Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
therapeutics that address major medical needs across the full
spectrum of cancer care, today announced the completion of
enrollment in the NeuVax™ (nelipepimut-S) Phase 3 PRESENT
(
Prevention of
Recurrence in
Early-
Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2
Expression
with
NeuVax Treatment) clinical
trial. NeuVax™ is a first-in-class, HER2-directed cancer
immunotherapy under evaluation to prevent breast cancer recurrence
after standard of care treatment in the adjuvant setting.
As anticipated, Galena over-enrolled the trial by 7.7% with a
total of 758 patients now in the intent-to-treat (ITT) population.
The protocol for the PRESENT trial, being conducted under an FDA
approved Special Protocol Assessment (SPA), called for 700
patients; and, the Company expects this higher number of ITT
patients will increase the confidence in both the timing and
quality of the statistics and the final outcome of the trial. The
primary endpoint is currently expected to be reached in 2018, after
the last patient dosed reaches her 36th month of treatment, or a
total of 141 events (recurrence or death) occur, whichever comes
later.
"Completion of enrollment in our Phase 3 PRESENT trial is a
landmark event for Galena and for breast cancer patients
worldwide," said Mark W. Schwartz, Ph.D., President and Chief
Executive Officer. "As we look forward to reaching our interim
analysis by the end of this year or in Q1, 2016, it is important to
note the significant medical need that Galena aims to address with
NeuVax. Despite advances in the diagnosis and treatment of breast
cancer, approximately 25% of node positive patients have a
recurrence within three years after achieving no evidence of
disease. NeuVax is designed to prevent these often fatal
recurrences, and we anticipate that data from the PRESENT study, as
well as our ongoing combination studies of NeuVax in breast cancer,
will demonstrate this capability."
"The women in the PRESENT trial are part of the approximately
fifty percent of breast cancer patients who have tumors that are
HER2 1+ or 2+, and currently have no available treatment options to
maintain their disease-free status after their standard of care
therapy. Based on our early work with NeuVax, we believe this
agent can have a meaningful impact for these women. I am
grateful to the hundreds of women who participated in this study
and for all of the sites and investigators who devoted their time
to help us accomplish this milestone," added Elizabeth A.
Mittendorf, M.D., Ph.D., Associate Professor, Department of
Surgical Oncology, The University of Texas MD Anderson Cancer
Center and the Principal Investigator of the PRESENT trial.
PRESENT is a randomized, double blind, placebo controlled,
international, Phase 3 trial and is the most advanced study in
Galena's pipeline. The trial is being run in 13 countries at
more than 140 sites. The PRESENT trial targets the
approximately 50%-60% of women with breast cancer who have low to
intermediate (immunohistochemistry [IHC] 1+/2+ or fluorescence in
situ hybridization [FISH] < 2.0) HER2 expression and achieved no
evidence of disease following current standard of care treatment
(surgery, chemotherapy, and radiation therapy). Patients
enrolled must be lymph node positive, haplotype (HLA) A2 or A3
positive, and have Stage IIa-IIIa breast cancer. Once patients
completed their current standard of care treatment, they are
administered an injection once a month for six months (Primary
Vaccine Series), then receive five booster injections once every
six months for a total of eleven injections over a three year
period. Currently there are no other treatment options for
these patients to maintain their disease-free status.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed
cancer immunotherapy under evaluation to prevent breast cancer
recurrence after standard of care treatment in the adjuvant
setting. It is the immunodominant peptide derived from the
extracellular domain of the HER2 protein, a well-established target
for therapeutic intervention in breast carcinoma. NeuVax has
been shown to bind to HLA-A2 and A3, as well as HLA-A24 and A26
molecules. The nelipepimut-S sequence stimulates specific CD8+
cytotoxic T lymphocytes (CTLs) following binding to specific HLA
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-S immune response can
also generate CTLs to other immunogenic peptides through inter- and
intra-antigenic epitope spreading leading to a broader, more robust
anti-tumor immune response.
NeuVax is currently in an international, Phase 3 study called
PRESENT (Prevention of Recurrence
in Early-Stage, Node-Positive
Breast Cancer with Low to Intermediate HER2
Expression with NeuVax
Treatment) being conducted under a Special
Protocol Assessment (SPA) granted by the U.S. Food and Drug
Administration (FDA). Additional information on the PRESENT trial
can be found at www.neuvax.com (clinicaltrials.gov identifier:
NCT01479244). Galena has two additional breast cancer studies
ongoing with NeuVax in combination with trastuzumab (Herceptin®;
Genentech/Roche): a Phase 2b trial in node positive and high risk
node negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier:
NCT01570036); and, a Phase 2 trial in neoadjuvantly treated node
positive and negative HER2 IHC 3+ patients not achieving a
pathological complete response (pCR) or adjuvantly treated node
positive HER2 IHC 3+ patients (clinicaltrials.gov identifier:
NCT02297698).
About HER2 1+/2+ Breast Cancer
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
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 biopharmaceutical
company developing and commercializing innovative, targeted
oncology therapeutics that address major medical needs across the
full spectrum of cancer care. Galena's development portfolio
ranges from mid- to late-stage clinical assets, including a robust
immunotherapy program led by NeuVax™ (nelipepimut-S) currently in
an international, Phase 3 clinical trial. The Company's
commercial drugs include Abstral® (fentanyl) Sublingual Tablets and
Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's
clinical and commercial strategy focuses on identifying and
advancing therapeutic opportunities to improve cancer
care, from direct treatment of the disease to the reduction of
its debilitating side-effects. For more information, visit
www.galenabiopharma.com.
Forward-Looking Statements
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 commercialization of Abstral®
and 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, 2014 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. 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.
Abstral and NeuVax are trademarks of Galena Biopharma,
Inc. All other trademarks are the property of their respective
owners.
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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