MARSEILLE, France—Trophos SA has announced a €6 million ($8.05 million) European Union award to support MitoCare, a two-and-a-half year international, translational medicine project involving a 16-partner consortium to be led by Trophos, a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology
MitoCare forms part of the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (FP7) and will investigate the efficacy and safety of TRO40303 in a Phase II proof-of-concept (POC) study to treat cardiac ischemia-reperfusion injury (IRI) in acute myocardial infarction (MI) patients and develop knowledge of biomarkers and models of cardiac ischemia-reperfusion injury.
"We are proud the European Union, after extensive expert evaluation, has chosen to support the MitoCare project and Trophos is very pleased to be collaborating with a distinguished panel of clinical, academic and SME [small and medium-sized enterprise] partners," says Damian Marron, Trophos' CEO. "There are around 1.6 million cardiac reperfusion procedures performed in hospitals and specialist clinics each year in the western world alone. This program fits perfectly with Trophos' strategy of creating value by targeting niche, high medical need markets. Cardiac reperfusion injury is a significant unmet medical need with no existing treatment that contributes to long-term morbidity, progression to heart failure and death following a MI."
"Trophos is excellently positioned to deliver on its goals with this program as well as with our lead product, olesoxime, in a Phase III study for the orphan neurological disease of amyotrophic lateral sclerosis as part of another EU-funded project, MitoTarget," adds Marron.
In conducting MitoCare, Trophos is leading a consortium of nine clinical centers, three basic research centers and four SME's (including Trophos), for a total of 16 teams around Europe specializing in clinical and basic research, biomarkers, imaging and informatics. MitoCare's main aims are to: demonstrate the therapeutic efficacy and safety of TRO40303, a novel mitochondrial pore modulator, in the treatment of ischemia-reperfusion injury in a Phase II POC study in acute MI patients; conduct translational research to gain a greater understanding of the biomarkers and confounding/predictive factors in cardiac IRI, and carry out research to improve understanding and use of pre-clinical models of cardiac IRI.
The TRO40303 clinical study will be sponsored by Trophos and performed by a consortium of prominent European clinical investigators, all of whom have extensive prior experience conducting and collaborating in large multicenter clinical trials in cardiac IRI.
The translational research will focus on exploration of predictive and confounding factors of response in humans, analysis of new markers for necrosis and heart failure, analysis of variability in pre-clinical models and comparison of human and preclinical data to identify the most predictable preclinical models.
TRO40303, the second of Trophos' proprietary cholesterol oxime mitochondrial pore modulators, is currently undergoing a Phase I study in healthy volunteers. Results from this study are expected in the first quarter of 2011.
The mechanism of action of TRO40303 involves prevention of stress-induced mitochondrial permeability transition, a target implicated in cardiac reperfusion injury as well as neurodegenerative diseases and other pathologies.
MitoCare forms part of the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (FP7) and will investigate the efficacy and safety of TRO40303 in a Phase II proof-of-concept (POC) study to treat cardiac ischemia-reperfusion injury (IRI) in acute myocardial infarction (MI) patients and develop knowledge of biomarkers and models of cardiac ischemia-reperfusion injury.
"We are proud the European Union, after extensive expert evaluation, has chosen to support the MitoCare project and Trophos is very pleased to be collaborating with a distinguished panel of clinical, academic and SME [small and medium-sized enterprise] partners," says Damian Marron, Trophos' CEO. "There are around 1.6 million cardiac reperfusion procedures performed in hospitals and specialist clinics each year in the western world alone. This program fits perfectly with Trophos' strategy of creating value by targeting niche, high medical need markets. Cardiac reperfusion injury is a significant unmet medical need with no existing treatment that contributes to long-term morbidity, progression to heart failure and death following a MI."
"Trophos is excellently positioned to deliver on its goals with this program as well as with our lead product, olesoxime, in a Phase III study for the orphan neurological disease of amyotrophic lateral sclerosis as part of another EU-funded project, MitoTarget," adds Marron.
In conducting MitoCare, Trophos is leading a consortium of nine clinical centers, three basic research centers and four SME's (including Trophos), for a total of 16 teams around Europe specializing in clinical and basic research, biomarkers, imaging and informatics. MitoCare's main aims are to: demonstrate the therapeutic efficacy and safety of TRO40303, a novel mitochondrial pore modulator, in the treatment of ischemia-reperfusion injury in a Phase II POC study in acute MI patients; conduct translational research to gain a greater understanding of the biomarkers and confounding/predictive factors in cardiac IRI, and carry out research to improve understanding and use of pre-clinical models of cardiac IRI.
The TRO40303 clinical study will be sponsored by Trophos and performed by a consortium of prominent European clinical investigators, all of whom have extensive prior experience conducting and collaborating in large multicenter clinical trials in cardiac IRI.
The translational research will focus on exploration of predictive and confounding factors of response in humans, analysis of new markers for necrosis and heart failure, analysis of variability in pre-clinical models and comparison of human and preclinical data to identify the most predictable preclinical models.
TRO40303, the second of Trophos' proprietary cholesterol oxime mitochondrial pore modulators, is currently undergoing a Phase I study in healthy volunteers. Results from this study are expected in the first quarter of 2011.
The mechanism of action of TRO40303 involves prevention of stress-induced mitochondrial permeability transition, a target implicated in cardiac reperfusion injury as well as neurodegenerative diseases and other pathologies.
