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Authors from the VA North Texas Health Care System Neurology Section and the Department
of Neurology at the University of Texas Southwestern Medical Center at Dallas have
highlighted the potential benefits for DNA-based vaccine administration in patients
with multiple sclerosis (MS). In a Perspective article published in the March issue
of Expert Review of Neurotherapeutics, the authors draw attention to some recent
promising observations and evaluate the potential for DNA vaccination in MS*.
Typically, DNA vaccines are composed of a bacterial plasmid that encodes a protein
of specific interest behind a strong promoter (a DNA nucleotide sequence that forms
a recognition site for the enzyme required for gene expression). The use of a DNA
vaccine is considered the most simple or minimal way to induce an immune response.
Multiple sclerosis is an autoimmune inflammatory neurodegenerative disease of the
central nervous system of unknown cause. The prevalence of the disease is known
to be 1.1-2.5 million cases worldwide, and the disease is diagnosed in women twice
as frequently as in men. Emerging evidence from recent studies suggests that aberrant
immune-regulation is an important component in the pathogenesis of MS.
The authors, Drs Olaf Stüve, Petra Cravens and Todd Eager, draw attention to recent
clinical studies involving BHT-3009, a DNA vaccine encoding full-length human myelin
basic protein. MS is a demyelinating disease i.e. it involves degeneration of the
myelin sheath surrounding axons - components of the neurons that make up nerve tissue.
The authors highlight a recent safety trial with BHT-2009 - the first trial with
a DNA vaccine for an autoimmune disease in human patients - which showed it to be
safe and well tolerated, although clinical efficacy is, as yet, difficult to assess.
However, a forthcoming Phase IIb clinical trial comparing two doses of BHT-3009
with placebo in 289 patients with relapsing-remitting multiple sclerosis (RRMS)
promises to reveal more about the potential clinical benefits of this approach.
DNA vaccination has advantages over existing treatments - DNA vaccines are non-infectious,
easily manufactured and inexpensive to produce. Subject to the outcome of the Phase
IIb study, we may see the initiation of a Phase III study. Depending on the duration
of that potential study, and provided that the use of BHT-3009 in a larger patient
cohort can demonstrate safety and efficacy, the authors suggest that approval for
its use in patients with RRMS could be possible within 5 years.
*DNA-based vaccines: the future of multiple sclerosis therapy. Stüve O, Cravens
PA and Eager TN. Expert Review of Neurotherapeutics 8(3) 351-360 (2008)
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DNA Vaccines May Offer Hope In MS
April 25, 2008
http://www.medicalnewstoday.com/articles/105330.php
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