FluoroPharma Medical, a biopharmaceutical company engaged in the development of breakthrough diagnostic imaging products that utilize positron emission tomography (PET) technology to detect and assess pathology before clinical manifestation of diseases, just announced that the company has recruited SGS Life Science Services as the contract research organization (CRO) for their Phase II study of CardioPET to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients.
CardioPET, one of FluoroPharma’s first in class PET imaging products, is a perfusion and fatty acid uptake indicator. The imaging agent allows assessment of acute and chronic coronary artery disease while patients are at rest. CardioPET may be an accurate alternative to standard treadmill stress-testing, which could be especially valuable in patients who are unable to exercise.
According to today’s press release, the phase II trial will be an open label trial designed to assess the safety and diagnostic performance of CardioPET as compared to stress echocardiography, myocardial perfusion imaging, and angiography. Two trial sites are planned in Belgium and results are expected in the second half of this year.
Thijs Spoor, President and Chief Executive Officer of FluoroPharma Medical, stated, “We are delighted to announce SGS Life Science Services as the CRO for this phase II trial; a significant milestone for FluoroPharma and our extraordinary pipeline of products. Symptomatic coronary artery disease (CAD) affects millions of patients worldwide and accounts for a significant and increasing percentage of all deaths. It is clear that novel diagnostic imaging agents are urgently required and we are focused on driving forward the development of our pipeline to meet these needs.
“We are very excited to be initiating this Phase II study for CardioPET,” added David Elmaleh, Chief Scientific Officer of FluoroPharma Medical. “CardioPET’s differentiated and superior imaging profile could have a significant impact on the evaluation of CAD patients across the spectrum of disease severity. Because CardioPET can detect perfusion and fatty acid uptake insufficiency in the myocardium; CardioPET could potentially be an accurate alternative to stress-testing in patients with CAD.”
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