Galena Biopharma Presents GALE-401 Combined Safety Data at the European Hematology Association 21st Congress
June 13 2016 - 7:05AM
Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of targeted
oncology therapeutics that address major unmet medical needs, today
announced that combined safety data from the Company’s GALE-401
clinical trials were presented at the European Hematology
Association 21st Congress. GALE-401 is Galena’s controlled
release (CR) version of anagrelide for the treatment of patients
with thrombocythemia, secondary to myeloproliferative disorders, to
reduce elevated platelet counts in patients suffering from
myeloproliferative neoplasms (MPNs).
A total of six trials have been run with GALE-401, five Phase 1
trials in healthy volunteers (N=98), and one Phase 2 single arm,
open label pilot study in MPN patients (N=18). The poster,
entitled, “Anagrelide Controlled Release (GALE-401) Safety Profile
Consistently Well Tolerated in Myeloproliferative Neoplasms
Patients and Healthy Volunteers” was designed to characterize the
safety profile of GALE-401 in all subjects treated to date.
The results demonstrated that GALE-401 is well tolerated in MPN
patients as well as in healthy volunteers. In the Phase 2 study,
fewer moderate to severe (Grade 3/4) adverse events (AEs) and fewer
AEs per patient (2.3 vs. 3.3) were observed with GALE-401 compared
to what has been reported previously with the immediate release
(IR) formulation.1 Additionally, for a small subset of subjects
treated in the Phase 2 study who were intolerant to anagrelide IR
(n=5), GALE-401 appears to offer a longer duration on therapy
compared to previous administration of anagrelide IR. Therefore, a
randomized trial comparing GALE-401 vs. anagrelide IR in anagrelide
naïve subjects, alternatively or together with a trial evaluating
anagrelide IR intolerant subjects is warranted.
“The clinical and pharmacokinetic profile of GALE-401 has shown
that by reducing the maximum plasma concentration (Cmax) of
anagrelide with our controlled release version, GALE-401 seems to
confer an improved overall safety profile and potentially offers an
improved tolerability compared to the approved product,” said Bijan
Nejadnik, M.D., Executive Vice President and Chief Medical
Officer. “Overall, in our Phase 2 study, we observed
predominantly mild to moderate toxicities that did not reveal any
unexpected AEs, and we are encouraged by the results as it relates
to patients who were previously intolerant to anagrelide IR who
were able to continue their treatment with GALE-401 for a
meaningful longer duration. Given this data, we plan to meet with
the FDA later this year to discuss the next stages of development
for the asset.”
In the healthy volunteer studies, single and multiple doses of
GALE-401 were safe and well tolerated and there were no clinically
relevant changes in vital signs, electrocardiograms, and safety
laboratory parameters other than a reduction in platelet counts.
The most frequent treatment emergent adverse events reported
included headache, pain in extremities or back, palpitations and
gastrointestinal disturbances. In the Phase 2 MPN trial, patients
treated with GALE-401 exhibited fewer of the more common adverse
events associated with anagrelide IR (cardiac; general;
gastrointestinal; respiratory, thoracic, and mediastinal; skin and
subcutaneous tissue; nervous system). Some of the less common
AEs of anagrelide IR were comparatively more frequent for GALE-401
(vascular; hepatobiliary; blood and lymphatic).
The poster presentation from the conference can be found on
Galena’s website here.
1Source: Verstovsek S, et al. ASH Poster Presentation 2015;
Agrylin® Prescription Information. Additional detail on the
trial can be found in the abstract the on the conference website
here
About GALE-401 (Anagrelide Controlled
Release)
GALE-401 (Anagrelide Controlled Release) contains the active
ingredient anagrelide. 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. Reducing the maximum plasma
concentration (Cmax) is expected to reduce side effects, but
preserve efficacy. GALE-401 is a reformulated, controlled
release version of anagrelide. A Phase 2 pilot study with
GALE-401 has been completed.
About Myeloproliferative Neoplasms
Myeloproliferative neoplasms (MPNs) are a closely related group
of hematological malignancies in which the bone marrow cells that
produce the body's blood cells develop and function abnormally. The
main MPNs are polycythemia vera (PV), chronic myelogenous leukemia
(CML), primary myelofibrosis (PMF), and essential thrombocythemia
(ET), all of which are associated with high platelet counts.
The MPNs are progressive blood cancers that can strike anyone at
any age, and for which there is no known cure.
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company committed
to the development and commercialization of targeted oncology
therapeutics that address major unmet medical needs. Galena’s
development portfolio is focused primarily on addressing the
rapidly growing patient populations of cancer survivors by
harnessing the power of the immune system to prevent cancer
recurrence. The Company’s pipeline consists of multiple mid- to
late-stage clinical assets, including novel cancer immunotherapy
programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax
is currently in a pivotal, Phase 3 breast cancer clinical trial
with several concurrent Phase 2 trials ongoing both as a single
agent and in combination with other therapies. GALE-301 is in a
Phase 2a clinical trial in ovarian and endometrial cancers and in a
Phase 1b given sequentially with 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.
Contact:
Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Mar 2024 to Apr 2024
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Apr 2023 to Apr 2024