Galena Biopharma Receives Notice of Allowance of Broad U.S. Patent for
Allowed Claims Cover the Use of NeuVax Alone or in Combination to Prevent
Recurrence of Any Her2/neu Expressing Tumor Having a FISH Rating of Less Than
PORTLAND, Ore., July 1, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc.
(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 notice of allowance of a
U.S. Patent for NeuVax™ (nelipepimut-S) covering the use of NeuVax alone or in
combination to prevent recurrence of any HER2/neu expressing tumor having a
fluorescence in situ hybridization (FISH) rating of less than about 2.0.
NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and
is Galena's lead development agent in multiple ongoing and planned clinical
trials.Once issued, the patent will expire in 2028, not including any patent
FISH is a diagnostic test used to identify patients with high levels of HER2
gene expression, or FISH greater than 2.0. These patients are eligible for
existing approved HER2-directed treatments.Currently there are no approved
HER2-directed therapies for patients who express lower levels of HER2, or less
than 2.0 by the FISH testing scale.
The patent will cover the use of NeuVax in patients with a FISH of less then
about 2.0, as a stand-alone therapy or in combination with an adjuvant and/or
other agents (e.g. other drugs such as Herceptin® (trastuzumab;
Genentech/Roche)).Importantly, this NeuVax patent provides Galena with
coverage for any tumor expressing low-to-intermediate levels of HER2.
"This allowance further strengthens our broad patent estate for NeuVax,
covering all tumor types expressing low-to-intermediate levels of HER2 both as
a monotherapy and in combination with other agents," said Mark J. Ahn, Ph.D.,
President and Chief Executive Officer."Our clinical development program with
NeuVax continues to grow with ongoing and planned clinical trials in breast
and gastric cancers.We look forward to completing enrollment in our Phase 3
PRESENT trial this year and advancing NeuVax in other programs to prevent
cancer recurrence for patients."
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-S 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 U.S. 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).
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing innovative, targeted
oncology treatments that address major unmet medical needs to advance cancer
care.For more information visit 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 NeuVax product candidate, 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, 2013 and most recent Quarterly Reports on Form 10-Q
filed with the SEC. Actual results may differ materially from those
contemplated by these forward-looking statements.
CONTACT: Remy Bernarda
VP, Marketing & Communications
Galena Biopharma, Inc.
Press spacebar to pause and continue. Press esc to stop.