Acceleron & Celgene Announce Interim Clinical Data for Sotatercept in Patients with End Stage Renal Disease on Hemodialysis a...
17 Marzo 2014 - 2:30PM
Business Wire
Sotatercept produces dose dependent increases
in hemoglobin with no dose dependent changes in blood pressure
Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel protein therapeutics for cancer and rare
diseases, today announced that its collaboration partner, Celgene
Corporation, will present interim data from an ongoing phase 2a
study of sotatercept in patients with end stage renal disease
(ESRD) on hemodialysis at the National Kidney Foundation 2014
Spring Clinical Meeting. The meeting will take place on April
22-26, 2014 at the MGM Grand in Las Vegas, NV.
The data to be presented are from an ongoing phase 2a dose
escalation study of sotatercept administered subcutaneously every
28 days to evaluate the pharmacokinetics, safety, tolerability,
efficacy, and pharmacodynamics of sotatercept for the correction of
anemia in patients with ESRD on hemodialysis. Dr. William Smith of
Celgene Corporation, Acceleron’s collaboration partner, will
present interim safety, pharmacokinetic and hemoglobin data from
the first 28-day dose cycle for two dose groups of sotatercept (0.3
mg/kg and 0.5 mg/kg) versus placebo. Following a single dose in the
placebo, sotatercept 0.3 mg/kg and sotatercept 0.5 mg/kg dose
groups, peak mean hemoglobin changes observed in the first 28 days
were 0.1, 0.5 and 0.8 g/dL, respectively. Adverse events were
mostly mild to moderate, unrelated to study drug, and generally
consistent with patients’ medical histories. No dose-dependent
changes in blood pressure were observed.
The data will be presented in a poster presentation on Wednesday
April 23rd from 6:00 - 7:30 PM PST.
About the Phase 2a Clinical Trial
The Phase 2a clinical trial of sotatercept is designed as a
randomized, placebo-controlled single dose and multi-dose, dose
escalation study to evaluate the pharmacokinetics, safety,
efficacy, tolerability and pharmacodynamics of sotatercept for the
correction of anemia in patients with end stage renal disease on
hemodialysis. The first dose group evaluated was a single dose of
0.1 mg/kg of sotatercept administered subcutaneously. Subsequent
dose groups to be studied are 0.3, 0.5 and 0.7 mg/kg administered
subcutaneously once every four weeks for up to eight cycles of
treatment. Each dose group will include up to 12 patients
randomized at a 3:1 ratio to receive either sotatercept or placebo.
The trial is being conducted at sites in the United States and may
enroll up to 56 patients. The primary endpoints are
pharmacokinetics and safety. Celgene has completed enrollment in
the 0.1, 0.3 and 0.5 mg/kg dose groups and is now enrolling
patients in the 0.7 mg/kg dose group. Secondary endpoints in the
study include effects on hemoglobin and serum markers of bone
metabolism. For additional information on this clinical trial,
please visit www.clinicaltrials.gov, identifier NCT01146574.
In December, 2013, Celgene initiated a second phase 2 clinical
trial of sotatercept in patients with end stage renal disease
(ESRD) who are on hemodialysis. This phase 2 clinical trial is
designed as a two-part study to assess the safety and efficacy of
sotatercept as a therapy to treat anemia and potentially to control
the adverse manifestations of chronic kidney disease mineral and
bone disorder (CKD-MBD). Part one of the study will enroll up to 60
patients and part two of the study will enroll up to 230 patients.
For additional information on this clinical trial, please visit
www.clinicaltrials.gov, identifier NCT01999582.
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) is a serious condition
characterized by the progressive loss of kidney function and is
most often caused by diabetes or high blood pressure. CKD is
classified in five stages according to the degree of kidney
impairment. End Stage Renal Disease (ESRD), also known as kidney
failure, is the most advanced stage of CKD and a life-threatening
condition in which patients require a either kidney transplant or
dialysis for survival. Anemia, low levels of red blood cells, is a
common secondary disorder to Chronic Kidney Disease and worsens
with progression of the disease. Disturbance in mineral and bone
metabolism, known as Chronic Kidney Disease Mineral and Bone
Disorder (CKD-MBD), is also a common complication in CKD patients
that affects almost all patients who are on dialysis. CKD-MBD can
lead to bone abnormalities and/or calcification in soft tissue,
especially blood vessels, and is associated with increased
morbidity and mortality in CKD patients.
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 the late stages of
erythropoiesis (red blood cell production). Sotatercept regulates
late-stage erythrocyte (red blood cell) precursor cell
differentiation and maturation. This mechanism of action is
distinct from that of erythropoietin (EPO), which stimulates the
proliferation of early-stage erythrocyte precursor cells. Acceleron
and Celgene are jointly developing sotatercept as part of a global
collaboration. Sotatercept is currently in multiple phase 2
clinical 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 novel
protein therapeutics for cancer and rare diseases. The company is a
leader in understanding the biology of the Transforming Growth
Factor-Beta (TGF-β) protein superfamily, a large and diverse group
of molecules that are key regulators in the growth and repair of
tissues throughout the human body, and in targeting these pathways
to develop important new medicines. Acceleron has built a highly
productive R&D platform that has generated innovative clinical
and preclinical protein therapeutic candidates with novel
mechanisms of action. These protein therapeutic candidates have the
potential to significantly improve clinical outcomes for patients
with cancer and rare diseases.
For more information, please visit www.acceleronpharma.com.
Acceleron PharmaSteven Ertel, 617-649-9234Senior Vice President
and Chief Business OfficerorMedia:Suda Communications LLCMaureen L.
Suda, 585-387-9248
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