathy.
According to Chief Operating Officer Dr. Richard Rosenbloom, “We continue to be very pleased with the progress of our Pharma subsidiary. As we work through the development and testing phases we become increasingly encouraged about the possible efficacy of our products, and we continue to receive positive feedback from the medical research community.”
The financial strength of its parent corporation and the company’s proven success in launching first-in-category health solutions supports the Pharma subsidiary in its efforts to develop groundbreaking formulations to combat a variety of health issues.
The following is a list of formulations currently in the Quigley Pharm pipeline and an update on their progress:
Influenza A -- QR435: Retroscreen LTD. at The University of London has started a final animal model influenza study in preparation for a proposed human Proof Of Concept Study to start in mid-2005. The study “Prophylactic potential of different QR-435 antiviral nasal spray formulations in the Influenza A/Panama/2007/99 (H3N2) virus ferret transmission model” will determine if there is any efficacy or safety issues with different dose forms of this naturally derived broad-spectrum anti-viral compound.
Systemic Radiation -- QR336: There were encouraging results seen in a preliminary non-GLP animal study of this naturally derived radio protective compound against ionizing radiation. A pre-IND meeting was held at the FDA in October with the Division of Medical Imaging and Radiopharmaceutical Drug Products. A GLP controlled animal study of the QR 336 formulation for the Radioprotection/Treatment of Radiation Lethality Induced by Four MeV Photons in the C3H Mouse will start this year, and predicated upon positive results will be followed by a second animal study.
Diabetic Neuropathy -- QR 333: Per the FDA’s instructions at the last Pre- IND Meeting for the continued development of this drug; the compound is undergoing a series of toxicity studies to support the safety of this naturally derived compound for the relief of symptoms of diabetic peripheral neuropathy, prior to beginning a human Phase IIB dose ranging study. The company expects the toxicity studies to be completed in the 1st Quarter of 2005. The company hopes to begin pivotal studies on this compound in 2005.
Virucidal Compound -- QR437: Ongoing pre-clinical research activities include: the completion of a second in vitro experiment to determine virucidal or virustatic properties against the HIV virus by QR437. The results of the first in vitro study determined that this naturally derived compound has significant dose dependant virucidal properties with a probable rapid mode of action. This type of compound might be used with condoms or intravaginal, oral and other topical dose forms as a first line defense against infection. Ongoing plans for this compound are pending; the company expects to announce next steps some time in 2005.
Quigley Pharma is also conducting research on their previously announced patented compound for the treatment of rheumatoid arthritis and similar diseases.
It has conducted one positive pre-clinical in vitro study on Avian Flu, demonstrating antiviral activity when tested in a virustatic test. Ongoing plans for this compound are pending; the company expects to announce next steps some time in 2005.
About Quigley Pharma
The Quigley Corporation is a leading developer and marketer of diversified health products including the COLD-EEZE(R) family of patented zinc gluconate glycine (ZIGG(TM)) lozenges and sugar free tablets. In September of 2004, The Company has also formed a wholly owned subsidiary, Quigley Manufacturing, Inc. with the acquisition of two FDA approved facilities to manufacture its COLD- EEZE(R) branded lozenges. InnerLight, Inc., a wholly owned subsidiary, was formed in January 2001 for the purpose of introducing new products to the marketplace through a network of independent distributors. In addition to Over-The-Counter (OTC) products, the Company has formed Quigley Pharma Inc. (http://www.quigleypharma.com/), a wholly owned ethical pharmaceutical subsidiary, to introduce a line of naturally derived patented prescription drugs. The Quigley Corporation’s customers include leading national wholesalers and distributors, as well as independent and chain food, drug and mass merchandise stores and pharmacies. 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 products 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.
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.
The Quigley Corporation
CONTACT: Karen Pineman, Media, kpineman@schwartz.com, Carl Hymans,Investors, both of G.S. Schwartz & Co. for Quigley Pharma, +1-212-725-4500
Web site: http://www.quigleyco.com/