Redx Pharma PLC said it reached an agreement with regulators in the U.K. to resume enrollment in an early stage clinical trial of its cancer drug RXC004.
The U.K.-based pharmaceutical company expects to resume the trial during the first half of 2019, having sorted out the terms of a repurposed study with the U.K.'s Medicines and Healthcare products Regulatory Agency.
The company had to pause the phase 1/2a clinical study after the first and only patient in the trial to receive RXC004 experienced clinically significant adverse events. While the company had not elaborated on the adverse events at the time, it said it believed they were related to the drug.
Under a revised study protocol, the company will restart administering patients at a lower dose of the therapy.
RXC004 is intended to fight cancer by targeting a signaling pathway within the human body that allows tumors to avoid detection by the patient's immune system. When combined with an anti-PD1 agent, such as Bristol-Myers Squibb Co.'s Opdivo, the investigational therapy could help convert so-called cold tumors into hot tumors — allowing it to improve the effectiveness of such anti-PD1 agents.