Fullerene-based Radioprotectors for Use during Brain Radiotherapy, Period of Performance 09/15/2014 - 05/15/2015

据估计，每年有22910例新发原发性脑肿瘤和50万例新发脑转移病例。作为治疗的一部分，这些患者中的大多数将接受分段的全脑或部分脑照射，这使他们面临发生晚期辐射引起的脑损伤的风险，包括认知功能的进行性下降。放疗也是脑转移的主要治疗方式。大多数幸存者的生活质量下降已经成为一个重要的和日益增长的关注，被认为是脑肿瘤治疗结果的最重要的衡量标准之一，在临床试验中仅次于生存。目前，对于辐射引起的认知障碍，还没有被证明成功的长期治疗方法或有效的预防策略。Luna提议开发一种基于富勒烯的放射保护器，用于脑部放射治疗，以提高幸存者的生活质量。富勒烯作为一种催化抗氧化剂、模拟sod和抗炎剂，已被证明具有延缓衰老和治疗神经退行性疾病的作用。概念验证将通过I期和II期的体外和体内实验进行验证，并将重点放在先进的临床前研究上，以证明安全性和有效性，以提高辐射的治疗率。

It is estimated that there are 22,910 new cases of primary brain tumor and 500,000 new cases of brain metastases each year. A majority of these patients will receive fractionated whole or partial brain irradiation as part of their treatment, putting them at risk for developing late radiation-induced brain injury, including a progressive decline in cognitive function. Radiation is also the primary treatment modality for brain metastases. The diminished quality of life of most survivors has become an important and growing concern, being recognized as one of the most important measurements of brain tumor therapy outcomes, second only to survival in clinical trials. Currently, there are no proven successful long-term treatments or effective preventative strategies for radiation-induced cognitive impairment. Luna proposes to develop a fullerene-based radioprotector for use during brain radiotherapy to improve the quality of life of those survivors. Fullerene has been shown effective to delay aging and treat neurodegenerative diseases as a catalytic antioxidant, SOD-mimetic and anti-inflammatory agent. The proof-of concept will be demonstrated through in vitro and in vivo experiments in Phase I and Phase II will focus on advanced preclinical studies to demonstrate safety and effectiveness to improve the therapeutic ratio of radiation.