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Wednesday, October 19, 2011

INVESTIGATIONAL LAQUINIMOD DEMONSTRATES ITS POTENTIAL AS A NEW ORAL TREATMENT FOR RRMS


Wed Oct 19, 2011 2:30am EDT
  • Late-breaking presentation of BRAVO results and additional analyses from ALLEGRO study reinforce novel clinical profile of laquinimod  
  • Pre-clinical evidence supports that laquinimod targets peripheral inflammation and keyneurodegenerative processes occurring directly in the CNS 
Jerusalem, Israel and Lund, Sweden, October 19, 2011 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase III clinical and pre-clinical data, which collectively demonstrate that once-daily oral laquinimod modulates the pathological processes of multiple sclerosis to impact disease activity, disability progression and brain volume loss. The data will be featured in more than 20 scientific posters and presentations this week at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam, The Netherlands.
Findings from the second Phase III study, BRAVO, being highlighted as late-breaking research, showed that at 24-months, the primary endpoint of reduction in annualized relapse rates (ARR) did not reach statistical significance (0 = 0.075); however, after applying a pre-specified sensitivity analysis to correct for meaningful imbalances in baseline characteristics (MRI) between treatment groups, laquinimod significantly reduced ARR (21.3%, p = 0.026). Laquinimod also demonstrated a significant reduction in the risk of disability progression as measured by the Expanded Disability Status Scale (EDSS) (33.5%, p = 0.044) and in MRI-measured brain volume loss (27.5%, p =< 0.0001). The safety and tolerability profile of laquinimod was favorable.
New exploratory analyses from ALLEGRO, the first Phase III study in the laquinimod clinical development program, demonstrated that laquinimod had an effect on the rate of severe relapses, showing a 38 percent reduction in the annualized rate of relapses requiring hospitalization and a 27 percent reduction in those requiring intravenous steroids. Treatment with laquinimod was also associated with a 36 percent reduction in the risk for three month confirmed EDSS progression (p=0.0122) and a 48 percent reduction in the risk for six month confirmed EDSS progression (p= 0.0023). Additionally, laquinimod had a positive impact on patient-reported fatigue and cognitive functioning, as assessed by the Modified Fatigue Impact Scale (MFIS) and the short-form (SF)-36 general health survey.

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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly. .

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