Excellent progress in multiple sclerosis

[Guest guest]

Dear All;

Thought you might be interested in this article which shows very

promising results with the use of a DNA vaccine for patients with

multiple sclerosis. The DNA vaccine encodes full-length human myelin

basic protein. Myelin basic protein is the target of antibodies in

multiple sclerosis. The study shows that the vaccine is safe and well

tolerated and produced favorable brain magnetic resonance imaging

(MRI) and immune response changes:

Induction of Antigen-Specific Tolerance in Multiple Sclerosis After

Immunization With DNA Encoding Myelin Basic Protein in a Randomized,

Placebo-Controlled Phase 1/2 Trial

Amit Bar-Or, MD; Vollmer, MD; Jack Antel, MD; L.

Arnold, MD; Caroline Anita Bodner, MSc; Campagnolo, MD; Jill

Gianettoni, BS; Farzaneh Jalili, BSc; Norman Kachuck, MD; Yves

Lapierre, MD; Masaaki Niino, MD, PhD; Oger, MD; Price, BS;

, MS; H. , MD, PhD; Fu-Dong Shi, MD, PhD;

J. Utz, MD; Valone, MD; Weiner, MD; Lawrence

Steinman, MD; Hideki Garren, MD, PhD

Arch Neurol. 2007;64:(doi:10.1001/archneur.64.10.nct70002).

ABSTRACT

Objective To assess safety and immune modulation by BHT-3009, a

tolerizing DNA vaccine encoding full-length human myelin basic

protein, in patients with multiple sclerosis (MS).

Design The study was a randomized, double-blind, placebo-controlled

trial. Subjects receiving placebo were crossed over into an active

arm after treatment unblinding.

Setting The trial was conducted at 4 academic institutions within

North America.

Patients Thirty patients with relapsing-remitting or secondary

progressive MS who were not taking any other disease-modifying drugs

were enrolled in the trial. Further, the patients were required to

have either 1 to 5 gadolinium-enhancing lesions on screening brain

magnetic resonance imaging (MRI), a relapse in the previous 2 years,

or disease worsening in the previous 2 years.

Interventions BHT-3009 was administered as intramuscular injections

at weeks 1, 3, 5, and 9 after randomization into the trial, with or

without 80 mg of daily oral atorvastatin calcium in combination.

Three dose levels of BHT-3009 were tested (0.5 mg, 1.5 mg, and 3 mg).

Main Outcome Measures The primary outcome measures were safety and

tolerability of BHT-3009. Secondary outcome measures included the

number and volume of gadolinium-enhanced lesions on MRI, relapses,

and analysis of antigen-specific immune responses.

Results BHT-3009 was safe and well tolerated, provided favorable

trends on brain MRI, and produced beneficial antigen-specific immune

changes. These immune changes consisted of a marked decrease in

proliferation of interferon-–producing, myelin-reactive CD4+ T cells

from peripheral blood and a reduction in titers of myelin-specific

autoantibodies from cerebral spinal fluid as assessed by protein

microarrays. We did not observe a substantial benefit of the

atorvastatin combination compared with BHT-3009 alone.

Conclusion In patients with MS, BHT-3009 is safe and induces antigen-

specific immune tolerance with concordant reduction of inflammatory

lesions on brain MRI.

Trial Registration clinicaltrials.gov Identifier: NCT00103974.

The full text of the article is available at:

http://archneur.ama-assn.org/cgi/content/full/64.10.nct70002

If this general strategy proves successful in further trials, this

strategy may be applicable to other autoimmune diseases with known

antibodies, such as type 1 diabetes mellitus, systemic lupus

erythematosus, rheumatoid arthritis, and myasthenia gravis.

Best regards,

Dave

(father of (22); PSC 07/03; UC 08/03)

[Guest guest]

>

Dear Dave -

Thanks so much for the terrific article/news. It piqued my

interest since I do have MS and I also hope it will help with other AI

diseases in the future.

Liz PSC 6/04

>

> Thought you might be interested in this article which shows very

> promising results with the use of a DNA vaccine for patients with

> multiple sclerosis.

[Guest guest]

> Dear All; Thought you might be interested in this article which

shows very promising results with the use of a DNA vaccine for

patients with multiple sclerosis. > If this general strategy proves

successful in further trials, this strategy may be applicable to other

autoimmune diseases with known antibodies, such as type 1 diabetes

mellitus, systemic lupus erythematosus, rheumatoid arthritis, and

myasthenia gravis.

Thank you for sharing this, . I'm going to pass along the

information to my autoimmune disease-riddled extended family.

--Meghan, mom to Wyatt-12yo, fap,psc,uc-crohn's,a/ihives