Results Announced from the Phase II Study of Dirucotide (MBP8298) in RRMS Patients
Dirucotide, previously known as MBP8298, has been in clinical trials primarily for the treatment of secondary-progressive multiple sclerosis (SPMS), but also for relapsing-remitting multiple sclerosis (RRMS). On January 30, 2009, dirucotide’s developer (BioMS Medical Corp.), announced the results of MINDSET-01, an exploratory phase II clinical trial designed to evaluate the effectiveness and safety of dirucotide in patients with RRMS.
MINDSET-01 enrolled 218 patients with RRMS at 24 sites in Europe. While the treatment did not meet its primary endpoint of reducing annualized relapse rates or reducing associated secondary MRI endpoints, it did meet certain secondary endpoints relating to the progression of MS. Changes in progression were measured using the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) score.
In this 15-month study, dirucotide (or placebo) was given via three single intravenous injections at zero, three, and nine months. Dirucotide was generally well tolerated and no patients withdrew from the study due to side effects – the most common of which were redness and burning sensation at the injection site. The study will have a 12-month active treatment, open-label extension period, to further measure the effectiveness and safety of dirucotide in RRMS patients.
Measuring progression according to the EDSS and MSFC scores are the primary and secondary outcomes in the ongoing SPMS trials, all of which are fully enrolled. These include the MAESTRO-01 (a pivotal phase III study taking place in Canada and Europe with 611 patients), the MASESTRO-02 (an open-label follow-up study with patients who have successfully completed the MAESTRO-01 trial), and the MAESTRO-03 (a pivotal phase III study taking place in the United States with 510 patients).
Dirucotide (a peptide) is a synthetic fragment of myelin basic protein (MBP). It replicates the site on the MBP molecule that is believed to be a target of attack by cells of the immune system – in 65 to 75 percent of all people with MS. This treatment is believed to induce or restore immunologic tolerance to attack.
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Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
Reviewed by Dr. Jack Burks, MSAA Chief Medical Officer