Genoscience Pharma, a clinical-stage biotechnology company working to discover and develop cancer treatment drugs, announced today that its most advanced compound, GNS561, has received approval from the Food and Drug Administration (FDA) to initiate a Phase Ib/IIa study in patients with advanced hepatocarcinoma (HCC).
This is the first-in-human study to be conducted under the Investigational New Drug (IND) protocol approved by the FDA. The Phase Ib/IIa study will evaluate the safety, activity and pharmacokinetics 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.
“The FDA approval of our first IND application is a major milestone for Genoscience Pharma,” said Philippe Halfon, chief executive officer. “We believe that GNS561, acting through a novel mechanism of action, has the potential to change the treatment paradigm of HCC.”
GNS561 is a liver selective drug with good tolerance and promising efficacy in different HCC animal models, according to the company, which added that it was more efficient than sorafenib to control tumor growth in preclinical models.
(Source: Genoscience Pharma)
Filed Under: Drug Discovery