SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of
November 2008
Commission File Number 000-31062
Oncolytics Biotech Inc.
(Translation of registrant’s name into
English)
Suite 210, 1167 Kensington Crescent NW
Calgary, Alberta, Canada T2N 1X7
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1): o
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a
Form 6-K if submitted solely to provide an attached annual report to security
holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): o
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a
Form 6-K if submitted to furnish a report or other document that the registrant
foreign private issuer must furnish and make public under the laws of the
jurisdiction in which the registrant is incorporated, domiciled or legally
organized (the registrant’s “home country”), or under the rules of the home
country exchange on which the registrant’s securities are traded, as long as
the report or other document is not a press release, is not required to be and
has not been distributed to the registrant’s security holders, and, if
discussing a material event, has already been the subject of a Form 6-K
submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this
Form, the registrant is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.
If “Yes” is marked, indicate below the file number assigned to the registrant
in connection with
Rule 12g3-2(b): 82 -
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210, 1167 Kensington Crescent N.W.
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces Decision to Pursue Phase II/III Pivotal Clinical Trial
CALGARY, AB, — November 4, 2008 — Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that it has made a decision to pursue a pivotal (Phase II/III) randomized trial
using the combination of REOLYSIN® with paclitaxel/carboplatin in refractory patients
with head and neck cancers. The decision was made following a review of results by the Company’s
Board of Directors from the Company’s ongoing U.K. Phase I and Phase II combination
REOLYSIN® and paclitaxel/carboplatin clinical trials. The results were presented
November 1, 2008 at the International Society for Biological Therapy of Cancer (iSBTc) annual
meeting in San Diego, CA.
“Eight out of nine head and neck patients reported on to date from the Phase I and Phase II studies
had either a partial response or stabilization of disease,” said Dr. Brad Thompson, President and
CEO of Oncolytics, “This response rate exceeds that of the current standard of care for this
patient group, and more than warrants proceeding to a pivotal program.”
Oncolytics is currently convening a group of experts in Europe and the U.S. to design a protocol
for the Phase II/III trial, which will then be submitted to the U.S. Food and Drug Administration
(FDA), and the European Medicines Agency (EMEA) for review.
Following FDA and EMEA review,
Oncolytics expects to file for approval for this trial early in 2009.
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 I/II
and Phase II human trials using REOLYSIN®, 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 belief as to the potential of REOLYSIN® 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® 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 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.
FOR FURTHER INFORMATION PLEASE CONTACT:
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Oncolytics Biotech Inc.
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The Equicom Group
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The Investor Relations Group |
Cathy Ward
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Nick Hurst
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Erika Moran |
210, 1167 Kensington Cr NW
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325, 300 5th Ave. SW
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11 Stone St, 3rd Floor |
Calgary, Alberta T2N 1X7
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Calgary, Alberta, T2P 3C4
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New York, NY 10004 |
Tel: 403.670.7377
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Tel: 403.538.4845
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Tel: 212.825.3210 |
Fax: 403.283.0858
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Fax: 403.237.6916
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Fax: 212.825.3229 |
cathy.ward@oncolytics.ca
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nhurst@equicomgroup.com
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emoran@investorrelationsgroup.com |
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