Galena Biopharma Confirms Regulatory Pathway for GALE-401 (Anagrelide Controlled Release)
December 28 2016 - 7:05AM
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
announced the Company has confirmed the regulatory pathway to
advance GALE-401 (Anagrelide Controlled Release) into a pivotal,
Phase 3 trial. After a productive meeting with the U.S. Food and
Drug Administration (FDA), the Company has confirmed the
development program and proposed clinical trial are appropriate for
a New Drug Application (NDA) filing using the 505(b)(2) regulatory
pathway.
The Phase 3 clinical trial will enroll patients
with essential thrombocythemia who have either failed or are
intolerant to hydroxyurea, and will compare GALE-401 to the best
available therapy (BAT) that will include a
sizable subpopulation of patients treated with anagrelide
immediate release. The Company expects to finalize the Phase 3
clinical trial protocol and initiate the trial in Q2, 2017.
“Confirmation of the 505(b)(2) regulatory pathway
and preliminary agreement with the Agency on our Phase 3 clinical
trial design is a significant step forward for our late stage
program,” Mark W. Schwartz, Ph.D., President and Chief Executive
Officer. “Our controlled release version of anagrelide can offer a
potential treatment option for patients with ET who have failed
hydroxyurea. We remain on track to initiate the trial in the second
quarter of 2017.”
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. A Phase 2 pilot study with
GALE-401 has been completed.
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 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, including GALE-401, 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.
Agrylin is a trademark of Shire LLC.
Source: Galena Biopharma, Inc.
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
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