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
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.
| |
|
|
|
|
| |
|
Oncolytics
Biotech Inc.
(Registrant) |
| |
| |
|
|
|
|
| |
| Date: November 3, 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. Collaborators Present Positive Phase I/II Combination
REOLYSIN® and Paclitaxel/Carboplatin 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 Phase I and Phase II U.K.
combination REOLYSIN® and paclitaxel/carboplatin clinical trials for patients with
advanced cancers. The principal investigator for the trial is Dr. Kevin Harrington of The
Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.
The results were presented 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.
“The most striking finding,” said George M. Gill, MD, Oncolytic’s Senior VP of Clinical and
Regulatory Affairs, “is that in nine evaluable late-stage head and neck cancer patients, eight of
whom have refractory disease, four had durable partial responses and four others showed stable
disease for periods of two, five plus, and eight cycles.”
Four of the responding patients continue on study, while a fifth patient is too early to evaluate
for response. These results appear to confirm preclinical evidence of synergy for
REOLYSIN® and platinum/taxane combinations. A U.S. Phase 2 trial has now been opened
in this patient population utilizing this regimen.
Fourteen patients have been treated to date in the Phase I and Phase II (REO 011) trials. The
detailed results are summarized in the following table:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| |
Primary Tumour |
|
|
REOLYSIN Dose |
|
|
Cycles |
|
|
Best Response |
|
| |
|
|
|
TCID50 |
|
|
|
|
|
|
|
|
|
| |
Phase I patients |
|
|
|
|
|
|
|
|
|
|
|
|
| |
Melanoma
|
|
|
3x109
|
|
|
|
2 |
|
|
|
PD |
|
| |
Squamous cell carcinoma
(SCC)
head & neck
|
|
|
3x109
|
|
|
|
8 |
|
|
|
Clinical CR, SD per CT scan |
|
| |
Peritoneal
|
|
|
3x109
|
|
|
|
3 |
|
|
|
PD |
|
| |
Melanoma (eye)
|
|
|
1x1010
|
|
|
|
2 |
|
|
|
PD |
|
| |
Head & neck
|
|
|
1x1010
|
|
|
|
8 |
|
|
|
PR |
|
| |
Nasopharynx
|
|
|
1x1010
|
|
|
|
8 |
|
|
|
PR |
|
| |
Endometrial
|
|
|
3x1010
|
|
|
|
8 |
|
|
|
SD |
|
| |
SCC nasopharynx
|
|
|
3x1010
|
|
|
|
1 |
|
|
|
PD |
|
| |
Head & neck
(laryngeal
carcinoma)
|
|
|
3x1010
|
|
|
|
2 |
|
|
|
SD |
|
| |
Phase II patients |
|
|
|
|
|
|
|
|
|
|
|
|
| |
Nasopharynx
|
|
|
3x1010
|
|
|
|
8 |
* |
|
|
SD |
|
| |
Nasopharynx with liver mets
|
|
|
3x1010
|
|
|
|
7 |
* |
|
|
PR |
|
| |
SCC nasolabial fold
|
|
|
3x1010
|
|
|
|
5 |
* |
|
|
SD |
|
| |
SCC nasopharynx
|
|
|
3x1010
|
|
|
|
4 |
* |
|
|
PR |
|
| |
SCC nasopharynx
|
|
|
3x1010
|
|
|
|
2 |
* |
|
|
Too early to evaluate |
|
| |
*still on study. CR=complete response, PR=partial response, SD=stable disease, PD=progressive
disease
The Phase I trial has two components. The first is an open-label, dose-escalating, non-randomized
study of REOLYSIN® given intravenously to patients with paclitaxel and carboplatin every
three weeks. In this portion of the trial, standard dosages of paclitaxel and carboplatin are
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 paclitaxel and carboplatin. Eligible
patients include those who have been diagnosed with advanced or metastatic solid tumours such as
melanoma, lung and ovarian that are refractory (have not responded) to standard therapy or for
which no curative standard therapy exists.
The Phase II 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 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/II trials 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:
| |
|
|
|
|
Oncolytics Biotech Inc.
|
|
The Equicom Group
|
|
The Investor Relations Group |
Cathy Ward
|
|
Nick Hurst
|
|
Erika Moran |
210, 1167 Kensington Cr NW
|
|
325, 300 5th Ave. SW
|
|
11 Stone St, 3rd Floor |
Calgary, Alberta T2N 1X7
|
|
Calgary, Alberta T2P 3C4
|
|
New York, NY 10004 |
Tel: 403.670.7377
|
|
Tel: 403.538.4845
|
|
Tel: 212.825.3210 |
Fax: 403.283.0858
|
|
Fax: 403.237.6916
|
|
Fax: 212.825.3229 |
cathy.ward@oncolytics.ca
|
|
nhurst@equicomgroup.com
|
|
emoran@investorrelationsgroup.com |
-30-