Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of hematology
and oncology therapeutics that address unmet medical needs, today
provided a corporate and clinical outlook for 2017 and announced
that Mark W. Schwartz, Ph.D., President and Chief Executive Officer
will give a company presentation at the Biotech Showcase 2017. The
presentation will take place on Wednesday, January 11, 2017 at
10:30 a.m. PT at the Hilton San Francisco Union Square. The
presentation will be webcast and available on the Investors section
of the Company's website at
http://investors.galenabiopharma.com/events.cfm.
“2017 looks to be promising for Galena Biopharma as we prepare
to initiate our Phase 3 clinical trial in patients with essential
thrombocythemia (ET) with GALE-401, our controlled release version
of anagrelide,” said Mark W. Schwartz, Ph.D., President and Chief
Executive Officer. “After a productive meeting with the U.S. Food
and Drug Administration (FDA) last month, we were pleased to
confirm that the GALE-401 development program is appropriate for a
New Drug Application (NDA) filing using the 505(b)(2) regulatory
pathway in patients who are intolerant to or failed to achieve an
optimal response with hydroxyurea. In the U.S., ET has a prevalence
of approximately 150,000 people and we estimate up to 25% of those
patients who receive initial treatment with hydroxyurea may be
candidates for the GALE-401 trial. We expect to finalize the
details of the Phase 3 clinical trial protocol including the trial
size, endpoints, and dosing this quarter and initiate the trial in
the second quarter of 2017.”
Dr. Schwartz continued, “We were also excited to announce last
month that the Phase 2 clinical trial with NeuVax™ (nelipepimut-S)
in Ductal Carcinoma in Situ (DCIS) resumed enrollment. In 2017, we
expect enrollment to be completed in both of our NeuVax and
trastuzumab combination trials. These investigator-sponsored trials
(ISTs) are relatively low cost and allow us to leverage our
resources to validate NeuVax as a potential treatment option
whether as a stand-alone therapy or in combination with other
agents. We believe there is substantial interest in the potential
efficacy of NeuVax in a number of breast cancer indications and
other malignancies such as gastric cancer, and ISTs such as these
allow us to expand the utility of the agent. Similarly, with
our folate binding protein (FBP) programs, GALE-301 and GALE-302,
our investigators provided a wealth of data in 2016 at various
medical conferences including a November publication in Oncotarget
on the GALE-301 interim analysis. These data on dosing and
treatment schedules are extremely valuable as they highlight the
potential utility of the vaccine in different cancer
indications.”
Dr. Schwartz concluded, “As 2017 begins, we have a well defined
pipeline and continue to be a late-stage company with a planned,
Phase 3 clinical trial initiation with GALE-401 next quarter.
We are pleased with the advancement of NeuVax in both the
combination and DCIS trials and look forward to reaching meaningful
enrollment milestones in these trials this year. The
dedication of our shareholders, our employees, study sites, and
patients will help us reach our ultimate goal of making a
difference in the treatment of hematologic conditions and
preventing recurrence in cancer patients.”
About GALE-401 (Anagrelide Controlled
Release)
GALE-401 is a controlled release formulation of anagrelide
(Anagrelide CR) currently in clinical development for essential
thrombocythemia. The currently available immediate release
formulation (Agrylin® or anagrelide IR) is approved by the FDA for
the treatment of patients with thrombocythemia, secondary to
myeloproliferative disorders, to reduce the elevated platelet count
and the risk of thrombosis and to ameliorate associated symptoms
including thrombo-hemorrhagic events. Adverse events associated
with anagrelide IR, such as nausea, diarrhea, abdominal pain,
palpitations, tachycardia, and headache, may be dose and plasma
concentration dependent. GALE-401 is a reformulated,
controlled release version of anagrelide that reduces the maximum
plasma concentration (Cmax) of the drug and is expected to reduce
side effects, but preserve efficacy.
About Essential Thrombocythemia
Essential Thrombocythemia (ET) is a chronic myeloproliferative
neoplasm (MPN) characterized by the overproduction of platelets by
megakaryocytes in the bone marrow. The U.S. prevalence of ET is
between 135,000 and 175,000 with approximately seventy-five percent
of patients receiving treatment.1 Common symptoms include headache,
vision disturbances or migraines, dizziness or lightheadedness,
coldness or blueness of fingers or toes, burning, redness, and pain
in the hands and feet. Complications for patients with ET include
blood clotting or bleeding or may be thrombotic in nature such as
stroke, heart attack, or transient ischemic attack.
As with other MPNs, ET is a progressive blood cancer that can
strike anyone at any age, and for which there is no known cure;
and, there is no single treatment option that is appropriate or
effective for all ET sufferers. While some ET patients may be
asymptomatic and require no treatment, others may require various
treatments and therapies based on the symptoms, their risk factors,
and potential complications. The treatment options are
limited and are generally hydroxyurea prescribed first line,
followed by other treatments including anagrelide immediate
release, interferon, aspirin or other agents depending on the
patient’s condition. Of these, only anagrelide IR is approved for
treatment of ET patients.
1Mehta et al, (2014) Epidemiology of myeloproliferative
neoplasms in the United States, Leukemia & Lymphoma, 55:3,
595-600, DOI: 10.3109/10428194.2013.813500
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. 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. In clinical studies, NeuVax is combined with
recombinant granulocyte macrophage-colony stimulating factor
(GM-CSF).
NeuVax is currently in two breast cancer studies in combination
with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in
node positive and triple negative HER2 IHC 1+/2+
(clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial
in high risk, node positive or negative HER2 IHC 3+ patients
(clinicaltrials.gov identifier: NCT02297698). A Phase 2
clinical trial is also ongoing with NeuVax in patients with ductal
carcinoma in situ (DCIS) (clinicaltrials.gov identifier:
NCT02636582), and a Phase 2 trial is planned in patients with
gastric cancer.
About GALE-301 and GALE-302
GALE-301 and GALE-302 are cancer immunotherapies that consist of
a peptide derived from Folate Binding Protein (FBP) combined with
the immune adjuvant, granulocyte macrophage-colony stimulating
factor (GM-CSF) for the prevention of cancer recurrence in the
adjuvant setting. GALE-301 is the E39 peptide, while GALE-302
is an attenuated version of this peptide, known as E39’. FBP
is a well-validated therapeutic target that is highly
over-expressed in ovarian, endometrial and breast cancers, and is
the source of immunogenic peptides that can stimulate cytotoxic T
lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer
cells. Two trials are ongoing with FBP peptides: the GALE-301 Phase
2a portion of the Phase 1/2a clinical trial is ongoing in ovarian
and endometrial adenocarcinomas (ClinicalTrials.gov Identifier:
NCT01580696); the GALE-301 plus GALE-302 Phase 1b clinical trial is
ongoing in breast and ovarian cancers (ClinicalTrials.gov
Identifier: NCT02019524).
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed
to the development and commercialization of hematology and oncology
therapeutics that address unmet medical needs. Galena’s pipeline
consists of multiple mid-to-late-stage clinical assets led by its
hematology asset, GALE-401, and novel cancer immunotherapy programs
including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. 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 development of Galena’s
product candidates, patient enrollment in our clinical trials, as
well as other statements related to the progress and timing of our
development activities, present or future licensing, collaborative
or financing arrangements, expected outcomes with regulatory
agencies, and projected market opportunities for product candidates
or that otherwise relate to future periods. 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,
2015 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.
NeuVax is a trademark of Galena Biopharma, Inc.
Source: Galena Biopharma, Inc.
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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