Marseille, France, 2009 October 7 - Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, announced today that olesoxime, its lead compound, has been selected as one of the five most interesting products entering phase 3 in the "Ones to Watch" report. A Thomson Reuters quarterly review of the latest phase changes in the pharmaceutical pipeline, the "Ones to Watch" is based on independent, strategic data and analysis from Thomson Pharma, the world's leading pharmaceutical competitive intelligence solution. For a copy of the full report with analysis, visit: http://science.thomsonreuters.com/info/matters/.
Olesoxime is currently in an ongoing pivotal efficacy study in Amyotrophic Lateral Sclerosis (ALS), which is supported by the EU MitoTarget project (see below). The trial protocol has benefited from EMEA Protocol Advice procedure. Efficacy results are expected in mid-2011 (see press release of 5th May 2009).
"We are delighted that the promise of olesoxime has been recognised by the independent experts of Thomson Reuters," said Damian Marron, Chief Executive Officer of Trophos." We believe olesoxime could be a valuable new medicine for the ALS community and we are looking forward to the results of the ongoing study, which we hope will demonstrate that promise and bring new hope to ALS patients."
Olesoxime (TRO19622) is the lead compound of the Trophos' proprietary cholesterol-oxime compound family of mitochondrial pore modulators. Preclinical studies have demonstrated that the compounds promote the function and survival of neurons and other cell types under disease-relevant stress conditions through interactions with the mitochondrial permeability transition pore (mPTP) and olesoxime has been shown to be active in the SOD1 model of ALS (Bordet et al., JPET 322:709-720, 2007).
Olesoxime has successfully completed phase I studies in healthy volunteers and phase Ib studies in ALS patients. These clinical trials demonstrated that the product is well-tolerated and has an excellent safety profile. They also showed that once-a-day oral dosing achieves the predicted exposure level required for efficacy, based on preclinical models. Drug interaction studies with riluzole, the only registered treatment for ALS, showed no interaction of TRO19622 on riluzole pharmacokinetics.
The ongoing clinical study of olesoxime is part of a three year collaborative project named MitoTarget. The European Commission has awarded a grant of nearly EUR 6 million for MitoTarget which will be carried out by a consortium led by Trophos. MitoTarget forms part of the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities. As well as the clinical trial, MitoTarget aims to enlarge the understanding of mitochondrial dysfunction in neurodegenerative diseases and assess the therapeutic potential of Trophos' novel proprietary class of mitochondrial pore modulator molecules in neurological diseases (see press release of 18 December, 2008).
About ALS (Amyotrophic Lateral Sclerosis):
ALS, more commonly known as Lou Gehrig's disease in the USA, is a progressive and fatal neurological disease that is estimated to affect over 100,000 people worldwide. There is no cure for ALS. The only drug approved for ALS is riluzole (Sanofi-Aventis), which has been demonstrated to give a 2-3 month survival benefit to ALS patients.
For more information about ALS, see http://www.alsa.org
About Trophos: http://www.trophos.com
Trophos is a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology. The Company has a novel and proprietary cholesterol-oxime based chemistry platform generating a pipeline of drug candidates, with the lead product, olesoxime (TRO19622), in phase II clinical trials and a second product, TRO40303, planned to enter the clinic in 2009. Trophos' mitochondrial pore modulator compounds enhance the function and survival of stressed cells via modulation of dysfunctional mitochondria through interactions at the permeability transition pore (mPTP). Recently published clinical studies support the therapeutic rationale for mitochondria targeted drugs in neurology (Alzheimer's disease) and cardiology (ischemia-reperfusion injury), which Trophos is uniquely placed to exploit.
Trophos gratefully acknowledges the use of data from Thomson Pharma provided by Thomson Reuters.
Olesoxime is currently in an ongoing pivotal efficacy study in Amyotrophic Lateral Sclerosis (ALS), which is supported by the EU MitoTarget project (see below). The trial protocol has benefited from EMEA Protocol Advice procedure. Efficacy results are expected in mid-2011 (see press release of 5th May 2009).
"We are delighted that the promise of olesoxime has been recognised by the independent experts of Thomson Reuters," said Damian Marron, Chief Executive Officer of Trophos." We believe olesoxime could be a valuable new medicine for the ALS community and we are looking forward to the results of the ongoing study, which we hope will demonstrate that promise and bring new hope to ALS patients."
Olesoxime (TRO19622) is the lead compound of the Trophos' proprietary cholesterol-oxime compound family of mitochondrial pore modulators. Preclinical studies have demonstrated that the compounds promote the function and survival of neurons and other cell types under disease-relevant stress conditions through interactions with the mitochondrial permeability transition pore (mPTP) and olesoxime has been shown to be active in the SOD1 model of ALS (Bordet et al., JPET 322:709-720, 2007).
Olesoxime has successfully completed phase I studies in healthy volunteers and phase Ib studies in ALS patients. These clinical trials demonstrated that the product is well-tolerated and has an excellent safety profile. They also showed that once-a-day oral dosing achieves the predicted exposure level required for efficacy, based on preclinical models. Drug interaction studies with riluzole, the only registered treatment for ALS, showed no interaction of TRO19622 on riluzole pharmacokinetics.
The ongoing clinical study of olesoxime is part of a three year collaborative project named MitoTarget. The European Commission has awarded a grant of nearly EUR 6 million for MitoTarget which will be carried out by a consortium led by Trophos. MitoTarget forms part of the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities. As well as the clinical trial, MitoTarget aims to enlarge the understanding of mitochondrial dysfunction in neurodegenerative diseases and assess the therapeutic potential of Trophos' novel proprietary class of mitochondrial pore modulator molecules in neurological diseases (see press release of 18 December, 2008).
About ALS (Amyotrophic Lateral Sclerosis):
ALS, more commonly known as Lou Gehrig's disease in the USA, is a progressive and fatal neurological disease that is estimated to affect over 100,000 people worldwide. There is no cure for ALS. The only drug approved for ALS is riluzole (Sanofi-Aventis), which has been demonstrated to give a 2-3 month survival benefit to ALS patients.
For more information about ALS, see http://www.alsa.org
About Trophos: http://www.trophos.com
Trophos is a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology. The Company has a novel and proprietary cholesterol-oxime based chemistry platform generating a pipeline of drug candidates, with the lead product, olesoxime (TRO19622), in phase II clinical trials and a second product, TRO40303, planned to enter the clinic in 2009. Trophos' mitochondrial pore modulator compounds enhance the function and survival of stressed cells via modulation of dysfunctional mitochondria through interactions at the permeability transition pore (mPTP). Recently published clinical studies support the therapeutic rationale for mitochondria targeted drugs in neurology (Alzheimer's disease) and cardiology (ischemia-reperfusion injury), which Trophos is uniquely placed to exploit.
Trophos gratefully acknowledges the use of data from Thomson Pharma provided by Thomson Reuters.
