Ascenta Therapeutics has been granted approval by the US Food and Drug Administration (FDA) to go ahead with Phase I trials for AT-406, a new treatment for patients with advanced cancer.
AT-406 is an orally active small molecule drug designed to promote programmed cell death (apoptosis) in tumour cells by blocking the activity of at least three inhibitors of apoptosis proteins to create conditions in which apoptosis can proceed.
Ascenta Therapeutics MD and CEO Mel Sorensen said that the company was pleased to be moving its second oral pro-apoptotic agent into human clinical trials.
"AT-406 has shown promising anti-tumour activity in a variety of pre-clinical models and we are eager to lay the groundwork for further clinical development with the results of this 'first-in-man' study," Sorensen said.
The multi-centre, single-agent, open-label Phase I accelerated dose escalation study will evaluate safety and determine the maximum tolerated dose and optimal dosing schedule of AT-406 in patients with advanced lymphomas and solid tumours.