Galena Biopharma Reports Clinical Biomarker Data Demonstrating the Role of
NeuVax(TM) in Preventing Breast Cancer Recurrence
NeuVax Demonstrates Consistent Reduction of Circulating Tumor Cells (CTCs) in
Vaccinated Patients, Corresponding With Its Previously Documented Increase in
CD8+ Cytotoxic T-Lymphocytes and Enhanced Delayed Type Hypersensitivity (DTH)
LAKE OSWEGO, Ore., Oct. 26, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc.
(Nasdaq:GALE), a biotechnology company focused on developing innovative,
targeted oncology treatments that address major unmet medical needs to advance
cancer care, presented data from the Phase 1/2 clinical trial of NeuVax™
(nelipepimut-S or E75) at the 27^th Annual Meeting of the Society for
Immunotherapy of Cancer. The event is being held October 26-28, 2012 at the
Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.
The poster presentation entitled: "Trends in Circulating Tumor Cells (CTCs) in
Multiple Adjuvant Trials of HER2-Directed Peptide Vaccines (PVs)" measured
CTCs from blood samples from NeuVax (nelipepimut-S or E75) patients using the
CellSearch^® system (Veridex). CTCs are cells that have detached from the
primary breast tumor and circulate in the bloodstream, and may then cause the
growth of additional tumors (metastases) in different tissues.These
recurrences may occur soon after the original cancer or many years after the
initial treatment.Increased presence of CTCs predicts the likelihood of a
recurrence of the cancer resulting in poor disease-free survival (DFS) and
overall survival (OS), suggesting a dormancy of isolated micrometastases.
These results showed a total of 26 patients receiving NeuVax had at least two
CTC measurements made during the vaccine treatment.In 16/26 NeuVax treated
patients, the CTCs decreased during the time of treatment, corresponding with
an increase in the patients' E75-specific CD8+ cytotoxic T-lymphocytes (killer
T-cells) and an increase in their delayed type hypersensitivity (DTH)
reactions. DTH is the measurable signal on the skin that the patient is
immunologically responding to treatment.None of these patients had a
recurrence of their cancer during the five year follow-up period.
Data presented indicate that vaccine treated patients were more likely to show
a decrease in CTCs than control patients.Furthermore, the use of NeuVax
boosters appears to provide long-term benefit from the return of CTC.As a
result, investigators concluded that these results lend credence to the notion
that breast cancer is a chronic disease and that monitoring CTC trends may be
clinically useful in the adjuvant setting as a surrogate for response to
"Even with the major advances in earlier diagnoses and better treatment
options,approximately 25% of resectable node-positive breast cancer patients
will still relapse within three years, despite having no evidence of disease
following surgery and chemotherapy/radiation treatment," stated Mark J. Ahn,
Ph.D., Galena's President and Chief Executive Officer. "The data presented
today shows that treatment with NeuVax reduces CTCs and therefore may prevent
growth of future micrometastasis, lending support to the idea of using the
woman's immune system to prevent relapse of her breast cancer."
Final NeuVax Phase 1/2 results will be reported at the San Antonio Breast
Cancer Symposia in December 2012.
About NeuVax (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant nine amino acid nonapeptide
derived from the extracellular domain of the HER2 protein, a well-established
target for therapeutic intervention in breast carcinoma.The nelipepimut
sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following
binding to HLA-A2/A3 molecules on antigen presenting cells (APC).These
activated specific CTLs recognize, neutralize and destroy through cell lysis
HER2 expressing cancer cells, including occult cancer cells and
micrometastatic foci.The nelipepimut immune response can also generate CTLs
to other immunogenic peptides through inter- and intra-antigenic epitope
spreading.Based on a successful Phase 2 trial, which achieved its primary
endpoint of disease free survival (DFS), the Food and Drug Administration
(FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3
PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer
with Low to Intermediate HER2 Expression with NeuVax Treatment) study.The
Phase 3 trial is ongoing and additional information on the study can be found
According to the National Cancer Institute, over 230,000 women in the U.S. are
diagnosed with breast cancer annually.Of these women, about 75% test positive
for HER2 (IHC 1+, 2+ or 3+). NeuVax targets approximately 50-60% of
HER2-positive patients (IHC 1+/2+ or FISH <2.2) who achieve remission with
current standard of care, but have no available HER2-targeted adjuvant
treatment options to maintain their disease-free status.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company that develops innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer care.For
more information please visit us at www.galenabiopharma.com.
The Galena Biopharma, Inc. logo is available at
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.Such statements include,
but are not limited to, statements about the possible benefits of Galena's new
product candidates.These forward-looking statements are subject to a number
of risks and uncertainties, including those identified under "Risk Factors" in
Galena'smost recently filed Annual Report on Form 10-K and Quarterly Report
on Form 10-Q and in other filings Galena periodically makes with the SEC.
Actual results may differ materially from those contemplated by these
forward-looking statements.Galena does not undertake to update any of these
forward-looking statements to reflect a change in its views or events or
circumstances that occur after the date of this presentation.
CONTACT: Madeline Hatton
Toll free: +1 (855) 855-GALE (4253), ext. 109
IR Sense, LLC
+1 (503) 400-6995
Galena Biopharma, Inc.
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