Catena/idebenone for PPMS in Phase II clinical trial

 
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PostPosted: Thu Jul 11, 2013 6:22 pm    Post subject: Catena/idebenone for PPMS in Phase II clinical trial Reply with quote

From MSFYi Newsletter, [June 2013]:

Quote:
Clinical Trial Investigates Drug for Primary-Progressive Multiple Sclerosis (MS)


Santhera Pharmaceuticals has obtained an exclusive license from the National Institutes of Health (NIH) to its rights on a patent granted in the USA for the use of idebenone for the treatment of primary-progressive MS (PPMS), a currently untreatable disease affecting about 40,000 patients in the Unites States. The NIH is investigating the efficacy of Catena® (idebenone) in PPMS in a placebo-controlled Phase II clinical trial (the IPPoMS trial).

Santhera is providing study medication under a clinical trial agreement which gives Santhera the rights to the results. Santhera has now obtained the exclusive rights to the use patent for idebenone in PPMS granted in the USA. Patients who complete the IPPoMS trial can enter into a 12-months open-label extension trial for which Santhera and the NIH recently signed a Materials Cooperative Research and Development Agreement (M-CRADA).

“Patients with PPMS do not respond to immunomodulatory therapies with proven efficacy in relapsing remitting MS,” said Bibiana Bielekova, M.D, the principal investigator of the IPPoMS trial. “Accumulating data indicate that mitochondrial dysfunction and related oxidative stress may play a major role in the pathogenesis of progressive MS. Idebenone enhances mitochondrial function and acts as an anti-oxidant against membrane damage in laboratory models and is a rational treatment choice in PPMS based on these pharmacological properties.”

Effective treatments for relapsing-remitting MS (RRMS) are limited to immune-modulatory therapies which have not been proven to be effective in people with PPMS. This subtype develops much slower than RRMS but presents a steady functional decline without any distinct episodes of regeneration or acute relapses. IT is estimated there are about 40,000 people with PPMS living in the United States.


Adult PPMS patients up to 65 years of age with disability ranging from none to moderately severe are eligible to enroll in the trial. This is a Phase I/II safety/efficacy trial with an adaptive trial design: one year of pretreatment baseline period serves the dual purpose of collecting patient-specific biomarkers of disease progression and collecting longitudinal neuroimaging and clinical data for selection of primary outcome measures. This baseline period is then followed by a double-blind, idebenone (2250 mg/day) versus placebo treatment phase for a total of 2 years.

Additional information can be obtained under http://www.clinicaltrials.gov (NCT00950248).
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agate
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PostPosted: Tue Jul 23, 2013 11:46 am    Post subject: (Abst.) Idebenone fails in mouse EAE Reply with quote

And then there's this.

From PubMed, July 23, 2013:

Quote:
J Neuroimmunol. 2013 Jul 18.

The antioxidant idebenone fails to prevent or attenuate chronic experimental autoimmune encephalomyelitis in the mouse

Fiebiger SM, Bros H, Grobosch T, Janssen A, Chanvillard C, Paul F, Dörr J, Millward JM, Infante-Duarte C.

Institute for Medical Immunology, Charité-Universitätmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany.

Oxidative stress and mitochondrial dysfunction appear to contribute to neurodegenerative processes during multiple sclerosis (MS). Thus, antioxidants may represent a therapeutic option for MS.

The antioxidant idebenone was proven to be beneficial in Friedreich's ataxia and Leber's hereditary optic neuropathy, two disorders caused by mitochondrial alterations. Here we showed that idebenone protected neuronal HT22 cells from glutamate-induced death in vitro. However, in experimental autoimmune encephalomyelitis, idebenone failed to affect disease incidence or onset when applied preventively, or to reduce disease severity when applied therapeutically.

Histopathological examination of CNS from idebenone treated mice showed no improvement in inflammation, demyelination, or axonal damage. Thus, we hypothesize that idebenone treatment will likely not benefit patients with MS.


PMID: 23871488
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