Posted by: Thixia | April 2, 2008

Maestro MBP 8298 – new drug on the horizon

 Maestro 01 to 03 MBP8298

I received this comment from a vistor to my blog.  See the results of my search below the comment.  . . .

MAESTRO 3 MPR-8298 is projected to be available in Europe by June 2011 and US by June 2012. Can’t we pressure the FDA for quicker action??? We need to organize and stop the nonsense in Washington.

From researching several websites I have compiled the following information about MBP8298.  I did not find information anywhere that MBP8298 has been okayed for use by any country.  All drugs have to go through three long, strict trials, followed by years of compiling the information and applying to each respective government.  The government will carefully read the data and send it back for more clarification.   The government might even ask for a further study.  This is not a short process.  No government wants to have their citizens become ill or more ill from a new drug that hasn’t been researched adequately.

Maestro 01 to 03 MBP8298

Product Overview and
Product Information

MBP8298 is a synthetic peptide that consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic myelin basic protein (MBP).  MBP8298 has been developed for the treatment of multiple sclerosis (MS), and is based on over 26 years of research.  

MS is generally considered an autoimmune disease, caused by immune attack against normal components of the central nervous system.  The specificity of the immune attack at the molecular level is determined in each case by the HLA type of the individual patient, and HLA type is known to be one factor that contributes to susceptibility to MS.

The MBP8298 synthetic peptide is a molecular replicate of the site of attack that is dominant in MS patients with HLA (haplotypes) DR-2 or DR-4.  These HLA types are found in 65-75% of all MS patients.

The apparent mechanism of action of MBP8298 is the induction or restoration of immunological tolerance with respect to ongoing immune attack at this molecular site.

The results of phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology (EJN), showed that MBP8298 safely delayed median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.

Intravenous synthetic peptide MBP8298 delayed disease progression in an HLA Class II-defined cohort of patients with progressive multiple sclerosis: results of a 24-month double-blind placebo-controlled clinical trial and 5 years of follow-up treatment.

MBP8298 represents the immuno-dominant target for both B cells and T cells in multiple sclerosis (MS) patients with haplotype (HLA) DR2. Its administration in accordance with the principle of high dose tolerance results in long-term suppression of anti-myelin basic protein (MBP) autoantibody levels in the cerebrospinal fluid (CSF) of a large fraction of progressive MS patients.  

MBP8298 was evaluated in a 24-month placebo-controlled double-blinded Phase II clinical trial in 32 patients with progressive MS.  The objective was to assess the clinical efficacy of 500 mg of MBP8298 administered intravenously every 6 months, as measured by changes in Expanded Disability Status Scale (EDSS) scores.

Contingency analysis for all patients at 24 months showed no significant difference between MBP8298 and placebo-treatments (n = 32, P = 0.29).  Contingency analysis in an HLA Class II defined subgroup showed a statistically significant benefit of MBP8298 treatment compared with placebo in patients with HLA haplotypes DR2 and/or DR4 (n = 20, P = 0.01).

Long-term follow-up treatment and assessment of patients in this responder group showed a median time to progression of 78 months for MBP8298 treated patients compared with 18 months for placebo-treatment (Kaplan-Meier analysis, P = 0.004; relative rate of progression = 0.23).  Anti-MBP autoantibody levels in the CSF of most MBP8298 treated patients were suppressed, but antibody suppression was not predictive of clinical benefit. Anti-MBP autoantibodies that reappeared in the CSF of one patient at 36 months, whilst under treatment with MBP8298, were not reactive with the MBP8298 peptide in vitro. The identification of a responder subgroup (62.5% of the patients in this study) enables a more efficient design of a large confirmatory clinical trial of MBP8298. The probability that patients with other less common HLA-DR haplotypes will respond to this treatment should not be ignored.

Clinical Trials for Phase III are currently underway and/or recruiting volunteers.

Drug Trial of MBP8298

Location of Study
Canada and Europe
48 trial sites in 10 countries

  

Description
The trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The trial is a randomized, double-blind study with the primary clinical endpoint defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

In April 2007 the independent Data Safety Monitoring Board completed an interim safety analysis on the first 100 patients enrolled and recommended the trial continue per the protocol. The next interim analysis, targeted for mid-2008, will look at both safety and efficacy of the first 200 patients who have completed 24 months of the clinical trial. Full analysis is targeted for 2009.

Description
Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial, may choose to receive MBP8298 on an un-blinded basis in MAESTRO-02 regardless of whether they were previously on placebo or drug. The trial will primarily evaluate the long-term safety of MBP8298.

Stage
Phase III

Location of Study
United States

Description
The pivotal phase III clinical trial in the US will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis. The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.

The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

For more information go to:

http://www.biomsmedical.com/

the makers of MBP8298

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Responses

  1. i have ms and would like to find out how i could try mbp8298. currently i take copaxone. i guess more info would also be good. thank you.

  2. Cory, I will do some research and get back to you.
    Bonnie

  3. Is MBP8298 Being used for primary progressive patients? How does one find out if they are in a DR2 or DR4 subgroup? Please let me know asap. Thanks, randistirn@hotmail.com

  4. I will look into it and post the information on the site.

    Bonnie


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