The National Cancer Institute at the National Institutes of Health estimates that there are more than 250,000 new cases of colon, rectal, bladder, cervical, prostate, testicular and endometrial cancer diagnosed every year in the United States. Around 50% of these patients are estimated to eventually require radiation therapy in the affected pelvic region, and of these, around 75% will experience radiation proctitis (RP) or rectal mucositis, especially patients who received treatment for colon, cervical and prostate cancers. These percentages represent over 100,000 potential patients every year, but there are very few treatment options for these serious side effects.
Rectal mucositis is a major side effect of cancer treatment and it is characterized by mucosal tissue inflammation and injury that can lead to painful ulceration of the mucosa. Radiation proctitis refers to the inflammation and injury of the lower part of the colon after radiation therapy usually following cancer treatment in the pelvic region, and can have an acute and a chronic form.
Patients experience the acute form usually within the first few weeks after therapy with symptoms like an urgent need to defecate, diarrhea and pain. Acute RP is caused by direct injury to the lining of the colon while chronic RP can start several months or even years after therapy and it is the result of injury to blood vessels that supply oxygen to the colon. Chronic RP symptoms are similar to the ones of the acute form and can also include intestinal blockage and rectal bleeding.
PlasmaTech Biopharmaceuticals, Inc. has an approved product for oral mucositis called MuGard in its portfolio that has been proven to offer clinical benefits in patients’ oral cavity. Oncologists who worked with MuGard in clinical settings suggested that it might also be effective in rectal mucositis and radiation proctitis. PlasmaTech has therefore developed a complementary version of MuGard for these specific medical conditions (ProctiGard) and has, in early 2014, filed for marketing clearance with the U.S. Food and Drug Administration (FDA). ProctiGard was given marketing clearance by the FDA in July 2014 for the management of symptoms related to rectal mucositis.
According to a news release, PlasmaTech believes that ProctiGard represents an important therapeutic option for the management of debilitating rectal mucositis and radiation proctitis as a result of exposure to x-rays or ionizing radiation, part of cancer radiation therapy.