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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 July, 2006
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 -
TABLE OF CONTENTS
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: July 18, 2006 |
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By: |
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/s/ Doug Ball
Doug Ball
Chief Financial Officer |
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210, 1167 Kensington Crescent NW
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces Approval for Phase II U.K. Clinical Trial
Investigating REOLYSIN® in Combination with Radiation Therapy
CALGARY, AB, — July 18, 2006 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today 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 to evaluate the anti-tumour effects of intratumoural administration of
REOLYSIN® in combination with low-dose radiation in patients with advanced cancers.
“Oncolytics will initiate this Phase II trial based on the promising safety and clinical responses
observed in our Phase Ia REOLYSIN®/radiation trial,” said Dr. Brad Thompson, President
and CEO of Oncolytics. “In the Phase Ia trial, partial tumour responses were observed in a number
of patients and the product was well-tolerated.”
The trial is an open-label, single-arm, multi-centre Phase II study of REOLYSIN®
delivered via intratumoural injection to patients during treatment with low-dose radiotherapy. Up
to 40 evaluable patients, including approximately 20 patients with head and neck and esophageal
cancers, and approximately 20 patients with other advanced cancers, will be treated with two
intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant
localized radiation dose of 20 Gy in five consecutive daily fractions. Eligible patients include
those who have been diagnosed with advanced or metastatic cancers including head, neck and
esophageal tumours that are refractory (have not responded) to standard therapy or for which no
curative standard therapy exists.
The primary objective of the trial is to assess the anti-tumour activity of the combination of
REOLYSIN® and low dose radiotherapy in treated and untreated lesions. Secondary
objectives include the evaluation of viral replication, immune response to the virus and to
determine the safety and tolerability of intratumoural administration of REOLYSIN® in
patients with advanced cancers who are receiving radiation treatment.
The Principal Investigators are: Dr. Kevin Harrington of the Targeted Therapy Laboratory, the
Institute of Cancer Research, Cancer Research U.K. Centre for Cell and Molecular Biology and
Honorary Consultant in Clinical Oncology at the Royal Marsden NHS Foundation Trust; Dr. Alan
Melcher of the Cancer Research U.K. Clinical Centre at St. James’s University Hospital in Leeds;
and Dr. Mark Saunders, consultant Clinical Oncologist at the Department of Clinical Oncology,
Christie Hospital, Manchester. The trial will initially enroll patients at the Royal Marsden, St.
James’s and Christie Hospitals in the U.K. and may also involve additional investigators and
hospitals.
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 and
Phase I/II human trials using REOLYSIN®, its proprietary formulation of the human
reovirus, alone and in combination with radiation. 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®/radiation
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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Damian McIntosh |
| 210, 1167 Kensington Cr NW |
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20 Toronto Street |
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11 Stone Street, 3rd Floor |
| Calgary, Alberta T2N 1X7 |
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Toronto, Ontario M5C 2B8 |
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New York, NY 10004 |
| Tel: 403.670.7377 |
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Tel: 416.815.0700 ext. 226 |
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Tel: 212.825.3210 |
| Fax: 403.283.0858 |
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Fax: 416.815.0080 |
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Fax: 212.825.3229 |
| cathy.ward@oncolytics.ca |
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nhurst@equicomgroup.com |
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dmcintosh@investorrelationsgroup.com |
| www.oncolyticsbiotech.com |
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