Oncolytics Biotech® Inc. Completes Patient Enrollment in U.S. Phase 2 Study of REOLYSIN® in Non-Small Cell Lung
Oncolytics Biotech® Inc. Completes Patient Enrollment in U.S. Phase 2 Study of
REOLYSIN® in Non-Small Cell Lung Cancer
PR Newswire
CALGARY, March 5, 2013
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 patients."
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.
Contact:
The Equicom Group
Nick Hurst
300 5^th Ave. SW, 10^th Floor
Calgary, Alberta, T2P 3C4
Tel: 403.218.2835
Fax: 403.218.2830
nhurst@tmxequicom.com
Dian Griesel, Inc.
Susan Forman
396 West Broadway, 2^nd Floor
New York, NY 10012
Tel: 212.825.3210
Fax: 212.825.3229
sforman@dgicomm.com
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement
Rate this Page