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   DIR Return to: TYSABRI (natalizumab)
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       #Post#: 980--------------------------------------------------
       ASCEND Phase 3 trial of Tysabri for SPMS
       "disappointing"
   DIR By: agate
       Date: October 21, 2015, 7:28 pm
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       Tysabri was given to 889 SPMS patients at EDSS 6 (walking aid
       required) for nearly 2 years.
       From BusinessWire, October 21, 2015:
       --- Quote ---
       > Biogen Reports Top-Line Results from Phase 3 Study Evaluating
       Natalizumab in Secondary Progressive MS
       >
       > ASCEND Phase 3 Trial Did Not Meet Primary and Secondary
       Endpoints; Natalizumab Demonstrated Statistically Significant
       Effect on Upper Limb Function in Patients
       >
       >
       > CAMBRIDGE, Mass.--(BUSINESS WIRE)--The Phase 3 ASCEND study
       investigating natalizumab in the treatment of secondary
       progressive multiple sclerosis (SPMS) did not achieve its
       primary and secondary endpoints, Biogen  reported today. During
       the study, natalizumab was generally well tolerated and adverse
       events were consistent with its known safety profile.
       >
       >
       > ASCEND evaluated the efficacy and safety of natalizumab to
       slow the accumulation of disability progression unrelated to
       relapse in SPMS patients, an unmet medical need. The majority of
       study participants had EDSS scores of 6.0 to 6.5 (walking aid
       required) and were non-relapsing for two years prior to
       enrollment in the study. The study’s composite primary endpoint
       evaluated the percentage of patients whose disability had
       progressed on one or more of three disability measurements
       comprising the composite endpoint.
       >
       > Natalizumab demonstrated a statistically significant effect on
       upper limb function (one of the three components of the primary
       composite endpoint) unrelated to relapses. Consistent with the
       established effects of natalizumab in relapsing multiple
       sclerosis, analyses of exploratory endpoints suggest that some
       patients received a benefit from treatment, including reduction
       of relapses and new MRI lesions.
       >
       > “While we’re disappointed with these results, we believe this
       research will provide the MS community important insights into
       this more advanced patient population, and the benefits that
       natalizumab may provide in areas such as upper limb function,”
       said Alfred Sandrock, M.D., Ph.D., group senior vice president
       and chief medical officer at Biogen. “Given the challenges of
       treating this advanced stage of MS, these results underscore the
       importance of treatment early in the course of disease with
       effective disease-modifying therapies before a patient advances
       to SPMS.”
       >
       > SPMS is characterized by ongoing nerve damage or loss and
       patients experience disability progression with increasingly
       less frequent relapses. Despite extensive clinical research,
       treatment options for patients with SPMS are extremely limited
       and none have demonstrated efficacy in slowing the progression
       of disability unrelated to relapse.
       >
       > Natalizumab is a high-efficacy treatment for patients with
       relapsing forms of MS, including relapsing-remitting MS. The
       safety and efficacy of natalizumab has been established across a
       robust clinical program and real-world use with more than a
       decade of clinical experience demonstrating its benefits on
       disease progression and sustained efficacy in relapsing MS with
       a well-characterized safety profile.
       >
       > Detailed results from ASCEND will be presented at a future
       medical conference.
       >
       > About ASCEND
       >
       > ASCEND (A Study to Characterize the Efficacy of Natalizumab on
       Disability in SPMS) was a randomized, double-blind,
       placebo-controlled, Phase 3 trial involving 889 patients in 15
       countries. Participants were randomized to receive either
       natalizumab 300 mg or placebo intravenously every four weeks for
       96 weeks.
       >
       > The primary endpoint of the study was the percentage of
       patients with confirmed progression of disability on one or more
       components of ASCEND’s composite endpoint: the Expanded
       Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) and
       the 9-Hole Peg Test (9HPT) where progression was confirmed at a
       second visit at least 6 months later and at week 96.
       --- End Quote ---
       The article can be seen here
  HTML http://www.businesswire.com/news/home/20151021005273/en/Biogen-Reports-Top-Line-Results-Phase-3-Study.
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