Access Pharmaceuticals Commences Clinical Trial for OraDisc(TM)
Innovative Drug Delivery Technology Has Potential to Improve the Treatment Of
Mouth Wounds and Canker Sores
DALLAS, Sept. 9 /PRNewswire/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: AXCS) ("Access") today announced the commencement of a clinical trial for the use of OraDisc to deliver amlexanox for the treatment of mouth wounds.
OraDisc is a polymer disc that adheres to the site of the wound or canker sore and slowly erodes over time releasing drug at the site. OraDisc overcomes the difficulties encountered in using conventional paste and gel formulations for conditions in the mouth, that is, applying the drug and keeping it in place over time. These difficulties impair patient compliance and limit the effectiveness of drugs for oral conditions.
The mouth wound trial, being conducted by The Queen's University of Belfast, School of Clinical Dentistry, is designed to evaluate the reduction in inflammation and the acceleration of healing in mouth wounds. The trial will utilize a quantitative thermographic technique to measure inflammation.
Later this year, Access will begin two clinical trials at The Queen's University for OraDisc with amlexanox for the treatment of canker sores. One study will test OraDisc for the prevention of canker sores when the product is applied at the first sign or symptom of the disease, and the other will test OraDisc for the treatment of canker sores.
Canker sores are a painful and recurring disease of the mouth affecting approximately 20% of the US population. Access' amlexanox in a paste form, marketed by Block Drug under the trade name Aphthasol(TM), is the only FDA approved drug for the treatment of canker sores.
"OraDisc is an ideal way to deliver a topical drug for oral conditions where keeping the compound in place is such a challenge," commented Kerry P. Gray, President and CEO. "OraDisc truly has the potential to enhance the effectiveness of amlexanox in the treatment of canker sores and other oral conditions. Also, expanding the canker sore indication to include prevention of the disease would be a significant marketing advantage."
Amlexanox is a drug that has been proven to be highly effective in a number of inflammatory conditions. Access' strategy is to expand the amlexanox commercial potential by developing new formulations for the treatment of other diseases. In addition, the Company in conjunction with marketing partners has commenced the roll out of the drug into other countries.
Commenting on amlexanox strategy, Mr. Gray said, "Amlexanox is essentially a safe and effective compound which we are going to investigate aggressively, expanding its clinical indications and introducing line extensions. New targets include mucositis, a debilitating oral condition affecting 40% of cancer patients and representing a potential $500 million market."
OraDisc is based on the bioerodeable mucoadhesive (BEMA(TM)) technology developed by Atrix Laboratories, Inc. |
