Soligenix (OTCBB:SNGXD) unveiled Friday preliminary results from a phase one/two clinical trial testing SGX201, an oral drug for the prevention of acute radiation enteritis, a toxic side effect of radiation therapy in certain cancer patients.
The study found that SGX201 was both safe and well-tolerated across all four dose groups in the trial.
Investors cheered the news, with shares rising nearly 8.6 percent to 76 cents Friday morning.
SGX201 is a time-release, oral formulation of BDP, a highly potent, topically active corticosteroid that has a "local effect" on inflamed tissue, the company said.
BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products to treat patients with allergic rhinitis and asthma.
The company's phase one/two randomized, dose-finding trial tested Soligenix's drug at five centres. Sixteen patients with rectal cancer scheduled to undergo radiation and chemo prior to surgery were enrolled in one of four dose groups, with the drug administered throughout the duration of radiation therapy, plus one additional week.
The aim of the study was to test the safety and tolerability of escalating doses of SGX201, as well as to assess the preliminary efficacy of the drug for the prevention of signs and symptoms of acute radiation enteritis.
The study showed that oral administration of SGX201 was safe and well tolerated across all four dose groups, and there was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting, and the assessment of enteritis, said Soligenix.
In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population, the company added.
Acute radiation enteritis is caused by the radiation-induced death of cells in the lining of the bowel. As bowel cells die and are not replaced, there is a resulting inflammatory response to dead cells and bacteria, with diarrhea, nausea, vomiting and pain being prominent symptoms.
The addition of chemotherapy may exacerbate the intestinal symptoms, and can result in the delay or interruption of the cancer treatment. There are over 100,000 patients each year in the United States who receive abdominal or pelvic external beam radiation treatment for cancer, and these patients are at risk of developing radiation enteritis.
"This clinical trial in radiation enteritis with SGX201 provided encouraging exploratory data, which we will be submitting for publication," said chief medical officer for Soligenix, Kevin Horgan, MD.
"Though the numbers are small, the low incidence of diarrhea relative to other similar studies was notable. These findings appear to be consistent with the potential for SGX201 having efficacy for this disorder for which there is currently no available therapy."
Principal investigator of the study, William Small, Jr., MD, added: "Radiation enteritis is a serious complication for colorectal cancer patients receiving radiation therapy that impacts their quality of life and can require treatment modification.
"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 find these exploratory data encouraging and I look forward to continuing to work with Soligenix on the continued development of SGX201 in this area of great unmet medical need."
The company's study was supported in large part by a two-year Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), which provided Soligenix with approximately $510,000.
Soligenix's SGX201 was awarded fast-track designation from the FDA for the prevention of radiation enteritis. Fast-track designation is designed to expedite the review of new drugs intended to treat serious or life threatening conditions.
Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain bioterrorism agents.
The company's lead product, orBec is a locally acting corticosteroid that has been initially developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common complication of hematopoietic cell transplantation.
Earlier this month, Soligenix unveiled positive results from preclinical studies of its proprietary vaccine thermo-stabilization technology, establishing proof-of-concept.
The company's technology allows vaccines that usually need to be refrigerated to maintain their efficacy at higher temperatures. Soligenix used its aluminum-adjuvant ricin toxin vaccine, RiVax, in the study.