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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 April 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 -
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: April 4, 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 Interim Phase I
Combination REOLYSIN®/Radiation Clinical Trial Data at AACR Conference
CALGARY,
AB, — April 4, 2006 — Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that interim results of its Phase I combination REOLYSIN®/radiation clinical trial
will be presented this morning at the American Association for Cancer Research (AACR) annual
meeting in Washington, D.C. The interim results indicated that the combination of intratumoural
REOLYSIN® and radiation was well tolerated and that both local clinical responses and early
indications of systemic effects were observed. The presentation is entitled “Phase I trial of
intratumoural administration of reovirus type 3 (Reolysin) in combination with radiation in patients
with advanced malignancies.”
“Indications of activity when combining REOLYSIN® with what is generally considered to be a
palliative dose of radiation are certainly encouraging,” said Dr. Brad Thompson, President and CEO
of Oncolytics. “On the strength of this data, we are currently designing a Phase II combination
REOLYSIN®/radiation trial, at this radiation dosage, for inclusion in our overall Phase II clinical
program. That trial is expected to begin following the completion of the ongoing Phase I trial.”
The Phase I open label study is evaluating the feasibility, safety and anti-tumour effects of
intratumoural administration of REOLYSIN® in combination with localized radiation therapy in
patients with advanced cancers, using two different radiation dosages and schedules. The primary
objective of the study is to determine the maximum tolerated dose and dose limiting toxicities, if
any, and the safety profile of REOLYSIN® when administered intratumourally to patients receiving
radiation treatment. The secondary objective is to examine any evidence of anti-tumour activity.
Patients with advanced or metastatic solid tumours that are refractory to standard therapy, or for
which no curative standard therapy exists, are eligible. The patients will have a target lesion
that has not previously been treated with radiation but for which palliative radiation treatment is
indicated. The treatment consists of a constant amount of radiation, in this case 20 Grays,
administered in five fractions on consecutive days, and two intratumoural injections of REOLYSIN®
on days two and four at the following dose escalation levels — 108, 109 and
1010 TCID50.
Preliminary observations in the first seven patients show that the combination of intratumoural
REOLYSIN® and radiation has been well-tolerated. Most toxicities have been mild, generally grade 1
and 2, and include fever, sweating and skin erythema. One patient in the second cohort developed
grade 3 fatigue and grade 2 flu-like symptoms and could not receive the second REOLYSIN® injection.
There has been no evidence that the REOLYSIN® injections exacerbated the acute reactions expected
from the radiation. There was also no evidence of viral shedding in the blood, urine, stool or
sputum on day eight post-REOLYSIN® injection.
Interim analysis has shown evidence of local responses and an indication of systemic effects.
Amongst the first five patients that completed treatment, three patients had partial tumour
responses. There was one case of progressive disease at one month, one case of stable disease at
one month, two cases of partial responses at one, two and three months and one case of stable
disease at one and two months, which became a pathological partial response at three months. CT
scans from the treated lymph node tumour in the first patient in the trial clearly show the partial
response, which has now lasted for over eight months. A metastatic tumour in this patient that was
outside the radiation field also showed a partial response.
Oncolytics will host a webcast at 12:00 p.m. ET today, April 4, 2006, to provide a clinical trial
update specifically focusing on the interim Phase I combination REOLYSIN®/radiation clinical trial
results being presented in an oral presentation at the AACR Annual Meeting. The presentation will
be available on the Oncolytics website later today.
The live audio webcast will be available at:
http://w.on24.com/r.htm?e=21624&s=1&k=60E516ABE1419DCAB6502DB7A33029D1 or through
www.oncolyticsbiotech.com. Please connect to the link at least 15 minutes prior to the webcast to
ensure adequate time for any software download that may be needed. A replay of the webcast will be
available at www.oncolyticsbiotech.com and will also be available by telephone through April 13,
2006. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation
number 21182106.
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 meeting 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 schedule, 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. |
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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 |
| www.oncolyticsbiotech.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 |
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jboidman@renmarkfinancial.com |
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