Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

Dec 21 2009

Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), for the prevention of acute radiation enteritis. This study will be supported in large part by a two-year Small Business Innovation Research (SBIR) grant award, which will provide Soligenix with approximately $510,000 in funding.

The Phase 1/2 protocol BDP-ENT-01 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 one of four escalating dose groups. The objectives of the study are 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 is expected to be completed in the first half of 2011.

Acute radiation enteritis is an unmet medical need and 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 and itself can cause significant GI toxicity. This treatment-related 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, SGX201 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 Soligenix on the continued development of SGX201."

"The initiation of this new clinical trial in radiation enteritis with SGX201 represents the next step in the expansion of our oral BDP product portfolio," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "Based on its known pharmacology, we anticipate that oral administration of SGX201 may help to prevent or reduce the severity of acute radiation enteritis and other inflammatory diseases of the GI tract. This is now the third active clinical trial underway with orBec® or oral BDP. We look forward to working with our Medical Advisory Board and investigational sites to complete this important proof of concept study."