Acceleron Pharma Inc. (Nasdaq:XLRN) today announced that the
presentations of the MEDALIST and BELIEVE Phase 3 trial results of
luspatercept in patients with lower-risk myelodysplastic syndromes
(MDS) and beta-thalassemia associated anemias, respectively, were
selected for “Best of ASH” by the American Society of Hematology at
its 60th Annual Meeting & Exposition in San Diego. Luspatercept
is an investigational therapy that is part of a global
collaboration between Acceleron and Celgene.
The Society describes its “Best of ASH” selections, chosen from
among the thousands of meeting abstracts, as “the biggest
breakthroughs from the meeting's scientific presentations.”
“Having both the MEDALIST and BELIEVE trials included in the
Best of ASH session at the close of the annual meeting is
extraordinarily gratifying,” said Habib Dable, President and Chief
Executive Officer of Acceleron. “Throughout its development,
luspatercept has demonstrated promising results in patients with
these two distinct diseases associated with anemia. Yesterday’s
event is a clear indication that the global hematology community
recognizes the potential clinical impact of luspatercept.”
The full titles of the trials highlighted during the Best of ASH
session are as follows:
‘MEDALIST’ trial presentation
Title: The MEDALIST Trial: Results of a Phase 3, Randomized,
Double-Blind, Placebo-Controlled Study of Luspatercept to Treat
Anemia in Patients with Very Low-, Low-, or Intermediate-Risk
Myelodysplastic Syndromes (MDS) with Ring Sideroblasts (RS) who
Require Red Blood Cell (RBC) Transfusions (Plenary Scientific
Session, Abstract #1)
‘BELIEVE’ trial presentation
Title: The BELIEVE Trial: Results of a Phase 3, Randomized,
Double-Blind, Placebo-Controlled, Study of Luspatercept in Adults
Who Require Regular Red Blood Cell (RBC) Transfusions Due to
β-Thalassemia (Abstract #163)
Luspatercept is an investigational therapy that is not approved
for any use in any country. Celgene and Acceleron are planning
regulatory application submissions of luspatercept in the
United States and Europe in the first half of
2019.
About Luspatercept
Luspatercept is a first-in-class erythroid maturation agent
(EMA) that is believed to regulate late-stage red blood cell
maturation. Acceleron and Celgene are jointly developing
luspatercept as part of a global collaboration. In addition to the
Phase 3 MEDALIST and BELIEVE studies reported at ASH, luspatercept
is being evaluated in multiple other clinical trials. The Phase 3
COMMANDS trial was recently initiated in first-line, lower-risk,
MDS patient population. The BEYOND Phase 2 trial in
non-transfusion-dependent beta-thalassemia and a Phase 2 trial in
myelofibrosis are ongoing. For more information, please visit
www.clinicaltrials.gov.
About MDS
Patients with lower-risk MDS suffer from insufficient production
of red blood cells, resulting in chronic anemia that can lead to
debilitating fatigue, diminished quality of life and increased
mortality. Many patients with lower-risk MDS-related chronic anemia
require frequent red blood cell transfusions.
About Beta-Thalassemia
Beta-thalassemia is caused by a genetic defect in the production
of hemoglobin, a protein that carries oxygen to red blood cells
throughout the body. Patients suffer from severe, chronic anemia
and often experience fatigue, organ enlargement, and bone
complications. Patients require lifelong therapy that includes
frequent red blood cell transfusions and treatment of the
consequent iron overload.
About Acceleron
Acceleron is a Cambridge-based, clinical-stage biopharmaceutical
company dedicated to the discovery, development, and
commercialization of therapeutics to treat serious and rare
diseases. The Company's leadership in the understanding of TGF-beta
biology and protein engineering generates innovative compounds that
engage the body's ability to regulate cellular growth and
repair.
Acceleron focuses its research and development efforts in
hematologic, neuromuscular, and pulmonary diseases. In hematology,
the Company and its global collaboration partner, Celgene, are
developing luspatercept for the treatment of chronic anemia in
myelodysplastic syndromes, beta-thalassemia, and myelofibrosis.
Acceleron is also advancing its neuromuscular franchise with two
distinct Myostatin+ agents, ACE-083 and ACE-2494, and a Phase 2
pulmonary program with sotatercept in pulmonary arterial
hypertension.
For more information, please visit www.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 of Acceleron’s compounds, the
timeline for clinical development and regulatory approval of
Acceleron’s compounds and the expected timing for reporting of data
from ongoing clinical trials. 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 risks and
uncertainties, including, but not limited to, that preclinical
testing of Acceleron’s compounds and data from clinical trials may
not be predictive of the results or success of ongoing or later
clinical trials, that the development of Acceleron’s compounds will
take longer and/or cost more than planned, that Acceleron or its
collaboration partner, Celgene, will be unable to successfully
complete the clinical development of Acceleron’s compounds, that
the Company or Celgene 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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181205005841/en/
Acceleron Pharma Inc.Todd James, IRC, (617) 649-9393Vice
President, Investor Relations and Corporate CommunicationsorCandice
Ellis, (617) 649-9226Manager, Investor RelationsorMedia:Matt
Fearer, (617) 301-9557Director, Corporate Communications
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