Biotechnology firm Soligenix of Princeton, NJ, has started phase I/II clinical trials of a drug designed to prevent radiation enteritis caused by radiation therapy procedures.
The company's SGX201 pharmaceutical is a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP). The clinical study will test the safety and efficacy of SGX201 in approximately 36 patients with rectal cancer who are scheduled to undergo concurrent radiation and chemotherapy prior to surgery.
The study is expected to be completed by the first half of 2011 and will be supported by a two-year Small Business Innovation Research (SBIR) grant award, which will provide Soligenix with approximately $510,000 in funding.
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 due to an inflammatory response to dead cells and bacteria, with chronic diarrhea, vomiting, and pain being the major symptoms, according to the company. The addition of chemotherapy often exacerbates the condition and can cause significant GI toxicity.
SGX201 would represent a prophylactic option that would enable physicians and patients to maintain planned treatment regimens to battle underlying malignancy without the complications of radiation enteritis, according to Soligenix.
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