e6vk
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 September 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.
| |
|
|
|
|
| |
|
Oncolytics
Biotech Inc.
(Registrant) |
| |
| |
|
|
|
|
| |
| Date: September 8, 2008 |
|
By: |
|
/s/ Doug Ball
Doug Ball
Chief Financial Officer |
 |
210, 1167 Kensington Crescent N.W.
Calgary, Alberta
Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Starts Patient Enrolment in U.S. Phase 2 Clinical Trial
Investigating REOLYSIN® in Combination with Paclitaxel and Carboplatin
CALGARY, AB, — September 8, 2008 — Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY)
announced today that it has started patient enrolment in a Phase 2 clinical trial using
intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin
in patients with advanced head and neck cancers. The Principal Investigator is Dr. Monica Mita of
the Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San
Antonio.
“We are extremely pleased to open the second disease-directed study with REOLYSIN®,”
said Dr. Mita. “This study represents a promising option for patients with head and neck tumors
refractory to standard chemotherapy and we are happy to have the opportunity to offer this option
to our patients.”
This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of
REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and
carboplatin.
Eligible patients include those with advanced or metastatic head and neck cancers that are
refractory to standard therapy or for which no curative standard therapy exists. The primary
objective of the Phase 2 trial is to measure tumour responses and duration of response, and to
describe any evidence of antitumour activity. The secondary objective is to determine the safety
and tolerability of REOLYSIN® when administered in combination with paclitaxel and
carboplatin to patients with advanced or metastatic head and neck cancers.
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
The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San
Antonio is among the nation’s leading academic research and treatment centers, serving more than
4.4 million people in the high-growth corridor of Central and South Texas including Austin, San
Antonio, Laredo and the Rio Grande Valley. CTRC is one of a few elite cancer centers in the country
to be named a National Cancer Institute (NCI) Designated
Cancer Center, and is one of only three in Texas. CTRC handles more than 120,000 patient visits
each year and is a world leader in developing new drugs to treat cancer. The CTRC Institute for
Drug Development (IDD) is internationally recognized for conducting the largest oncology Phase I
clinical drug trials program in the world, and participated in the clinical and/or preclinical
development of many of the cancer drugs approved by the U.S. Food & Drug Administration. For more
information, visit our Web site at www.ctrc.uthscsa.edu.
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 U.S. Phase 2 combination REOLYSIN®/paclitaxel and
carboplatin clinical 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
tolerability of REOLYSIN® outside a controlled test, 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:
| |
|
|
|
|
Oncolytics Biotech Inc.
Cathy Ward
210, 1167 Kensington Cr NW
Calgary, Alberta T2N 1X7
Tel: 403.670.7377
Fax: 403.283.0858
cathy.ward@oncolytics.ca
|
|
The Equicom Group
Nick Hurst
325, 300 5th Ave. SW
Calgary, Alberta, T2P 3C4
Tel: 403.538.4845
Fax: 403.237.6916
nhurst@equicomgroup.com
|
|
The Investor Relations Group
Erika Moran
11 Stone St, 3rd Floor
New York, NY 10004
Tel: 212.825.3210
Fax: 212.825.3229
emoran@investorrelationsgroup.com |
-30-