A small Phase 1/2 clinical study was completed testing SGX201 in prevention of acute radiation enteritis. Sixteen patients with rectal cancer scheduled to undergo concurrent radiation and chemotherapy prior to surgery were randomized to one of four SGX201 dose groups. The objectives of the study were to evaluate the safety and maximal tolerated dose of escalating doses of SGX201, as well as the preliminary efficacy of SGX201 for prevention of signs and symptoms of acute radiation enteritis. The study demonstrated that oral administration of SGX201 was safe and well tolerated across all four dose groups with evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events. This program was supported in part by a Small Business Innovation Research (“SBIR”) grant awarded by the NCI.
Evaluation of the data from the phase 1/2 study suggests that study in acute radiation enteritis is warranted, assuming additional government funding. A study design for this patient population is in development.
The program for the prevention of acute radiation enteritis has been granted Fast Track Designation by the FDA.
About Acute Radiation Enteritis
External radiation therapy is used to treat many types of cancer, including cancer of the bladder, uterus, cervix, rectum, prostate, and vagina. Radiation treatment invariably causes damage to healthy tissue leading to acute and chronic toxicities. The bowel is very sensitive to radiation.
Radiation enteritis is the inflammatory syndrome that develops after the intestine is exposed to radiation. It is common after radiation therapy to the abdomen, pelvis, or rectum. Patients with acute enteritis may have nausea, vomiting, abdominal pain and bleeding. Symptoms will usually resolve within 2-6 weeks after therapy has ceased. However, acute radiation injury increases the risk of development of chronic radiation enteropathy and up to 20% of the patients who receive pelvic irradiation develop symptoms of chronic radiation enteritis. There are over 100,000 patients annually in the U.S. who receive abdominal or pelvic radiation treatment for cancer and are at risk of developing acute and chronic radiation enteritis.