DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

Sep 8 2009

DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biotechnology company, announced today that the National Institutes of Health (NIH) has awarded DOR a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 1/2 clinical trial evaluating DOR201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis. The award will provide DOR with approximately $500,000 over a two-year period.

The grant application included the Phase 1/2 protocol BDP-ENT-01, which is designed as a multicenter, open-label, sequential, dose-escalation study in approximately 36 patients. Patients with rectal cancer who are scheduled to undergo concurrent radiation and chemotherapy prior to surgery will be enrolled in four dose groups. The objectives of the study are to evaluate the safety and maximal tolerated dose of escalating doses of DOR201, as well as the preliminary efficacy of DOR201 for prevention of signs and symptoms of acute radiation enteritis. The study is expected to be initiated in 2009.

Acute radiation enteritis is caused by radiation-induced death of cells in the lining of the bowel. As bowel cells die and are not replaced, gastrointestinal toxicity develops over the next few days and weeks due to an inflammatory response to dead cells and bacteria, with chronic diarrhea, vomiting and pain being the major symptoms. The addition of chemotherapy often exacerbates the onset, severity and debilitation related to intestinal symptoms. Radiation enteritis often results in delay or interruption of the cancer treatment. There are over 100,000 patients annually in the United States who receive abdominal or pelvic external beam radiation treatment for cancer, and these patients are at risk of developing acute and chronic radiation enteritis.

"Radiation enteritis is a serious complication for colorectal cancer patients receiving radiation therapy that impacts their quality of life and can require treatment modification," stated William Small, Jr., MD, FACRO, Professor and Vice Chairman, Department of Radiation Oncology, Associate Medical Director, Robert H. Lurie Comprehensive Cancer Center of Northwestern University and a Principal Investigator for the Phase 1/2 clinical study. "Based on oral BDP's proven pharmacology in treating severe gastrointestinal inflammation, DOR201 represents a potential prophylactic option that would enable physicians/patients to maintain planned treatment regimens to battle the underlying malignancy. I look forward to working with DOR on the continued development of DOR201."

"In addition to the FDA's clearance of our IND and its granting of fast-track designation, this grant award further validates the merits of our DOR201 clinical program," stated Christopher J. Schaber, PhD, President and CEO of DOR. "Based on its known pharmacology, we believe that oral administration of BDP may help to prevent or reduce the severity of acute radiation enteritis and the deleterious effects it has on the patient's and treating physician's ability to deal with the underlying malignancy. We look forward to working with our Medical Advisory Board and investigational sites to initiate this study."