Quotient Clinical, the Translational Pharmaceutics® Company, and Sunesis Pharmaceuticals have announced the initiation of a clinical mass balance/ADME trial for vosaroxin – a candidate therapeutic for acute myelogenous leukemia (AML).
For this program, Quotient will employ its ‘real-time adaptive manufacturing’ approach to supply 14C radiolabeled vosaroxin to a specialist oncology clinic in the Netherlands. The intravenous product will be manufactured on a ‘per patient’ basis, and supplied to the clinic ready for dosing within less than two weeks of patient notification. This approach offers the most efficient use of the radiolabeled drug, and tailors drug product manufacturing to ongoing patient recruitment.
Mark Egerton, CEO of Quotient Clinical, commented:
“Vosaroxin represents an exciting potential therapeutic option for AML patients, and we are delighted to be supporting Sunesis on its clinical mass balance/ADME program. Our real-time adaptive manufacturing approach offers increased flexibility and enables customization of drug product supply to the requirements of individual patients and trials.”
Gene Jamieson, Vice President of Technical Operations at Sunesis Pharmaceuticals, added:
“Working with Quotient Clinical will help to accelerate the clinical mass balance/ADME program for this promising therapeutic. The Company’s real-time manufacturing capabilities will ensure efficient, cost-effective and timely delivery of radiolabeled vosaroxin to the clinic, allowing faster treatment of patients as they are enrolled into the study.”