Acceleron Announces Publication of Luspatercept Phase 2 Myelodysplastic Syndromes Study Results in The Lancet Oncology
05 Septiembre 2017 - 6:00AM
Business Wire
Acceleron Pharma Inc. (NASDAQ: XLRN), a clinical stage
biopharmaceutical company focused on the discovery, development and
commercialization of innovative therapeutics to treat serious and
rare diseases, announced that The Lancet Oncology has published
results from the Phase 2 study of luspatercept in patients with
lower-risk myelodysplastic syndromes (MDS).
“The efficacy and safety results in this Phase 2 study support
continued research into luspatercept for the treatment of
refractory anemia which often requires red blood cell transfusions
in lower-risk MDS patients,” said Uwe Platzbecker, M.D., Professor
of Hematology and Head of the MDS program at the University
Hospital in Dresden, Germany. “This novel investigational
therapy has the potential to address a significant need in MDS
patients who currently have very limited options for managing
chronic anemia. We have already begun exploring luspatercept’s
activity across a range of MDS patient populations.”
“We are pleased that The Lancet Oncology chose to publish these
results,” said Matthew Sherman, M.D., Chief Medical Officer of
Acceleron. “The positive clinical activity demonstrated in
this study informed our earlier decision to initiate the pivotal
MEDALIST Phase 3 trial in lower-risk MDS, and we expect to report
top-line results from this trial in mid-2018.”
The article, entitled “Luspatercept for the treatment of anaemia
in patients with lower-risk myelodysplastic syndromes: a phase 2
dose-finding study with long-term extension study” is now available
online and will be published in a future print issue of The Lancet
Oncology. The journal also published online a companion Comment
article, “Defeating anaemia in myelodysplastic syndromes: another
step forward,” by Valeria Santini, M.D., Associate Professor of
Hematology at the University of Florence Medical School in
Florence, Italy.
Phase 2 presentations of luspatercept in MDS presented at recent
medical conferences include updated longer-term follow-up and new
expansion cohort preliminary results beyond that incorporated in
this publication. Presentations outlining these results are
available online under the science page on the Company’s website at
www.acceleronpharma.com.
The MEDALIST trial, a global Phase 3 study of luspatercept in
lower-risk MDS patients, is fully enrolled and top-line results are
expected in mid-2018. The MEDALIST trial enrolled patients who are
ring sideroblast-positive, red blood cell transfusion dependent,
and are erythropoiesis-stimulating agent (ESA)-refractory or
ESA-treatment ineligible, based on erythropoietin levels greater
than 200 units per liter at baseline. In early 2018, Acceleron and
Celgene plan to initiate the COMMANDS Phase 3 trial in first-line,
lower-risk MDS patients.
Luspatercept is an investigational product that is not approved
for use in any country.
About Luspatercept
Luspatercept is a modified activin receptor type IIB fusion
protein that acts as a ligand trap for members of the transforming
growth factor-beta superfamily involved in the late stages of
erythropoiesis (red blood cell production). Luspatercept regulates
late-stage erythrocyte (red blood cell) precursor cell
differentiation and maturation. This mechanism of action is
distinct from that of erythropoiesis stimulating agents (ESAs),
which stimulate the proliferation of early-stage erythrocyte
precursor cells. Acceleron and Celgene are jointly developing
luspatercept as part of a global collaboration. Phase 3 clinical
trials are underway to evaluate the safety and efficacy of
luspatercept in patients with myelodysplastic syndromes (the
MEDALIST study) and in patients with beta-thalassemia (the BELIEVE
study). For more information, please visit
www.clinicaltrials.gov.
About Acceleron
Acceleron is a clinical stage biopharmaceutical company focused
on the discovery, development and commercialization of innovative
therapeutics to treat serious and rare diseases. Its pioneering
research platform leverages the powerful biology behind the body’s
ability to rebuild and repair its own cells and tissues. The
Company’s lead therapeutic candidate, luspatercept, is being
evaluated in Phase 3 studies for the treatment of the hematologic
diseases myelodysplastic syndromes (MDS) and beta-thalassemia under
a global partnership with Celgene. Acceleron is also advancing its
ACE-083 clinical program in the field of neuromuscular disease, and
has a comprehensive preclinical research effort targeting fibrotic
and other serious diseases.
For more information, please
visit www.acceleronpharma.com/. Follow Acceleron on Social
Media: @AcceleronPharma and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements about the
Company's strategy, future plans and prospects, including
statements regarding the development of the Company's compounds,
the timeline for clinical development and regulatory approval of
the Company’s compounds and the expected timing for reporting of
data from ongoing clinical trials. The words "anticipate,"
"believe," "could," "estimate," "expect," "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 the Company'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 the Company's compounds
will take longer and/or cost more than planned, that the Company or
its collaboration partner, Celgene, will be unable to successfully
complete the clinical development of the Company’s compounds, that
the Company or Celgene may be delayed in initiating, enrolling or
completing any clinical trials, and that the Company'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 the
Company's most recent Annual Report on Form 10-K, and other filings
that the Company 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 the
Company does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
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Acceleron Pharma Inc.Todd James, IRC, 617-649-9393Vice
President, Investor Relations and Corporate CommunicationsOrCandice
Ellis, 617-649-9226Manager, Investor Relations and Corporate
CommunicationsOrMedia:BMC CommunicationsBrad Miles,
646-513-3125
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