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Clinical performance validation of a novel biomarker for quantitative imaging of coronary artery disease.

Periodic Reporting for period 2 - MPIPETrace (Clinical performance validation of a novel biomarker for quantitative imaging of coronary artery disease.)

Reporting period: 2017-04-01 to 2019-03-31

The objective of this project was conducting Phases I and II clinical trials of our novel biomarker for Myocardial Perfusion Imaging using Positron Emission Tomography (PET) for diagnostics of coronary artery disease (CAD). CAD is the most common form of heart disease and is the leading cause of death in Europe and the Western World. PET Myocardial Perfusion Imaging (MPI) offers the unique possibility of measuring and quantifying myocardial blood flow and coronary flow reserve in absolute terms, which serve as a prognostic marker for adverse cardiac events: It can predict the risk of heart attacks. PET also offers advantages such as: superior image quality and diagnostic ability, reduction of unnecessary invasive downstream procedures and reduction of patients’ risks due to reduced radiation doses and shorter period of radiation retention. Currently, there is an unmet need of simple and efficient PET myocardial perfusion imaging agents. Our analysis shows that the adoption of Positron Emission Tomography for Myocardial Perfusion Imaging will occur as a result of numerous clinical advantages and the growing abundance and availability of PET scanners in recent and future years. There is compelling evidence that our novel biomarker is addressing a high growth trend in a high volume market of the cardiovascular disease nuclear imaging, specifically the growing need of non-invasive cardiac diagnostics methods.
We set out to advance a novel PET/CT compound for improved diagnosis of cardiac diseases. The project targeted execution of clinical trials phase I and II which we have successfully completed according to plan made within a proposal.
Having met successfully the end-points of phase I clinical trials, namely safety and early elimination of the injected dose of [11C] DMDPA in young healthy male adults, we proceeded in conducting phase II clinical trial.
The main objectives of phase II clinical trial were to assess the safety of [11C] DMDPA in subjects with known or suspected CAD (Coronary Artery Disease) and to optimize the dose levels for injection at vasodilatation stress and at rest.
With no patient withdrawal and no SAEs (serious adverse events) reported coupled with optimizing dose levels for injection, the main objectives of the study were achieved.
As secondary end-points of the trial the evaluation and optimization of image parameters and diagnostic ability were defined.
With defect magnitude evidenced coupled with the ability to diagnose perfusion disturbances and quantitatively assessing myocardial perfusion, the secondary objectives of the study were met.
In conclusion, study results show that the injected dose levels of [11C] DMDPA tested in patients with known or suspected CAD were safe and well tolerated. Optimized dose levels were defined and diagnostic ability was manifested thus [11C] DMDPA is a relevant candidate for MPI.
Our ambition is to improve clinical decisions in the area of Coronary artery disease (CAD) by early diagnoses prior to the first symptoms by introducing a new non-invasive screening procedure thus decrease costs and risks associated with invasive diagnosis of patients. Furthermore, we intend to educate, promote and standardize the PET perfusion agents for cardiology and CAD diagnosis and stratification, in a similar manner as in the case of PET use for oncological purposes to date. Consequently, we would like to see CAD, the single most common cause of death in Europe, responsible for 1.8 million deaths annually, be removed from the number one cause of death. Moreover, we aim to overcome the current technology limitation causing women suffering from a lesser early diagnosis than men, thus decreasing women mortality.
In the backdrop of the world ageing population, especially in Europe, we intend to contribute to the sustainability and equity of European health. The main two areas of contribution are decreasing the current number of annual deaths in Europe of 4 million and freeing related resources estimated today at EUR 200 M annually. Improving health and releasing resources will provide society at large more flexibility in deciding on social fund allocation and priorities.
Quality Control laboratory
Synthesis module for the production of radiopharmaceuticals.
Solutions used for DMDPA quality control tests
Synthesis module for the production of radiopharmaceuticals.
Production of DMDPA radiotracer for clinical trials