The study will evaluate OncoGel administered in combination with pre-operative chemoradiotherapy versus pre-operative chemoradiotherapy alone in 124 patients. The primary endpoint of the study is a blinded assessment of tumor response, overall survival is one of the secondary endpoints. Protherics expects to have preliminary data available from the Phase IIb study in the first half of 2010.
Andrew Heath, CEO of Protherics, said: “Following the encouraging Phase IIa study, we are hopeful that the Phase IIb study will provide further data to support the use of OncoGel as a potential treatment to increase the life expectancy for people with oesophageal cancer, a particularly devastating cancer.”