Access Receives FDA Clearance to Initiate a Phase II OraRinse(TM) Clinical Trial
DALLAS, Jan. 27 /PRNewswire/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: AXCS - news; ``Access') today announced that the FDA has cleared OraRinse(TM) to commence a Phase II clinical study for the prevention and treatment of mucositis.
Mucositis is a debilitating condition involving extensive inflammation and ulceration of soft tissue in the mouth and throat and affects an estimated 400,000 cancer patients in the United States undergoing chemotherapy and radiation treatment. OraRinse(TM) is a 0.5% mucoadhesive solution of amlexanox. Amlexanox in a 5% paste formulation is approved by the FDA for the accelerated healing and resolution of pain for the treatment of canker sores. In addition to the clinical data supporting the use of amlexanox for the treatment of canker sores, Access has recently reported the completion of a pilot oral wound healing study which generated positive results.
Institutional Review Board approval, which is required prior to the commencement of the study, has been received from one clinical site and the first patient should be enrolled in the study within ten days. The placebo controlled multi-center study will enroll approximately 60 patients. The study will be conducted in head and neck cancer patients undergoing radiation and chemotherapy and will evaluate the ability of OraRinse(TM) to prevent, or reduce the severity of mucositis.
Commenting on the clinical trial, Kerry P. Gray, President and CEO of Access, stated ``The quality of life of many cancer patients undergoing radiation or chemotherapy is significantly compromised by mucositis, can lead to nutritional deprivation and can be the side effect that limits treatment. A treatment that can reduce the occurrence of the disease, severity of the disease or accelerate healing with a corresponding reduction in pain would represent a significant clinical benefit.'
The study is planned to be completed in the second half of 2000, at which time a decision will be made on the clinical plan to achieve the most expeditious route for a product license application either, an NDA in the United States or a foreign filing.
Mr. Gray continued, ``This is Access' third product candidate in Phase II/III clinical studies. It is anticipated that an additional three products will enter clinical testing during the next 6-9 months, with the potential for additional product candidates to be developed from the Company's platform technologies.'
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(TM) that provides rapid delivery and reservoir of a drug in the skin. |
