In April 2008, ImClone announced the establishment of an agreement with the FDA under a special protocol assessment for this trial. The SPA is a written agreement between the trial’s sponsor and the FDA regarding the design and size of the Phase III trial to be used in generating the primary clinical data necessary to support approval of an efficacy claim in conjunction with the submission of a new drug application or biologics licensing application.
Eric Rowinsky, executive vice president and chief medical officer of ImClone, said: “Since the growth of breast cancer is dependent on anti-vascular endothelial growth factor receptor-2 (VEGFR-2) activation, IMC-1121B presents a unique opportunity to optimize this therapeutic approach as IMC-1121B uniquely binds to the VEGFR-2 receptor itself, thereby blocking many VEGF ligands from activating it.
“Unlike bevacizumab that targets only a single ligand, and unlike small molecule drugs that target many unrelated receptors, IMC-1121B specifically targets only VEGFR-2. This clinical trial will help us understand whether this approach produces greater activity with fewer side effects.”