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Trophos Hosts Round-Table Meetings at ECTRIMS to Design POC Trial to Treat Progression in Multiple Sclerosis


10/25/2011 10:08:34 AM

Marseille, France, October 25, 2011 - 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 Trophos organized two round-table meetings to establish the endpoints and design for phase two proof of concept studies in multiple sclerosis (MS) for novel agents such as Trophos’ olesoxime that promote neuro-axonal repair and remyelination. The roundtable meetings were held at the 27th European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress held in Amsterdam from 19th to 22nd October, 2011.

“Trophos is very pleased to have been able to bring together leading MS experts and patient associations to focus on the design of a phase 2 proof of concept trials for therapies that address disease progression in MS,” said Rebecca Pruss, CSO at Trophos. “Disease progression in MS may reflect chronic and progressive neurodegeneration while relapses only reflect acute focal inflammation of the CNS. As a result, despite recent advances in treating relapses, therapeutic strategies promoting remyelination and providing neuroprotection are now key needs in MS. Trophos believes olesoxime has the potential to bring a new treatment approach in multiple sclerosis through neuronal protection and remyelination aimed at addressing the long term progression and disability associated with the disease. Our next step will be to obtain funding to undertake such a trial with olesoxime, which we look to start in 2012.”

The first aim of the meetings was to identify the optimal clinical trial design and guide the future clinical development of therapies that promote neuroprotection or remyelination in MS to obtain proof of concept prior to a long-term Phase three study measuring disease progression. Questions addressed included efficacy endpoints, the relevant MS patient population, concomitant immunomodulatory therapy and validation of new assessment methodologies. The second aim was to evaluate the feasibility (number of patients, time and cost) of a proof of concept study of olesoxime as a putative neuroprotective and remyelinating agent complementary to immmunodulatory therapy.

The meetings included world-renowned experts from the US and the EU in MS trial methodology, imaging and other evaluation techniques. Also attending were representatives of US end EU patient associations, for whom advancing new treatments for progressive MS is a key objective.

Trophos and partners in the MS-Repair consortium also presented results in pre-clinical models detailing Trophos’ novel approach in multiple sclerosis (MS). The presentation was titled:

Olesoxime promotes oligodendrocyte maturation and myelination and could be a promising complementary therapy for the treatment of multiple sclerosis, Bordet et al (Poster P495). It showed that Olesoxime promoted oligodendrocyte maturation and myelination in several in vitro (oligodendrocyte progenitor cells, oligodendrocyte–neuron co-cultures, organotypic brain slice cultures) and two in vivo models (cuprizone and lysophosphatidyl choline induced demyelination).

These results are also included in a manuscript recently accepted and in press in Annals of Neurology describing in detail the rationale for the use of olesoxime in MS. The reference for the paper is:

Olesoxime Accelerates Myelination and Promotes Repair in Models of Demyelination, Magalon et al, Ann Neurol 2011, in press.

The above results were obtained by a collaboration supported by the ANR project MS-Repair awarded to Trophos and two academic partners in Marseille, Dr Pascale Durbec at the Institut de Biologie du Développement de Marseille Luminy CNRS – Université de la Méditerranée UMR6216 and Dr Angèle Viola at the Centre de Résonance Magnétique Biologique et Médicale CNRS – Université de la Méditerranée UMR6612, in February 2009.

Olesoxime (TRO19622) is the lead compound of Trophos' proprietary cholesterol-oxime compound family of mitochondrial pore modulators, developed for their ability to 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). The data announced show that olesoxime also has the ability to promote remyelination in addition to providing neuroprotection. Olesoxime is currently in two pivotal clinical efficacy studies, the first in over 500 patients with Amyotrophic Lateral Sclerosis with results expected in the fourth quarter 2011 (see releases of May 9 2009, March 17 2010 and September 22 2011) and the second a pivotal clinical study in Spinal Muscular Atrophy (see releases of October 15 2010 and September 8 2011).

“Olesoxime’s potential as a novel treatment in MS further highlights the promise of Trophos’ cholesterol oxime mitochondrial pore modulators in neurodegenerative diseases. Multiple sclerosis is one of the more common neurodegenerative diseases with an estimated 1.5 - 2.5 million sufferers globally,” added Damian Marron, CEO of Trophos. “We will now focus on obtaining funding to allow us to move olesoxime into a proof of concept study in MS.”

About Trophos:

Trophos is a clinical stage pharmaceutical company developing innovative therapeutics 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 three development and a second product, TRO40303, in early clinical development. 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, which Trophos is uniquely placed to exploit.

Trophos has two strategic partnership agreements with Actelion; an acquisition option agreement and a research collaboration agreement.

Trophos was founded in 1999, is based in Marseille, France and currently has 37 employees.

Mark Tidmarsh

ANDREW LLOYD & ASSOCIATES

http://www.ala.com

mark@ala.com

Brighton Business Centre 95 Ditchling Road Brighton BN1 4ST ENGLAND

Tel: +44 1273 675100

Fax: +44 1273 675400

55 rue Boissonade 75014 Paris FRANCE

Tel: +33 1 56 54 07 00

Fax: +33 1 56 54 07 01

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