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New Pharmacy Drug by Soligenix
by admin on: February 4th, 2011

Soligenix, Inc. announced that it started a Phase 1/2 clinical trial that evaluates SGX20. SGX20 is a time-release formulation of beclomethasone 17,21-dipropionate (oral BDP). It is used to prevent acute radiation enteritis. This research is supported by a Small Business Innovation Research (SBIR) grant award. This award granted about $510,000 to Soligenix in funding.

The protocol is an open-label, multicenter, sequential, dose-escalation study involving 36 patients. Patients suffering from rectal cancer, and those who are about to be given chemotherapy and concurrent radiation before surgery, are to be enrolled in one of four escalating dose groups. The main objectives of this study are to assess the maximum tolerated dose, and safety of increasing doses of SGX201. It also aims to study the efficacy of SGX201, in order to prevent the symptoms and signs of acute radiation enteritis.

Christopher J. Schaber, PhD, President and CEO of Soligenix said, “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.” “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.”

Acute radiation enteritis is caused by cell death in the bowels due to radiation. These cells die, but are not replaced, leading to gastrointestinal toxicity. An inflammatory response follows, accompanied by chronic diarrhea, pain, and vomiting. Chemotherapy intensifies the onset, debilitation, and severity of the symptoms, and causes high gastrointestinal toxicity.The 100,000 patients who receive radiation treatment in United States every year are at a high risk of suffering from acute radiation enteritis.

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