生物谷報道：加拿大研究人員在最新一期美國《神經(jīng)病學文獻》月刊上發(fā)表研究報告說,，有種ＤＮＡ疫苗能幫助治療多發(fā)性硬化癥,。
據(jù)路透社１３日報道,，加拿大蒙特利爾神經(jīng)學院神經(jīng)免疫學專家阿米特·巴爾－奧爾等人對３０名多發(fā)性硬化癥患者使用一種名叫ＢＨＴ－３００９的ＤＮＡ疫苗進行了為期兩年的治療,。他們將ＢＨＴ－３００９疫苗注入患者體內(nèi),，使患者體內(nèi)生成能保護大腦等處神經(jīng)細胞的髓鞘堿性蛋白質(zhì),，從而促成對病人有利的抗原免疫變化,。
初步研究結(jié)果表明,，這種ＤＮＡ疫苗對病人無害，接受疫苗注射的多發(fā)性硬化癥患者在治療期間復發(fā)幾率減少,，腦部損傷也比對照組患者小得多,。
路透社報道說，這種疫苗由美國加州一家生物科技公司生產(chǎn),，目前仍處于實驗階段,。加拿大研究人員目前已擴大實驗規(guī)模，為２９０名多發(fā)性硬化癥患者注射這種疫苗,，以進一步了解疫苗的效果,。
多發(fā)性硬化癥是一種自體免疫性疾病,，癥狀包括視力模糊、身體失去平衡,、協(xié)調(diào)能力差,、極度疲勞、癱瘓和失明等,。
原始出處:
Arch Neurol, Aug 2007; doi:10.1001/archneur.64.10.nct70002
Early Release Article, posted August 13, 2007
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; Timothy Vollmer, MD; Jack Antel, MD; Douglas L. Arnold, MD; Caroline Anita Bodner, MSc; Denise Campagnolo, MD; Jill Gianettoni, BS; Farzaneh Jalili, BSc; Norman Kachuck, MD; Yves Lapierre, MD; Masaaki Niino, MD, PhD; Joel Oger, MD; Mary Price, BS; Susan Rhodes, MS; William H. Robinson, MD, PhD; Fu-Dong Shi, MD, PhD; Paul J. Utz, MD; Frank Valone, MD; Leslie Weiner, MD; Lawrence Steinman, MD; Hideki Garren, MD, PhD
Arch Neurol. 2007;64:(doi:10.1001/archneur.64.10.nct70002).
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.
Author Affiliations: Montreal Neurological Institute (Drs Bar-Or, Antel, Lapierre, and Niino and Mss Bodner and Jalili) and NeuroRx Research (Dr Arnold), Montreal, Quebec, Canada; Barrow Neurological Institute, Phoenix, Arizona (Drs Vollmer, Campagnolo, and Shi and Mss Price and Rhodes); Bayhill Therapeutics, Inc, Palo Alto, California (Ms Gianettoni and Drs Valone and Garren); University of Southern California, Los Angeles (Drs Kachuck and Weiner); University of British Columbia, Vancouver, British Columbia, Canada (Dr Oger); and Stanford University, Stanford, California (Drs Robinson, Utz, Steinman, and Garren).
