Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced the initiation of a Phase 1 clinical study to assess the safety, dosimetry and tolerability of LMI1195, a novel F-18 small molecule tracer for imaging cardiac neuronal function, in healthy subjects, undergoing positron emission tomography (PET) imaging.
Heart failure is a serious medical condition, in which the heart muscle progressively loses its ability to pump blood, that affects more than five million people in the United States and results in about 1.1 million hospitalizations and 300,000 deaths each year. Patients with heart failure are six to nine times more likely than the general population to suffer sudden cardiac death as a result of abnormal cardiac neuronal function resulting in a fatal arrhythmia. According to the American Heart Association, the total cost of heart failure is estimated to be $37.2 billion in 2009, putting very significant health and financial burdens on patients, their families and society as a whole.
“Given the high incidence of heart failure and associated deaths, there is a significant need to develop new diagnostic tools to help clinicians improve risk stratification and better identify heart failure patients at risk of arrhythmia and sudden cardiac death who might benefit from direct interventional therapy,” said D. Scott Edwards, vice president, global research & development, Lantheus Medical Imaging, Inc. “We look forward to the Phase 1 trial results and advancing the LMI1195 clinical development program.”
The Phase 1 open-label, non-randomized, single-dose study will be conducted in the United States. The study is designed to estimate the radiation dosimetry of LMI1195 in healthy subjects undergoing a PET scan. The study will also evaluate the safety and tolerability of the tracer, gather pharmacokinetic and metabolic data, and assess PET imaging parameters and image quality.
“The initiation of this study represents an important milestone in our strategy to develop a rich pipeline of diagnostic products to advance patient care,” said Don Kiepert, president and chief executive officer of Lantheus Medical Imaging, Inc. “LMI1195 is our second pipeline product to enter clinical development that uses molecular imaging and PET technology to improve cardiovascular imaging. We’re excited about the promise of this imaging agent to change how heart failure patients are evaluated.”
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