Safety and Efficacy of SeeMore (TM) in Heart Patients

This is a Phase II open-label, baseline-controlled study. Approximately 10 adult male or nonpregnant female patients known to have had a myocardial infarct (nonacute) are intended to be enrolled at the current dose.

Prior to entry into this study, all subjects will undergo a standard physical examination including medical history, details regarding the prior myocardial infarct(s), prescription and over-the-counter drug questionnaire, vital signs, ECG, evaluation of the major organ systems, hematology, serum chemistries, and urinalysis. In addition, female subjects will undergo a serum pregnancy test. All subjects will sign an Informed Consent prior to entry into the study.

EVP 1001-1 will be administered intravenously over approximately one minute. Safety will be assessed by monitoring vital signs, ECG, and blood test after giving EVP 1001-1. MRI will be performed before and after EVP-1001-1 to measure enhancement relative to areas of myocardial infarction.

Inclusion criteria

• be at least 18 years of age.
• if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile
• provide written informed consent after having received oral and written information about the study
• be in stable health based on medical history, examination and tests
• have potassium, calcium and hematocrit values within normal limits
• have a prior known myocardial infarction

Exclusion criteria

• have a positive pregnancy test (females)
• received an investigational drug or device within 30 days prior to administration of SeeMore™
• have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
• have a history of drug abuse or alcoholism
• have had a myocardial infarct, unstable angina, stroke of transient ischemic attack (TIA) within the past six months
• are taking a digitalis preparation or calcium channel blocker
• have arrhythmias requiring medication
• have a prolonged PR interval, history of an atrioventricular conduction disorder or sick sinus syndrome
• have a prolonged QTc interval, ventricular arrhythmia or history of torsades
• have NYHA Grade III or IV heart failure
• have abnormal liver function tests or a history of liver disease
• have uncontrolled hypertension
• have potassium, calcium or hematocrit values outside normal limits
• have altered a prescription medication within 14 days or an over-the-counter medication within 7 days
• are noncompliant or otherwise unlikely to perform as required by the protocol
• if a new cardiac arrhythmia develops prior to the scheduled time for SeeMore™ administration, SeeMore™ will be withheld.