CALGARY, Sept. 2 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC,
NASDAQ: ONCY) announced today that following U.S. Food and Drug Administration
(FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using
intravenous administration of REOLYSIN(R) in combination with paclitaxel and
carboplatin in patients with non-small cell lung cancer (NSCLC) with K-RAS or
EGFR-activated tumours. The Principal Investigator is Dr. Miguel
Villalona-Calero, Professor Division of Hematology/Oncology and Department of
Internal Medicine and Pharmacology at The Ohio State University Comprehensive
"In this era of personalized cancer treatment, we are quite excited about
this trial," said Dr. Villalona-Calero. "Although we have had for some time
treatments that target EGFR, K-RAS has been an elusive target. REOLYSIN(R) has
the potential to target K-RAS activated tumors, possibly enhancing the
beneficial effects produced by chemotherapy."
"This trial gives Oncolytics the opportunity to treat NSCLC patients in a
first-line clinical setting," said Dr. Brad Thompson, President and CEO of
Oncolytics. "Assuming we achieve an acceptable response rate, the combination
of REOLYSIN(R) with paclitaxel and carboplatin for NSCLC would be a strong
candidate for registration studies."
This trial is a single arm, two-stage, open-label, Phase 2 study of
REOLYSIN(R) given intravenously with paclitaxel and carboplatin every 3 weeks.
Patients will receive four to six cycles of paclitaxel and carboplatin in
conjunction with REOLYSIN(R), at which time REOLYSIN(R) may be continued as a
monotherapy. It is anticipated that up to 36 patients will be treated in this
Eligible patients include those with metastatic or recurrent NSCLC with
K-RAS or EGFR-activated tumours, who have not received chemotherapy treatment
for their metastatic or recurrent disease. Patients must have demonstrated
mutations in K-RAS or EGFR, or EGFR gene amplification in their tumours
(metastatic or primary) in order to qualify for the trial.
The primary objectives of the Phase 2 trial are to determine the
objective response rate of REOLYSIN(R) in combination with paclitaxel and
carboplatin in patients with metastatic or recurrent NSCLC with K-RAS or
EGFR-activated tumours, and to measure progression-free survival at 6 months.
The secondary objectives are to determine the median survival and duration of
progression-free survival in patients, and to evaluate the safety and
tolerability of REOLYSIN(R) in combination with paclitaxel and carboplatin in
this patient population.
REOLYSIN(R) 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 K-RAS along the RAS pathway
lead to RAS pathway activation.
Recent clinical studies in NSCLC with EGFR-based therapies have shown
that patients with mutations or overexpression of EGFR, which are commonly
found in NSCLC, derive clinical benefit from these therapies. An agent such as
REOLYSIN(R) that selectively replicates in cancers with an activated RAS
pathway resulting from EGFR mutations or overexpression may show similar
benefit. However, patients with mutant K-RAS, or up to 20% of the more than
180,000 patients diagnosed every year in the U.S. with NSCLC, do not derive
benefit from EGFR-based therapies. The introduction of screening for K-RAS
mutations, and the exclusion of K-RAS mutated patients will lead to higher
response rates in EGFR-mutated or overexpressed patients treated with
EGFR-based therapies. This excluded patient group is therefore prescreened for
RAS pathway activation resulting from mutations in K-RAS, and an agent such as
REOLYSIN(R) may be indicated for this patient group. This study targets
patients with either EGFR-activated tumours or K-RAS mutations.
"Previous preclinical data indicates that reovirus tends to localize in
the lungs, and we have seen clinical responses in metastatic lung lesions with
REOLYSIN(R) as a monotherapy or in combination with paclitaxel and
carboplatin," said Dr. Brad Thompson, President and CEO of Oncolytics. "A
significant clinical opportunity for REOLYSIN(R) is in the treatment of
patients with metastatic cancers including NSCLC who have a mutated K-RAS gene
and are unlikely to respond to treatment with EGF receptor inhibitors."
About Lung Cancer
Lung cancer is the second most common cancer in men and women and is the
leading cause of cancer death. More people die of lung cancer than of colon,
breast and prostate cancers combined. During 2008, there will be about 215,020
new cases of lung cancer in the U.S., of which 85% to 90% will be NSCLC. Only
about 15% of people diagnosed with lung cancer are still alive after five
years. There is no single, first-line therapy approved for NSCLC in the U.S.,
but first-line combination treatments include avastin/paclitaxel/carboplatin,
vinorelbin/cisplatin, gemcitabine/cisplatin, paclitaxel/cisplatin and
docetaxel/cisplatin. Other therapies approved for second and third-line
treatments are used as well. For more information about lung cancer, please go
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 Phase 1/2 and Phase 2 human trials
using REOLYSIN(R), its proprietary formulation of the human reovirus, alone
and in combination with radiation or chemotherapy. 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 U.S. Phase 2 combination REOLYSIN(R)/paclitaxel and carboplatin clinical
trial for patients with recurrent or metastatic NSCLC with K-RAS or
EGFR-activated tumours, and the Company's belief as to the potential of
REOLYSIN(R) 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(R) 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(R), 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.
For further information:
For further information: Oncolytics Biotech Inc., Cathy Ward, 210, 1167
Kensington Cr NW Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403)
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