Cell>Point announced today encouraging results following the conclusion of its Phase 2a cardiovascular clinical study performed by Cardiovascular Imaging Technologies of Kansas City, Missouri.
The study imaged patients with technetium-99m-labeled EthylenediCysteine-Glucosamine (99mTc-EC-G), Cell>Point's proprietary nuclear imaging product candidate, which is target specific for detecting the presence and extent of ischemia in patients with Coronary Artery Disease (CAD).
The results from the Phase 1 and 2a studies show that 99mTc-EC-G has the potential to accurately diagnose myocardial ischemia (that is, decrease in blood flow and oxygen to heart muscle) in as little as 30 minutes post injection in patients studied at rest only.
"Based on what we have observed in clinical data for Phase 1 and Phase 2a, and assuming further confirmation in Phase 2b, it is our belief that 99mTc-EC-G has the ability to dramatically shift the paradigm for nuclear cardiac imaging in terms of significantly shortening procedure time, increasing diagnostic accuracy, and easing the patient's experience by eliminating the need in most cases for a separate stress study," said Cell>Point President David Rollo, M.D., Ph.D.
The multicenter Phase 2b trial will evaluate the diagnostic accuracy (sensitivity and specificity) of a 99mTc-EC-G study performed at rest only compared to a two-day 99mTc-Cardiolite rest/stress study to determine the presence, anatomical location, and severity of ischemia in patients with CAD. Diagnostic catheterization will be used as the standard of truth. Camargo Pharmaceutical Services of Cincinnati will perform the role of general manager over the clinical research and regulatory function for the study. Premier Research of Research Triangle Park, North Carolina, will continue their role as the clinical research organization for the study.
Leading the Phase 2b study as principal investigator will be Gary Heller, M.D., Ph.D., Professor of Medicine and Nuclear Medicine at the University of Connecticut School of Medicine, and a world-renowned nuclear cardiologist who has authored several hundred clinical articles and a number of textbooks in nuclear cardiology.
According to the American Heart Association, over 10 million nuclear cardiology scans are performed annually in the United States. Over 90 percent of the scans are Myocardial Perfusion Imaging (MPI) procedures, a $1.8 billion U.S. market.
A typical MPI procedure, which comprises both a rest and stress study, takes between 5 and 7 hours to complete. For the stress component of the MPI study, patients are subjected to physical and/or pharmacologic stress, which is often an issue and an inconvenience for the patient. Because of the required time separation between the stress and rest studies, the patient is typically asked to return the next day to complete the full study. This significantly increases the time commitment for the patient and further restricts camera availability for additional patient studies. It is one of Cell>Point's goals with 99mTc-EC-G to substantially reduce the need for the patient to undergo a stress study, thus positively impacting the patient's time commitment as well as camera access for additional nuclear cardiac imaging studies.