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January 30, 2019

CStone secures approval in China for Phase I trial of BLU-554

CStone Pharmaceuticals has received approval from China’s National Medical Products Administration (NMPA) for its clinical trial application (CTA) to begin a Phase I clinical trial of BLU-554 (CS3008) for the treatment of hepatocellular carcinoma (HCC).

CStone Pharmaceuticals has received approval from China’s National Medical Products Administration (NMPA) for its clinical trial application (CTA) to begin a Phase I clinical trial of BLU-554 (CS3008) for the treatment of hepatocellular carcinoma (HCC).

HCC is the most common form of liver cancer and is estimated to affect around 466,000 people and cause 422,000 deaths annually in China.

BLU-554 is a fibroblast growth factor receptor 4 (FGFR4) inhibitor developed by CStone’s partner Blueprint Medicines.

The company previously secured exclusive rights to develop and commercialise BLU-554 in China, Hong Kong, Macau and Taiwan.

CStone and Blueprint intend to enrol patients with advanced HCC, which was not previously treated with a tyrosine kinase inhibitor (TKI).

“We also plan to conduct a Phase I trial of BLU-554 in combination with CS1001 for the treatment of advanced HCC patients in China.”

The trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of BLU-554.

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CStone and Blueprint Medicines are expected to start enrolling patients for the trial in China soon.

CStoneCEO and chairman Dr Frank Jiang said: “Compared with current treatments, BLU-554 has produced encouraging data in terms of tolerability and disease control rates.

“We also plan to conduct a Phase I trial of BLU-554 in combination with CS1001 for the treatment of advanced HCC patients in China in the second half of 2019.”

Blueprint Medicines reported preliminary data from the Phase I trial of BLU-554 in August 2017. The data revealed that heavily pre-treated patients with FGFR4-driven HCC achieved an objective response in six of the 38 patients enrolled in the trial.

It was also reported that 26 of the patients achieved disease control and 18 patients had a reduced tumour burden.

Five patients who never received TKI therapy also showed preliminary evidence of prolonged disease control.

BLU-554 was also reported to be well-tolerated in the trial.

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