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 Docetaxel
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 docetaxel
(Taxotere®) in patients with advanced cancers including bladder, prostate, lung and
upper gastro-intestinal. The principal investigator is Professor Hardev Pandha of The Royal Surrey
Hospital, U.K. Docetaxel is used in patients with lung, breast and prostate cancers, and is also
used widely in the treatment of many other types of cancers.
“The trial is expected to yield data that will further characterize responses in these target
patient populations and will help in designing the late-stage development program for
REOLYSIN®,” said Dr. Brad Thompson, President and CEO of Oncolytics.
In preclinical studies conducted at the U.S. National Cancer Institute (NCI) and Royal Surrey
Hospital in the U.K., the combination of REOLYSIN® and various taxanes including
docetaxel has been shown to be synergistic against a variety of cancer cell lines.
The trial (REO 010) has two components. The first is an open-label, dose-escalating,
non-randomized study of REOLYSIN® given intravenously with docetaxel every three weeks.
A standard dosage of docetaxel 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 docetaxel.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
such as bladder, lung, prostate or upper gastro-intestinal 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
docetaxel. 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 600,000 people are diagnosed annually with bladder, lung,
prostate and upper gastro-intestinal cancers.
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 docetaxel (taxotere®) please visit www.taxotere.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®/docetaxel 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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600, 205 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: 403.266.2453
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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 |
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