An Open label Follow-On Study to Assess the Ongoing Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis.

The main hypothesis is that MBP8298 will significantly delay the worsening of
disability of patients with secondary progressive MS (SPMS) and having a
positive HLA DR2 and/or DR4. The disability will be measured with the EDSS
score.
Several genes have influence on the mechanism of the immune system. Some of
these genes, including HLA DR2 and DR4 are being associated with MS. The
mechanism of action of MBP8298 is the induction of immunologic tolerance with
respect to the ongoing auto-immune response against the MBP peptide.

To obtain ongoing safety data of 500 mg MBP8298 given intravenously every six
months in subjects previously enrolled in the MBP8298-01 study *A Double Blind
Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of
MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis*.

This is a follow-on study for subjects previously enrolled in and completed the
two-year randomized, double blind, placebo-controlled, parallel-group trial
(MBP8298-01) in Secondary Progressive Multiple Sclerosis (SPMS) subjects.
The study will be an open-label design as all subjects will be offered MBP8298
as treatment in this protocol irrespective of their treatment assignment in the
MBP8298-01 study.
As this study is an open-label design, safety oversight will be performed by an
independent Pharmacovigilance Group. The Pharmacovigilance Group will provide
an ongoing and regular review of serious adverse events and aggregate
laboratory alert values from all subjects to identify any potential new safety
data trends. The group will confer at least quarterly with the medical monitor
and will notify the sponsor within 24 hours of the observance of any potential
new safety findings.
The Investigator will be responsible for the clinical care of the subject and
will perform the physical examination, assessment of adverse events, and
administer the study drug to the subjects. Alternatively, the Investigator may
delegate the administration of study drug to an appropriately qualified person.
The Investigator may, in this follow-on study, be involved in the EDSS, MSFC
and MSQOL54/SF-36 assessments. In the MBP8298-01 trial, there was a requirement
for an independent neurologist to perform the EDSS assessment. For this trial,
there is no requirement for an independent neurologist.
It is recognized that some subjects may desire to take some time off following
the completion of the MBP8298-01 trial, prior to enrolling in the MBP8298-SP-02
trial. A discussion on a case-by-case basis between the Investigator and
Medical Monitor is required prior to consideration of this type of request.
Additionally, the time interval between the fourth dose on the parent study and
first dose on the follow-on study may not exceed one year.
This follow-on study will continue until the product receives regulatory
registration status, is denied registration by a Regulatory Authority or is
terminated by the Sponsor.
At the time the study closes, all remaining subjects will undergo a final visit
and study treatment will be discontinued.

500 mg MBP8298 will be administered intravenously 8 times once per 6 months for
a period of 18-48 months.

A patient follow up will be done every 6 months. During this visits several
analyses will be done, which take approximately 4 hours per patient visit of
the patients time.
In animal studies several side effects were seen: facial flushing, edema,
erythema and histamine release, decreased blood pressure, and increased heart
rate and in a study with rats testicular atrophie was reported.
Clinical studies reported the following adverse events: facial flushing, blood
pressure effects and a burning sensation on the spot of the injection. Patients
who were treated previously with copaxane and had an allergic reaction have a
higher risk for an anafylactic shock on MBP8298.