Form 6-K
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 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 -
TABLE OF CONTENTS
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, 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 Crescent NW
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc.’s Research Collaborators Present
Positive REOLYSIN® Clinical Trial Data at ASCO Conference
CALGARY, AB, — June 5, 2006 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today
announced that two of its research collaborators presented positive interim and final results of
two Phase I clinical trials at poster sessions at the American Society of Clinical Oncology (ASCO)
Annual Meeting on June 4, 2006 in Atlanta, Georgia. The data cover interim results of Oncolytics’
Phase I systemic administration trial being conducted in the U.K. and final results of Oncolytics’
Phase I recurrent malignant glioma trial conducted in Canada.
“The results of these trials and previously completed and reported trials are consistent in
showing that REOLYSIN® is well tolerated and can demonstrate activity in tumours when
delivered locally or systemically to patients with a wide variety of advanced cancers,” said Dr.
Brad Thompson, President and CEO of Oncolytics.
Interim 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 30 patients have been treated to date in the escalating frequency and
dosage portion of the trial to a maximum daily dose of 1x1011 TCID50. To date
these 30 patients have received 65 courses of therapy, for a total of 284 daily treatments.
Patients have been 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 cohorts whose patients have completed treatment (seven), anti-tumour activity was noted in
patients with colorectal, prostate, pancreatic, bladder, and NSCL cancer. 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 at six months) and had CEA tumour marker reduction of 27% and 60%
respectively. One patient with metastatic prostate cancer had stable disease at 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 at 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 at four 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.
In a second poster presentation, final results of a Canadian Phase I trial for recurrent
malignant glioma indicated that intratumoural administration of REOLYSIN® was well
tolerated by the patients and a maximum tolerated dose was not reached. A total of 12 patients
were treated with a single, intratumoural injection of REOLYSIN® at dosages of
1x107, 1x108, and 1x109 TCID50 in a delivery volume of
0.9 ml.
Toxicities possibly related to the REOLYSIN® treatment in this trial were generally mild
(grade 1 and 2) and included fever, headache and neutropenia. A transient grade 3 elevation in GGT
was noted. Three patients lived longer than one year, and one of these patients is still alive
approximately 45 months post-treatment.
The primary objective of the Company’s Canadian Phase I trial was to determine the MTD, DLT, and
safety profile of REOLYSIN® when administered intratumourally to patients. A secondary
objective was to examine any evidence of anti-tumour activity. The study examined the use of a
single, intratumoural injection of REOLYSIN®, delivered using imaging-guided surgery, in
patients with malignant glioma that had recurred despite other treatments, including surgery and
radiation therapy.
Both ASCO posters can be found 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 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
Company’s expectations related to the interim results of the Phase I UK Systemic Administration
clinical trial investigating delivery of REOLYSIN® for advanced cancers, and the final
results of the Phase I Canadian trial for recurrent malignant glioma 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 |
| Cathy Ward |
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Nick Hurst |
| 210, 1167 Kensington Cr NW |
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20 Toronto Street |
| Calgary, Alberta T2N 1X7 |
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Toronto, Ontario M5C 2B8 |
| Tel: 403.670.7377 |
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Tel: 416.815.0700 ext. 226 |
| Fax: 403.283.0858 |
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Fax: 416.815.0080 |
| cathy.ward@oncolytics.ca |
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nhurst@equicomgroup.com |
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| The Investor Relations Group |
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RenMark Financial Communications |
| Damian McIntosh |
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John Boidman |
| 11 Stone Street, 3rd Floor |
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2080 Rene Levesque Blvd. W. |
| New York, NY 10004 |
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Montreal, PQ H3H 1R6 |
| Tel: 212.825.3210 |
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Tel: 514.939.3989 |
| Fax: 212.825.3229 |
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Fax: 514.939.3717 |
| dmcintosh@investorrelationsgroup.com |
|
jboidman@renmarkfinancial.com |
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