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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 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 -
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 5, 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 Crescent N.W.
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Announces
Positive Clinical Data from U.S. Phase I REOLYSIN® Trial
CALGARY, AB, — June 5, 2007 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today positive results from its U.S. Phase I clinical trial examining the systemic
administration of REOLYSIN® in patients with advanced cancers. The results indicate
that REOLYSIN® can be delivered systemically to patients with advanced and metastatic
cancers and cause anti-tumour activity.
“REOLYSIN® administered as a one-hour infusion on a monthly schedule is safe and
well-tolerated even in multiple doses,” said Principal Investigator Dr. Sanjay Goel of the
Montefiore Medical Center and Albert Einstein College of Medicine, New York. “This preliminary
data suggests there is anti-tumour activity of REOLYSIN® administered as a single agent,
and warrants further studies either alone or in combination with cytotoxic chemotherapy, which are
currently being planned.”
A total of 18 patients were treated in the escalating dosage trial to a maximum daily dose of
3x1010 TCID50 in a one-hour infusion. Of the 18 patients treated,
eight demonstrated stable disease as measured by RECIST (Response Evaluation Criteria in Solid
Tumours) including a patient with progressive breast cancer who experienced a 28.5% shrinkage in
tumour volume. The trial was originally designed to demonstrate the safety of a single, one-hour
infusion of REOLYSIN®. During the treatment of the 4th cohort of patients
however, Oncolytics applied for and was granted approval to allow subsequent patients to receive
repeat monthly treatments of REOLYSIN®. Of the patients eligible for retreatment, three
patients received a range of two to seven one-hour infusions of REOLYSIN®.
Toxicities possibly related to REOLYSIN® treatment in this trial were generally mild
(grade 1 or 2) and included chills, fever and fatigue.
The primary objective of the Company’s U.S. Phase I trial is to determine the maximum tolerated
dose, (MTD), dose limiting toxicity (DLT), and safety profile of REOLYSIN® when
administered systemically to patients. A secondary objective is to examine any evidence of
anti-tumour activity. Eligible patients included those who had been diagnosed with advanced or
metastatic solid tumours that are refractory (have not responded) to standard therapy or for which
no curative standard therapy exists.
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 results of the Phase I US Systemic Administration clinical
trial investigating delivery of REOLYSIN® for advanced 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 success and timely completion of clinical studies
and trials, actual patient tolerance, 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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Erika Moran |
210, 1167 Kensington Cr NW
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325, 300 5th Ave. SW
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11 Stone St, 3rd Floor |
Calgary, Alberta T2N 1X7
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Calgary, Alberta, T2P 3C4
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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: 403.237.6916
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Fax: 212.825.3229 |
cathy.ward@oncolytics.ca
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nhurst@equicomgroup.com
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emoran@investorrelationsgroup.com |
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