The FDA has sent a letter to Cell >Point indicating agreement on a Special Protocol Assessment (SPA) for the company's Phase III pivotal clinical study of technetium-99m-EC-G ( 99mTc-EC-G) in lung cancer.
The Phase III study will assess use of Cell >Point’s molecular imaging product candidate, 99mTc-EC-G (EthylenediCysteine-n-acetyl-Glucosamine), in the diagnosis and staging of lung cancer.
Study patients receive 99mTc-EC-G intravenously, and an image of the cancer area is taken using a SPECT, according to the Centennial, Colo.-based company. Patients in the study will receive a SPECT scan with 99mTc-EC-G, and a PET scan with fluorine-18 FluoroDeoxyGlucose ( 18F-FDG). Results will then be independently evaluated, scored and compared for accuracy in diagnosing the presence and location of primary as well as metastatic lesions.
A SPA is a binding declaration between the trial sponsor and the FDA indicating that the Phase III study design, endpoints and statistical analyses are acceptable to support regulatory approval of the product. Final marketing approval depends on study results and an evaluation of benefit/risk profile.