On December 12, 2019 Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer treatment drugs, reported the extension of the Phase 1/2 clinical trial assessing GNS561 to patients with secondary liver cancers (Press release, GenoScience, DEC 12, 2019, View Source [SID1234552424]). Until recently, the current clinical had been enrolling patients with advanced primary liver cancers, i.e. hepatocellular carcinoma and intra-hepatic cholangiocarcinoma. The protocol amendment for extending the clinical study to patients with advanced pancreatic or colorectal cancer with liver metastasis was approved in all countries already participating to the study: USA, Belgium and France. The first patient with metastatic pancreatic cancer has been enrolled since December 10th, 2019 at the Saint-Joseph Hospital.

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"This is a major step for Genoscience Pharma. We were looking forward to extending the indications of our clinical trial to other significant unmet needs in digestive oncology. This approval encourages us to develop our efforts to treat more patients with no satisfactory therapeutic options. It will also improve the inclusion rate, so therapeutic effects are expected to be observed sooner" said Pr Eric Raymond, Chief Medical Officer of Genoscience Pharma.

In addition, the number of patients to be enrolled in Phase 2 was extended to 20 patients per cancer type (hepatocarcinoma, intra-hepatic cholangiocarcinoma, pancreatic cancer with liver metastasis, colorectal cancer with liver metastasis), for a total of 80 patients.

"Such approval to increase in the number of patients to be enrolled is fundamental to enable us achieving our goal to obtain a breakthrough therapy designation for GNS561 from the end of the Phase 2a." said Dr Philippe Halfon, Chief Executive Officer and Founder of Genoscience Pharma.