Pilot Phase II Study of Access Pharmaceuticals OraDisc(TM) in Wound Healing Produces Positive Results
Product Shows Statistical Significance in Healing Oral Wounds
DALLAS, Jan. 6 /PRNewswire/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: AXCS - news; ``Access') today announced the results of a pilot Phase II study of OraDisc(TM) in oral wound healing. The data generated by this study confirms that amlexanox accelerates the healing of oral wounds.
The study was designed as a small pilot study to assess whether amlexanox aided in accelerating the healing process of oral wounds other than canker sores, consequently only a limited number of patients were enrolled. Despite the small patient population, when the wound size was evaluated after five days of treatment, statistical significance was achieved compared with no treatment and placebo.
OraDisc(TM) is a polymer disc that adheres to the site of a wound or canker sore and slowly erodes over time releasing drug at the site. OraDisc(TM) 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.
Kerry P. Gray, President and CEO of Access stated, ``We are delighted with the results achieved in this study. Now that we have further confirmation of wound healing, in addition to the healing of canker sores, we plan to evaluate amlexanox in further studies for additional wound healing indications. These positive results potentially open additional large market opportunities where Access can develop amlexanox.'
The Company has ongoing development programs evaluating the use of amlexanox in the prevention and treatment of canker sores utilizing the OraDisc(TM) formulation, mucositis, oral lichen planus and atopic dermatitis. In previously conducted studies, it has been shown that amlexanox has numerous modes of action that impact inflammatory disease, and based on these studies, it is anticipated that products can be developed to effectively treat a number of oral and topical conditions.
Mr. Gray continued, ``Expanding our amlexanox franchise with product line extensions and additional indications is an important component of the Company's strategy, which is designed to generate near-term product revenues and profitability. As amlexanox is approved by the FDA in an indication, having the ability to leverage this asset offers Access a significant advantage in generating profitability through numerous product revenue streams and reduced development costs.'
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. |
