More than 250,000 new cases of colon, rectal, bladder, cervical, prostate, testicular and endometrial cancer are estimated by the National Cancer Institute at the National Institutes of Health to be diagnosed every year in the United States. Around 50% of these patients are thought to eventually require radiation therapy in the affected pelvic region, and of these, around 75% will experience radiation proctitis or rectal mucositis. Despite the fact that these serious side effects of radiation therapy can in the end potentially affect over 100,000 cancer patients every year, there are very few treatment options available.
Rectal mucositis is characterized by mucosal tissue inflammation and injury that can lead to painful ulceration of the rectal mucosa, and radiation proctitis refers to inflammation and injury of the lower part of the colon. Both conditions can be side effects of exposure to x-rays or ionizing radiation as part of radiation therapy for cancer treatment. Radiation proctitis has 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, caused by the direct injury to the lining of the colon. On the other hand, chronic radiation proctitis 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. The symptoms of chronic radiation proctitis are similar to the ones of the acute form and can also include intestinal blockage and rectal bleeding.
PlasmaTech Biopharmaceuticals, Inc. has developed a product for oral mucositis known as MuGard, which has been proven to offer clinical benefits in the patient’s oral cavity in multiple clinical trials. Oncologists who had a positive experience with MuGard suggested that it could also be effective for cases of rectal mucositis and radiation proctitis. PlasmaTech has therefore developed a complementary version of MuGard for these specific medical conditions, which was named ProctiGard. In early 2014, PlasmaTech has filed for ProctiGard marketing clearance with the U.S. Food and Drug Administration (FDA) for the management of symptoms related to rectal mucositis. Approval was given in July 2014.
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 cancer radiation therapy.