The Phase 1b clinical trial called MUK eleven (NCT03015922) testing Reolysin (pelareorep) as a combination therapy for relapsing myeloma patients has dosed its first patient, Oncolytics Biotech recently announced.
Reolysin is a proprietary formulation of the human reovirus that replicates inside cancer cells, leading to their death. By releasing specific cancer proteins when a cancer cell dies, the virus also promotes strong immune responses against the remaining cancer cells.
Reolysin is being tested as a potential rescue treatment in combination with Celgene Corporation‘s Revlimid (lenalidomide) or Imnovid (pomalidomide), which also modulate the immune system.
“This is an important trial for Oncolytics as it’s the first to discretely examine the innate immunity component of Reolysin’s mechanism of action,” Matt Coffey, president and CEO of Oncolytics Biotech, said in a press release.
MUK eleven is part of Oncolytics’ strategy “to assess the safety and efficacy of Reolysin in combination with immunomodulatory and immuno-oncology drugs, the impact of these combinations on the immune system and to explore new clinical applications,” Coffey added.
MUK eleven is a new immunotherapy trial that aims to modulate the immune system to treat myeloma. The study, run through the Myeloma UK Clinical Trial Network (CTN) in collaboration with the charity Myeloma UK, the University of Leeds, and Celgene, started last March. It will enroll approximately 44 patients whose myeloma is relapsing despite treatment with Revlimid or Imnovid.
The trial will determine the effectiveness, safety, and adverse effects of Reolysin plus Revlimid or Reolysin plus Imnovid. This is a dose-escalation study, meaning that the dose of Reolysin gradually will be increased after evaluating the associated toxicity. The goal is to assess the maximum tolerated dose (MTD) of Reolysin that can be given in these combinations.
“We are pleased to have enrolled the first patient in MUK eleven, a trial focused on a novel area of myeloma research,” said Simon Ridley, PhD, director of research at Myeloma UK. “Our Clinical Trial Network is focused on strategic, collaborative and innovative approaches to delivering trials and treatments to patients and this pioneering trial has the potential to offer a novel future treatment strategy in myeloma.”
The first patient will receive one 28-day treatment cycle. The same dose will be tested in a second patient if no dose-limiting toxicities (DLTs) are observed. The dose will then be increased until reaching the MTD of Reolysin, defined as the highest dose with no associated safety issues. At that point, 10 additional patients will start the treatment cycle at the MTD.
After starting at two trial sites, researchers plan to expand testing to six additional sites once a minimum of 12 patients in each group has been reached. Preliminary results are expected in the first quarter of 2018.