Access Pharmaceuticals, an emerging bio-pharmaceutical company, and a developer of new products for oncology supportive care, has received 510(K) marketing clearance from the US Food and Drug Administration (US FDA) for ProctiGard, its novel treatment for symptomatic management of rectal mucositis.
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 commercialisation of a portfolio of follow-on proprietary products," said Jeffrey Davis, chief executive officer, 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 tumours 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 50per cent of these patients require radiation therapy, and roughly 75per cent of patients undergoing pelvic irradiation experience radiation proctitis. Access is actively evaluating commercialisation options for ProctiGard, including the seeking of global marketing partners.
Rectal mucositis, and specifically radiation proctitis, is the inflammation and damage to the lower portion of the colon, primarily the sigmoid colon and rectum, after exposure to x-rays or ionising radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon, and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment, and symptoms include diarrhoea, nausea, cramps, urgency, mucus discharge and painful defecation. Experts believe that RP occurs due to damage to the blood vessels that occurs as part of the radiation therapy.