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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 June 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: June 10, 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. Announces Start of Enrolment in Phase 1/2
Ovarian Cancer Clinical Trial with REOLYSIN®
CALGARY, AB, — June 10, 2008 — Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that patient enrolment has started in a Phase 1/2 clinical trial for patients with
metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous (IV) and
intraperitoneal (IP) administration of REOLYSIN®, Oncolytics’ proprietary formulation of
the human reovirus. The National Cancer Institute (NCI), part of the National Institutes of
Health, is sponsoring the trial under its Clinical Trials Agreement with Oncolytics, while
Oncolytics will provide clinical supplies of REOLYSIN®. The Principal Investigator is
Dr. David E. Cohn, Associate Professor, Division of Gynecologic Oncology at The Ohio State
University College of Medicine in Columbus, Ohio.
“REOLYSIN® is an exciting agent to investigate in patients with ovarian cancer,” said
Dr. Cohn. “Targeting a specific alteration commonly present in these tumors will hopefully lead to
efficacy with minimal toxicity.”
“We are looking forward to working closely with the NCI to examine the effects of using
REOLYSIN® with two concurrent methods of administration,” said Dr. Brad Thompson,
President and CEO of Oncolytics. “Our REOLYSIN® clinical program has now expanded to
include ten Phase 1/2 or Phase 2 trials in the U.S. and the U.K. using REOLYSIN® as a
monotherapy or in combination with radiation or chemotherapy.”
In the Phase 1 portion of the trial, patients will receive a constant dose of IV
REOLYSIN® on days 1-5 every 28 days, as well as an escalating dose of IP
REOLYSIN® on days 1-2 every 28 days. In the Phase 2 portion of the study, patients will
receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days as well as the Maximum
Tolerated Dose (MTD) of IP REOLYSIN® from the Phase 1 portion.
The primary objectives of the Phase 1 trial are to determine the safety and tolerability of
intravenous and intraperitoneal administration of REOLYSIN®, and the MTD of IP
REOLYSIN® when used with a fixed dose of IV REOLYSIN®. The primary objective
of the Phase 2 trial is to determine the objective response rate of treatment with IV and IP
REOLYSIN® in patients with recurrent, platinum-refractory ovarian, peritoneal and tubal
carcinomas. The Phase 1/2 trial is expected to enroll up to 70 patients.
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian
cancer in the U.S. in 2008, and more than 15,000 will die from it.
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.S. NCI Phase I/II systemic and intraperitoneal administration
clinical trial for patients with metastatic ovarian, peritoneal and fallopian tube cancers, 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.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: 403.670.7377
Fax: 403.283.0858
cathy.ward@oncolytics.ca
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The Equicom Group
Nick Hurst
325, 300 5th Ave. SW
Calgary, Alberta T2P 2V7
Tel: 403.538.4845
Fax: 403.237.6916
nhurst@equicomgroup.com
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The Investor Relations Group
Erika Moran
11 Stone St, 3rd Floor
New York, NY 10004
Tel: 212.825.3210
Fax: 212.825.3229
emoran@investorrelationsgroup.com |
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