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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
May 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 -
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
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Oncolytics
Biotech Inc.
(Registrant) |
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| Date: May 14, 2008 |
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By: |
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/s/ Dr. Matt Coffey
Dr. Matt Coffey
Chief Scientific Officer |
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210, 1167 Kensington Crescent N.W.
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces U.K. Phase II Clinical Trial
Investigating REOLYSIN® in Combination with Paclitaxel and Carboplatin
CALGARY, AB, — May 14, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that that it has received a letter of approval from the U.K. Medicines and
Healthcare products Regulatory Agency (MHRA) for its Clinical Trial Application (CTA) to begin a
Phase II clinical trial using intravenous administration of REOLYSIN® in combination
with paclitaxel and carboplatin in patients with advanced head and neck cancers. The principal
investigator is Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS
Foundation Trust.
“Interim data recently presented from our U.K. Phase I dose escalation trial of
REOLYSIN® in combination with paclitaxel and carboplatin indicated strong and durable
responses in patients with advanced head and neck cancers,” said Dr. Brad Thompson, President and
CEO of Oncolytics. “We believe it is important to further explore these findings by conducting a
Phase II trial in this specific patient population.”
This trial is a 14 patient, single arm, open-label, dose-targeted, non-randomized, multi-centre
trial of REOLYSIN® given intravenously in combination with a standard dosage of
paclitaxel and carboplatin. Patients with a variety of advanced cancers, including head and neck
cancers, will continue to be treated in the ongoing U.K. combination paclitaxel and carboplatin
trial.
Eligible patients include those with advanced or metastatic head and neck cancer that are
refractory to standard therapy or for which no curative standard therapy exists. The primary
objective of the Phase II trial is to measure tumour responses and duration of response, and to
describe any evidence of antitumour activity. The secondary objective is to determine the safety
and tolerability of REOLYSIN® when administered in combination with paclitaxel and
carboplatin to patients with advanced or metastatic head and neck cancer.
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
expectations related to the U.K. Phase II combination REOLYSIN®/paclitaxel and
carboplatin clinical trial, and 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.
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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