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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 December, 2006
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: December 22, 2006 |
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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 Paclitaxel and Carboplatin
CALGARY, AB — December 22, 2006 — 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 paclitaxel and
carboplatin in patients with advanced cancers including melanoma, lung, and ovarian. The principal
investigators are Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden
NHS Foundation Trust and Dr. Geoff Hall of St. James’s Hospital in Leeds, U.K. The combination of
paclitaxel and carboplatin chemotherapy is used in cancer patients with ovarian and lung cancers,
and is also used widely in the treatment of many other types of cancer.
“The approval of this trial represents an important step forward for Oncolytics, allowing us to
move quickly into a treatment combination that could result in a first-line therapy indication for
REOLYSIN®,” said Dr. Brad Thompson, President and CEO of Oncolytics.
In studies conducted by the U.S. National Cancer Institute (NCI), the combination of
REOLYSIN® and paclitaxel was uniformly synergistic against six non-small cell lung
cancer cell lines examined, including cell lines resistant to paclitaxel or REOLYSIN®.
Preclinical studies conducted at Cornell University also found that REOLYSIN® in
combination with platinum drugs enhanced the cytotoxicity of the chemotherapeutic agents.
This trial (REO-011) has two components. The first is an open-label, dose-escalating,
non-randomized study of REOLYSIN® given intravenously with paclitaxel and carboplatin
every three weeks. Standard dosages of paclitaxel and carboplatin 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 standard dosages of paclitaxel and carboplatin.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
such as melanoma, 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
carboplatin and paclitaxel. 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., more than 300,000 people are diagnosed annually with melanoma, lung and
ovarian 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 paclitaxel and carboplatin, visit www.bms.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®/paclitaxel and
carboplatin 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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