BHT-3009, a myelin basic protein-encoding plasmid for the treatment of multiple sclerosis.
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| Abstract |
Even though the etiology of multiple sclerosis (MS) remains largely unknown, research data support the hypothesis that autoimmunity plays a major role in disease development. Several disease-modifying agents have been approved for the treatment of MS; however, there is still a need for antigen-specific treatments that combine efficacy and safety. DNA vaccination represents a new therapeutic alternative in this respect. Preclinical studies in different models of autoimmunity have demonstrated that injection of plasmid DNA encoding a self-antigen in mice restores self-tolerance, leaving immunity against infectious and tumor antigens intact. Based on this evidence, the first DNA vaccine for MS has been created. Bayhill Therapeutic Inc's BHT-3009 encodes full-length, human myelin basic protein (MBP), and has recently been evaluated in a phase I/II and a phase II clinical trial. BHT-3009 was safe and well tolerated in both trials, inducing immune tolerance that extended beyond MBP to other myelin antigens. In addition, a reduction in the number of active lesions was observed, which was accompanied by a decrease in clinical relapse rates, particularly in patients with high immunological activity at baseline. BHT-3009 appears to be a promising new approach for the treatment of MS, although further clinical trials are warranted to confirm the early findings.
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| Authors | Jorge Correale, Marcela Fiol |
| Journal | Current opinion in molecular therapeutics (Curr Opin Mol Ther) Vol. 11 Issue 4 Pg. 463-70 (Aug 2009) ISSN: 2040-3445 [Electronic] England |
| PMID | 19649992 (Publication Type: Journal Article) |
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