Oral IFN-tau treatment in RRMS patients

描述（由申请人提供）：这个SBlR-AT I期项目将评估重组羊干扰素tau （rolFN-tau）在多发性硬化症（MS）患者中的安全性、作用机制和临床效果。IFN-tau是一种具有生物活性的1型干扰素，包括抗炎作用，类似于其他1型干扰素lfn - α和ifn - β。然而，与ifn - α和ifn - β相比，lFN-tau具有口服生物活性。在啮齿类动物和人类中，口服IFN-tau诱导IL-10并降低lfn - γ，并预防实验性过敏性脑脊髓炎（ms的一种动物模型）的症状和体征。此外，基于I期临床试验的结果，lFN-tau似乎具有极好的耐受性，并且比注射lfn - α或ifn - β产生的副作用更少。在拟议的项目中，将在20例复发-缓解型多发性硬化患者中进行为期9个月的临床试验，评估每日口服单剂量rolFN-tau的效果。安全性和耐受性将被仔细监测，而IFN-tau对T细胞介导免疫的影响将通过测量治疗前、治疗期间和治疗后血清和全血白细胞（WBC）中Th1和Th2细胞因子的水平来确定。疾病进展的评估将基于每月通过MRI连续测定钆增强斑块的数量。这项试验的结果将使我们能够确定lFN-tau在多发性硬化症中的安全性和治疗潜力，并为设计更大规模、更长期的对照临床试验提供基础

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