Biovaxpharma-Inhalosomes - Development of a nonionic surfactant vesicle platform formulation for drug encapsulation and pulmonary delivery

Inhalosome是一种脂质纳米颗粒，旨在满足有效治疗严重肺部疾病(如癌症、感染和自身免疫)的未得到满足的需求。目前的系统治疗只有部分有效，因为它们是一种全面的方法，低水平的药物进入肺部。将开发吸食体囊泡作为一种平台药物包囊技术，该技术可以雾化用于肺部给药，以提供显着的治疗改进。最初的目的是证明Inhalosome用于治疗肺癌，特别是非小细胞肺癌(NSCLC)的可行性。有了这个项目，Inhalosome原型将被制造成cGMP，并使用生产的Inhalosome制剂测试制剂的稳定性，随后的研究将评估Inhalosome-Displatin的毒理学，并在第一和第二阶段研究中证明用于人类治疗非小细胞肺癌的安全性和有效性。人们预计，顺铂-Inhalosome联合治疗将显著提高NSCLC化疗的有效性，提高存活率和延长预期寿命，并将改善患者体验。

Inhalosomes are lipid nanoparticles designed to tackle the unmet need for effective treatment of serious pulmonary diseases, such as in cancer, infection and autoimmunity. Current systemic treatments are only partially effective as they are a blanket approach where low levels of drug reach the lung. Inhalosome vesicles will be develop as a platform drug encapsulating technology that can be aerosolized for lung delivery to provide significant improvements in therapy. The initial intention is to demonstrate the feasibility of Inhalosomes for the treatment of lung cancer, particularly non-small cell lung cancer (NSCLC). With this project, the Inhalosome prototype will be manufactured to cGMP and the stability of the formulation tested Using the manufactured Inhalosome preparation, subsequent studies will evaluate the Inhalosome-cisplatin for toxicology and in Phase I and II studies to demonstrate safety and efficacy in man for treating NSCLC. Expectations are that the Cisplatin-Inhalosome combination will significantly increase the effectiveness of NSCLC chemotherapy treatment, increasing the survival rate and extend life expectancy and will improve the patient experience.