CALGARY, May 19, 2015 /PRNewswire/ - Oncolytics Biotech
Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced
that following submission to the U.S. Food and Drug
Administration ("FDA") for review, the Investigational New Drug
Application containing the protocol titled "MC1472: Phase 1
Study of Replication Competent Reovirus (REOLYSIN®) in
Combination with GM-CSF in Pediatric Patients with Relapsed or
Refractory Brain Tumors" is now active. The study sponsor is
Mayo Clinic based in Rochester,
Minnesota, and the Study Chair is Dr. Richard Bram of Mayo Clinic.
"This is the first time we have been able to assess this
treatment combination in patients," said Dr. Brad Thompson, President and CEO of Oncolytics.
"Pediatric patients with high grade primary brain tumors have few,
if any, treatment options so we are eager to determine if this
regimen can make a difference for a group with poor survival
outcomes."
The study is an open-label Phase I trial to clarify the safety,
and determine possible efficacy, of GM-CSF given prior to
administration of intravenous REOLYSIN® for children
with malignant high grade brain tumors. GM-CSF will be administered
on days one and two of each cycle with REOLYSIN®
administered on days three, four and five. Cycles will be given
every 28 days for up to 12 cycles if patients remain without
evidence of tumor progression and without intolerable
toxicity. The primary outcome for the nine to 18 patients of
the Phase 1 study will be safety and tolerability. Secondary goals
include median progression free and overall survival in this
patient population.
Eligible patients include those between the ages of 10 and 21
with histologically confirmed high grade (grade 3 or 4) primary
brain tumor either classified as a glioma (including astrocytoma,
anaplastic oligodendroglioma and glioblastoma multiforme),
medulloblastoma, atypical teratoid/rhabdoid tumor or primitive
neuroectodermal tumor. Patients must have no known curative therapy
available and can have had up to two chemotherapy regimens for the
brain tumor previously.
Oncolytics has conducted three previous clinical studies in
adults with brain cancers including gliomas, and has found that
REOLYSIN® can infect a variety of brain tumors when
delivered intravenously. In April
2014, the Company announced the findings from a clinical
study showing that intravenously delivered REOLYSIN® can
cross the blood brain barrier and a pre-clinical study in animals
examining the synergies associated with treatment with GM-CSF prior
to administering REOLYSIN®. The Company has received
Orphan Drug Designation from the FDA for the use of
REOLYSIN® in the treatment of malignant gliomas.
According to the US Central Brain Tumor Registry an estimated
4,620 new cases of primary malignant and non-malignant brain and
central nervous system tumors will be diagnosed in pediatric and
adolescent patients in 2015. In patients between zero and 19 years
old, the overall total incidence of HGG (including anaplastic
astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed
glioma, and malignant glioma) is approximately 0.8 per 100,000.
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 later-stage, randomized human trials in
various indications 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 the U.S. Securities Act of 1933, as amended, and
U.S. Securities Exchange Act of 1934, as amended, and
forward-looking information within the meaning of Canadian
securities laws. Statements, other than statements of historical
facts, included in this press release that address activities,
events or developments that Oncolytics expects or anticipates will
or may occur in the future, including such things as, the Company's
expectations related to the study in pediatric patients with
relapsed or refractory brain tumors, the Company's belief as to the
potential of REOLYSIN® as a cancer therapeutic,
and other such matters are forward-looking statements and
forward-looking information and 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 and
forward-looking information. Such risks and uncertainties include,
among others, risks related to the statistical sufficiency of
patient enrollment numbers in separate patient groups, 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 and
forward-looking information. Investors are cautioned against
placing undue reliance on forward-looking statements and
forward-looking information. The Company does not undertake to
update these forward-looking statements and forward-looking
information, except as required by applicable laws.
SOURCE Oncolytics Biotech Inc.