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  • Final Report Summary - 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)

Final Report Summary - 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)

Executive Summary:
The CosmoPHOS-nano Project (EU FP7 NMP – GA 310337) was a Large-scale Five-year Nanomedicine R&D Project co-funded by the European Union. It started on March 1, 2013 and finished on February 28, 2018. The CosmoPHOS-nano Project consortium consisted of 22 world-class Participants, including 15 Universities and Research Organizations and 7 Companies. The CosmoPHOS Ltd, established in Thessaloniki, Greece (Ellas), is the CosmoPHOS-nano Project’s technology commercialization and new business development European SME (European small-medium enterprise).

The highly ambitious CosmoPHOS-nano Project was one of the global-largest Nanomedicine R&D Projects in Cardiology and Cardiovascular Medicine that successfully developed and nonclinically tested the highly innovative CosmoPHOS System, which is anticipated eventually to be used in humans for the therapy of atherosclerotic coronary artery disease (CAD) of the heart. CAD causes the heart attacks (acute myocardial infarctions) and is the No1 cause of human death and morbidity in Europe and worldwide.
Additionally, the CosmoPHOS-nano Project successfully tested nonclinically a New Therapy Method and a New Imaging Method for the atherosclerotic coronary artery disease (CAD) of the heart, which could potentially bring a Radical Medical Innovation in the state-of-the-art of CAD therapy in humans by using the CosmoPHOS System.

The nonclinical data / results of the CosmoPHOS-nano Project are extremely promising and the CosmoPHOS System has the potential to become a very powerful, safe, and affordable medical solution for CAD, without the need for new investments in heavy and expensive medical equipment and infrastructure in the current clinical setting.

The CosmoPHOS System is a highly innovative nanotechnology-enabled, portable, theranostic (therapeutic and diagnostic), combination system for ultimate future human use, comprising the following two Interacting Components:
A. The CosmoPHOS – Near-infrared Photoactivatable Biocompatible Nanomedicine (CosmoPHOS – NIR PBN); and
B. The CosmoPHOS – Medical Devices (CosmoPHOS – MDs).

The CosmoPHOS System could potentially lead to a New Era the therapy of atherosclerotic coronary artery disease (CAD) of the heart in humans by enabling the following radically innovative therapy and imaging medical methods / modalities and combinations of them:
a) Endovascular targeted near-infrared nanotechnology-enabled photodynamic therapy (endovascular targeted NIR nano-PDT);
b) Endovascular in vivo nanotechnology-enabled near-infrared fluorescence/optical-enabled imaging (endovascular in vivo nano-NIRF/optical-enabled imaging);
c) Follow-up therapy monitoring; and
d) Theranostics.

The CosmoPHOS System has been very cleverly designed to be fully compatible with the current clinical setting and clinical practice in Europe and worldwide, and fully compatible and fully complementary with all the existing state-of-the-art treatment and imaging methods / modalities and technologies of atherosclerotic coronary artery disease (CAD) of the heart in humans, which currently include: a) Medicines (Drugs, Monoclonal Antibodies, etc.), b) Minimal Invasive PTCA (Percutaneous Transluminal Coronary Angioplasty) with or without coronary “stent” implantation (Bare Metal Stents - BMS and Drug Eluting Stents - DES), c) CABG (Coronary Artery By-pass Graft) Surgery, and d) Imaging modalities (Coronary Angiography, MSCT Coronary Angiography, etc.).

The future medical / clinical indications of the CosmoPHOS System are anticipated to be the following:
1) Therapy of atherosclerotic coronary artery disease (CAD) of the heart (the cause of heart attacks – the No1 cause of human death and morbidity in Europe and worldwide);
2) Therapy of atherosclerotic carotid artery disease (the major cause of strokes - the No3 cause of human death and morbidity in Europe and worldwide);
3) Therapy of atherosclerotic peripheral artery disease;
4) Therapy of atherosclerosis in general;
5) Therapy of “stent” restenosis; and
6) Potentially, therapy of other diseases such as, but not limited to, cancer (the No2 cause of human death and morbidity in Europe and worldwide) and inflammatory and autoimmune diseases.

Project Context and Objectives:
The CosmoPHOS-nano Project was a translational, multidisciplinary, medical product-development, and business-oriented Nanomedicine R&D Project which aimed to develop, nonclinically evaluate, and clinically validate the CosmoPHOS System (the highly innovative end-product of the CosmoPHOS-nano Project), for ultimate future human use in the therapy of atherosclerotic coronary artery disease (CAD) of the heart that causes the heart attacks (acute myocardial infarctions) and is the No1 cause of human death and morbidity in Europe and worldwide.

In order to implement the above presented concept, the CosmoPHOS-nano project aimed to accomplish the following four objectives:

1) Technological Objective: Develop the CosmoPHOS System. This technological objective was split into two sub-objectives:
• Sub-objective one: Develop the CosmoPHOS – NIR PBN; and
• Sub-objective two: Develop the CosmoPHOS – MDs.

2) Nonclinical Objective: Nonclinically evaluate the CosmoPHOS System in vitro and in vivo (in small and large animal models of atherosclerosis), cGMP / Clinical-grade manufacture the CosmoPHOS System according to EU guidelines, perform toxicological / pharmacokinetic / safety studies of the CosmoPHOS System, and obtain regulatory approval for investigational human use of the CosmoPHOS System.

3) Clinical Objective: Conduct a first-in-man phase-I clinical trial in 20 CAD patients, in order to study the safety, feasibility, and tolerability of the regulatory approved CosmoPHOS System.

4) Impact-related Objective: Reduce in the long-term the deaths and morbidity of CAD by up to 40%, resulting in a substantial decrease of the enormous European and global healthcare costs for CAD, which rank No1 among all categories of healthcare costs, while increase the competitiveness of the European healthcare industry in CAD market, which is the global-largest healthcare market, and generate globally a huge positive impact to Patients and to their Families as well as to the Society at large.

Project Results:
The main S&T achievements of the highly successful R&D work performed during the 60 months of the CosmoPHOS-nano Project can be summarized as follows:
1) 139 different CosmoPHOS – NIR PBNs were developed and tested in vitro. The most effective and safe of these CosmoPHOS – NIR PBNs were additionally tested in vivo in small and large animal models of atherosclerosis;
2) 2 generations of the CosmoPHOS – Therapy MDs were developed and tested in the lab. The most effective and safe 2nd generation CosmoPHOS – Therapy MDs were additionally tested in vivo in large animal models of atherosclerosis;
3) 2 generations of the CosmoPHOS – Imaging MDs were developed and tested in the lab. The most effective and safe 2nd generation CosmoPHOS – Imaging MDs were additionally tested in vivo in large animal models of atherosclerosis;
4) The CosmoPHOS-nano Project Consortium selected: a) the best CosmoPHOS – NIR PBN, b) the best CosmoPHOS – Therapy MDs, and c) the best CosmoPHOS – Imaging MDs. These were the selected components of the CosmoPHOS System that proceeded to the second stage of the CosmoPHOS-nano Project;
5) Preparatory cGMP / Clinical-grade Manufacturing studies for the CosmoPHOS System were undertaken;
6) Preparatory Toxicological / Pharmacokinetic / Safety in vitro and in vivo studies for the CosmoPHOS System were also undertaken;
7) The CosmoPHOS System was tested in the large-scale nonclinical in vivo safety and efficacy studies in large animal models of atherosclerosis, where the CosmoPHOS System showed very high in vivo efficacy, safety, feasibility, and tolerability; and
8) The extensive data analysis of the highly successful results of the large-scale nonclinical in vivo safety and efficacy studies of the CosmoPHOS System in large animal models of atherosclerosis has been completed, and will be utilized for the development of the CosmoPHOS System’s Regulatory Dossier for investigational human use approval by the Competent Authorities.

At the end of the CosmoPHOS-nano Project, the highly innovative CosmoPHOS System is totally ready to proceed to the Full cGMP / Clinical-grade Manufacturing and Full Toxicological / Pharmacokinetic / Safety Evaluation Stage, in order to obtain Regulatory Approval and to enter into the Clinical Validation Stage in a First-in-man Phase-I Clinical Trial in CAD (Coronary Artery Disease) Patients.

The Participants that utilized animals in all the above in vivo studies of the CosmoPHOS-nano Project have all the required National Authorizations from the relevant National Animal Experiment Boards and Ethics Committees.

The CosmoPHOS-nano Project was a medical product-development and business-oriented project. For this reason, highest priority has been given to the securing of the Strategic Foreground IP (Intellectual Property) of the CosmoPHOS System, over the dissemination activities.

Two Joint International Patent Applications (PCTs) have been already filed during the contractual duration of 60 months of the CosmoPHOS-nano Project.

However, the complete securing of the entire Strategic Foreground IP of the CosmoPHOS System through the filing of New Patent Application(s) is still ongoing, and for this reason the most important publications of the CosmoPHOS-nano Project are still pending. For more information regarding the dissemination activities of the CosmoPHOS-nano Project, please see Section 4.2 – A (Publications) of the Final Report.

Once the entire Strategic Foreground IP of the CosmoPHOS System will be secured with New Patent Application(s) after the contractual duration of 60 months of the CosmoPHOS-nano Project, then the Flagship Scientific Article of the CosmoPHOS-nano Project will be drafted and will be submitted for publication in a very high impact factor peer-review Scientific Journal. Other very important publications of the CosmoPHOS-nano Project will also follow.

Potential Impact:
Globally, atherosclerotic coronary artery disease (CAD) of the heart is the No1 cause of human death and morbidity, and is predicted to remain so for the next 20 years. Every year, approximately 7.3 million deaths (3.8 million men and 3.5 million women) are due to heart attacks (acute myocardial infarctions) caused by CAD (source: WHO). CAD is the No1 cause of human death in Europe, accounting for 2 million deaths every year. It is estimated that over one in five deaths each year in Europe are due to CAD (22% in women and 21% in men), placing CAD as the primary healthcare problem in Europe. The direct and indirect economic cost of Cardiovascular Diseases for the EU is approximately €300 billion per year, and globally is approximately $860 billion per year, while the major part of that cost is due to CAD (sources: European Cardiovascular Disease Statistics 2008, and Bloom D.E. World Economic Forum 2011). It is estimated that CAD costs the Healthcare Systems approximately one quarter (22%) of the total healthcare expenditure (source: Frost & Sullivan report “At what price–heart disease in Europe” 2008). Approximately one million working years are lost every year in EU because of CAD mortality, and 90 million working days are lost every year in EU because of CAD morbidity (source: CLARIFY Registry).

Nowadays, Cardiology and Cardiovascular Medicine in Europe and worldwide address only the risk factors of CAD with medicines such as statins, antiplatelet drugs, antihypertensive drugs, antidiabetic drugs / insulins, monoclonal antibodies, and other medicines, and also address the obstructive coronary atherosclerotic plaques of the heart (with more than 70% stenosis of the coronary artery lumen) by performing either catheter-based coronary artery balloon angioplasty (PTCA) with or without coronary “stent” implantation (Bare Metal Stents - BMS and Drug Eluting Stents - DES), or by performing coronary artery bypass graft surgery (CABG).

However, the vast majority of heart attacks (acute myocardial infractions) are caused by the rupture or erosion of coronary atherosclerotic plaques of the heart which are non-obstructive / non-flow-limiting (with less than 70% stenosis of the coronary artery lumen, and in the most of the cases even less than 50% stenosis of the coronary artery lumen). These are the so-called “vulnerable” coronary atherosclerotic plaques which, in the majority of the cases, do not exhibit prior clinical symptoms, and this is the reason why nowadays, despite the overall progress of Cardiology and Cardiovascular Medicine, atherosclerotic coronary artery disease (CAD) of the heart still remains by far the No1 cause of human death and morbidity in Europe and worldwide.

The CosmoPHOS System has the potential to provide therapy, imaging, therapy monitoring, and theranostics for these extremely dangerous and life-threatening “vulnerable” coronary atherosclerotic plaques of the heart in humans, which are the culprit lesions in the vast majority of heart attacks (acute myocardial infarctions), and by doing this, the CosmoPHOS System has the potential to address the most significant unmet medical need in the current CAD treatment strategy in Europe and worldwide.

It is anticipated that the CosmoPHOS System has the potential to achieve a substantial reduction by up to 40% of CAD deaths and morbidity in Europe and worldwide. This is because the CosmoPHOS System has the potential to provide therapy for the clinically asymptomatic, non-obstructive / non-flow-limiting (<70% luminal stenosis), extremely dangerous and life-threatening “vulnerable” coronary atherosclerotic plaques of the heart in humans, which are the culprit lesions in the 86% of all heart attacks (acute myocardial infarctions) in Europe and worldwide, and which are very poorly treated nowadays.

The CosmoPHOS System has been very cleverly designed to be:
A. Fully compatible with the current clinical setting and clinical practice in Europe and worldwide; and
B. Fully compatible and fully complementary with all the existing state-of-the-art treatment and imaging methods / modalities and technologies of atherosclerotic coronary artery disease (CAD) of the heart in Europe and worldwide.
This has the potential to substantially facilitate the adoption and the wide clinical future use of the CosmoPHOS System in Europe and worldwide for the therapy, not only treatment, of the extremely dangerous and life-threatening “vulnerable” coronary atherosclerotic plaques of the heart in humans, which are very poorly treated nowadays.

The CosmoPHOS-nano Project was a medical product-development and business-oriented project. For this reason, highest priority has been given to the securing of the Strategic Foreground IP (Intellectual Property) of the CosmoPHOS System, over the dissemination activities. For more information regarding the dissemination activities of the CosmoPHOS-nano Project, please see Section 4.2 – A (Publications) of the Final Report.

The CosmoPHOS-nano Project has a Long-term Strategic Business Plan for Commercial Exploitation of the CosmoPHOS System through the CosmoPHOS Ltd.

The CosmoPHOS Ltd is the CosmoPHOS-nano Project’s technology commercialization and new business development European SME (European small-medium enterprise). The CosmoPHOS Ltd is established in Thessaloniki, Greece (Ellas) and it was founded in 2012 by Dr med Panagiotis (Panos) N. Trohopoulos. Dr med Panagiotis (Panos) N. Trohopoulos has also founded the CosmoPHOS-nano Project in 2004, and he was the Scientific / Exploitation / Strategic Coordinator and the driving force of the entire CosmoPHOS-nano Project.

The CosmoPHOS Ltd will strongly lead all the efforts to secure financial support / funding / investments (public and/or private) during the post-project period in order to successfully carry out the Long-term Strategic Business Plan for Commercial Exploitation of the CosmoPHOS System.

More specifically, the CosmoPHOS Ltd will be focused in the anticipated primary medical / clinical indication of the CosmoPHOS System which is the therapy of atherosclerotic coronary artery disease (CAD) of the heart (the cause of heart attacks – the No1 cause of human death and morbidity in Europe and worldwide), strongly leading all the efforts to secure financial support / funding / investments (public and/or private) in order to successfully achieve the following objectives:
a) cGMP / Clinical-grade Manufacturing, Toxicological / Pharmacokinetic / Safety Studies, and Phase-I Clinical Trial(s) of the CosmoPHOS System;
b) Phase-II Clinical Trial(s) of the CosmoPHOS System;
c) Phase-III Clinical Trial(s) of the CosmoPHOS System;
d) Regulatory Approval of the CosmoPHOS System for human use by the Competent Authorities; and
e) Marketing Authorization and Commercial Exploitation of the CosmoPHOS System through the CosmoPHOS Ltd, in order to ultimately reach the CAD patients in Europe and worldwide.
Atherosclerotic coronary artery disease (CAD) of the heart concerns the young population, the middle-age population, as well as the aging population of the Society in Europe and worldwide.

Furthermore, if additional financial support / funding / investments (public and/or private) will be secured through the strong leadership of the CosmoPHOS Ltd, then the same Long-term Strategic Business Plan for Commercial Exploitation of the CosmoPHOS System would also be implemented in parallel for the following anticipated additional medical / clinical indications of the CosmoPHOS System:
1) Therapy of atherosclerotic carotid artery disease (the major cause of strokes - the No3 cause of human death and morbidity in Europe and worldwide);
2) Therapy of atherosclerotic peripheral artery disease;
3) Therapy of atherosclerosis in general;
4) Therapy of “stent” restenosis; and
5) Potentially, therapy of other diseases such as, but not limited to, cancer (the No2 cause of human death and morbidity in Europe and worldwide) and inflammatory and autoimmune diseases.

The unique technology of the CosmoPHOS System is way ahead of any potential competitors in Europe, USA, Asia, Australia, and worldwide, and the CosmoPHOS System has the potential to become a Disruptive “Made in EU” Blockbuster Medical Product capable to treat the largest patient population in Europe and worldwide. This could result to:
1. Achieve a significant reduction in CAD / atherosclerotic cardiovascular diseases deaths and morbidity in Europe and worldwide, and potentially achieve a significant reduction in the deaths and morbidity caused by other diseases such as, but not limited to, cancer and inflammatory and autoimmune diseases in Europe and worldwide;
2. Achieve a significant reduction in the hospitalization and re-hospitalization of CAD / atherosclerotic cardiovascular diseases patients in Europe and worldwide, and potentially achieve a significant reduction in the hospitalization and re-hospitalization of patients with other diseases such as, but not limited to, cancer and inflammatory and autoimmune diseases in Europe and worldwide;
3. Achieve a significant improvement in the quality of life and in the working productivity of CAD / atherosclerotic cardiovascular diseases patients in Europe and worldwide, and potentially achieve a significant improvement in the quality of life and in the working productivity of patients with other diseases such as, but not limited to, cancer and inflammatory and autoimmune diseases in Europe and worldwide;
4. Alleviate the Healthcare Systems (public and private) and the Health Insurance Companies / Life Insurance Companies in Europe and worldwide by decreasing substantially the enormous healthcare costs of CAD / atherosclerotic cardiovascular diseases, which rank No1 among all categories of healthcare costs, and potentially by decreasing substantially the healthcare costs of other diseases such as, but not limited to, cancer and inflammatory and autoimmune diseases in Europe and worldwide;
5. Increase the competitiveness of the European Healthcare Industry in the global market since the CosmoPHOS System, which has the potential to treat the largest patient population in Europe and worldwide, will be manufactured in Europe and will be sold around the world;
6. Create numerous new jobs in Europe; and
7. Generate globally a huge positive impact to Patients and to their Families, as well as to the Society at large.

List of Websites:
Prof Seppo Ylä-Herttuala
ITÄ -SUOMEN YLIOPISTO
Yliopistonranta 1 E
P.O. Box 1627
Kuopio 70211
FINLAND
Tel: +35 8403552075
E-mail: seppo.ylaherttuala@uef.fi

CosmoPHOS-nano Project website address: http://cosmophos-nano.eu


Dr med Panagiotis (Panos) N. Trohopoulos
CosmoPHOS Ltd
77 Tsimiski Street
GR – 54622
Thessaloniki
GREECE (ELLAS)
Tel: +30 2310419888
Cell: +30 6937088800
E-mail: panagiotis.trohopoulos@cosmophos.com

CosmoPHOS-nano Project website address: http://cosmophos-nano.eu

Reported by

ITÄ-SUOMEN YLIOPISTO
Finland
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