Galena Biopharma Enrolls 700th Patient in NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT Clinical Trial
February 09 2015 - 7:05AM
- Key PRESENT trial enrollment milestone
achieved
- Over-enrollment planned with expected completion near
the end of Q1
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major medical needs across the full
spectrum of cancer care, today announced enrollment of the 700th
patient 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. There are currently no available, targeted treatment
options to maintain the disease-free status for these women.
Seven hundred is the patient enrollment target as defined by the
PRESENT Phase 3 clinical trial protocol. A Special Protocol
Assessment (SPA) was granted by the U.S. Food and Drug
Administration (FDA) on the PRESENT trial, certifying the agreement
with the FDA regarding the study endpoints, study design and
statistical assumptions of the clinical trial. As previously
mentioned by the Company, Galena is continuing to enroll those
identified patients who are completing their standard of care and
have passed their initial qualifications for potential enrollment
in the trial. The Company expects over-enrollment will
increase the confidence in both the timing and quality of the
statistics and the final outcome of the trial. Completion of
final enrollment in the trial is expected near the end of the first
quarter of 2015.
"Reaching enrollment of our 700th patient is a significant
milestone for the PRESENT trial and for our NeuVax cancer
immunotherapy franchise," said Mark W. Schwartz, Ph.D., President
and Chief Executive Officer. "We are grateful to all the women
who volunteered to participate in our study, and we now look
forward to completing enrollment near the end of this quarter and
reaching our event-driven, interim analysis, which we anticipate
occurring at the end of 2015/early 2016 timeframe. Next year,
we also expect several key milestones from our portfolio of NeuVax
trials, including our ongoing Phase 2b trial with NeuVax in
combination with Herceptin®."
PRESENT is a randomized, double blind, placebo controlled,
international, Phase 3 trial and the leading study in Galena's
pipeline. The trial is currently running in 13 countries at
more than 140 sites. The PRESENT trial targets the
approximately 50%-60% of women with breast cancer who are low to
intermediate (immunohistochemistry [IHC] 1+/2+ or fluorescence in
situ hybridization [FISH] < 2.0) HER2 expression and achieved no
evidence of disease with current standard of care treatment
(surgery, chemotherapy, and radiation therapy). Patients must
be lymph node positive, haplotype (HLA) A2 or A3 positive, and have
Stage IIa-IIIa breast cancer. Once patients have completed
their current standard of care treatment, with no available
HER2-targeted adjuvant treatment options to maintain their
disease-free status, patients 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. The final endpoint is
currently expected to be reached in 2018, after the last patient
dosed reaches her 36th month of treatment, or 141 events
(recurrence or death), whichever comes later.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a cancer immunotherapy treating
patients 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. The nelipepimut-S sequence stimulates specific CD8+
cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3
molecules on antigen presenting cells (APCs). 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. NeuVax is currently in an
international, Phase 3 PRESENT (Prevention of
Recurrence in
Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression
with NeuVax Treatment) study
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. Galena has two
additional breast cancer studies ongoing with NeuVax in combination
with Herceptin® (trastuzumab; Genentech/Roche): a Phase 2b trial in
node positive and triple negative HER2 IHC 1+/2+, and a Phase 2
trial in neoadjuvant node positive and negative HER2 IHC 3+
patients.
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 and development of Galena's product
candidates, including patient enrollment and the timing of
completion of 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, 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. 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.
Herceptin is a registered trademark of
Genentech/Roche. Abstral and NeuVax are trademarks of Galena
Biopharma, Inc. All other trademarks are the property of their
respective owners.
CONTACT: Remy Bernarda
Senior VP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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