CALGARY, Oct. 28, 2013 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”)
(TSX:ONC) (NASDAQ:ONCY) today announced a poster presentation
containing updated efficacy data from a Phase 2 study examining the use
of REOLYSIN® in combination with carboplatin and paclitaxel in patients with stage
IV non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumors (REO 016) was made at International
Association for the Study of Lung Cancer (IASLC). The conference is
being held from October 27th to 30th, 2013 in Sydney, Australia.
The poster presentation included new efficacy data that correlated a
number of molecular abnormalities with best response, progression free
survival (PFS) and one-year survival. Current data in these patients
demonstrates that 20 of 36 evaluable patients (56%) survived a year or
more. There were 13 patients with only EGFR mutations or
amplifications, of whom nine (69.2%) survived a year or longer. Four of
four (100%) patients with BRAF and EGFR amplification survived a year
or longer.
“This is the first time we have reported data correlating the presence
of specific biomarkers with efficacy, which covers both best response
and survival in patient tumours with a Ras-activated pathway,” said Dr.
Brad Thompson, President and CEO of Oncolytics. “Although the study
examined a relatively small number of patients, this data is
encouraging, especially in light of a growing focus among healthcare
professionals on personalizing cancer treatment based on tumour type.
We are taking a closer look at the specific role biomarkers play in a
number of our ongoing studies and, based on this data, intend to
conduct a randomized trial in this indication.”
The chart below summarizes key findings for the 36 evaluable patients:
Molecular Abnormality |
Number of patients |
Best Response |
Number progression free at six months |
Number surviving one year |
BRAF mutation, EGFR amplification |
4 | 2 PR, 1 SD, 1 PD | 2 | 4 |
EGFR amplification |
10 | 5 PR, 5 SD | 4 | 7 |
EGFR mutation, EGFR amplification |
3 | 1 PR, 1 SD, 1 PD | 1 | 2 |
KRAS | 12 | 3 PR, 8 SD | 6 | 4 |
KRAS, EGFR amplification |
7 | 6 SD, 1 PD | 1 | 3 |
Total | 36 |
11 PR, 11 SD (30% response rate) |
14 (38%) | 20 (56%) |
Partial response (PR), stable disease (SD), progressive disease (PD)
Patients received REOLYSIN (3 x 1010 TCID50) intravenously daily on days one to five, in combination with paclitaxel
at initial doses of paclitaxel 175 mg/m2 and carboplatin AUC 5, on day one of each 21-day cycle. Overall, 37
patients received 209 cycles (per patient median four, range one to
18). The study treatment was found to be well tolerated.
The Company’s collaborators also presented a poster on results from the
Company’s U.S. Phase 2 single arm clinical trial in patients with
squamous cell carcinoma of the lung (SCCLC) using intravenous
administration of REOLYSIN in combination with carboplatin and
paclitaxel (REO 021). This is the same poster that was previously
presented on October 22, 2013 at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics conference held
in Boston, MA.
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a
conference call and webcast on Monday, October 28, 2013 at 6:00 a.m. MT
(8:00 a.m. ET) to discuss in more depth the Company’s lung cancer
program. To access the conference call by telephone, dial
1-888-231-8191 or 1-647-427-7450. A live audio webcast will also be
available at the following link: http://www.newswire.ca/en/webcast/detail/1248341/1375429 or through the Company’s website at www.oncolyticsbiotech.com/presentations. Please connect at least 10 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/presentations and will also be available by telephone through November 4, 2013. To
access the telephone replay, dial 1-416-849-0833 or 1-855-859-2056 and
enter reservation number 92453959 followed by the number sign.
About Lung Cancer
The American Cancer Society estimates that in 2013, approximately
228,190 new cases of lung cancer will be diagnosed. Between 85% and 90%
of all lung cancers are classified as non-small cell lung cancer
(NSCLC); squamous cell carcinomas account for 25-30% of all lung
cancers. Lung cancer is by far the leading cause of cancer death among
both men and women. There will be an estimated 159,480 deaths from lung
cancer in the United States in 2013, accounting for around 27% of all
cancer deaths. Lung cancer is the leading cause of cancer death, with
more people dying each year of lung cancer than from colon, breast, and
prostate cancers combined. For more information about SCC lung cancer,
please go to www.cancer.org.
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 human trials
including a Phase III trial in head and neck cancers using REOLYSIN®, its proprietary formulation of the human reovirus. For further
information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
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 II non-small cell lung cancer trial, the U.S.
Phase II squamous cell carcinoma lung cancer trial, future trials in
these indications, 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, development and
manufacturing of pharmaceuticals, changes in technology, general
changes to the economic environment 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 should consider statements that
include the words “believes”, “expects”, “anticipates”, “intends”,
“estimates”, “plans”, “projects”, “should”, or other expressions that
are predictions of or indicate future events or trends, to be uncertain
and forward-looking. 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.
SOURCE Oncolytics Biotech Inc.
Released October 28, 2013