Cell>Point submits IND application for Phase 1b/2 99mTc-EC-G diagnostic trial in assessing CAD patients

Cell>Point announced today that it has submitted to the Food and Drug Administration 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 to include ischemia (reduced blood supply), recent Acute Myocardial Infarction (heart attack) and questionable heart muscle cell (myocyte) viability.

Cell>Point anticipates a following Phase 2/3 trial agent would focus on ischemia.

Trials aim to show that ^99mTc-EC-G can be used as an alternative to traditional Myocardial Perfusion Imaging (MPI) agents, with the difference — and possible advantage — being that ^99mTc-EC-G is target-specific for the region of ischemia. Preclinical studies showed that it targets and concentrates in ischemic heart muscle tissue (myocardium). It is a "hot spot" imaging agent, and would be the first such agent for CAD.

By contrast, current MPI agents show a relative decrease in perfusion in regions of ischemia or infarction. They are "cold spot" imaging agents and require two images — one at stress, and one at rest — and take approximately five hours if performed the same day.

Thus a possible advantage of ^99mTc-EC-G would be eliminating the need for a second image, whether a rest or an Attenuation Correction image, as are required in the traditional MPI process. This could result in reduced cost of care.

Cell>Point believes additional benefits may be greater sensitivity in detecting ischemic tissue that is viable or salvageable, and more accurate diagnoses meaning fewer equivocal results and "false positives" and less patient worry.

The diagnostic also appears to correctly identify Congestive Heart Failure.

MPI, the diagnostic standard for ischemia, is used in nine to 10 million U.S. patients annually.

MPI agents, after intravenous administration and uptake in the heart, are imaged with SPECT (Single Photon Emission Computed Tomography) cameras, as is Cell>Point's agent.

CAD is the most common cause of death in most Western countries and has been the leading cause of death in the United States for the past 80 years. In 2008, nearly 27 million U.S. adults were living with heart disease.

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.