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TROPHOS - клин испытания с 29-09-07 во Франции

 
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СообщениеДобавлено: Чт Окт 11, 2007 9:05 am    Заголовок сообщения: TROPHOS - клин испытания с 29-09-07 во Франции Ответить с цитатой

http://csma.org.ua/trail/48601FR.pdf
http://csma.org.ua/trail/48601FR.pdf
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СообщениеДобавлено: Пн Июн 29, 2009 10:57 am    Заголовок сообщения: Trophos will progress TRO19622 towards a Phase II Ответить с цитатой

http://www.trophos.com/news/pr20081218a.htm

EUR 7 million grants boost Trophos cholesterol-oxime programs for ALS, MS and other neurodegenerative diseases

EU awards EUR 6 million (USD 8 million) to Trophos led consortium

France’s ANR grants EUR 800,000 (USD 1 million) for MS-Repair project

Marseille, December 18th, 2008- Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics for indications with under-served needs in neurology and cardiology, announced today that some EUR 7 million in funding has been awarded for two projects associated with its proprietary cholesterol-oxime class of compounds.


MitoTarget: The European Commission has awarded a three year grant of nearly EUR 6 million to support a 3 year collaborative project named MitoTarget, which will be carried out by a consortium led by Trophos. MitoTarget forms part of the Seventh Framewo
rk Programme of the European Community for Research, Technological Development and Demonstration Activities and will investigate the efficacy and safety of Trophos compound TRO19622 in a clinical study in Amyotrophic Lateral Sclerosis (ALS) patients, and develop the understanding of mitochondrial dysfunction and therapeutic potential of a novel proprietary class of molecules in neurological diseases.

MS-Repair: A further EUR 800,000 will come from France’s Agence Nationale pour la Recherche (ANR) to study the potential of its proprietary cholesterol-oxime compounds in in-vivo models of multiple sclerosis (MS). The two-year collaborative project called MS-Repair, will seek to establish preclinical proof of principle for Trophos proprietary compounds in models of MS.

Trophos expects both projects to provide proof of principle that a new class of therapeutic agents targeting mitochondrial dysfunction in neurons or their supporting cells could have wide ranging therapeutic benefits and commercial po
tential.

“We are delighted with the vote of confidence shown by these two grants in Trophos and its neuroprotection programs,” said Damian Marron, CEO at Trophos. “The European Commission, after extensive expert evaluation, has chosen to support the MitoTarget project and Trophos is very pleased to be collaborating with a distinguished panel of academic and clinical investigators on furthering our understanding of the potential of this proprietary class of drug candidates, notably through the important ALS clinical trial that will take place with Trophos’ lead molecule, TRO19622.

“Recently published clinical studies support the therapeutic rationale for mitochondria-targeted drugs in both neurology (Alzheimer’s disease) and cardiology (ischemia-reperfusion injury), and Trophos is uniquely placed to explore the validated therapeutic and commercial potential of this emerging field to create value for patients, the medical community and our investors,” added Marron.

About MitoTarget
Troph
os is leading a consortium of five basic research centers and 14 clinical centers at 16 institutions around Europe specializing in research and/or healthcare. MitoTarget’s main aims are to i) demonstrate the therapeutic efficacy and safety of TRO19622, a novel mitochondrial pore modulator, in Amyotrophic Lateral Sclerosis (ALS) patients and, ii) to gain a greater understanding of the role of mitochondrial dysfunction in neurodegenerative diseases and of the therapeutic potential of a proprietary class of mitochondrial pore modulator, cholesterol-oxime compounds, to treat other indications such as Alzheimer’s Disease.

The ALS 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 multi-centre clinical trials in ALS. The trial will assess safety and efficacy with a primary end-point of improvement of survival at 18 months. Trophos has been granted orphan drug
designation for TRO19622 for the treatment of ALS 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. The trial protocol has also been the subject of an EMEA Protocol Advice procedure.

The basic research component of MitoTarget will characterize mitochondrial function in neurons to better understand how mitochondrial dysfunction, leading to oxidative stress and activation of cell death pathways, is implicated in various neurodegenerative diseases and aging. Using preclinical model systems, partners will investigate the ability of the new class of cholesterol-oxime compounds discovered by Trophos to correct mitochondrial dysfunction and promote neuron survival and axonal growth.

About MS-Repair
MS-Repair is a collaborative research project coordinated by Trophos and supported by the French ANR that will explore the potential of Trophos compounds, including TRO19622, to provide significant benefit in pre
clinical demyelination models of multiple sclerosis. Positive evidence of efficacy in these models will provide the necessary proof of principle to motivate further clinical development of these compounds for treatment of MS.

About TRO19622
TRO19622 is representative of Trophos’ proprietary, mitochondrial pore modulator, cholesterol-oxime compounds that were identified in the neuronal cell screening platform developed at Trophos. Preclinical studies have demonstrated that these compounds promote the function and survival of neurons and other cell types under disease relevant stress conditions (Bordet et al., JPET 322:709-720, 2007) through interactions with the mitochondrial permeability transition pore (mPTP).

TRO19622 has successfully completed phase I studies in healthy volunteers and phase Ib studies in ALS and SMA patients. These clinical trials demonstrated that the product is well tolerated, has an excellent safety profile and 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 impact or interaction of TRO19622 on riluzole pharmacokinetics.

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 www.alsa.org.

About Multiple Sclerosis
Multiple sclerosis is an autoimmune condition that affects the transmission of messages from the central nervous system to the rest of the body. MS has a prevalence between 2 - 150 per 100,000, is more common in women and usually manifests itself in young adults between 20 and 40 years of age. Sufferers experience recurrent episodes
of inflammation and destruction of the myelin sheath that surrounds and protects nerves, resulting in progressive demyelination. There is no cure for MS, approved disease-modifying treatments are modestly effective at decreasing the number of attacks and slowing disease progression, and have various adverse side effects.

For more information about MS, see here.

About Trophos
Trophos is a clinical stage pharmaceutical company developing innovative therapeutics for indications with underserved needs in neurology and cardiology. The Company has a novel and proprietary cholesterol-oxime based chemistry platform generating a pipeline of drug candidates, with a lead product, TRO19622, in phase II clinical trials. 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 mit
ochondria targeted drugs in neurology (Alzheimer’s disease) and cardiology (ischemia-reperfusion injury). Trophos is uniquely placed to exploit this validated therapeutic approach with its proprietary chemistry platform targeting the mitochondria.


For media enquiries, please contact
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100 / +33 1 56 54 07 00
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СообщениеДобавлено: Вт Июн 30, 2009 9:25 am    Заголовок сообщения: Ответить с цитатой

http://www.trophos.com/news/pr20090319.htm

Trophos SA extends its partnership with AFM and will perform efficacy trial of olesoxime in Spinal Muscular Atrophy

Orphan Drug Designation granted in US and SMA Phase 1b data to be presented at American Academy of Neurology

Marseille, March 19th, 2009- Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics for indications with under-served needs in neurology and cardiology, announced today that it will receive €6.7M over the next three years from the Association Francaise contre les Myopathies (AFM), which will substantially cover the cost of the further clinical development of its lead drug candidate olesoxime (TRO19622) as a treatment for Spinal Muscular Atrophy (SMA). This funding will support an important clinical trial seeking to demonstrate the efficacy of olesoxime in SMA patients.

Trophos is currently undertaking a Protocol Assistance procedure with
the EMEA in order to finalize the design of the clinical efficacy study and to determine the regulatory requirements for approval of olesoxime for the treatment of SMA. It is currently anticipated the trial will commence around the end of this year, subject to the outcome of the discussions with the EMEA.

"Trophos is very pleased to be renewing its long standing strategic partnership with the AFM for the continued development of olesoxime for SMA, which has been instrumental in advancing our SMA program" said Damian Marron, CEO of Trophos "Olesoxime is uniquely suited for development for this devastating condition, for which no treatments exist today. This program is a key part of our ongoing commitment to rare and underserved motor neuron diseases and this agreement underlines and strengthens our joint efforts to further the clinical development of olesoxime for SMA."

Trophos further disclosed today that olesoxime has recently been granted Orphan Drug Designation (ODD) for
the treatment of SMA by the US FDA, following the earlier, similar Orphan Medicinal Product designation by the EMEA. This is recognition of the potential of olesoxime for the treatment of SMA and brings a number of development, regulatory and marketing exclusivity benefits. Trophos has previously received orphan drug status for olesoxime for the treatment of Amyotrophic Lateral Sclerosis in the US and EU.

Trophos also announced that an oral presentation on its successful phase Ib safety and PK study in SMA patients will be made at the American Academy of Neurology meeting being held in Seattle in April. The title of the talk is "Safety and Pharmacokinetics (PK) of TRO19622 in Spinal Muscular Atrophy (SMA) Children and Adults" and it will be presented in Scientific Sessions: Anterior Horn: SMA and Kennedy's Disease (3:45 PM-5:00 PM) on Wednesday April 29th.

Olesoxime is the lead drug candidate from Trophos’ novel and proprietary cholesterol-oxime based pipeline of drug candidates that
enhance the function and survival of stressed cells via modulation of dysfunctional mitochondria, through interactions at the permeability transition pore (mPTP).. Preclinical studies have demonstrated that these compounds promote the function and survival of neurons and other cell types under disease relevant stress conditions (Bordet et al., JPET 322:709-720, 2007). Olesoxime has successfully completed a phase 1b study in SMA patients (see above), having previously completed phase I/Ib studies in healthy volunteers and ALS patients. These clinical trials demonstrated that the product is well tolerated, has an excellent safety profile and that once-a-day oral dosing achieves the predicted exposure level required for efficacy, based on preclinical models.

About Spinal Muscular Atrophy
Spinal Muscular Atrophy (SMA) is an autosomal recessive genetic disease that affects the motor neurons of the voluntary muscles that are used for activities such as crawling, walking, head and neck control, and swallo
wing. Approximately 1 in 6,000 babies born are affected and about 1 in 40 people are genetic carriers. SMA patients are divided into three subtypes depending on disease onset and severity but all suffer from degeneration of motor neurons controlling voluntary muscles with proximal limb and trunk muscle weakness leading to respiratory distress and in the most severe cases, ultimately death. For further information, see www.curesma.org.

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 a lead product, TRO19622, in phase II clinical trials. 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.


For media enquiries, please contact
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100 / +33 1 56 54 07 00
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СообщениеДобавлено: Пн Июл 20, 2009 11:04 am    Заголовок сообщения: Ответить с цитатой

http://trading-family.com:80/laterhitting/2009/07/18/trophos-starts-phase-ib-clinical-trial-of-tro19622-in-spinal-muscular-atrophy/

18 juillet 2009
Trophos Starts Phase Ib Clinical Trial Of TRO19622 In Spinal Muscular Atrophy
Classé dans : Non classé — laterhitting @ 23:54
Trophos SA, a biopharmaceutical comrades specializing in the discovery and development of drugs for neurological disorders, announced that the followers has begun enrolling Spinal Muscular Atrophy (SMA) patients in a Phase Ib clinical trial of its lead product, TRO19622. The clinical trial will involve 20 typeface 1b-3 SMA patients age-old between 6 - 25 years of age and inclination assess the pharmacokinetics and safety of pharmaceutical product after dispensation of sole and multiple doses, ages-daily, by the vocalized itinerary. The study is being conducted at three centers in France. The clinical program in SMA is supported by the Association Française cont
re les Myopathies (AFM, http:// www.afm-france.org), from top to bottom a critical partnership begun in 2000.

TRO19622 is representative of novel compounds identified using the proprietary neuronal cell screening stand developed at Trophos. Preclinical studies have demonstrated that these compounds promote the survival of a wide range of neurons answerable to infection significant stress conditions. TRO19622 has successfully completed Phase I/Ib studies in both healthy volunteers and ALS patients demonstrating the product is well tolerated, has an excellent safety profile and that once-a-daylight dosing achieves the predicted conversancy level required for efficacy, based on preclinical models. The European Commission has granted the business an ‘Orphan Medicinal Product’ designation in compensation TRO19622 as a treatment for SMA. Trophos is currently enrolling patients in a European Angle IIa trial to assess the efficacy of TRO19622 in painful diabetic neuropathy and expects to begin a Phase II/III
trial in ALS in 2008.

“We are enchantee ‘ to keep begun enrolling patients in our ongoing clinical enlargement program in SMA, a debilitating infection with tremendous unmet medical need,” said Jean-Louis Abitbol, CMO at Trophos. “The barring aegis profile of TRO19622 in sturdy volunteers and ALS patients supports more distant clinical enlargement in juvenile/adolescent SMA patients. The successful completion of these Phase Ib studies will sanction Trophos, subject to regulatory approvals, to catechumen Phase II/III clinical trials to reckon TRO19622 efficacy in the SMA degree.”

“We at the AFM are an association which has for divers years been actively encouraging the development of innovative therapies to treat long forgotten diseases on behalf of patients, including those suffering from SMA,” said Laurence Tiennot-Herment, AFM president. “Now, not quite four years after the identification of a office-seeker molecule, there is a clinical trial underway. This shows decidedly again how a steadf
ast league can play a outstanding position in promoting drug development.”
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