- Preliminary results show that treatment with
investigational drug sotatercept can increase hemoglobin and
achieve transfusion independence in patients with myelofibrosis
-
- Acceleron to host conference call and live
webcast on Monday, December 5th at 9:00 a.m. EST (6:00 a.m. PST)
-
Acceleron Pharma Inc. (NASDAQ:XLRN) and Celgene Corporation
(NASDAQ:CELG), today announced preliminary results from an ongoing
investigator initiated Phase 2 study with investigational drug
sotatercept in patients with myelofibrosis at the 58th Annual
Meeting of the American Society of Hematology (ASH) in San Diego,
California. Sotatercept is being developed as part of the global
collaboration between Acceleron and Celgene.
“These initial and encouraging data support our efforts for
further clinical development work with our Acceleron-partnered
programs in myelofibrosis,” said Michael Pehl, President,
Hematology and Oncology for Celgene. “We believe these programs
have the potential to address a major unmet need in patients with
myelofibrosis.”
Highlights of the Sotatercept Myelofibrosis Phase 2 Data
Presented at ASH
Results
- 19 patients were enrolled and treated
with sotatercept (12 patients at 0.75 mg/kg and 7 at 1 mg/kg) and
14 of these patients have received at least 5 doses of sotatercept
and are evaluable for response
- 36% (5/14) of the evaluable patients
achieved an anemia response, defined as a composite of
RBC-transfusion-independence and hemoglobin response (increase of
≥1.5 g/dL from baseline on every determination consecutively over
≥84 days without RBC transfusions).
Overall Safety
- Most adverse events were grades 1 or
2.
- Adverse events at least possibly
related to study drug that occurred include grade 3 hypertension
leading to discontinuation, grade 1 myalgia, bone pain, pain in
extremity and injection site reaction.
- 13 patients have discontinued from the
study: 5 due to no response, 2 proceeded to stem cell
transplantation, 2 had MF progression, 1 transformed to AML, 1 each
withdrew consent, had unrelated medical problems and
hypertension
Sotatercept is an investigational product that is not approved
for use in any country.
Acceleron ASH Conference Call Information
Acceleron will host a conference call and live webcast to
discuss data presented at the ASH meeting on December 5, 2016, at
9:00 a.m. EST (6:00 a.m. PST). To participate by teleconference,
please dial 877-312-5848 (domestic) or 253-237-1155 (international)
and refer to the Acceleron ASH Review.
To access the live webcast, please select “Events &
Presentations” in the Investors section on Acceleron’s website
(www.acceleronpharma.com) at least 10 minutes beforehand to ensure
time for any downloads that may be required.
An archived webcast recording will be available on the Acceleron
website beginning approximately two hours after the event.
About the Phase 2 Study
Data were presented from an ongoing investigator sponsored Phase
2 study of sotatercept in subjects with myelofibrosis at the
conference. Subjects enrolled were red blood cell (RBC)
transfusion-dependent, have hemoglobin <10 g/dL on every
determination during the 84 days preceding study entry without RBC
transfusions, or have hemoglobin <10 g/dL despite intermittent
RBC transfusions without fulfilling the criteria for transfusion
dependence. Patients received open-label sotatercept at 0.75 mg/kg
or 1 mg/kg, dosed subcutaneously once every three weeks.
The primary outcome measures for the study include anemia
response and safety. Anemia response is a composite of
RBC-transfusion-independence and hemoglobin response (increase of
≥1.5 g/dL from baseline on every determination consecutively over
≥84 days without RBC transfusions). Subjects must have received ≥5
cycles of sotatercept to be evaluable for response.
About Sotatercept
Sotatercept is an activin receptor type IIA fusion protein that
acts as a ligand trap for members in the Transforming Growth
Factor-Beta (TGF-β) superfamily involved in fibrosis and late stage
erythropoiesis (red blood cell production). Acceleron and Celgene
are jointly developing sotatercept as part of a global
collaboration. Sotatercept is currently in multiple Phase 2
investigator initiated trials. 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. This
approach to drug discovery has generated four therapeutic
candidates that are currently in clinical trials. 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 Corp. Acceleron is also advancing clinical
programs in the fields of oncology and neuromuscular diseases 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.
About Celgene
Celgene Corporation, headquartered in Summit, New
Jersey, is an integrated global biopharmaceutical company engaged
primarily in the discovery, development and commercialization of
innovative therapies for the treatment of cancer and inflammatory
diseases through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow
Celgene on Social
Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.
Forward-Looking Statements
Acceleron:
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements about
Acceleron's strategy, future plans and prospects, including
statements regarding the development of sotatercept, the timeline
for clinical development and regulatory approval of Acceleron’s
compounds, the expected timing for the reporting of data from
ongoing trials, and the structure of Acceleron’s planned or pending
clinical trials. The words "anticipate," "appear," "believe,"
"continue," "could," "estimate," "expect," "forecast," "goal,"
"intend," "may," "plan," "potential," "predict," "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.
Each forward-looking statement is subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied in such statement. Applicable risks
and uncertainties include the risks 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 data may not be available when Acceleron expects it to
be, that Acceleron or its collaboration partner, Celgene, will be
unable to successfully complete the clinical development of
Acceleron’s compounds, that the development of Acceleron’s
compounds will take longer or cost more than planned, that
Acceleron or Celgene may be delayed in initiating or completing any
clinical trials, and that Acceleron's compounds will not receive
regulatory approval or become commercially successful products.
Other risks and uncertainties include those identified under the
heading "Risk Factors" included in Acceleron's Annual Report on
Form 10-K which was filed with the Securities and Exchange
Commission (SEC) on February 25, 2016, 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 reflect
Acceleron’s current views with respect to future events, and
Acceleron does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
Celgene:
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those regarding the
potential benefits of, and plans relating to the collaboration
between Acceleron and Celgene; the potential of luspatercept as a
therapeutic drug; and the benefit of each company’s strategic plans
and focus. The words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “would,” “could,”
“potential,” “possible,” “hope” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such
statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from current expectations and beliefs. For example,
there can be no guarantee that any product candidate will be
successfully developed or complete necessary preclinical and
clinical phases, or that development of any of product candidates
will successfully continue. There can be no guarantee that any
positive developments will result in stock price appreciation.
Management's expectations and, therefore, any forward-looking
statements in this press release could also be affected by risks
and uncertainties relating to a number of other important factors,
including: results of clinical trials and preclinical studies,
including subsequent analysis of existing data and new data
received from ongoing and future studies; the content and timing of
decisions made by the U.S. FDA and other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies; the ability to obtain and maintain
requisite regulatory approvals and to enroll patients in planned
clinical trials; unplanned cash requirements and expenditures;
competitive factors; the ability to obtain, maintain and enforce
patent and other intellectual property protection for any product
candidates ; the ability to maintain key collaborations; and
general economic and market conditions. These and other risks are
described in greater detail under the caption "Risk Factors"
included in each company’s public filings with the Securities and
Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof, and neither
company has any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required by law.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161205005432/en/
For Acceleron:Investors:Todd James,
IRC, 617-649-9393Senior Director, Investor Relations and Corporate
CommunicationsorMedia:BMC Communications LLCBrad Miles,
917-570-7340orFor
Celgene:Investors:908-673-9628investors@celgene.comorMedia:908-673-2275media@celgene.com
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