Telix has received approval from the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the Phase I study of its TLX101 investigational drug (4-L-[131I] iodo-phenylalanine, or 131I-IPA) for the treatment of newly diagnosed glioblastoma (GBM) patients.
Telix’s partner in Greater China, Grand Pharmaceutical Group, submitted the investigational new drug (IND) application.
The Phase I study will establish the safety profile of the investigational therapy in Chinese population, enabling them to be enrolled in the company’s planned global pivotal registration trial for TLX101.
Primary objective demonstrating the safety and tolerability was met in the IPAX-1 study of intravenous 131I-IPA administered concurrently with external beam radiation therapy (EBRT) in recurrent GBM patients.
In addition, the preliminary efficacy data showed a median overall survival of 13 months from the commencement of treatment in the recurring setting, or 23 months from initial diagnosis.
Telix Asia Pacific CEO Dr David Cade said: “Building on the successful IPAX-1 study of TLX101 therapy in patients with recurrent GBM, we are pleased to commence this follow-on study in newly diagnosed Chinese patients.
“Completion of this Phase I trial is critically important to the development of this asset, as it will enable Chinese patients to be included in the future global registration trial for TLX101 and potentially enable parallel regulatory submissions in Western markets and China.
“With our partner for Greater China, Grand Pharma, Telix’s goal is to provide new treatment options for this aggressive cancer with significant unmet medical need as efficiently as possible in this large market.”
Telix has now started the IPAX-2 study in Australian sites for confirming TLX101’s safety profile as a front-line therapy along with standard of care treatment.
In parallel, this study will be carried out in Chinese subjects in the same disease setting.
The company is also planning to initiate IPAX-3 label-indicating Phase II/III study in a larger patient population.