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This Is MS: Cladribine

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News: Phase III Trial of Oral MS Therapy Mylinax (Cladribine) Initiated

Cladribine

Serono and IVAX announced today a new Phase III trial of an oral MS drug called Mylinax. Mylinax is an oral form of the drug cladribine, an injectable medication that has shown positive results in clinical trials for MS. This two-year, 1200 patient trial is scheduled to begin in the first quarter of 2005, and puts Mylinax in the lead position to become the first oral therapy for multiple sclerosis. Note that one of the primary endpoints for measuring success is disability progression-- very important since MRI scans and lesion counts do not necessarily reflect the true health status of an MS patient.

"Serono and IVAX Corporation announced today that they will initiate a Phase III study with Mylinax(R) (a proprietary oral formulation of cladribine) in the first quarter of 2005....Endpoints will include assessments of clinical relapses, disability progression and MRI (magnetic resonance imaging) brain scans...

Ernesto Bertarelli, CEO of Serono [said], 'With the initiation of the Phase III program of Mylinax(R), we are getting closer to realizing our objective to bring the first oral disease-modifying treatment to people with multiple sclerosis.'"

Click "read more" for the full story...

Note: Thanks to our member Dignan for being the first to bring this story to our attention.

Posted by Administrator on Wednesday, January 12 @ 05:08:36 EST (5125 reads)
(Read More... | 9450 bytes more | News | Score: 5)

New Oral MS Drug (Cladribine) Passes First Trial

Cladribine

This morning, Serono (maker of Rebif) and IVAX announced the completion of Phase I of trials for a possible ORAL (!) MS drug called Cladribine. Remember, this is very early on in the game but it is great to see research being done in drugs that don't require a needle! We will work to find out more info about this drug, particularly since the press release talks about how Cladribine has already shown efficacy for MS in Phase II and Phase III trials using an *injectable* form of the drug.

What a great day for MS news... lots of positives today!

"Serono and IVAX Corporation announced today positive results from two clinical trials with a new proprietary oral formulation of cladribine, a potential new treatment for multiple sclerosis (MS). The study results showed that the formulation of oral cladribine which has been developed by Serono and IVAX has met the targets for an orally administered product, with blood levels of cladribine in the expected therapeutic range. Efficacy studies of oral cladribine in MS patients are planned to start late 2004.

Previous Phase II and Phase III clinical trials have demonstrated the positive effect of injectable cladribine in patients with MS. In these trials, cladribine caused a dramatic reduction in new lesion development in the brain as seen on magnetic resonance imaging (MRI) scans. Patients with relapsing remitting MS receiving cladribine also experienced clinical benefits.

"As the originator of Rebif®, a current reference treatment for multiple sclerosis, Serono has a long-term commitment to patients with multiple sclerosis," said Ernesto Bertarelli, CEO of Serono. "This is a major step in the development of the first oral disease modifying treatment for multiple sclerosis."

Click "read more" for the full article...

Posted by Administrator on Tuesday, March 23 @ 15:42:54 EST (3989 reads)
(Read More... | 10594 bytes more | Score: 4)

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