form6vk
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 January
2007
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: January 3, 2007 |
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By: |
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/s/ Doug Ball
Doug Ball
Chief Financial Officer |
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210, 1167 Kensington Cr. N.W.
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial
Investigating REOLYSIN® in Combination with Gemcitabine
CALGARY, AB, — January 3, 2007 - 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 clinical
trial using intravenous administration of REOLYSIN® in combination with gemcitabine
(Gemzar®) in patients with advanced cancers including pancreatic, lung and ovarian. The
principal investigators are Dr. Johann de Bono of The Royal Marsden NHS Foundation Trust and The
Institute of Cancer Research, London and Professor Jeff Evans of the University of Glasgow and the
Beatson Oncology Centre in Glasgow, Scotland. Gemcitabine is used in patients with lung, pancreatic
and ovarian cancers and is also used widely in the treatment of many other types of cancers.
“The combination of REOLYSIN® and gemcitabine was synergistic in preclinical
studies,” said Dr. Brad Thompson, President and CEO of Oncolytics. “The data gathered in this
study is expected to assist the company in further defining the optimal path to product
registration. Drug combination studies allow us to investigate REOLYSIN® with
drugs that are part of the current standard of care.”
Preclinical studies conducted at Cornell University demonstrated that the combination of
gemcitabine and REOLYSIN® was synergistic against selected cancer cell lines. This work
was verified by additional studies conducted by the U.S. National Cancer Institute (NCI).
This trial (REO 009) has two components. The first is an open-label, dose-escalating,
non-randomized study of REOLYSIN® given intravenously with gemcitabine every three
weeks. A standard dosage of gemcitabine will be delivered with escalating dosages of
REOLYSIN® intravenously. A maximum of three cohorts will be enrolled in the
REOLYSIN® dose escalation portion. The second component of the trial will immediately
follow and will include the enrolment of a further 12 patients at the maximum dosage of
REOLYSIN® in combination with a standard dosage of gemcitabine.
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 objective of the trial is to
determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and
dosing schedule and safety profile of REOLYSIN® when administered in combination with
gemcitabine. Secondary objectives include the evaluation of immune response
to the drug combination, the body’s response to the drug combination compared to chemotherapy alone
and any evidence of anti-tumour activity.
In the U.K. and the U.S., approximately 280,000 people are diagnosed with pancreatic, lung and
ovarian cancers 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 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
For more information about Gemzar®, go to www.gemzar.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. combination REOLYSIN®/gemcitabine 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.
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
600, 205 5th Ave. SW
Calgary, Alberta T2P 2V7
Tel: 403.538.4845
Fax: 403.266.2453
nhurst@equicomgroup.com
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The Investor Relations Group
Damian McIntosh
11 Stone St, 3rd Floor
New York, NY 10004
Tel: 212.825.3210
Fax: 212.825.3229
dmcintosh@investorrelationsgroup.com |
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