Oncolytics Biotech Inc. Collaborators Present Positive Phase I/II Trial Results in Advanced Solid Cancers with a Focus on the Head and Neck at the AACR-NCI-EORTC Meeting
CALGARY, Nov. 17 /PRNewswire-FirstCall/ -- Oncolytics Biotech
Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today
announced updated results from a Phase I/II U.K. trial (REO 011) of
REOLYSIN(R) combined with paclitaxel/carboplatin for patients with
advanced cancers in a poster presentation at the 2009
AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference
being held in Boston, Massachusetts. The poster presentation is
entitled "Phase I/II Trial of Oncolytic Reovirus (REOLYSIN) in
Combination with Carboplatin/Paclitaxel in Patients with Advanced
Solid Cancers with Emphasis on Squamous Cell Carcinoma of the Head
and Neck (SCCHN)."
The investigators reported that REOLYSIN was well tolerated when
administered intravenously in combination with paclitaxel and
carboplatin. Of 19 evaluable patients with head and neck cancer,
mostly SCCHN refractory to prior platinum-based chemotherapy for
recurrent/metastatic disease, eight experienced partial responses
and six had stable disease. The total clinical benefit rate
(complete response + partial response + stable disease) observed in
head and neck cancer patients in the trial was 74%. Of four
patients with malignant melanoma on the trial, one experienced a
partial response and one had stable disease.
"A 42% response rate and a 74% clinical benefit rate in a
platinum refractory patient population that typically has a poor
prognosis and limited therapeutic options is very encouraging,"
said Dr. Brad Thompson, President and CEO of Oncolytics. "These
results further validate our decision to advance REOLYSIN in
combination with paclitaxel and carboplatin into a Phase III trial
in this patient population."
An independent, confirmatory Phase II trial (REO 015) using the
same combination of REOLYSIN and carboplatin/paclitaxel for
patients with head and neck cancers is currently underway in the
U.S. Interim results from both the U.K. and the U.S. studies formed
the basis for the Company's decision to conduct a Phase III pivotal
program looking at REOLYSIN in combination with
carboplatin/paclitaxel in this patient population. The Company has
reached an agreement with the U.S. Food and Drug Administration
(FDA) under the Special Protocol Assessment (SPA) process for the
design of the Phase III trial.
A copy of the poster will be available on the Oncolytics website today. 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 Section 21E of the Securities Exchange Act of 1934,
as amended. Forward-looking statements, including the implication
of the materials presented at the AACR-NCI-EORTC Molecular Targets
and Cancer Therapeutics conference with respect to REOLYSIN; the
Company's belief as to the potential of REOLYSIN as a cancer
therapeutic; the Company's expectations as to the success of its
research and development programs in 2009 and beyond, the Company's
planned operations, the value of the additional patents and
intellectual property; the Company's expectations related to the
applications of the patented technology; the Company's expectations
as to adequacy of its existing capital resources; the design,
timing, success of planned clinical trial programs; and other
statements related to anticipated developments in the Company's
business and technologies 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 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, uncertainties related to the regulatory process
and general changes to the economic environment. 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.
CONTACT: The Equicom Group, Nick Hurst, 300 5th Ave. SW, 10th
Floor,
Calgary, Alberta, T2P 3C4, Tel: (403) 218-2835, Fax: (403)
218-2830,
nhurst@equicomgroup.com; The
Investor Relations Group, Erika Moran, 11 Stone
St, 3rd Floor, New York, NY, 10004, Tel: (212) 825-3210, Fax: (212)
825-3229,
emoran@investorrelationsgroup.com
Posted: November 2009
