Oncolytics Biotech(R) Inc. Completes Patient Enrollment in U.S. Phase 2 Study of REOLYSIN(R) in Non-Small Cell Lung Cancer
CALGARY, March 5, 2013 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC) (NASDAQ:ONCY) today announced that it has completed patient
enrollment in a Phase 2 clinical trial evaluating intravenous
administration of REOLYSIN(®) in combination with paclitaxel and carboplatin in patients with
non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours (REO 016).
This trial is a single arm, single-stage, open-label, Phase 2 study of
REOLYSIN given intravenously with paclitaxel and carboplatin every
three weeks. Patients received four to six cycles of paclitaxel and
carboplatin in conjunction with REOLYSIN, following which REOLYSIN
could be continued as a monotherapy.
Eligible patients included those with metastatic or recurrent NSCLC with
Kras or EGFR-activated tumours, who had not received chemotherapy treatment
for their metastatic or recurrent disease. Patients must have
demonstrated mutations in Kras or EGFR, or EGFR gene amplification in their tumours (metastatic or
primary) in order to qualify for the trial.
The Company previously reported in November 2012 that 33 patients had
received Reovirus (REOLYSIN) (3 x 10(10) TCID(50)) intravenously daily on days one to five, in combination with
carboplatin and paclitaxel. Molecular tumor demographics included: 16 Kras, three EGFR, four BRAF mutations, and 10 EGFR amplified only. Response
evaluation data reported among 30 evaluable patients showed 27 patients
had stable disease or better for a 90% clinical benefit rate (nine
partial response (PR) (30%) and 18 stable disease (SD) (60%)). Three
patients had progressive disease (PD) as their best response.
“We have seen encouraging results in both this and other trials looking
at primary and metastatic lung disease and are continuing to push our
lung program forward on that basis,” said Dr. Brad Thompson, President
and CEO of Oncolytics. “We have extended our work in this indication
beyond this drug combination and are currently evaluating REOLYSIN in
conjunction with docetaxel or pemetrexed in a second line open-label,
randomized, non-blinded, Phase II clinical study sponsored by the NCIC
Clinical Trials Group at Queen’s University in Kingston, Ontario that
will enroll up to 150 squamous cell and adenocarcinoma of the lung
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 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 Phase 2 non-small
cell lung cancer trial of REOLYSIN in combination with paclitaxel and
carboplatin, and 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 statement 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.