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, 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 -
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210, 1167 Kensington Cr. N.W.
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc.’s Research Collaborators Present REOLYSIN®
Phase I UK Systemic Administration Clinical Trial Results
CALGARY, AB, — November 9, 2006 — Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that Dr. Timothy Yap of The Royal Marsden Foundation Trust, and The Institute of
Cancer Research presented a poster today at the 18th EORTC-NCI-AACR Symposium on
Molecular Targets and Cancer Therapeutics. The meeting is being held from November 7-10, 2006 in
Prague, Czech Republic.
The poster, entitled “A Phase I Study of Wild-Type Reovirus, Which Selectively Replicates in Cells
Expressing Activated Ras, Administered Intravenously to Patients with Advanced Cancer” covers
additional clinical results from Oncolytics’ first systemic administration study. Interim results
were previously announced at the American Society of Clinical Oncology (ASCO) in June 2006.
“REOLYSIN® delivered systemically, demonstrated activity in patients with colorectal,
bladder, prostate, pancreatic, endometrial and NSCL cancers,” said Dr. Brad Thompson, President and
CEO of Oncolytics. “This broad range of responses shows that REOLYSIN® could be
potentially active across numerous cancer indications.”
Results of the Company’s UK Phase I systemic administration clinical trial investigating the use of
REOLYSIN® to treat patients with advanced cancers indicated that REOLYSIN®
can be delivered systemically to various tumour types and cause virus-mediated tumour responses. A
total of 33 patients have been treated to date in the trial to a maximum daily dose of
1x1011 TCID50. These 33 patients have received approximately 75 courses of
therapy, for a total of 328 daily treatments. Patients were entered into the study at the
following dose levels (all TCID50): 1x108 for 1 day, 1x108 for 3
days, 1x108, 3x108, 1x109,
3x109, 1x1010 and 3x1010 for five days, and
1x1011 for three days. A maximum tolerated dose (MTD) was not reached
and the treatment appears to have been well tolerated by the patients.
Toxicities possibly related to REOLYSIN® treatment in this trial have generally been
mild (grade 1 or 2) and have included chills, fever, headache, cough, runny nose, sore throat and
fatigue. Transient grade 3 toxicities include lymphopenia, neutropenia and troponin I. These
symptoms were more frequently observed from day two of treatment and usually lasted less than six
hours.
Of the patients assessed to date (32), anti-tumour activity was noted in seven patients. Patients
were assessed with CTR scans, and where possible tumour marker assessment, and histopathology of
tumour biopsies. Two patients with colorectal cancer had tumour stabilization (one for three
months, the other classified as stable disease for six months) and had CEA tumour marker reduction
of 27% and 60% respectively. One patient with metastatic prostate cancer had stable disease for
four months, had a 50% decrease in PSA, and had extensive product-induced necrosis with associated
intratumoural viral replication in metastatic lesions in the lymph nodes. One patient with
metastatic bladder cancer had stable disease for four months and had a minor tumour response in a
metastatic lesion in a lymph node (reduction from 2.5 to 1.9 cm). A patient with pancreatic cancer
and a patient with NSCL cancer had stable disease for four months. A patient with endometrial
cancer had stable disease for five months.
The primary objective of the Company’s UK Phase I trial is to determine the 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 include 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.
The poster will be available on the Oncolytics website following the presentation.
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 I/II human trials using REOLYSIN®, its proprietary formulation of the human reovirus,
alone and in combination with radiation. 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 symposium with respect to REOLYSIN®, the
Company’s expectations related to the results of trials investigating delivery of
REOLYSIN®, 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 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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For Canada:
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For Canada:
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For United States: |
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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20 Toronto Street
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11 Stone St, 3rd Floor |
Calgary, Alberta T2N 1X7
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Toronto, Ontario M5C 2B8
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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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