On September 14, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN (pelareorep), a first-in-class, systemically delivered immuno-oncolytic virus that activates the innate and adaptive immune systems, reported that the first patient has been treated in the Phase 1b trial MUK eleven, studying REOLYSIN in combination with Celgene Corporation’s immunomodulatory drugs (IMiDs), Revlimid or Imnovid as a rescue treatment in relapsing myeloma patients (Press release, Oncolytics Biotech, SEP 14, 2017, View Source [SID1234520513]).
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"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," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "MUK eleven and REO 024, our trial evaluating the induction of an inflamed tumor phenotype of REOLYSIN in a combination with Keytruda, collectively demonstrate our 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."
"We are pleased to have enrolled the first patient in MUK eleven, a trial focused on a novel area of myeloma research," said Dr. Simon Ridley, 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."
MUK eleven is a first-of-its-kind immunotherapy trial that aims to modulate the immune system to target myeloma. The trial, run through the Myeloma UK Clinical Trial Network (CTN) in collaboration with charity Myeloma UK, the University of Leeds and Celgene, launched in March of this year and will recruit approximately 44 patients across up to eight CTN centres in the UK. MUK eleven will study REOLYSIN (pelareorep) in combination with Celgene’s Imnovid (pomalidomide) or Revlimid (lenalidomide) in patients whose myeloma is progressing while being treated with one of these IMiDs. In addition to assessing the safety and tolerability of these combinations, the trial will investigate whether the addition of REOLYSIN extends disease control in this patient group.
MUK eleven is a dose escalation trial where dose limiting toxicities (DLTs) will inform decisions to increase dose, and patients being treated with pomalidomide will be evaluated separately from those taking lenalidomide. Beginning at two CTN centres, cohorts of two participants each will be treated with REOLYSIN in combination with an IMiD. The first patient will receive one 28-day treatment cycle and if no DLTs are experienced at the end of the cycle, the second patient will begin treatment at the same dose. Doses may be escalated once participants in each cohort have completed the DLT monitoring period and will be increased between cohorts until the occurrence of DLTs define the maximum tolerated dose (MTD). Once the MTD has been identified with no associated safety issues, 10 additional patients will be enrolled at the MTD. Once a minimum of 12 patients in each IMiD group have been treated, up to six additional trial sites may be added to the trial. Based on this trial design, preliminary data are expected to be available in the first quarter of 2018.
About REOLYSIN
REOLYSIN is a non-pathogenic, proprietary isolate of the unmodified reovirus. A first-in-class systemically delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.