Soligenix Inc., formerly known as DOR BioPharma Inc., is a late-stage biotechnology company focused on developing products to treat potentially fatal side effects of cancer treatments, as well as for serious gastrointestinal diseases and vaccines for bioterrorism agents. The company yesterday announced it has commenced a phase ½ clinical trial to evaluate the safety and maximal tolerated dose of SGX201 for the prevention of acute radiation enteritis, a condition in which the lining of the bowel becomes swollen and inflamed during or after radiation therapy to the abdomen, pelvis or rectum.
The phase 1/2 protocol BDP-ENT-01 is a study of approximately 36 patients with rectal cancer that are scheduled for concurrent radiation and chemotherapy. Prior to surgery, the patients will be enrolled in one of four of Soligenix’s escalating dose groups.
According to the company, each year there are more than 100,000 patients in the United States who receive abdominal or pelvic external beam radiation treatment for cancer; consequently, these patients are at risk of developing acute and chronic radiation enteritis. Acute radiation enteritis is an unmet medical need that can result in delays or interruptions in cancer treatment.
“Radiation enteritis is a serious complication for colorectal cancer patients receiving radiation therapy that impacts their quality of life and can require treatment modification,” William Small, Jr., MD, FACRO, professor and vice chairman for the Department of Radiation Oncology, associate medical director for Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and a principal investigator for the phase 1/2 clinical study stated in the press release. “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.”
Christopher J. Schaber, PhD, president and CEO of Soligenix, said the study reflects the company’s plans to enhance its current product offering and will open the door to treat gastrointestinal diseases.
“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,” Dr. Schaber stated. “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.”
The company said $510,000 of the clinical trial costs will be financed partially by a two-year Small Business Innovation Research (SBIR) grant award. The study is expected to be completed in the first half of 2011.