Clinical-stage biotechnology company, Genoscience Pharma, has announced that initiation of a Phase Ib/IIa study of its most advanced compound, GNS561, for the treatment of patients with advanced hepatocarcinoma (HCC), has received approval from the US Food and Drug Administration (FDA).
Liver
This will be the first-in-human trial to be conducted under the investigational new drug (IND) protocol approved by the FDA. It will evaluate the safety, activity and pharmacokinetics of escalating doses of GNS561 in patients with liver cancer. Up to 36 patients will be enrolled in the dose escalation stage (Phase Ib) and then additional patients will be included in the continuation phase to obtain a total of 20 subjects that can be evaluated at the recommended dose.
“The FDA approval of our first IND application is a major milestone for Genoscience Pharma,” said Philippe Halfon, chief executive officer, 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.”
“We value our collaboration with the FDA as well as other government authorities that reviewed our submission. We look forward to sharing the details of our upcoming Phase Ib/IIa trial,” he added.