Stimuvax(R) Phase II data highlight three-year survival results for patients with non-small cell lung cancer
September 05 2007 - 8:00AM
PR Newswire (US)
EDMONTON, Sept. 5 /PRNewswire-FirstCall/ -- Biomira Inc.
(NASDAQ:BIOM) (TSX: BRA) today announced the presentation of
three-year survival results from a randomized Phase II trial of the
Stimuvax(R) MUC-1 vaccine in non-small cell lung cancer (NSCLC).
The results suggest that Stimuvax combined with best supportive
care (BSC) may provide survival benefits to patients with
unresectable stage IIIB NSCLC who had either responded or had
stable disease after initial radio-chemotherapy, compared with
patients receiving BSC alone. Dr. Charles Butts, from the
Department of Medical Oncology, Cross Cancer Institute, Edmonton,
Alberta and lead investigator of the Phase II study presented the
data yesterday (Abstract # B1-01) at the International Association
for the Study of Lung Cancer (IASLC) Congress in Seoul, South
Korea. The updated survival results show that approximately twice
as many patients were still alive at three years in the Stimuvax
arm compared with BSC alone (49% (n=17) vs. 27% (n=8)),
representing a 45% reduction in mortality. As previously reported,
patients with stage IIIB locoregional disease who received Stimuvax
in this trial also experienced a 17.3 month difference in median
survival compared with patients receiving BSC alone (30.6 months
vs. 13.3 months, respectively). Patients receiving Stimuvax in this
trial also reported mild to moderate side effects limited to
flu-like symptoms, gastro-intestinal disturbances and mild
injection site reactions. "The updated survival data are
encouraging and support the need for further investigation via the
ongoing Phase III trial of Stimuvax as a maintenance therapy for
patients with advanced lung cancer," commented Dr. Butts. Based on
the Phase II results, Stimuvax has entered its Phase III
development and the START (Stimulating Targeted Antigenic Responses
to NSCLC) trial is currently open for enrollment. The START trial
is being conducted by Merck KGaA of Darmstadt, Germany, which has
licensed worldwide development and commercialization rights to
Stimuvax from Biomira. Stimuvax is being developed in Europe by
Merck KGaA and in the United States by its affiliate, EMD Serono
Inc. "Patients with unresectable stage III non-small cell lung
cancer have significant unmet medical need, and the START study is
the first Phase III program to evaluate a therapeutic cancer
vaccine in this population," said Dr. Robert L. Kirkman, MD,
President and Chief Executive Officer of Biomira. "If these
survival results are statistically confirmed in the Phase III
trial, Stimuvax has the potential to become an important tool in
the treatment of lung cancer." According to the American Cancer
Society, lung cancer is the leading cause of cancer-related deaths
in both men and women worldwide, with approximately 80% of cases
classified as NSCLC. Current survival rates for NSCLC are low, with
only 16% of patients alive five years post-diagnosis. Unfortunately
for most patients, current treatments provide limited success.
Stimuvax is an innovative cancer vaccine designed to stimulate the
body's immune system to identify and destroy cancer cells
expressing MUC1, a protein antigen that is widely expressed on
common cancers including lung, breast and colorectal. About the
Phase II Trial 171 patients with ECOG 0-2 stage IIIB/IV NSCLC with
stable or responding disease after any first-line chemotherapy with
or without radiotherapy were randomized to receive Stimuvax plus
BSC or BSC alone. Patients were stratified by stage of disease
(IIIB LR or stage IIIB with malignant pleural effusion, and stage
IV). Patients in the Stimuvax arm received a single intravenous
dose of cyclophosphamide 300mg/m2 followed by 8 weekly subcutaneous
immunizations with Stimuvax (1,000(micro)g). While the overall
study results were not statistically significant, in the
randomization stratum of patients with stage IIIB locoregional
disease, Stimuvax showed a median survival of 30.6 months versus
13.3 months in the control group - an improvement of 17.3 months.
In the Phase IIb study, side effects were primarily limited to
flu-like symptoms, GI disturbances and injection site reactions.
About START - Phase III Trial START is a multi-center, randomized,
double-blind, placebo-controlled study that will evaluate patients
with documented unresectable stage IIIA or IIIB NSCLC who have had
a response or stable disease after at least two cycles of
platinum-based chemo-radiotherapy. The study is expected involve
more than 1,300 patients in approximately 30 countries. For more
information on the START study, or to find a participating center
and eligibility criteria, go to http://www.nsclcstudy.com/. The
study is also listed on http://www.clinicaltrials.gov/. About
Stimuvax Stimuvax is an innovative cancer vaccine designed to
induce an immune response to cancer cells that express MUC1, a
protein antigen widely expressed on common cancers. MUC1 is over
expressed on many cancers such as lung cancer, breast cancer and
colorectal cancer. Stimuvax is thought to work by stimulating the
body's immune system to identify and destroy cancer cells
expressing MUC1. About Biomira Biomira is a biotechnology company
specializing in the development of innovative therapeutic products
for the treatment of cancer. Biomira's goal is to develop and
commercialize novel synthetic vaccines and targeted small molecules
that have the potential to improve the lives and outcomes of cancer
patients. Forward Looking Statements This press release contains
forward looking statements, including, without limitation,
statements related to the therapeutic and commercial potential of
Stimuvax; future clinical development plans; the details of the
clinical trials; and the anticipated future size of the market for
Stimuvax. Any statements contained in this press release that are
not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will," "intends," "potential,"
"possible" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Biomira's current expectations. Forward-looking
statements involve risks and uncertainties. Various factors could
cause actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing,
duration and results of clinical trials, the timing and results of
regulatory reviews, and the safety and efficacy of Stimuvax. There
can be no guarantee that the results of earlier trials will be
predictive of either safety or efficacy in future trials. Biomira
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in the company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
DATASOURCE: Biomira Inc. CONTACT: Investor and Media Relations
Contact: Julie Rathbun, Rathbun Communications, (206) 769-9219
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