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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