Proprietary drug to treat radiodermatitis

总结 放射性皮炎是一种皮肤组织损伤，发生在95%接受放射治疗（RT）的癌症患者中。 虽然现代RT，例如，调强放射治疗（IMRT）或立体定向体部放射治疗（SBRT）， 放射性皮肤炎是皮肤癌患者治疗中的主要毒性反应 SBRT以及其他接受常规RT治疗的癌症患者，其中IMRT/SBRT不可用 或不适合，例如，乳腺癌患者。严重的放射性皮炎会导致皮肤糜烂，阿片类药物耐受性疼痛 和长期纤维化。目前的治疗主要是为了改善“皮肤烧伤”，而不是促进愈合。 Allander Biotechnologies，LLC.开发了一种专利药物，通过抗炎治疗放射性皮炎， 抗纤维化、促进DNA损伤修复和促进上皮再生。到目前为止，我们已经建立了一个 药物生产平台，有效性，安全性和药效学（PD）标志物的可行性，以开发我们的 将药物转化为局部应用的药物产品。在第二阶段的应用中，我们将开发良好制造 实践（GMP）-可规模化生产，并为我们的原料药和制剂建立参考标准。 我们将进行IND（研究性新药）-使能PD和药代动力学（PK）研究。我们将评估 我们的药物在小鼠和犬放射性皮炎局部治疗期间的潜在毒性。我们还将表演 啮齿动物中符合药物非临床研究质量管理规范（GLP）的全身毒理学研究，通过有意全身 运送我们的药物到第二阶段资助结束时，我们将获得CMC（化学、制造）的IND数据 和对照组）、临床前PD/PK、小鼠和犬中的潜在皮肤和全身毒性， 啮齿类动物中的局部治疗剂量和GLP全身毒理学。这些数据将使我们能够设计GLP 在更大的物种中进行毒理学研究，这将在IND申请之前完成额外的资金 启动I期临床试验

Summary Radiodermatitis is skin tissue damage that occurs in 95% of cancer patients receiving radiotherapy (RT). Although modern RT, e.g., intensity-modulated RT (IMRT) or stereotactic body RT (SBRT), spares more skin areas from RT damage than regular RT, radiodermatitis is still the major toxicity in skin cancer patients treated with SBRT as well as in other cancer patients treated with regular RT where IMRT/SBRT are either unavailable or not suitable, e.g., breast cancer patients. Severe radiodermatitis causes skin erosion, opiate-resistant pain and long-term fibrosis. Current treatments largely aim to ameliorate “skin burn” rather than promoting healing. Allander Biotechnologies, LLC. has developed a proprietary drug to treat radiodermatitis via anti-inflammation, anti-fibrosis, promoting DNA damage repair, and promoting re-epithelialization. To date, we have established a drug production platform, feasibility for efficacy, safety, and pharmacodynamics (PD) markers to develop our drug into a topically applied drug product. In this Phase II application, we will develop Good Manufacturing Practice (GMP)-scalable production and establish reference standards for our drug substance and drug product. We will perform IND (investigational new drug)-enabling PD and pharmacokinetics (PK) studies. We will evaluate potential toxicity of our drug during topical treatment of radiodermatitis in mice and dogs. We will also perform Good Laboratory Practice (GLP) compliant systemic toxicology studies in rodents via intentional systemic delivery of our drug. By the end of Phase II funding, we will have IND data for CMC (Chemistry, Manufacturing and Controls), preclinical PD/PK, potential cutaneous and systemic toxicities in mice and dogs resulted from topical treatment doses, and GLP systemic toxicology in rodents. These data will allow us to design GLP toxicology studies in a larger species, which will be completed with additional funding for IND filing before initiating a Phase I clinical trial.