The primary endpoint of the trial is to determine the safety, tolerability and pharmacokinetics of the drug, although the design allows the collection of efficacy data as well.
The trial also has the provision to recruit up to 18 additional patients in an expanded Phase Ib cohort at the maximum tolerated dose of the drug.
Principal investigator of the study Devalingam Mahalingam said G-202 has shown much promise in pre-clinical testing, so he is hopeful it will show good clinical activity in my patients.
GenSpera president and CEO Craig Dionne said they have carefully selected their clinical hospitals for both their expertise and to reach a cross-section of patients, and are pleased to bring this third center of excellence into the trial.