Radiopharmaceutical developer Cell>Point has received a letter from the U.S. Food and Drug Administration (FDA) indicating agreement on a special protocol assessment (SPA) for a phase III trial of technetium-99m-labeled glucosamine (Tc-99m EC-G) in lung cancer.
The study will assess use of Cell>Point's Tc-99m EC-G for diagnosing and staging lung cancer. Study patients will receive Tc-99m EC-G intravenously, and an image of the cancer area will be obtained using SPECT.
An SPA is a binding declaration between the trial sponsor and the FDA indicating that the phase III clinical study design, end points, 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, Cell>Point said.
