Soligenix, Inc., a late-stage biopharmaceutical company, has started treatment on patients enrolled in its Phase 2 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer patients.
“Patients in the study will be under treatment for the next seven weeks and then we have a one month follow-up so we won't have any real data until closer to the end of the year,” Soligenix Senior Vice President and Chief Medical Officer Rick Straube told American Pharmacy News this week.
Straube is a board-certified pediatrician with clinical research experience in host-response modulation. He joined Soligenix in January 2014 and leads the company’s clinical research with primary responsibility for the execution and completion of its multiple clinical programs, including the Phase 2 study in oral mucositis and the company’s Phase 2/3 study in pediatric Crohn's disease.
“We are very pleased with how this worked,” Straube said about recently finishing up the enrollment of additional patients for the company’s Phase 2 clinical trial of SGX942.
“We completed our enrollment in the initial group of patients last year and our Data Review Committee (DRC) looked at the data and suggested we reopen enrollment in March,” he said.
Enrollment of the additional patients was completed in August. They are randomized into either a single SGX942 dose group or a placebo group to allow for a more targeted assessment of the drug’s potential effect and to inform final dose selection in this patient population.
Specifically, the trial is focused on demonstrating the safety and biologic activity of SGX942 in patients with cancer of the mouth and oropharynx who often experience debilitating oral mucositis as a consequence of chemoradiation therapy.
The efficacy assessment is the comparison of the incidence and/or duration of both ulcerative and severe oral mucositis throughout the subjects’ seven-week course of chemoradiation therapy and for an additional four weeks thereafter.
“From a purely tactical standpoint we are very pleased” with how the trial ran for the initial group of patients, Straube told American Pharmacy News. “We do not have a lot of positive previous data from any drug in this patient population.”
He added that Soligenix will “have to look into the data long and hard and make a determination if it is strong enough data to arrange funding to conduct further studies.”
It’s more likely that if the data is positive, he said, then the company “will find a partner to work with in order to help move this into a Phase 2 B trial, which would be used to look for the effectiveness of the drug within this patient population.”