INJURED - Shepherd Center

{
{ Research
Slowing
the progression of
Multiple
Sclerosis
Shepherd Center participates in clinical study of drug to
treat debilitating form of MS. By Jane M. Sanders
This spring, Joann Dickson wants to be able to walk in
to her son’s middle school graduation ceremony without
experiencing the extreme fatigue that plagues her because
of secondary progressive multiple sclerosis.
Joann, 49, of Newnan, Ga., is largely pinning her hopes on dirucotide
(MBP8298), an experimental drug being studied in clinical trials at
Shepherd Center and other sites. The drug may delay disease progression
in people with secondary progressive multiple sclerosis (SPMS),
an advanced and especially debilitating form of MS characterized by
irreversible decline in both neurological and physical function. Joann
was diagnosed with SPMS when she was pregnant with her now-14-
year-old son Julian. Since then, the disease has progressed, now forcing
Joann to primarily rely on a motorized scooter for mobility.
“If the medicine will help with my mobility, along with the physical
therapy I’m doing at Shepherd Center, that’s what I want – to be more
mobile,” Joann explains. She also hopes the drug will address the balance
problems and fatigue she experiences when walking. “It’s so tiring to
walk. It takes the last little bit of energy I have,” she adds.
Photo by Leita Cowart
Joann shares similar expectations with eight other people participating
in the MAESTRO-03 phase III clinical trial of dirucotide (MBP8298)
at the Andrew C. Carlos Multiple Sclerosis Institute at Shepherd Center.
The hospital is one of 68 sites participating in the two-year study. Since
late summer 2008, the sites have been administering the drug intravenously
every six months to about 510 patients nationwide.
MAESTRO-03 is a double-blind, placebo-controlled study that is
evaluating the efficacy and safety of dirucotide (MBP8298), which is
licensed by BioMS Medical Corp. of Edmonton, Alberta, Canada. In a
previous study, published in the European Journal of Neurology in
August 2006, the drug showed a five-year delay in median time to
disease progression in a subgroup of MS patients who have immune
response genes HLA-DR2 and/or HLA-DR4. These genes are found in
up to 75 percent of all MS patients.
In early September 2008, the U.S. Food and Drug Administration
(FDA) granted dirucotide (MBP8298) a fast-track designation, which is
given to products that are intended to treat a serious or life-threatening
condition and that demonstrate the potential to address unmet medical
needs for that condition. Fast-track designation can potentially facilitate
development and expedite the review process. There are few FDA-approved
drugs to treat SPMS, which is the form of MS that afflicts 40 to
45 percent of the 2.5 million people worldwide who have the disease.
“Patients in the study at Shepherd Center are excited about this drug
getting fast tracked,” says Carlyn Kappy, MAESTRO-03 research coordinator
at Shepherd Center. “They say, ‘Maybe it will at least work for
somebody else if it doesn’t work for me.’ They don’t have a lot of other
options out there.”
Dirucotide (MBP8298) appears to work by “teaching tolerance” to a
patient’s immune system, so that the disease is not as aggressive in attacking
and destroying patches of the protective myelin covering of the
central nervous system, explains Dr. Ben Thrower, medical director of
the MS Institute at Shepherd Center and the hospital’s lead investigator
for MAESTRO-03.
Researchers are evaluating the efficacy of dirucotide (MBP8298)
with the Expanded Disability Status Scale (EDSS), which measures a
patient’s mobility. Study participants also undergo tests of upper extremity
agility and serial memory, as well as regular MRI exams. Using these
tools, along with physical examinations, researchers evaluate whether
study participants’ neurological symptoms are changed from one exam
to the next one three months later.
While Joann and other study participants eagerly await the results of
the MAESTRO-03 clinical trial, a lot of other research on treatments
for MS is under way, Dr. Thrower notes. One such drug, which also
recently received a fast-track designation, is BG00012, an oral therapy
licensed by Biogen Idec for treating relapsing-remitting MS. This drug
is also being studied at Shepherd Center and 159 other sites. For more
information, see www.clinicaltrials.gov.
Left: Joann Dickson of Newnan, Ga., is participating in a Shepherd
Center clinical trial of dirucotide (MBP8298), an experimental drug
being studied for its ability to delay disease progression in people
with secondary progressive multiple sclerosis.
14 Spinal column
www.shepherd.org