Oral IFN-tau treatment in RRMS patients

RRMS 患者的口服 IFN-tau 治疗

• 批准号: 6859382
• 负责人: Lorelie Villarete
• 金额: $ 32.65万
• 依托单位: PEPGEN CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-01 至 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6859382
• 关键词: T lymphocyte; antibody; antibody formation; cellular immunity; clinical research; clinical trial phase II; drug screening /evaluation; human therapy evaluation; immunotherapy; interferons; magnetic resonance imaging; multiple sclerosis; oral administration; patient oriented research; pharmacokinetics

DESCRIPTION (provided by applicant): This SBlR-AT Phase I project will evaluate the safety, mechanism of action, and clinical effects of recombinant ovine Interferon tau (rolFN-tau) in patients with multiple sclerosis (MS). IFN-tau is a Type 1 interferon that possesses biological activity, including anti-inflammatory effects, similar to that of other Type 1interferons, lFN-alpha and IFN-beta. However, in contrast to IFN-alpha and IFN-beta, lFN-tau is orally bioactive. When administered orally, IFN-tau induces IL-10 and reduces lFN-gamma in rodents and humans, and prevents the symptoms and signs of experimental allergic encephalomyelitis (EAE), an animal model of MS. Moreover, based on the results of Phase I clinical trials, lFN-tau appears to be extremely well tolerated and causes fewer side effects than injected lFN-alpha or IFN-beta. In the proposed project, the effects of a single daily oral dose of rolFN-tau will be evaluated in twenty patients with relapsing-remitting MS in a nine-month clinical trial. Safety and tolerability will be carefully monitored, while the effects of IFN-tau on T cell-mediated immunity will be determined by measuring the levels of Th1 and Th2 cytokines in serum and in white blood ceils (WBC) from whole blood from before, during, and after treatment. Assessment of disease progression will be based on serial monthly determinations of the number of gadolinium-enhanced plaques by MRI. The results of this trial should allow us to determine the safety and therapeutic potential of lFN-tau in MS and provide the basis for designing a larger, longer controlled clinical trial

描述（由申请人提供）：该SBLR-AT I期项目将评估重组卵巢干扰素Tau（Rolfn-Tau）对多发性硬化症患者（MS）的安全性，作用机理和临床作用。 IFN-TAU是具有生物学活性（包括抗炎作用）的1型干扰素，类似于其他类型1个插入量，LFN-Alpha和IFN-β。但是，与IFN-Alpha和IFN-β相反，LFN-TAU是口服生物活性的。口服时，IFN-TAU会诱导IL-10并减少啮齿动物和人类中的LFN-γ，并防止MS动物模型（MS动物模型）实验性过敏性脑脊髓炎（EAE）的症状和迹象。此外，根据I期临床试验的结果，LFN-TAU的耐受性非常好，并且与注射的LFN-Alpha或IFN-β相比，副作用更少。在拟议的项目中，将在9个月的临床试验中评估二十名复发复发性MS的患者的每日口服剂量的Rolfn-Tau的影响。将仔细监测安全性和耐受性，而IFN-TAU对T细胞介导的免疫力的影响将通过测量血清中的Th1和Th2细胞因子的水平以及白血球天花板（WBC）的水平（WBC），从整体，过程中，期间和治疗后。疾病进展的评估将基于MRI对Gadolinium增强斑块数量的每月确定。该试验的结果应使我们能够确定MS中LFN-TAU的安全性和治疗潜力，并为设计更大，更长的受控临床试验提供了基础