Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating SGX942, a first-in-class innate defense regulator (IDR), as a treatment for oral mucositis in patients undergoing chemoradiation (CRT) therapy for head and neck cancer.
This Phase 2 study is a multicenter trial focused on patients with tumors of the mouth and oropharynx who often experience debilitating oral mucositis as a consequence of tumor treatment with intensity modulated radiation and chemotherapy. The primary efficacy will be assessed on the basis of the incidence and duration of both ulcerative and severe oral mucositis throughout the course of radiation treatment. Other key efficacy measures will assess patient reported outcomes, pharmacoeconomic parameters such as hospitalization and radiation-associated side effects including mouth stiffness (trismus) and dryness (xerostomia).
"Oral mucositis remains a debilitating side effect of cancer treatments and is particularly severe and prevalent in head and neck cancer patients. Our current understanding of oral mucositis highlights the role of the innate immune response in exacerbating the damage done by CRT," stated Stephen T. Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and Member of the Soligenix Oral Mucositis Medical Advisory Board. "SGX942 is the first innate defense regulator in development for oral mucositis and its mechanism offers a promising option to treat the debilitating consequences of CRT."
"The initiation of the oral mucositis Phase 2 trial marks another important next step in the development of SGX942 and is our first opportunity to demonstrate the potential clinical efficacy of SGX942," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to working with our esteemed Medical Advisory Board and clinical investigators to complete this study."