Soligenix Inc (OTCBB:SNGX), a Biopharma firm developing products to meet unmet medical needs in biodefense, oncology and inflammation, said that it received a positive recommendation from DRC to continue with its enrollment process for Phase 2 Clinical Study of SGX942. The trial is meant for treatment of oral mucositis in Neck and Head Cancer patients.
The Phase 2 Clinical Trial is a first-in-class IDR meant for curing oral mucositis in patients who are taking CRT therapy for neck and head cancer. After DRC review, the committee said that enrollment should cover an additional twenty subjects randomized into either a placebo group or a single SGX942 dose group to achieve better-targeted evaluation of the drug’s potential effect. Also, it will let Soligenix know about final dose selection in patient population.
The Phase 2 Study
Soligenix stated that the Phase 2 trial of SGX942 is a double-blind, placebo-controlled, dose-ranging and randomized study, initially set to enroll almost 75 subjects across three placebo and SGX942 dose groups that will focus on the biologic and safety activity of SGX942 in patients suffering with tumors of the oropharynx and mouth. These patients experience unbearable oral mucositis as a result of tumor treatment with CRT. Under the study, the primary efficacy evaluation will be the comparison of duration and incidence of both oral and ulcerative mucositis throughout the patients in seven courses of CRT. The evaluation will be continued for an additional four weeks thereafter.
The management view
Soligenix Inc (OTCBB:SNGX) said that the clinical study was specifically designed to assess three dose levels of placebo versus SGX942 and, if statistically supported, to continue the enrollment process in any dose/patient groups that represent a strong case. Richard Straube, Senior VP and CMO of Soligenix, said that the positive recommendation from DRC will enable the company to enroll more number of subjects in the dose group.