Old 05-05-2009, 09:13 PM #1
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Default Trophos in Europe

From PharmaLive:

Marseille, France, May 5th, 2009 - Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics for indications with under-served needs in neurology and cardiology, announced today the initiation of the pivotal efficacy study of olesoxime in Amyotrophic Lateral Sclerosis (ALS). The study is supported by EU MitoTarget project (see below). The trial protocol has benefited from EMEA Protocol Advice procedure. Efficacy results are expected in mid-2011.

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.

"We need new treatments that can prolong survival and ideally improve function in ALS patients," said Vincent Meninger, Professor of Neurology at France's Pitié-Salpétrière hospital, Principal Investigator. "Olesoxime has a promising profile and we are looking forward to the results of this study, which we hope will demonstrate that promise and bring new hope to ALS patients."

"The initiation of this important clinical study is a major step in the development of olesoxime," added Jean-Louis Abitbol, Chief Medical Officer at Trophos. "ALS or Lou Gehrig's disease is a devastating illness that is fatal within five years of diagnosis in 80 percent of cases. It urgently requires new therapies that prolong survival as an add-on to riluzole and improve the patient's respiratory and muscular functions. We believe olesoxime could be a valuable new medicine for the ALS community and we are delighted to be cooperating with major clinical centers around Europe to undertake this clinical trial as part of our MitoTarget project, which is supported by the European Union FP7 program."

Trial design and end-points The study is an 18-month randomized, parallel group, double-blind, placebo controlled trial comparing olesoxime against placebo in patients diagnosed with ALS for between 6 and 36 months who are being treated with riluzole. Olesoxime will be dosed at 330 mg once a day oral capsules and riluzole will be dosed in both arms at 50 mg twice a day. Around 500 patients will be recruited into the study in 15 centers in France, Germany, UK, Belgium, the Netherlands and Spain.

The primary end-point of the study is the overall 18 month survival rate. Secondary end-points will include the ALS Functional Rating Scale, time to assisted ventilation, vital capacity (a measure of respiratory function), Manual Muscular Testing and quality of life. Safety and tolerability will be closely monitored and an independent Data Safety Monitoring Board will oversee the trial.

The study is sponsored by Trophos and is being performed by a consortium of prominent European clinical investigators, all of whom have extensive prior experience conducting and collaborating in large multi-center clinical trials in ALS.

"This study is another critical step that further supports the work done by Trophos on mitochondrial mechanism of action, the modulation of mitochondrial dysfunction and release of apoptotic factors," said Damian Marron, Trophos CEO. "Trophos discovered olesoxime using the neuronal cell screening platform developed internally. Further Phase II clinical trials are underway and in planning with olesoxime in additional indications."

MitoTarget This 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 ).

Information for physicians and patients A dedicated website will be established shortly for the MitoTarget project with a link from the Trophos website. The MitoTarget website will include specific sections for physicians and patients and will enable interested parties to identify and contact the nearest participating study center. Many of the centers will also be publicizing the study through their own websites and other means.

Orphan drug designations Trophos has been granted orphan drug designation for olesoxime for the treatment of ALS and SMA (spinal muscular atrophy) by the U.S. Food and Drug Administration and 'Orphan Medicinal Product' designation for both ALS and SMA by the European Commission in the EU.
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Old 05-05-2009, 10:15 PM #2
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rocmg

Thats really great news, thanks for sharing.
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