Galena Biopharma Expands NeuVax(TM) Intellectual Property With European
PORTLAND, Ore., Aug. 21, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma
(Nasdaq:GALE), a biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major unmet medical
needs to advance cancer care, today announced the European Patent Office
notified the Company of an intention to grant a Pharmaceutical Use Patent for
NeuVax™ (nelipepimut-S). The patent covers the use of NeuVax as a vaccine for
the prevention of relapse in breast cancer patients with an immunochemistry
(IHC) rating of 1+ or 2+ for HER2/neu protein expression and a fluorescence in
situ hybridization (FISH) rating of less than 2.0 for HER2/neu gene
expression.The patent protection is afforded in all of the European countries
and will expire in April 2028.
"This patent expands our intellectual property protection for NeuVax in
Europe, and further validates our novel, cancer immunotherapy approach to
preventing the recurrence of breast cancer in women who otherwise have no
treatment options," said Mark J. Ahn, Ph.D., President and CEO."NeuVax is the
only drug currently in Phase 3 development for patients with early-stage,
node-positive breast cancer with low-to-intermediate HER2 expression status."
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant 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 (CTLs) 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 PRESENT trial
is ongoing and additional information on the study can be found at
www.neuvax.com.A randomized, multicenter investigator sponsored, 300 patient
Phase 2b clinical trial is also enrolling patients to study NeuVax in
combination with Herceptin® (trastuzumab; Genentech/Roche).
According to the National Cancer Institute, over 230,000 women in the U.S. are
diagnosed with breast cancer annually. Of these women, only about 25% are HER2
positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who
are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and 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 commercializing and developing innovative, targeted
oncology treatments that address major unmet medical needs to advance cancer
care.For more information please visit us at www.galenabiopharma.com.
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 progress of the development of
Galena's product candidates, including patient enrollment in our clinical
trials, as well as statements about our expectations, plans and prospects.
These forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including those identified under "Risk Factors"
in Galena's Annual Report on Form 10-K for the year ended December 31, 2012
and Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 filed
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 press release.
CONTACT: Remy Bernarda
Senior Director, Communications
Galena Biopharma, Inc.
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