Lantheus Medical to Begin Phase 3 Trial of Injection Agent for CAD
Lantheus Medical Imaging Inc. has received a Special Protocol Assessment (SPA) approval for a Phase 3 clinical trial for the assessment of myocardial perfusion using PET imaging of an injection agent in patients with suspected coronary artery disease.
Lantheus Medical Imaging Inc. has received a Special Protocol Assessment (SPA) approval for a Phase 3 clinical trial for the assessment of myocardial perfusion using PET imaging of an injection agent in patients with suspected coronary artery disease.
The company plans to start the first of two planned trials of flurpiridaz F-18 in the second quarter of 2011. An SPA means the company’s proposed trial protocol is acceptable for approval.
“We believe that flurpiridaz F-18 can improve the diagnosis and evaluation of coronary artery disease, ultimately reducing the need for additional medical tests and procedures,” Lantheus president and CEO Don Kiepert said in a statement.
Data from a preliminary Phase 2 trial showed that PET imaging with flurpiridaz F-18 provided better image quality than technetium-99m sestamibi singe photon emission computer tomography (SPECT), which is the current standard for noninvasive detection of CAD, according to the company. A full data set from the Phase 2 clinical trial will be presented in May at the Nuclear Cardiology and Cardiac CT Conference.
The goal of the Phase 3 trial is to assess the sensitivity and specificity of flurpiridaz F-18 injection PET myocardial perfusion imaging in about 1,350 patients with known or suspected CAD at about 100 clinical sites.