BDI, US Ellison Inhalation Lung Cancer New Drug China Global Phase 2 Clinical Trial Approved

[Asia Economy Reporter Hyungsoo Park] VIDI announced on the 4th that the inhalation lung cancer treatment drug under development by Ellison Pharmaceuticals will officially proceed with global Phase 2 clinical trials in China. It successfully received approval from the China National Medical Products Administration (NMPA) for the Phase 2 clinical trial of the lung cancer treatment drug ‘ILC’.

In Phase 2 clinical trials, the new drug candidate will be administered as a monotherapy to patients with limited-stage small cell lung cancer (LS-SCLC) who have no prior experience with lung cancer treatment. The trial will focus on evaluating the drug’s efficacy, safety, and pharmacokinetics, including absorption, distribution, metabolism, and excretion.

ILC, made by reducing the anticancer drug cisplatin to nano size and combining it with a lipid layer, is exclusively licensed worldwide by Ellison. It is an anticancer drug administered via inhalation using a medical nebulizer. This aerosol method allows direct delivery to the lungs, enabling effective administration of the drug at high concentrations. It also minimizes systemic toxicity, resulting in fewer side effects.

Ellison demonstrated the drug’s efficacy by conducting efficacy tests on patients treated with ILC after lung tumor removal. The test results showed a progression-free survival period of up to 12 months, measuring the time during which the cancer did not worsen.

They also succeeded in shortening the administration time, which was previously criticized as a drawback. In a feasibility study on ILC administration conducted last year with Nasdaq-listed Windtree Therapeutics, the previous method requiring about 2 hours of nebulizer administration was reduced to 20 minutes.

Jinhyuk Lee, Head of the Bio Business Division, said, "ILC is the world’s first inhalation lung cancer treatment drug under development as a new drug," adding, "We will support Ellison’s work to successfully continue the clinical trials and strive to maximize synergy between the two companies."

Ellison holds four clinical pipelines including ILC. The pancreatic cancer single second-line treatment ‘Glufosfamide’ aims for new drug approval (NDA) in 2022, and the brain cancer treatment ‘DBD’ is expected to proceed to Phase 3 clinical trials around 2021.

This content was produced with the assistance of AI translation services.