KUALA LUMPUR, July 16 -- The China National Medical Products Administration recently authorised LintonPharm Co Ltd to proceed with a Phase III trial for catumaxomab in patients with peritoneal carcinomatosis.
According to a statement, peritoneal carcinomatosis is a form of advanced gastric cancer that has spread to the tissue that lines the abdominal cavity.
The two-stage, multi-centre, open-label, randomised, controlled registrational clinical trial will evaluate the safety and efficacy of an intraperitoneal infusion of the bi-specific antibody catumaxomab into the abdominal cavity.
In addition, LintonPharm recently received Clinical Trial Application authorisation for the same indication from the Taiwan Ministry of Health and Welfare and the Korea Ministry of Food and Drug Safety.
“Gastric cancer is the sixth most common cancer globally. Approximately, 70 per cent of patients are located in China and the majority of these patients are diagnosed with late stage disease,” said LintonPharm co-founder and Chief Scientific Officer, Dr Horst Lindhofer.
“Given this high unmet need, we are hopeful that catumaxomab will offer a new treatment option to gastric patients.”
Based in China, LintonPharm is a clinical-stage, research-oriented biopharmaceutical company, developing innovative T cell engaging bispecific antibodies with the goal of turning malignant cancers into manageable and possibly, curable diseases.
-- BERNAMA
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