KUALA LUMPUR, April 14 -- China’s health authority, National Medical Products Administration (NMPA) has authorised LintonPharm Co Ltd to proceed with a Phase 1/2 clinical trial evaluating the safety and efficacy of catumaxomab.
The clinical trial will involve patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) whose tumours have recurred due to Bacillus Calmette-Guerin (BCG) vaccine failure.
“Regulatory clearance to move forward with our clinical programme evaluating catumaxomab in bladder cancer is another significant milestone for LintonPharm and supports our goal of exploring the potential for this targeted therapy in a broad range of cancers,” said LintonPharm Co-founder and Chief Executive Officer, Robert Li, Ph.D., DABT.
“Patients with NMIBC BCG failure have high rates of tumour recurrence and often face a lifetime of surgical intervention which may impact bladder function. New treatment options are needed and we are hopeful that this study puts us one step closer toward helping these patients.”
According to a statement, this is LintonPharm’s second clinical programme evaluating catumaxomab. In July last year, the company announced authorisation of a Phase 3 trial in advanced gastric cancer which screened its first patient in October last year.
Recently, Lindis Biotech, partner of LintonPharm, initiated a dose-finding Phase 1 trial with catumaxomab in NMIBC patients in Germany and reported an excellent safety profile, which supports the conduct of the Phase 1/2 trial in China.
Bladder cancer is the 10th most common cancer worldwide. In 2020, bladder cancer was diagnosed in approximately 573,278 patients globally and approximately 1.8 million people were living with this form of cancer over a five-year period.
-- BERNAMA
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