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Soligenix Announces Initiation of a Phase 1/2 Clinical Trial of SGX201 for the Prevention of Acute Radiation Enteritis
Date:12/21/2009

ing the bowel, leading to acute and chronic toxicities. The large and small bowels are very sensitive to radiation. The larger the dose of radiation, the greater the potential damage to normal bowel tissue. Most tumors in the abdomen and pelvis need large doses, and almost all patients receiving radiation to the abdomen, pelvis or rectum will show signs of acute enteritis.

Patients with acute enteritis may have nausea, vomiting, abdominal pain and bleeding, among other symptoms. Some patients may develop dehydration and require hospitalization. With diarrhea, the gastrointestinal tract does not function normally, and nutrients such as fat, lactose, bile salts and vitamin B12 are not well absorbed.

Symptoms will usually resolve within 2-6 weeks after therapy has ceased. Radiation enteritis is often not a self-limited illness, as over 80% of patients who receive abdominal radiation therapy complain of a persistent change in bowel habits. Moreover, acute radiation injury increases the risk of development of chronic radiation enteropathy, and overall 5% to 15% of the patients who receive abdominal or pelvic irradiation will develop chronic radiation enteritis.

About SGX201

SGX201 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. BDP is also the active ingredient in orBec®, currently in Phase 3 and Phase 2 development by Soligenix for the treatment and prevention of acute Graft-versus-Host disease (GVHD), respectively. SGX201 is a time-release formulation of BDP specifically designed for oral use. SGX201 has been awarded fast-track designation from the FDA for the treatment of radiation enteritis.

About Soligenix, Inc.

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SOURCE Soligenix, Inc.
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