The cancer charity Myeloma UK has launched a Phase 1 clinical trial testing Reolysin (pelareorep), a modulator of the immune system and cytotoxic agent, in myeloma patients.
The MUK eleven Phase 1 study (NCT03015922) will test the safety and tolerability of Oncolytics’ Reolysin, in combination with Imnovid (pomalidomide) or Revlimid (lenalidomide), as a rescue treatment in 44 patients with relapsing myeloma. The trial will be conducted at up to six Myeloma UK Clinical Trial Network centers.
The trial will recruit patients currently receiving either Imnovid or Revlimid whose disease is relapsing. Reolysin will then be combined with these treatments.
The dose escalation study also aims to determine the maximum tolerated dose (MTD) of Reolysin that can be given in combination with the two other drugs, and will investigate if adding Reolysin to these therapies extends the control of multiple myeloma.
“This trial, the first of its kind, is a novel way of activating a patient’s own immune system to target their myeloma (immunotherapy) using a natural virus and lenalidomide or pomalidomide, which could offer a new treatment strategy in myeloma,” MUK eleven chief investigator Gordon Cook, PhD, said in a press release. Cook also is a consultant haematologist at Leeds Teaching Hospitals Trust.
This clinical trial follows earlier preclinical studies conducted by Cook’s research team, in which Reolysin was found to have dual action modes to fight multiple myeloma. The drug was found to be both directly cytotoxic and to activate immune effector cells to target and destroy cancer cells. This anti-cancer activity of Reloysin can be enhanced by immunomodulatory agents to eliminate the cancer.
This new clinical trial is part of a series of early stage studies being conducted by the Myeloma UK Clinical Trial Network, under coordination of the Clinical Trials Research Unit at the University of Leeds, which are examining and speeding patients’ access to novel therapies.
“This is an important collaboration for Oncolytics, as testing [immunomodulatory drugs] combinations with Reolysin is one of the three pillars of our clinical development plan,” said Matt Coffey, PhD, president and CEO of Oncolytics said. “We are eager to find out if Reolysin can enhance the benefits of these immune modulators and we are excited to start working with Myeloma UK and Celgene.”
“We focus on strategic, collaborative and innovative approaches to delivering trials and treatments to patients,” said Simon Ridley, Myeloma UK Director of Research. “Our Clinical Trial Network is focused on ensuring that patients now, and in the future, are getting access to the exciting new treatment combinations we are seeing coming down the line, and so we are pleased to launch this novel trial which focuses on a pivotal area of myeloma research”