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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 January 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: January 31, 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. Proceeds to Full Enrolment in U.S. Phase II Sarcoma Clinical Trial
CALGARY, AB, — January 31, 2008 — Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that it has met the initial criteria to proceed to full enrolment in its U.S. Phase
II trial to evaluate the intravenous administration of REOLYSIN® in patients with
various sarcomas that have metastasized to the lung.
According to the trial protocol, to proceed to full enrolment of 52 patients, Oncolytics had to
demonstrate that at least one patient in the first 38 patients treated experienced a complete or
partial response, or stable disease for greater than six months. The third patient treated in the
study was demonstrated to have stable disease by RECIST criteria for more than six months as
measured by CT scan. A PET scan taken at the same time showed that any residual mass was
metabolically inert.
A total of 12 patients have received REOLYSIN® treatment to date, with five remaining on
study. All 12 patients have been treated at the Cancer Therapy and Research Center, University of
Texas Health Science Center in San Antonio, Texas (CTRC at UTHSCSA).
“We are very pleased to proceed to the second stage of the REOLYSIN® study,” said Dr.
Monica Mita, Principal Investigator at CTRC at UTHSCSA. “This unique targeted compound has met our
expectations so far in terms of both tolerability and efficacy endpoints and we feel it is very
important to continue to offer this agent to our patients.”
“While still early, these are very encouraging results,” said Dr. Karl Mettinger, Chief Medical
Officer of Oncolytics. “There are few treatment options for patients with bone or soft tissue
cancers, and we are pleased that the trial participants appear to be benefiting from
REOLYSIN® treatment.”
Patients are expected to be enrolled at three additional sites, which include the Montefiore
Medical Center/Albert Einstein College of Medicine in the Bronx, New York, the University of
Michigan Comprehensive Cancer Center in Ann Arbor, Michigan, and the Mayo Clinic in Rochester,
Minnesota.
The trial (REO 014) is a Phase II, open-label, single agent study whose primary objective is to
measure tumour responses and duration of response, and to describe any evidence of antitumour
activity of intravenous, multiple dose REOLYSIN® in patients with bone and soft tissue
sarcomas metastatic to the lung. REOLYSIN® is delivered intravenously to patients at a
dose of 3x1010 TCID50 for five consecutive days. Patients may receive
additional five-day cycles of therapy every four weeks for a maximum of eight cycles. Up to 52
patients will be enrolled in the study.
Eligible patients must have a bone or soft tissue sarcoma metastatic to the lung deemed by their
physician to be unresponsive to or untreatable by standard therapies. These include patients with
osteosarcoma, Ewing sarcoma family tumours, malignant fibrous histiocytoma, synovial sarcoma,
fibrosarcoma and leiomyosarcoma.
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
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. Phase II sarcoma 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
325, 300 5th Ave. SW
Calgary, AB, T2P 3C4
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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