CALGARY, Jan. 10 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC, NASDAQ:ONCY) announced today that a U.S. Phase I study of
REOLYSIN® in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil
(5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant
Kras mutant colorectal cancer (REO 022) is now open to enrollment. The
principal investigator is Dr. Sanjay Goel of the Montefiore Medical
Center at The Albert Einstein College of Medicine in New York.
“We continue to advance REOLYSIN into clinical testing in new
indications where we believe the product may have sound clinical and
commercial potential,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “We are focusing our clinical program increasingly to look
at patients with Kras mutant cancers by either pre-screening patients for Kras status, as in the case of this study and the Phase II trial we are
running in non-small cell lung cancer (REO 016), or by selecting
indications with widespread Kras involvement, such as our ongoing Phase II study in advanced pancreatic
cancer (REO 017).”
The trial is a Phase I dose escalation study with three dose levels,
comprising cohorts of three to six patients, to determine a maximum
tolerated dose and dose-limiting toxicities with the combination of
REOLYSIN and FOLFIRI. FOLFIRI will be administered on the first day of
a two week (14-day) cycle, while REOLYSIN will be administered on days
one through five of a four week (28-day) cycle.
Eligible patients include those with histologically confirmed cancer of
the colon or rectum with Kras mutation and measurable disease. They must have progressed on or within
190 days after last dose of oxaliplatin regimen as front-line therapy
in the metastatic setting or be intolerant to oxaliplatin. The study is
expected to enroll 12 to 20 patients.
The rationale for conducting the study is based on signals of efficacy
seen in a range of preclinical and clinical work with REOLYSIN. This
includes a National Cancer Institute screen of seven colorectal cancer
cell lines (four with ras mutations), all of which were susceptible to
REOLYSIN; preclinical research into the efficacy of REOLYSIN in
combination with various chemotherapeutic agents in colorectal cancer
cell lines; observation of CEA responses and stable disease in
colorectal patients in a phase I study of REOLYSIN as a monotherapy;
and interim results from a translational study with REOLYSIN as a
monotherapy that is currently ongoing, which showed evidence of viral
replication and tumour cell death in four of six patients with
metastatic colorectal cancer analyzed to date, two of which had
confirmed Kras mutations in codon 12.
About Colorectal Cancer
The American Cancer Society estimates that nearly 143,000 Americans were
diagnosed with colorectal cancer and an estimated 51,370 died from the
disease in 2010. The prognosis for patients diagnosed with colorectal
cancer at the localized stage is good with a five-year survival rate of
91%, however only about 39% of cases are diagnosed at this stage;
five-year survival rates drop to 70% with the spread to adjacent organs
or lymph nodes and 11% for distant metastases. Colorectal cancer is the
third leading cause of cancer death among both men and women in the
United States.
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. REOLYSIN
preferentially replicates in cancer cells that have an activated RAS
pathway. Approximately two thirds of all cancers have an activated RAS
pathway, including most metastatic disease. A large number of
mutations, including mutations in EGFR, Her2 or Kras along the RAS pathway lead to RAS pathway activation. 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 I dose escalation study of REOLYSIN
in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil
(5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant
Kras mutant colorectal cancer, 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 laws.
SOURCE Oncolytics Biotech Inc.
Released January 10, 2011