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
August 2008
Commission File Number 000-31062
Oncolytics Biotech Inc.
(Translation of registrants 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 registrants home country), or under the rules of the home
country exchange on which the registrants 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 registrants 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
U.S. NCI Starts Enrolment in Phase 2 Systemic Melanoma Clinical Trial with REOLYSIN®
CALGARY, AB, August 12, 2008 - Oncolytics Biotech Inc. (Oncolytics) (TSX:ONC, NASDAQ:ONCY)
announced today that the U.S. National Cancer Institute (NCI), part of the National Institutes of
Health, has started enrolment in a Phase 2 clinical trial for patients with metastatic melanoma
using systemic administration of REOLYSIN®, Oncolytics proprietary formulation of the
human reovirus. The trial is being carried out by the Mayo Phase 2 Consortium under the NCIs
Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of
REOLYSIN®. The Principal Investigator is Dr. Evanthia Galanis of the Mayo Clinic Cancer
Center.
The primary objectives of the study are to assess the antitumour effects of REOLYSIN® in
patients with metastatic malignant melanoma, as well as the safety profile of REOLYSIN®.
Secondary objectives include assessment of progression free survival and overall survival.
Patients will receive systemic administration of REOLYSIN® at a dose of
3x1010 TCID50 per day on days 1-5 of each 28 day cycle, and patients may
receive up to 12 cycles of treatment. The trial is expected to enroll up to 47 patients with
metastatic melanoma.
Approximately 60,000 people are diagnosed with melanoma in the U.S. every year.
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 Companys
expectations related to the U.S. NCI Phase 2 systemic administration clinical trial for patients
with metastatic melanoma, and the Companys belief as to the potential of REOLYSIN® as a
cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the
Companys 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 Companys 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 Companys 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 2V7
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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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