• GNS561 is currently assessed in a Phase 1/2 in second-line patients with primary liver cancer
• Second-line patients with advanced pancreatic or colorectal cancer with liver metastasis could now be enrolled in this current clinical study
• The first patient with advanced pancreatic cancer and liver metastasis has been enrolled at the Saint-Joseph, AP-HP, Paris since December 10th, 2019
Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer treatment drugs, today announces the extension of the Phase 1/2 clinical trial assessing GNS561 to patients with secondary liver cancers. 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.
“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.
About Genoscience Pharma
Genoscience Pharma, a French clinical-stage biotechnology company, is developing a potential new disruptive standard of care against liver cancers thanks to our platform. The hit lead GNS561 is an investigational best-in-class drug, tackling cancer cells through lysosomal membrane permeabilization, and shows outstanding results during its preclinical development and preliminary first-in-human clinical data. In addition to killing cancer cells, for the first time, our small molecule is capable to kill cancer stem cells, bringing a new hope to overcome cancer resistance. Following an exploration of liver cancer business potential, the company decided to focus on malignant diseases encountering highly unmet medical needs: primary and secondary liver cancers. We are collaborating with several clinical investigators in Europe and in the US that expressed their interest in GNS561.
Forward-Looking Statements
This press release may involve and contain forward-looking statements by the company about its product candidate GNS561, including its potential benefits. Such statements are based upon the current beliefs and expectations of Genoscience Pharma’s management and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, but are not limited to: additional financing, the company’s ability to implement its chosen strategy, dependence upon third parties, other risks and uncertainties inherent in research and development, including the possibility of unfavorable study results, changes in the competitive environment, changes in regulations, clinical or industrial risks and all risks linked to the company’s growth. There are no guarantees that future clinical trials will be completed or successful or that any Genoscience Pharma therapeutics will receive regulatory approval for any indication or prove to be commercially successful. While those factors presented here are considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof; Genoscience Pharma does not undertake any obligation to update such statements to reflect subsequent events or circumstances.
