The Company indicated its development of ProctiGard™ is a direct response to dialogue with the oncology community that is looking for better, more effective treatment options for rectal mucositis and radiation proctitis, a debilitating oncology side effect. Access believes that ProctiGard is a first-in-class treatment option that addresses a significant unmet medical need. Access currently holds global commercialization rights for ProctiGard.

"This second FDA marketing clearance is an important milestone for Access following the decision to focus on the development and commercialization of a portfolio of follow-on proprietary products," said Jeffrey Davis, CEO of Access Pharmaceuticals. He continued, "Rectal mucositis and radiation proctitis, presenting as inflammation and damage to the lower part of colon, is a common adverse event of the radiotherapy of tumors in the abdominal and pelvic region with no well-established effective standard of care. With the introduction of ProctiGard™, we look forward to providing cancer patients with an important treatment that manages this debilitating disease."

Radiation proctitis (RP) is a condition analogous to oral mucositis in the oral cavity, concerning the inflammation and damage to lower parts of the colon following pelvic radiation to the region. Rectal mucositis, a broader condition, can also be caused by factors other than radiation, including bacterial, viral or fungal infections, parasites, contact allergies or food allergies, and surgery. It is estimated that there are in excess of 250,000 new cases of prostate, cervical, rectal, testicular, bladder and endometrial cancer diagnosed each year. Approximately 50% of these patients require radiation therapy, and roughly 75% of patients undergoing pelvic irradiation experience radiation proctitis. Access is actively evaluating commercialization options for ProctiGard™, including the seeking of global marketing partners.