XT-101: A Potent IL-10 Based Therapy for Treating Multiple Sclerosis.

描述(申请人提供)：Xalud Treateutics建议评估其新的、有效的抗炎疗法XT-101在运动治疗中的适用性 多发性硬化症(MS)退行性和炎症性自身免疫性啮齿动物模型中的损害、步态障碍和神经病理性疼痛。XT-101是一种非病毒形式的基因治疗，可使脊髓周围的脑膜细胞分泌强大的、自然的、抗炎的白介素10(IL-10)。基于广泛的临床前研究，Xalud认为分泌的IL-10将减少炎症并使Xalud女士看到的病理小胶质细胞和星形胶质细胞活动正常化。她建议在MS的炎症性和神经退行性啮齿动物模型中研究XT-101，并进行各种细胞和组织分析，以更好地了解和阐明XT-101的生物学效应。Xalud希望在这些模型中证明XT-101可以减少运动障碍，减轻步态障碍，并解决神经病理性疼痛。Xalud还预计XT-101将对MS病理的许多因素产生积极影响，包括：免疫细胞渗透、炎症、谷氨酸运输减少、脱髓鞘和神经元凋亡。支持拟议的研究将极大地加速XT-101的临床应用开发。Xalud目前正在进行使用XT-101治疗神经性疼痛的IND毒理学研究，预计将在2013年底提交IND申请。拟议研究提供的额外疗效数据将支持XT-101在神经病理性疼痛、步态障碍和可能其他与多发性硬化症相关的适应症中启动人体试验。Xalud认为，XT-101如果开发成功，将对多发性硬化症的临床治疗产生巨大影响，并极大地提高多发性硬化症患者的生活质量。神经性疼痛和步态障碍影响了几乎所有的MS患者，并大大降低了他们参与社会和享受生活的能力。此外，XT-101可能会减缓目前无法治愈的进展型多发性硬化症的疾病进展。由于XT-101的作用方法与所有现有或即将到来的多发性硬化症治疗方法明显不同，它有可能成为当前医疗实践的一个极其有用的补充和补充。

DESCRIPTION (provided by applicant): Xalud Therapeutics proposes to evaluate the applicability of its novel and potent anti-inflammatory therapy, XT-101, for the treatment of motor impairment, gait disorders, and neuropathic pain in degenerative and inflammatory autoimmune rodent models of multiple sclerosis (MS). XT-101 is a non-viral form of gene therapy that causes the meningeal cells surrounding the spinal cord to secrete the powerful, natural, anti- inflammatory interleukin-10 (IL-10). Based on extensive pre-clinical research, Xalud believes that the secreted IL-10 will reduce inflammation and normalize the pathological microglia and astrocyte activity that is seen in MS. Xalud proposes to study XT-101 in both inflammatory and neurodegenerative rodent models of MS and to conduct various cell and tissue analyses to better understand and elucidate the biological effects of XT-101. Xalud expects to demonstrate in these models that XT-101 reduces motor impairment, alleviates gait disorders and resolves neuropathic pain. Xalud also expects that XT-101 will have a positive effect on numerous elements of MS pathology including: immune cell infiltration, inflammation, reduced glutamate transport, demyelination, and neuronal apoptosis. Support of the proposed studies would greatly accelerate the development of XT-101 for clinical applications. Xalud is currently conducting IND-enabling toxicology studies for the use of XT-101 in neuropathic pain and expects to file an IND in late 2013. The additional efficacy data provided by the proposed studies would support the initiation of human trials of XT-101 in neuropathic pain, gait disorders and possibly other MS-related indications. Xalud believes that XT-101, if successfully developed, could have a tremendous impact on the clinical treatment of MS and greatly improve the quality of life MS patients. Neuropathic pain and gait disorders impact almost all MS patients and greatly reduce their ability to participate in society and enjoy life. Further, XT-101 may slow disease progression in the currently untreatable progressive forms of MS. Because the method of action of XT-101 is markedly different from all existing or imminent MS treatments, it has the potential to be an extremely useful addition and complement to current medical practice.