Oncolytics Biotech(R) Inc. Collaborators to Present Positive Phase 2 REOLYSIN Clinical Data in Pancreatic Cancer at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference
CALGARY, Nov. 14, 2011 /PRNewswire/ – Oncolytics Biotech Inc. (TSX:ONC,
NASDAQ:ONCY) (“Oncolytics”) today announced that interim results from a
Phase 2 clinical trial using intravenous administration of REOLYSIN(Ã‚® )in combination with gemcitabine (Gemzar(Ã‚®)) in patients with advanced pancreatic cancer will be presented at the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
Therapeutics. The conference is being held in San Francisco, CA from
November 12(th) to 16(th), 2011.
The poster, entitled “A Phase II Study of REOLYSIN(Ã‚®) in Combination with Gemcitabine in Patients with Advanced Pancreatic
Adenocarcinoma”, authored by Mita et al, indicated that as of the date of submission of the poster that 12
patients were evaluable for response. All patients except one reported
symptomatic improvement. Seven patients had stable disease (SD) for 12
weeks or longer, for a clinical benefit rate (complete response (CR) +
partial response (PR) + SD) of 58%.This included two patients who had
SD for 36 weeks or longer. An additional patient had an unconfirmed PR
of less than six weeks. The treatment was well tolerated with
manageable adverse events.
This study is using a one sample, two-stage design. In the first stage,
17 patients were to be enrolled, and best response noted. If less than
three responses (defined as CR or PR or SD for 12 weeks or more) were
observed, the study would have concluded that the combination was
inactive and been terminated. If three or more responses were observed
among the 17 patents, the study would enroll an additional 16 patients
for a total of 33 evaluable patients. As previously disclosed, this
endpoint was met after six evaluable patients were enrolled. If at
least eight responses are observed out of 33 patients, the study will
conclude that the drug combination is active. This study will be
updated if and when this endpoint is reached.
“Pancreatic cancer typically offers a dismal prognosis, so it is highly
encouraging to see the clinical benefit rate reported in this study.
The median progression free survival for pancreatic patients on
gemcitabine is nine weeks(1), whilst the majority of the patients on this study had not progressed
as of 12 weeks,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “We intend to continue testing REOLYSIN with various
chemotherapeutic agents including gemcitabine and
carboplatin/paclitaxel across multiple trials to further understand its
potential in the treatment of pancreatic cancer.”
(1)Burris,H.A. et al. (1997) Improvements in survival and clinical benefit
with gemcitabine as first-line therapy for patients with advanced
pancreas cancer: a randomized trial. J ClinOncol 15(6):2403-2413.
Conference Call Information
Dr. Brad Thompson, President and CEO of Oncolytics, will host a
conference call and webcast on Monday, November 14(th), 2011 at 6:30 a.m. MT (8:30 a.m. ET) to discuss in more depth the
presentation covering the U.S. Phase II pancreatic cancer data. To
access the conference call by telephone, dial 1-647-427-7450 or
1-888-231-8191. A live audio webcast will also be available at the
following link: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=3743300 or through the Company’s website at www.oncolyticsbiotech.com. Please connect at least 10 minutes prior to the webcast to ensure
adequate time for any software download that may be needed. A replay of
the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through November 21(st), 2011. To access the telephone replay, dial 1-416-849-0833 or
1-855-859-2056 and enter reservation number 27729561 followed by the
About Pancreatic Cancer
The American Cancer Society estimates that 44,030 Americans will be
diagnosed with pancreatic cancer and 37,660 Americans will die from the
disease in 2011, making this type of cancer the fourth leading cause of
cancer death for both men and women in the United States. For more
information about pancreatic cancer, please go to www.cancer.org.
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 to be presented at the AACR-NCI-EORTC 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 2011 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.