A new, promising
treatment, which is being specifically tested for secondary progressive
MS, may be added to the mix in the near future.
The drug, natalizumab (Tysabri), from
Biogen Idec is currently in Phase 3b Clinical Trials. Officially titled
“A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of
the Efficacy of Natalizumab on Reducing Disability Progression in
Subjects With Secondary Progressive Multiple Sclerosis, With Optional
Open-Label Extension,” the trial is split into two parts. Part 1 is
investigating if natalizumab slows the accumulation of disability not
related to relapses relative to a placebo, and Part 2 is a continuation
of the safety evaluation of natalizumab, where all participants may
receive natalizumab. The trial began in July 2011 and is estimated to be
completed in December 2014, with longer-term endpoints being collected
for a total of approximately four years.
Two groups of patients between the ages
of 18 and 58 years are being evaluated in parallel: one group is
receiving 300 mg of natalizumab intravenously every four weeks, and the
other is receiving a placebo intravenously every four weeks. Neither the
patients nor the evaluators are aware of who is in which group, making
it a double-blind placebo-controlled trial. Primary endpoints will be
determined through a series of tests, including a timed 25-foot walk and
a questionnaire of work productivity and activity impairment.
Positive results from earlier-stage
Secondary Progressive MS natalizumab trials are attributed to the
anti-inflammatory properties of natalizumab. Continual inflammation
surrounding neurons scarred by autoimmune attacks worsens disability in
patients with SPMS, and the proposed benefit of natalizumab is a
reduction in the number of attacks by immune cells on neurons.
Natalizumab is similar to another drug, vedolizumab, which is under
development by Takeda Pharmaceuticals for the treatment of ulcerative
colitis,and was covered in the news last week on BioNews Texas. Both
attenuate inflammation-promoting effects of the immune system.
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