CALGARY, May 10 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC,
NASDAQ:ONCY) announced today that the Cancer Therapy Evaluation
Program, Division of Cancer Treatment and Diagnosis, U.S. National
Cancer Institute (NCI), which is part of the National Institutes of
Health, has agreed to sponsor a Phase I study of REOLYSIN® alone in patients with relapsed multiple myeloma. The NCI is sponsoring
the trial under its Clinical Trials Agreement with Oncolytics, while
Oncolytics will provide clinical supplies of REOLYSIN. The Principal
Investigator is Dr. Craig Hofmeister of The Ohio State University
Comprehensive Cancer Center – Arthur G. James Cancer Hospital and
Richard J. Solove Research Institute.
“While progression free survivals have improved with novel therapies
over the last decade, the cure fraction remains low and additional
options are needed,” said Dr. Craig Hofmeister, principal investigator.
“Multiple myeloma cells are frequently RAS activated, especially in
relapse, so we are very interested in looking at REOLYSIN for these
The study will initially be a proof of concept, open-label Phase I study
of REOLYSIN in patients with relapsed multiple myeloma. Approximately
12 patients will receive REOLYSIN, in a dose escalation up to 3 x 1010 TCID50 per day administered intravenously on days one through five every 28
The primary endpoint for the dose escalation portion of this study will
be adverse events using CTCAE criteria. Correlative studies will focus
on the efficiency with which reovirus replicates in patient myeloma
cells. Investigators will use standard cohorts-of-three phase I dose
escalation design with three to six patients being treated at each dose
level. Secondary endpoints will 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 a Phase II metastatic melanoma
trial, a Phase I/II and a randomized Phase II ovarian, peritoneal and
fallopian tube cancer trials, a randomized Phase II trial in pancreatic
cancer and a Phase I trial in pediatric patients with relapsed or
refractory solid tumors.
The American Cancer Society estimates that 20,180 Americans were
diagnosed with myeloma and an estimated 10,650 Americans were expected
to die from the disease in 2010. The prognosis for patients diagnosed
with myeloma varies but the five-year survival rate for the period
between 1999 and 2005 was approximately 37%.
About the NCI
The U.S. National Cancer Institute (NCI) is part of the National
Institutes of Health and the U.S. Department of Health and Human
Services. NCI’s main responsibilities include coordinating the National
Cancer Program; conducting and supporting cancer-related research;
training physicians and scientists; and disseminating state-of-the-art
information about cancer detection, diagnosis, treatment, prevention,
control, palliative care, and survivorship.
About The Ohio State University Comprehensive Cancer Center
The Ohio State University Comprehensive Cancer Center – Arthur G. James
Cancer Hospital and Richard J. Solove Research Institute (cancer.osu.edu) is one of only 40 Comprehensive Cancer Centers in the United States
designated by the National Cancer Institute. Ranked by U.S. News &
World Report among the top cancer hospitals in the nation, The James is
the 205-bed adult patient-care component of the cancer program at The
Ohio State University. The OSUCCC-James is one of only seven funded
programs in the country approved by the NCI to conduct both Phase I and
Phase II clinical trials.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the
development of oncolytic viruses as potential cancer therapeutics.
Oncolytics’ clinical program includes a variety of human trials
including a Phase III trial in head and neck cancers using REOLYSIN,
its proprietary formulation of the human reovirus. For further
information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements, including the Company’s
expectations related to the Phase 1 multiple myeloma trial sponsored by
the NCI, and the Company’s belief as to the potential of REOLYSIN as a
cancer therapeutic, involve known and unknown risks and uncertainties,
which could cause the Company’s actual results to differ materially
from those in the forward-looking statements. Such risks and
uncertainties include, among others, the availability of funds and
resources to pursue research and development projects, the efficacy of
REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a
controlled test, the success and timely completion of clinical studies
and trials, the Company’s ability to successfully commercialize
REOLYSIN, uncertainties related to the research and development of
pharmaceuticals and uncertainties related to the regulatory process.
Investors should consult the Company’s quarterly and annual filings
with the Canadian and U.S. securities commissions for additional
information on risks and uncertainties relating to the forward-looking
statements. Investors are cautioned against placing undue reliance on
forward-looking statements. The Company does not undertake to update
these forward-looking statements, except as required by applicable
SOURCE Oncolytics Biotech Inc.
Released May 10, 2011