Æterna Zentaris and its partner Keryx Biopharmaceuticals have received fast-track designation from the US FDA for perifosine (KRX-0401).
Perifosine is a first-in-class oral anti-cancer agent that inhibits the phosphoinositide 3 kinase (PI3K)/Akt pathway for the treatment of refractory advanced colorectal cancer.
A double-blind, randomised phase 3 trial to evaluate perifosine in patients with refractory metastatic colorectal cancer is expected to commence this quarter under a special protocol assessment with the FDA.
The FDA fast-track programme is aimed to facilitate the development and expedite the review of new drugs that can treat life-threatening conditions and address unmet medical needs.
The trial, to be conducted in North America, is expected to finish in 2011.
Keryx is a partner and licencee for perifosine in Canada, Mexico and the US.