The Phase II study will enroll up to 24 subjects with advanced (stage IV) renal cell carcinoma at four to six sites in the US. The primary endpoint for the study is decrease in tumor size. Secondary endpoints include time to tumor progression. The duration of the study is expected to be two years.
The company intends to initiate an additional Phase II study of Curaxin CBLC102 in multiple cancer types in early 2008.
Michael Fonstein, president and CEO of Cleveland BioLabs, said: “We are pursuing multiple Phase II trials for Curaxin CBLC102 in order to determine the most responsive cancer targets for its mechanism of action and establish optimal dosing regimens. Moreover, we have exploited our understanding of the mechanism of action of CBLC102 to develop a pipeline of proprietary, anticancer drug candidates.”