– Data analyses from the Phase 3 MEDALIST and
BELIEVE trials find treatment with luspatercept maintains
health-related quality of life in patients with lower-risk
myelodysplastic syndromes and transfusion-dependent
beta-thalassemia, respectively –
– Longitudinal analyses from the BELIEVE trial
show reductions in red blood cell transfusions and iron chelation
therapy in luspatercept-treated patients –
– Longer-term update from Phase 2 trial finds
durable response to luspatercept treatment in patients with
myelofibrosis-associated anemia –
Acceleron Pharma Inc. (Nasdaq: XLRN), a leading
biopharmaceutical company in the discovery, development, and
commercialization of TGF-beta superfamily therapeutics to treat
serious and rare diseases, announced today that data from six
clinical abstracts on REBLOZYL (luspatercept-aamt) will be
presented at the 62nd American Society of Hematology (ASH) Annual
Meeting & Exposition held virtually December 5-8, 2020.
The ASH presentations include updates from the Phase 3
placebo-controlled MEDALIST and BELIEVE trials assessing the safety
and efficacy of luspatercept treatment in patients with lower-risk
myelodysplastic syndromes (MDS) and in patients with
transfusion-dependent beta-thalassemia, respectively. Among the
results to be presented are improvements in certain health-related
quality of life measures for luspatercept-treated patients in both
trials as well as longitudinal trends of red blood cell transfusion
reductions and reductions of iron chelation therapy in BELIEVE
trial participants.
Key Presentations
- Title: Health-Related Quality of Life Outcomes for Patients
with Transfusion-Dependent Beta-Thalassemia Treated with
Luspatercept in the BELIEVE Trial Oral Presentation Presenter:
Maria Domenica Cappellini, MD Session 904. Outcomes
Research—Non-Malignant Conditions
- Title: Health-Related Quality of Life Outcomes in Patients
with Myelodysplastic Syndromes with Ring Sideroblasts Treated with
Luspatercept in the MEDALIST Study Moderated Digital Poster
Presentation Presenter: Esther Natalie Oliva, MD Session 903.
Health Services Research—Malignant Conditions (Myeloid
Disease)
- Title: Longitudinal Effect of Luspatercept Treatment on Iron
Overload and Iron Chelation Therapy in Adult Patients with
Beta-Thalassemia in the BELIEVE Trial Moderated Digital Poster
Presentation Presenter: Olivier Hermine, MD, PhD Session 112.
Thalassemia and Globin Gene Regulation
- Title: Sustained Reductions in Red Blood Cell (RBC)
Transfusion Burden and Events in Beta-Thalassemia with
Luspatercept: Longitudinal Results of the BELIEVE Trial
Moderated Digital Poster Presentation Presenter: Ali T. Taher, MD,
PhD Session 112. Thalassemia and Globin Gene Regulation
Additional Presentations
- Title: Efficacy and Safety of Luspatercept Treatment in
Patients with Myelodysplastic Syndrome/ Myeloproliferative Neoplasm
with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): A
Retrospective Analysis from the MEDALIST Study Moderated
Digital Poster Presentation Presenter: Rami S. Komrokji, MD Session
637. Myelodysplastic Syndromes—Clinical Studies
- Title: Duration of Response to Luspatercept in Patients
Requiring Red Blood Cell (RBC) Transfusions with Myelofibrosis (MF)
– Updated Data from the Phase 2 ACE-536-MF-001 Study Moderated
Digital Poster Presentation Presenter: Aaron T. Gerds, MD Session
634. Myeloproliferative Syndromes: Clinical
The clinical abstracts can be found on the ASH Annual Meeting
website (http://www.hematology.org/Annual-Meeting/Abstracts/).
The REBLOZYL ASH presentations, which will include additional
information beyond the abstracts, will be posted to the
“Publications” page under the “Science & Pipeline” section in
the “Science” section on the Company’s website,
www.acceleronpharma.com, following the conference.
About REBLOZYL® (luspatercept-aamt)
REBLOZYL (luspatercept-aamt), a first-in-class erythroid
maturation agent, promotes late-stage red blood cell maturation in
animal models. Bristol Myers Squibb and Acceleron are jointly
developing REBLOZYL as part of a global collaboration. REBLOZYL is
currently approved in the U.S. for the treatment of:
- anemia in adult patients with beta-thalassemia who require
regular red blood cell transfusions, and
- anemia failing an erythropoiesis stimulating agent and
requiring 2 or more red blood cell units over 8 weeks in adult
patients with very low- to intermediate-risk myelodysplastic
syndromes with ring sideroblasts (MDS-RS) or with
myelodysplastic/myeloproliferative neoplasm with ring sideroblasts
and thrombocytosis (MDS/MPN-RS-T).
In Europe, REBLOZYL is approved for the treatment of:
- Adult patients with transfusion-dependent anemia due to very
low-, low- and intermediate-risk myelodysplastic syndromes (MDS)
with ring sideroblasts, who had an unsatisfactory response or are
ineligible for erythropoietin-based therapy.
- Adult patients with transfusion-dependent anemia associated
with beta-thalassemia.
In Canada, REBLOZYL is approved for the treatment of adult
patients with red blood cell (RBC) transfusion-dependent anemia
associated with beta-thalassemia.
REBLOZYL is not indicated for use as a substitute for red blood
cell transfusions in patients who require immediate correction of
anemia.
About Acceleron
Acceleron is a biopharmaceutical company dedicated to the
discovery, development, and commercialization of therapeutics to
treat serious and rare diseases. Acceleron’s leadership in the
understanding of TGF-beta superfamily biology and protein
engineering generates innovative compounds that engage the body's
ability to regulate cellular growth and repair.
Acceleron focuses its commercialization, research, and
development efforts in hematologic and pulmonary diseases. In
hematology, REBLOZYL® (luspatercept-aamt) is the first and only
erythroid maturation agent approved in the United States, Europe,
and Canada for the treatment of anemia in certain blood disorders.
REBLOZYL is part of a global collaboration partnership with Bristol
Myers Squibb. The Companies co-promote REBLOZYL in North America
and are also developing luspatercept for the treatment of anemia in
patient populations of MDS, beta-thalassemia, and myelofibrosis. In
pulmonary, Acceleron is developing sotatercept for the treatment of
pulmonary arterial hypertension (PAH), having recently presented
positive topline results of the PULSAR Phase 2 trial. The Company
is currently planning multiple Phase 3 trials with the potential to
support its long-term vision of establishing sotatercept as a
backbone therapy for patients with PAH at all stages of the
disease.
For more information, please visit acceleronpharma.com. Follow
Acceleron on social media: @AcceleronPharma and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements about
Acceleron’s strategy, future plans and prospects, including
statements regarding the development and commercialization of
Acceleron’s compounds, the timeline for clinical development and
regulatory approval of Acceleron’s compounds, the expected timing
for reporting of data from ongoing clinical trials, and the
potential of Reblozyl® (luspatercept-aamt) as a therapeutic drug.
The words "anticipate," "believe," "could," "estimate," "expect,"
"goal," "intend," "may," "plan," "potential," "project," "should,"
"target," "will," "would," and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to, that the results of
any clinical trials may not be predictive of the results or success
of other clinical trials, that regulatory approval of Acceleron’s
compounds in one indication or country may not be predictive of
approval in another indication or country, that the development of
Acceleron’s compounds will take longer and/or cost more than
planned, that Acceleron or its collaboration partner, Bristol Myers
Squibb Company will be unable to successfully complete the clinical
development of Acceleron’s compounds, that Acceleron or Bristol
Myers Squibb may be delayed in initiating, enrolling or completing
any clinical trials, and that Acceleron’s compounds will not
receive regulatory approval or become commercially successful
products. These and other risks and uncertainties are identified
under the heading “Risk Factors” included in Acceleron’s most
recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q,
and other filings that Acceleron has made and may make with the SEC
in the future.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Acceleron does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201104005596/en/
Investors: Jamie Bernard, IRC, 617-649-9650 Associate Director,
Investor Relations
Media: Matt Fearer, 617-301-9557 Director, Corporate
Communications
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