Genoscience wins FDA approval for Phase Ib/IIatrial of GNS561

7th December 2017 (Last Updated December 7th, 2017 00:00)

Genoscience Pharma has received approval from the US Food and Drug Administration (FDA) to begin a Phase Ib/IIa study of GNS561 to treat hepatocarcinoma (HCC), the most common form of liver cancer.

Genoscience Pharma has received approval from the US Food and Drug Administration (FDA) to begin a Phase Ib/IIa study of GNS561 to treat hepatocarcinoma (HCC), the most common form of liver cancer.

The trial represents the first-in-human study to be carried out as part of the investigational new drug (IND) protocol approved by FDA.

It intends to evaluate the safety, activity and pharmacokinetics of escalating doses of GNS561, which is a solute carrier transporter (SLCT) inhibitor.

Up to 36 patients in six groups will be included during the dose escalation phase, as well as additional patients in the continuation phase to obtain a total of 20 evaluable subjects at the recommended dose.

The FDA approval of our first IND application is a major milestone for Genoscience Pharma.

"We believe that GNS561, acting through a novel mechanism of action, has the potential to change the treatment paradigm of HCC."

Genoscience Pharma CEO Philippe Halfon said: “The FDA approval of our first IND application is a major milestone for Genoscience Pharma.

“This strengthens our position as a drug discovery and development company focused on the development of innovative anti-cancer drugs for the betterment of patients.

“We believe that GNS561, acting through a novel mechanism of action, has the potential to change the treatment paradigm of HCC.”

Currently, more than 780,000 new cases of liver cancer are estimated to be diagnosed annually, making the disease to be the fifth most common cancer worldwide.

Liver cancer is also claimed to be the second leading cause of cancer-related deaths globally, accounting for around 746,000 deaths every year.