Marseille, France, April 5, 2018 — Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer drugs, announces today the first administration of GNS561 in a Phase 1/2a clinical study in advanced hepatocellular carcinoma. This is the first clinical trial investigating this drug candidate, stemming from Genoscience Pharma’s research.
This clinical research in liver cancer is led by Professor Ahmad Awada, head of medical oncology and principal investigator at the Jules Bordet Cancer Institute in Brussels, Belgium.
This international phase 1/2a study performed in Europe and the USA will evaluate safety, activity and the pharmacokinetics and pharmacodynamics of escalating doses of GNS561. Up to 36 patients will be enrolled in six cohorts during the dose escalation phase. Additional patients will be enrolled in the continuation phase to obtain a total of 20 evaluable subjects at the recommended dose.
“This clinical program represents a paradigm shift for our company; it will provide a wealth of valuable additional knowledge and data to drive our platform of metal transporter modulators towards various clinical applications for cancer therapy,” said Professor Philippe Halfon, president and CEO of Genoscience Pharma.
“Since being granted a rapid approval from regulatory authorities and institutional review boards, we have initiated the first-in-class GNS561 studies. The enrollment and treatment of the first patient represents a major milestone for Genoscience Pharma,” said Professor Eric Raymond, chief medical officer.
“We are excited to be enrolling our first patient with GNS561. We are hopeful that this novel anticancer drug will prove to be a significant and effective weapon against liver cancer,” said Pr. Ahmad Awada, principal investigator.
The study is run as an international clinical trial conducted in Europe and the USA. Professor Ghassan Abou Alfa at Memorial Sloan Kettering in New York is co-principal investigator. His work focuses on preclinical and early-stage testing to optimize the development of stem cell-targeted cancer drugs.
About liver cancer
With more than 780,000 new cases diagnosed each year, liver cancer is the fifth most common cancer worldwide. It is the second leading cause of cancer-related deaths globally, accounting for approximately 746,000 deaths annually. The majority of liver cancers are detected at the advanced stage. New treatment options are urgently needed for these patients. HCC is the most common form of liver cancer, accounting for 90 percent of the worldwide total.
GNS561 is a novel Solute Carrier Transporter (SLCT) inhibitor demonstrating potent antitumor activity against a range of human cancer cell lines, including HCC. It also shows activity in cell lines resistant to current standard-of-care treatment options for HCC. GNS561 is an orally bioavailable compound initially being developed for the treatment of primary liver cancer, including advanced HCC. It is also being investigated preclinically in other solid tumors.
About Genoscience Pharma
Genoscience Pharma is a clinical-stage pharmaceutical company, focused on the discovery and development of novel small molecule anticancer therapeutics, including novel Solute Carrier Transporter inhibitors, to improve cancer treatment and clinical outcomes for patients. Genoscience Pharma plans to develop its products internationally, particularly in Europe, the US and Asia.