Cell Point seeks IND for new SPECT agent
Cell Point has submitted to the FDA an investigational new drug (IND) application for a Phase 1b/2 trial of its 99mTc-EC-G diagnostic in assessing patients with coronary artery disease (CAD).
The trial will evaluate patients with a number of cardiovascular issues, including ischemia, recent acute myocardial infarction and questionable heart muscle cell (myocyte) viability, said the Centennial, Colo.-based Cell Point.
99mTc-EC-G targets and concentrates in ischemic, infarcted tissues and “Hot Spot” Imaging with 99mTc-EC-G may eliminate the need for subsequent rest or attenuation correction image required in traditional myocardial perfusion imaging, added Cell Point.
CPC Clinical Research, an academic research organization with headquarters in Denver, prepared the IND and will assist Cell Point in managing the Phase 1b/2 trial.
The trial will evaluate patients with a number of cardiovascular issues, including ischemia, recent acute myocardial infarction and questionable heart muscle cell (myocyte) viability, said the Centennial, Colo.-based Cell Point.
99mTc-EC-G targets and concentrates in ischemic, infarcted tissues and “Hot Spot” Imaging with 99mTc-EC-G may eliminate the need for subsequent rest or attenuation correction image required in traditional myocardial perfusion imaging, added Cell Point.
CPC Clinical Research, an academic research organization with headquarters in Denver, prepared the IND and will assist Cell Point in managing the Phase 1b/2 trial.