Access Receives U.K. Medicine Control Agency Clearance to Initiate Phase III OraDisc(TM) Clinical Trials; Company's Second Product to Enter Phase III Clinical Studies
DALLAS, Jan. 19 /PRNewswire/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: AXCS - news) today announced that the United Kingdom Medicine Control Agency has cleared the Company to commence a clinical trial program for OraDisc(TM). Access filed a Clinical Trial Exemption Application (CTX), the FDA equivalent of an IND, in November 1999.
OraDisc(TM), a polymer disc formulation which adheres to the disease site and slowly erodes locally releasing the drug, is potentially an improved delivery vehicle for the oral delivery of amlexanox. Applying conventional paste and gel formulations and keeping them in place over time has proven difficult, thereby impairing patient compliance and limiting the effectiveness of drugs for oral conditions. Utilizing this technology it is anticipated that higher drug concentrations will be achieved at the disease site, increasing the effectiveness of the product.
Access plans to immediately commence a Phase III clinical study in Northern Ireland. The study, which will enroll approximately 60 patients, will evaluate OraDisc(TM) for the prevention of canker sores by applying the product at the first sign or symptom of the disease. A technique developed by Professor Lamey, of Queens University of Belfast, enables the detection of canker sores prior to the ulcer developing by using thermographics which identifies inflammatory sites.
A second Phase III study is planned to evaluate the ability of OraDisc(TM) to accelerate the healing and reduce pain once a canker sore has developed. The design of this study is similar to the studies conducted with amlexanox 5% paste, which has been proven effective in the acceleration of healing and pain resolution for canker sores. Access has previously announced that OraDisc(TM) achieved statistical significance in the acceleration of healing oral wounds.
Kerry P. Gray, President and CEO of Access, stated ``Upon successful completion of the planned studies, a Product License Application will be submitted to the UK authorities which will be the basis for European approval. This improved dosage form and the expansion of the indication, to include the prevention of ulcer formation when applied early in the disease process, could significantly expand the market potential of amlexanox in the canker sore indication.'
Clinical reports indicate that up to 20% of the population suffer from canker sores. In the United States, market research indicates that 15 million patients suffer recurrent canker sores of which 5 million patients are chronic sufferers, which constitute the groups most likely to seek physician advice on the condition.
Mr. Gray continued, ``This is the second product of the Company's portfolio now in Phase III clinical development. The stated goal of the Company is to have at least 6 product candidates in clinical development this year, of which 5 product candidates will be in Phase II/III.'
Access Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both novel low development risk product candidates and technologies with longer-term major product opportunities. In conjunction with Block Drug Company, Access has developed Aphthasol(TM), the only FDA-approved product for the treatment of canker sores, and is developing Amlexanox for mucositis and other topical diseases. Access is currently developing a unique polymer platinate for use in the treatment of cancer and is developing in conjunction with its partner Strakan, Ltd. a topical zinc delivery system called ResiDerm© that provides rapid delivery and reservoir of a drug in the skin. |
