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  • Periodic Report Summary 2 - COSMOPHOS-NANO (Novel nanotechnology-enabled system for endovascular in vivo near-infrared fluorescence molecular imaging and endovascular near-infrared targeted photodynamic therapy of atherosclerotic heart disease)
FP7

COSMOPHOS-NANO Report Summary

Project ID: 310337
Funded under: FP7-NMP
Country: Finland

Periodic Report Summary 2 - COSMOPHOS-NANO (Novel nanotechnology-enabled system for endovascular in vivo near-infrared fluorescence molecular imaging and endovascular near-infrared targeted photodynamic therapy of atherosclerotic heart disease)

Project Context and Objectives:
The CosmoPHOS-nano Project is a large-scale, translational, medical product-development and business-oriented nanomedicine R&D project aiming to develop, non-clinically evaluate and clinically validate the novel CosmoPHOS System (the end-product of the CosmoPHOS-nano Project) to address atherosclerotic Coronary Artery Disease (CAD) of the heart, which causes heart attacks and is by far the No1 cause of human death and morbidity in Europe and worldwide.

The CosmoPHOS System is a radical innovative nanotechnology-enabled portable theranostic (therapeutic and diagnostic) combination medical product that enables endovascular in vivo near infrared fluorescence-based molecular imaging, endovascular near infrared targeted photodynamic therapy, real-time and follow-up therapy monitoring, and theranostics of CAD and atherosclerosis in general. The CosmoPHOS System could also be used in other diseases.

Cardiology today, in Europe and worldwide, addresses only the risk factors of CAD by using drugs, and the obstructive coronary artery atherosclerotic plaques (> 70% stenosis of coronary artery lumen) by catheter-based coronary balloon angioplasty (PTCA) or bypass surgery (CABG).

But, heart attacks generally result from the rupture or erosion of atherosclerotic plaques which are non-occlusive / non-flow-limiting and which are causing, in the majority of cases, < 50% stenosis of the coronary artery lumen without any prior clinical symptoms, the so-called “vulnerable” plaques.

Today there is no imaging modality to detect these “vulnerable” coronary atherosclerotic plaques at risk, and most importantly there is no effective therapy to address these “vulnerable” plaques. This is the reason why CAD is still the No1 cause of human death and morbidity in Europe and worldwide.

The novel CosmoPHOS System is a smart nanotechnology-enabled system that addresses the pathobiology of the human coronary atherosclerotic plaques, and not only the CAD risk factors as the conventional Cardiology is doing today without much success.

The CosmoPHOS System enables molecular imaging, targeted therapy, real-time and follow-up therapy monitoring, and theranostics of CAD, and consists of the following two interacting components,:
1) The CosmoPHOS – theranostic near infrared photoactivatable biocompatible nanomedicines (CosmoPHOS – NIR PBNs), and
2) The CosmoPHOS – medical devices (CosmoPHOS – MDs).

The CosmoPHOS-nano is a five-year large-scale R&D Project co-funded by the European Union (EU FP7 NMP – GA 310337), started on March 1, 2013 until February 28, 2018, and plans to conduct a First-in-man Phase-I Clinical Trial during the last project year in CAD patients to evaluate the safety and feasibility of the CosmoPHOS System for human use.

The CosmoPHOS-nano Project is the world’s largest R&D project of nanomedicine in cardiology, and consists of 19 world-class participants including 13 universities and research foundations and 6 Companies.

Additionally, the CosmoPHOS-nano Project will be the first R&D Project in the history of medicine that will experimentally apply Nanomedicine Technology for patients suffering from atherosclerotic coronary artery disease (CAD) of the heart, and it is the first EU FP7 NMP Funded Large-scale Project planning to apply nanomedicine for cardiac patients.

Project Results:
The CosmoPHOS-nano Project is a medical product-development, and business-oriented Project. This is the reason why despite the huge volume of the highly successful data generated by the Consortium during the First and the Second Reporting Period, we are reluctant to reveal at present more information about the technology of the CosmoPHOS System (the end-product of the CosmoPHOS-nano Project). Part of the Strategic Foreground IP has already secured through Patent Application submission, but once all the Strategic Foreground IP will be secured under Patents protection in the near future, we would be in the position to disseminate more information.

For the time being, we could summarize the main results of the work performed during the first 36 months since the beginning of the CosmoPHOS-nano Project as follows:
1) Numerous different CosmoPHOS – NIR PBNs have been successfully developed and tested both in vitro and in vivo. Many of these CosmoPHOS – NIR PBNs tested are highly effective and safe both in vitro and in vivo (in small and large animal models of atherosclerosis). The CosmoPHOS-nano Project Consortium has unanimously selected the best CosmoPHOS – NIR PBNs to proceed to the Second Stage of the CosmoPHOS-nano Project, towards the Final Non-Clinical Development and Evaluation and the First-in-man Phase-I Clinical Trial;
2) The CosmoPHOS – Molecular Imaging System (CosmoPHOS – MD) has been successfully developed and tested both in vitro and in vivo (in large animal models of atherosclerosis) with great success;
3) The CosmoPHOS – Therapy System (CosmoPHOS – MD) has been successfully developed and tested both in vitro and in vivo (in large animal models of atherosclerosis) with great success; and
4) The advanced Prototype of the Integrated CosmoPHOS System has been successfully developed and tested both in vitro and in vivo (in large animal models of atherosclerosis) for safety, feasibility, and tolerability, as well as for efficacy with great success.

After the successful completion of all the above in vitro and in vivo studies performed during the first 36 months since the beginning of the CosmoPHOS-nano Project (First and Second Reporting Period), the conclusion is that the advanced Prototype of the Integrated CosmoPHOS System is very safe, very well tolerable, cause no death or any other adverse events, and it is very effective in large animal models of atherosclerosis. For all the above reasons, this advanced Prototype of the Integrated CosmoPHOS System is ready to proceed to the Second Stage of the CosmoPHOS-nano Project, towards the Final Non-Clinical Development and Evaluation, before entering the clinical validation stage in the First-in-man Phase-I Clinical Trial during the last project-year.

Potential Impact:
We anticipate that the novel CosmoPHOS System (the end-product of the CosmoPHOS-nano Project) has the potential to achieve a significant reduction in coronary artery disease (CAD) mortality and morbidity rate, which is the No1 cause of human death and morbidity in Europe and worldwide, since it addresses the clinically asymptomatic, non-occlusive (<70% luminal stenosis) “vulnerable” coronary atherosclerotic plaques at risk, which are the culprit lesions for the 86% of all acute myocardial infarctions (heart attacks) that are poorly treated today by the conventional Cardiology, only by drug administration – mainly statins (lipid lowering drugs) and antiplatelet drugs (to reduce thrombosis).

The CosmoPHOS System has been designed to be fully compatible with the current clinical setting, being patient-friendly, cardiologist-friendly, and hospital personnel-friendly. The design of the portable CosmoPHOS System provides a clear clinical advantage, making it easily adoptable by cardiologists and hospital personnel, requiring only minor training. The wide use of the novel CosmoPHOS System in the everyday clinical practice, for the early detection and therapy of the asymptomatic “vulnerable” plaques at risk, in combination with all current imaging and treatment modalities/technologies, has the potential to achieve a significant reduction in CAD deaths and morbidity both in Europe and worldwide, and significantly reduce also the rehospitalisation associated with CAD patients, which is very high.

The CosmoPHOS System can be used not only in CAD, but also in atherosclerosis in general, as well as in other diseases.

Dr med Panagiotis (Panos) N. Trohopoulos (CosmoPHOS Ltd) from Thessaloniki, Greece (Ellas) founded the CosmoPHOS-nano Project 12 years ago, since 2004, and he is the Scientific / Exploitation / Strategic Coordinator of the CosmoPHOS-nano Project. The CosmoPHOS-nano consortium has many years’ history of collaboration, and the CosmoPHOS-nano Project is underpinned by a team devoted to delivering a novel powerful and affordable healthcare solution against the leading cause of death, without the need for heavy and expensive medical equipment. The aim is to provide a New Treatment Strategy for Atherosclerotic Coronary Artery Disease, which will drive down the healthcare costs and the impact that CAD has on Patients, the Healthcare Systems and the Society.

The direct and indirect economic cost of Cardiovascular Diseases for the European Union is approximately €300 billion per year, and the major portion of that cost is due to CAD (source: European Cardiovascular Disease Statistics 2008). CAD places an enormous financial burden on Europe. It is estimated that CAD cost the healthcare systems of the EU just under €24 billion in 2006, approximately one quarter (22%) of the complete healthcare expenditure (source: Frost & Sullivan report “At what price – heart disease in Europe”, March 19, 2008). Furthermore, the socio economic costs due to production losses associated with CAD cost the EU over €35 billion (source: source: Frost & Sullivan report “At what price – heart disease in Europe”, March 19, 2008). Approximately one million working years were lost because of CAD mortality. An additional 90 million working days were lost because of CAD morbidity (source: CLARIFY Registry Investigators).

The CosmoPHOS-nano Project has a clear Strategic Business Plan for the commercial exploitation of the CosmoPHOS System through the CosmoPHOS Ltd. The ultimate goal of the CosmoPHOS-nano Project is that the CosmoPHOS System will be a radical innovative “Made in the EU” medical product capable to treat major patient populations in Europe and Worldwide. This will increase the competitiveness of the European Healthcare Industry in the global market since the CosmoPHOS System will be manufactured in Europe and will be distributed to the whole world, creating numerous new jobs in Europe, especially in the Healthcare Industry Sector.

List of Websites:
www.cosmophos-nano.eu

Contact

Jaana Backman, (Head of the Research Sciences)
Tel.: +35 8505554446
E-mail
Record Number: 188152 / Last updated on: 2016-08-24
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