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

吸入体是脂质纳米颗粒，旨在解决癌症、感染和自身免疫等严重肺部疾病有效治疗的未满足需求。目前的全身治疗只是部分有效，因为它们是一种地毯式的方法，低水平的药物到达肺部。吸入体囊泡将被开发为平台药物包封技术，可以雾化肺输送，为治疗提供重大改进。最初的目的是证明吸入体治疗肺癌，特别是非小细胞肺癌（NSCLC）的可行性。在这个项目中，吸入体原型将按照cGMP生产，并测试配方的稳定性。使用制造的吸入体制剂，随后的研究将评估吸入体-顺铂的毒理学，并在I期和II期研究中证明用于治疗非小细胞肺癌的安全性和有效性。预期顺铂-吸入体联合治疗将显著提高NSCLC化疗的有效性，提高生存率，延长预期寿命，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.