Expansion of Phase II Clinical Trial
July 17, 2013
Izun Pharmaceuticals Corporation recently announced that it has expanded its ongoing Phase II clinical trial assessing the effect of its novel drug candidate, IZN-6N4, on Oral Mucositis (OM) to two additional medical centers, Memorial Sloan-Kettering Cancer Center and Beth Israel Medical Center, a component of the Continuum Cancer Centers of New York. The studies are evaluating the onset and incidence of OM in head and neck cancer patients undergoing chemo and radiation therapy (CRT).
OM is a frequent and severe side effect that develops as a result of CRT; it is a painful and ulcerated inflammation of the oral mucosa that impacts significantly on the quality of life of cancer patients. In severe cases, CRT has to be modulated or discontinued due to the OM, impacting negatively on the success of the treatment regimen.
Izun developed this patented drug internally and continues development in collaboration with a multi-national pharmaceutical company. The Phase II trials were initiated in five medical centers in Israel, and the initial phase of the trial was completed with excellent results.
Only 25% of the patients who were treated with the aggressive CRT regimen developed OM whereas historical data projected that OM would occur in at least 75% of these patients. “There is a great need for a product that can prevent OM and, based on our early data, we are optimistic of a positive outcome in the Phase II trial,” stated Dr. William Levine, CEO and Chairman of Izun. He continued, “We are excited to have two such eminent cancer centers joining us. Their input and participation enhance the current clinical teams and the additional recruitment should allow for a more rapid completion of the trial.”