March 15, 2012 - Cell>Point announced that it has received a letter from the U.S. Food and Drug Administration (FDA) indicating agreement on a Special Protocol Assessment (SPA) for Cell>Point’s Phase 3 pivotal clinical study of technetium-99m-EC-G in lung cancer.
The Phase 3 study will assess use of Cell>Point’s molecular imaging product candidate, technetium-99m-EC-G (EthylenediCysteine-n-acetyl-Glucosamine), in the diagnosis and staging of lung cancer.
Study patients receive technetium-99m-EC-G (99mTc-EC-G) intravenously, and a picture, or image, of the cancer area is taken using a Single Photon Emission Computed Tomography (SPECT) camera, commonly referred to as a gamma camera.
“We are extremely pleased to receive agreement from the FDA for this Special Protocol Assessment since it provides us confidence that our study design and statistical analysis plan have the potential to provide results that lead to product approval,” said David Rollo, M.D., Ph.D., president of Cell>Point.
Patients in the study will receive a SPECT scan with 99mTc-EC-G, and a PET scan (Positron Emission Tomography) 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.
About Special Protocol Assessments
A Special Protocol Assessment is a binding declaration between the trial sponsor and the FDA indicating that the Phase 3 clinical 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.
Technetium-99m-EC-G is a cancer and cardiovascular diagnostic imaging agent developed for use with SPECT cameras, which are widely available throughout the world. In cancer, Phase 2 clinical trial results showed 100 percent concordance between 99mTc-EC-G and 18F-FDG in non-small cell lung cancer lesion
location, size and confidence that lesions represented cancer. For cardiology, Cell>Point is preparing to start a Phase 2 clinical study to evaluate technetium-99m-EC-G in diagnosing patients with Coronary Artery Disease (CAD). One of the Phase 2 objectives is to compare results of giving technetium-99m-EC-G to patients “at rest” to results of a traditional Myocardial Perfusion Imaging (MPI) “stress and rest” study. (The EC-G rest-only study takes 30 to 45 minutes, whereas a traditional MPI study takes 5 to 7 hours.) Results from the Phase 1b CAD study were very encouraging.
For Technetium-99m-EC-G, the company has completed a Brazil license and a select-country Asia Pacific license.
For more information: www.cellpointweb.com