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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
November 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: November 3, 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. Collaborators Present Positive Combination
REOLYSIN® and Docetaxel Results at iSBTc Annual Meeting
CALGARY,
AB, — November 3, 2008 — Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced today that it has achieved positive interim results in its U.K. combination
REOLYSIN® and docetaxel clinical trial for patients with advanced cancers.
Prof. Hardev Pandha of the Royal Surrey Hospital, U.K., presented the results at the International
Society for Biological Therapy of Cancer (iSBTC) annual meeting on November 1, 2008. The meeting
was held in San Diego, California from October 31-November 2, 2008.
Fourteen patients have been treated to date in the dose escalation portion of the trial and eleven
patients are evaluable for response. The detailed results are summarized in the following table:
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Primary Tumour |
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REOLYSIN Dose |
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Cycles |
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Best Response |
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TCID50 |
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Breast |
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1x1010 |
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8 |
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PR
CR in liver |
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Gastric
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3x1010
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8 |
* |
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PR
32% reduction in lymph nodes |
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Mesothelioma
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1x1010
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6 |
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Minor response
23% reduction in lymph nodes |
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Prostate
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3x109
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6 |
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SD on scans
30% reduction in PSA |
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Squamous Cell
Carcinoma
Head and Neck
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3x109
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3 |
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Minor response
26% reduction in lymph node |
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Unknown
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3x109
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6 |
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SD |
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Pancreas
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3x1010
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6 |
* |
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SD |
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Prostate
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3x1010
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5 |
* |
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SD |
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Prostate
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3x1010
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5 |
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SD |
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Melanoma
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1x1010
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4 |
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SD |
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Pancreas
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3x1010
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2 |
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SD, but progressed clinically |
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*patients still on study. CR=complete response, PR=partial response, SD=stable disease
“These are extraordinary results for a Phase I trial,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “To see tumour stabilization or better in this patient population is highly unusual.”
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.
In this portion of the trial, which was completed in August 2008, standard dosages of docetaxel
were delivered to patients with escalating dosages of REOLYSIN® intravenously. The
second component of the trial includes the enrolment of a further nine patients at the top dose of
REOLYSIN® in combination with a standard dosage of docetaxel. Patients may receive up
to eight cycles of treatment in this study.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours
including 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.
The poster will be available today on the Oncolytics website at www.oncolyticsbiotech.com.
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/II
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 implication
of the materials presented at this meeting with respect to REOLYSIN®, the Company’s
expectations related to the results of trials investigating delivery of REOLYSIN®, the
Company’s analysis of the results of the Phase I 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 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, uncertainties related to the regulatory
process and general changes to the economic environment. 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, except as required by applicable laws.
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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