Oncolytics Biotech Inc. (ONCY)

[onco_investor]

P1 Relapsed/Refractory Multiple Myeloma clinical trial started

http://www.clinicaltrials.gov/ct2/show/NCT01533194?term=reolysin&rank=11

Run from the Arthur G. James Cancer Hospital & Richard J. Solove Research Institute an sponsored/paid for by the US National Cancer Institute.

Enrollment planned for 12

Detailed Description:
OBJECTIVES:

Primary

Determine safety and tolerability of wild-type reovirus (Reolysin) in patients with relapsed multiple myeloma.
Obtain evidence of reovirus replication by immunohistochemical co-localization of reovirus and tubulin staining in marrow clot sections obtained on course 1 day 8.

Secondary

Obtain preliminary data on response as determined by International Myeloma Working Group (IMWG) criteria after infusion of Reolysin as a single agent.

Obtain pilot overall and progression-free survival data for all treated patients.

Assess neutralizing anti-reovirus assay (NARA) results on days 1, 8, 15, and once on days 22-28 during course 1. (exploratory)

Assess feasibility of staining for RAF/MEK/ERK in CD138+ cells using marrow clot sections obtained from pre-treatment specimen. (exploratory)

Cryopreserve peripheral blood mononuclear cells (PBMCs) for future ancillary studies focused initially on lymphocyte subset(s) and myeloid-derived suppressor cell changes after Reolysin infusion during course 1. (exploratory)

Cryopreserve CD138+-selected cells at screening and after treatment for future ancillary studies of genetic and epigenetic changes focused in part on endoplasmic reticulum (ER) stress. (exploratory)

OUTLINE: This is a dose-escalation study.

Patients receive wild-type reovirus IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspirate at baseline and periodically during study for RAF/MEK/ERK expression and wild-type reovirus replication analysis by immunohistochemistry. Blood and cryopreserved CD138+ selected cell samples are also collected for future ancillary studies.

After completion of study treatment, patients are followed up for 4 weeks and then every 6 months thereafter.