Cell>Point completes cancer diagnostic phase 2 trial; reports favorable trends in primary tumor imaging

Cell>Point announced today that it has closed the Phase 2 portion of its Phase 2/3 trial of 99mTc-EC-G in evaluating patients with non-small cell lung cancer (NSCLC).

“We are very encouraged by the favorable trends observed in imaging the primary tumor in our Phase 2 study and therefore have closed the trial”

The Phase 2/3 clinical trial compares the efficacy and safety of 99mTc-EC-G administered and then imaged with a SPECT /CT camera to 18F-FDG administered and then imaged with a PET/CT camera in the evaluation of patients with confirmed NSCLC. The Phase 2 trial endpoint is that diagnosing the presence of NSCLC with 99mTc-EC-G and SPECT/CT will not be "inferior to" 18F-FDG and PET/CT.

18F-FDG is FluoroDeoxyGlucose. It is the current standard for diagnosing and staging lung cancers. SPECT/CT is Single Photon Emission Computed Tomography - Computed Tomography. PET/CT is Positron Emission Tomography - Computed Tomography.

"We are very encouraged by the favorable trends observed in imaging the primary tumor in our Phase 2 study and therefore have closed the trial," said David Rollo, M.D., Ph.D., Cell>Point president.

"We are looking forward to completing the Phase 3 trial this year. Some of the Phase 2 images will be included in the Phase 3 trial."

Cancer diagnostic imaging agents, like Cell>Point's, that leverage the large installed base of SPECT/CT cameras should help increase access to cancer imaging. SPECT/CT cameras are found in over 97 percent of U.S. hospitals, whereas PET or PET/CT cameras are in approximately five percent of U.S. hospitals. PET/CT systems can cost from $1.5 million to as much as $2.5 million, while SPECT/CT cameras cost $500,000 to $650,000 or approximately one-quarter the cost of the more expensive PET/CT systems.

The Phase 2/3 "combined" trial is aimed at determining the presence as well as the extent of cancer (cancer spread to other parts of the body) to allow physicians to determine the optimal treatment for patients earlier and more efficiently. The Phase 2 trial was designed to be adaptive and consisted of learning and confirming the optimal protocol to obtain the best possible images for diagnosing presence and location of a patient's cancer. Example adaptations include dose level or alteration of imaging parameters.

Cell>Point will next submit a report to the Food and Drug Administration (FDA) summarizing the Phase 2 data and seeking agreement with the FDA on how to proceed with the final Phase 3 portion of the trial.

Phase 2 trial sites included Montefiore Medical Center, University of Chicago Medical Center, John Hopkins University, Mayo Clinic, Baptist Health South Florida, Decatur Memorial Hospital, and British Columbia Medical Center in North Vancouver, Canada.

Cell>Point intends to perform additional clinical trials for several cancer types to include breast, prostate, colon, non-Hodgkin's Lymphoma, and head/neck cancers.




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