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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 9, 2008 |
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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 N.W.
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Starts Patient Enrolment in
U.K. Combination REOLYSIN®/Cyclophosphamide Trial
CALGARY, AB, — May 9, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that it has begun patient enrolment in a clinical trial using intravenous
administration of REOLYSIN® in combination with cyclophosphamide, a chemotherapeutic
agent as well as immune modulator, in patients with advanced cancers. The Principal Investigators
are Dr. James Spicer of King’s College in London, Dr. Johann de Bono and Dr. Kevin Harrington of
The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, and Professor
Hardev Pandha of the Royal Surrey County Hospital NHS Trust, Surrey and Mount Alvernia Hospitals.
“We are hopeful that this trial will provide more information on how we might improve the
effectiveness of this promising new approach to treating cancer,” said Dr. Spicer.
“In animal models, pretreatment with low-dose immune modulators has been shown to significantly
enhance the antitumour activity of REOLYSIN®ref.,” added Dr. Brad Thompson, President
and CEO of Oncolytics. “This study will help confirm if this can also be achieved in humans. If
it can, it could lead to exciting opportunities to expand the use of REOLYSIN® for
cancer treatment.”
The trial (REO 012) is an open-label, dose-escalating, non-randomized trial of REOLYSIN®
given intravenously with escalating doses of cyclophosphamide. A standard dose of
REOLYSIN® is administered intravenously over five consecutive days, while an intravenous
dose of cyclophosphamide is administered three days before REOLYSIN® treatment and
continues through the course of the treatment cycle. The total number of patients studied will
depend on the number of dose levels tested, but it is anticipated to be approximately 30 patients.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
including pancreatic, lung and ovarian cancers that are refractory (have not responded) to standard
therapy or for which no curative standard therapy exists. The primary objectives of the trial
include determining the Minimum Effective Immunomodulatory Dose (MED) of cyclophosphamide to obtain
successful immune modulation. Secondary objectives include determining the safety profile of the
combination and gathering any evidence of anti-tumour activity.
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.
Ref:
Clin. Cancer Res. 2008 14:259-269
Cancer Gene Ther. 2006 Aug; 13(8): 815-8
Cancer Res, 2003 Jan 15; 63(2):348-53
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. combination REOLYSIN®/cyclophosphamide 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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