Oncolytics Biotech(R) Inc. Announces Phase I Study in Pediatric Patients with Relapsed or Refractory Solid Tumors to be Conducted by the Children’s Oncology Group and Sponsored by the National Cancer Institute
(TSX:ONC, NASDAQ:ONCY) announced today that the Children’s Oncology
Group (COG) intends to conduct a Phase I trial of REOLYSIN((R)) in combination with cyclophosphamide in pediatric patients with
relapsed or refractory solid tumors. The study will be conducted in
collaboration with 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, under its Clinical
Trials Agreement with Oncolytics. Oncolytics will provide clinical
supplies of REOLYSIN for this study. The study chair will be Dr.
The study is an open label, multicentre, dose escalation Phase I study
of REOLYSIN in patients aged three to 21 years with relapsed or
refractory solid tumors. Patients will receive intravenous REOLYSIN on
days one through five of each 28-day treatment cycle. Some patients
will also receive oral cyclophosphamide on days one through 21.
Treatments repeat every 28 days for up to 12 cycles in the absence of
disease progression or unacceptable toxicity.
The primary objectives of the trial include estimating maximum tolerated
dose, and defining and describing the toxicities of REOLYSIN and
REOLYSIN plus oral cyclophosphamide in this patient population.
Secondary objectives include defining antitumor activity of REOLYSIN
within the confines of a Phase I study, evaluating the development of
neutralizing antibodies to REOLYSIN following intravenous
administration of REOLYSIN alone and in combination with
cyclophosphamide, and assessing the biologic activity of REOLYSIN.
After completion of study treatment, patients are to be followed up
periodically for up to one year.
“This trial builds on a range of completed preclinical work and clinical
studies in adult patients, including a U.K. Phase I clinical study
examining the use of REOLYSIN in conjunction with cyclophosphamide and
a U.S. Phase II clinical study in sarcoma using REOLYSIN as a
monotherapy,” said Dr.
“It is very important to investigate the use of an agent in adults
prior to proceeding to use in pediatric patients. With the work in
adults well advanced, we can now move ahead in younger patients.”
Information on the study will be available at www.clinicaltrials.gov.
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 Oncolytics Biotech Inc.
Oncolytics is a
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 trial in pediatric patients with
relapsed or refractory solid tumours sponsored by the COG in
collaboration with 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((R)) 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 laws.
SOURCE Oncolytics Biotech Inc.