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Progen Pharmaceuticals receives second IND application approval in Asia for liver cancer drug

Progen Pharmaceuticals receives second IND application approval in Asia for liver cancer drug

Progen Pharmaceuticals (ASX: PGL) licensee Medigen Biotechnology Corporation can now move to site selection and patient enrolment for a PATRON Phase III study of its liver cancer drug, PI-88, in Korea following approval from the Korea Food and Drug Administration of its Investigative New Drug application.

This is the second Investigative New Drug application approval obtained by Medigen Biotechnology, following the approval granted by the Taiwan Food Administration in April.

The number of patients with hepatocellular carcinoma, the most common form of liver cancer, registered in South Korea is the third highest in Asia, behind China and Japan.

This latest approval means Medigen Biotechnology can now open sites and begin patient enrolment under its PATRON Phase III study of PI-88.

The Phase III, randomised, placebo-controlled, multinational trial will enrol about 500 subjects globally, with the majority of patients enrolled from Asia. The study is expected to be conducted in Taiwan, South Korea, China, Hong Kong and some countries in Europe with high hepatocellular carcinoma prevalence.

It is designed to confirm the efficacy and safety of PI-88 in the adjuvant treatment of hepatocellular carcinoma after surgical resection. The primary endpoint of the study is disease-free survival.

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