Oncolytics Biotech Inc. Announces NCI Sponsorship of Phase I Study of REOLYSIN for Relapsed Multiple Myeloma

Strategic Insights -

The Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), has agreed to sponsor a Phase I study of REOLYSIN alone in patients with relapsed multiple myeloma. This study is part of a larger effort to explore additional treatment options for multiple myeloma patients who have relapsed despite novel therapies. The Principal Investigator, Dr. Craig Hofmeister of The Ohio State University Comprehensive Cancer Center, emphasized the need for new treatments, citing the low cure fraction and frequent RAS activation in relapsed multiple myeloma cells.

Key Takeaways:

  • The NCI is sponsoring a Phase I study of REOLYSIN alone in patients with relapsed multiple myeloma.
  • The study will be an open-label Phase I study with 12 patients receiving REOLYSIN in a dose escalation up to 3 x 10^10 TCID50 per day administered intravenously.
  • The primary endpoint for the dose escalation portion of the study is adverse events using CTCAE criteria, while correlative studies will focus on reovirus replication efficiency in patient myeloma cells.
  • Investigators will use a standard cohorts-of-three phase I dose escalation design with three to six patients being treated at each dose level.
  • Secondary endpoints include clinical benefit, duration of response, and time to progression.
  • This is the sixth clinical trial using REOLYSIN to be sponsored by the NCI.
  • The NCI is currently conducting multiple clinical trials using REOLYSIN, including Phase II metastatic melanoma and Phase I/II ovarian cancer trials.
  • Dr. Craig Hofmeister, principal investigator, emphasized the need for new treatments, citing the low cure fraction and frequent RAS activation in relapsed multiple myeloma cells.

Statistics:

  • 12 patients will receive REOLYSIN in the Phase I study.
  • The study will use a dose escalation up to 3 x 10^10 TCID50 per day administered intravenously on days one through five every 28 days.
  • Six patients will be treated at each dose level in the standard cohorts-of-three phase I dose escalation design.
  • The NCI is currently conducting six clinical trials using REOLYSIN.

Sources:

  • Oncolytics Biotech Inc., "Oncolytics Biotech's REOLYSIN to be investigated in Phase I study for relapsed multiple myeloma," [www.oncolyticsbiotech.com](http://www.oncolyticsbiotech.com) (undated)
  • Clinical Trials Week, "Oncolytics Biotech Inc. Announces NCI Sponsorship of Phase I Study of REOLYSIN for Relapsed Multiple Myeloma," Clinical Trials Week via NewsRx.com (2011)