Navigation Links
Sorbent Therapeutics Initiates Phase 2b Clinical Trial of CLP-1001 for Treatment of Signs and Symptoms of Fluid Overload in Patients with Heart Failure
Date:4/11/2013

SUNNYVALE, Calif., April 11, 2013 /PRNewswire/ -- Sorbent Therapeutics, Inc., a biopharmaceutical company developing therapies for cardiovascular and renal diseases, today announced that patient dosing has commenced in its Phase 2b clinical trial of CLP-1001.  This trial, known as STEPWISE (a randomized, double-blind, multi-center STudy comparing cross-linkEd Polyelectrolyte (CLP) WIth placebo in HF SubjEcts), is designed to evaluate the safety and efficacy of CLP-1001 in addressing signs and symptoms of fluid overload in patients with congestive heart failure (HF).  CLP-1001 is a novel, non-absorbed oral polymer that acts by binding to and removing excess sodium and fluid in the GI tract independently of the kidneys.

"The objective of the STEPWISE trial is to further understand the magnitude of the effect of CLP-1001 on key measures and clinical endpoints of heart failure-induced congestion compared to current standard of care," said Howard C. Dittrich , M.D., F.A.C.C., Chief Medical Officer of Sorbent.  "Fluid overload in heart failure patients contributes importantly to hospitalizations -- including re-hospitalizations -- slows in-patient recovery, and results in poor quality of life and physical limitations.  Based on the positive clinical benefits observed in our Phase 2a clinical trial, we look forward to advancing CLP-1001 through late-stage registration studies."   

STEPWISE is a double-blind, randomized, placebo-controlled, multicenter, study designed to evaluate CLP-1001 in patients with heart failure.  Approximately 250 patients on stable, optimized, guideline heart failure therapy that have signs and symptoms of current fluid overload after a recent HF-related hospitalization will be randomized to receive 15 grams of CLP-1001 or placebo.  The primary objective of this trial is to assess the change from baseline to eight weeks across several standard measures of patient quality of life and physical functioning, including 6-Minute Walk Test, body weight, Kansas City Cardiomyopathy Questionnaire, NT-pro BNP and time to first occurrence of HF hospitalization, decongestion therapy, or death.  Secondary objectives for the Phase 2b study are to assess the safety and tolerability of CLP-1001 compared with placebo and to evaluate the effects after eight weeks of treatment on dyspnea (Visual Analog Scale), signs of fluid overload, blood pressure, diuretic dose and New York Heart Association (NYHA) classification.

In Sorbent's previous Phase 2a study, among 111 patients with heart failure, CLP-1001 demonstrated improvements of signs and symptoms of fluid retention, including greater weight loss, improved breathing and average distance walked in the 6-Minute Walk Test versus placebo. 

About Heart Failure
Heart failure is a progressive condition in which the heart muscle becomes weakened after injury, most commonly caused by heart attack or high blood pressure, and gradually loses its ability to pump enough blood to supply the body's needs.  Heart failure affects approximately 7.4 million individuals in the United States annually and the prevalence of heart failure is expected to significantly increase over the next decade.  Despite available therapies, heart failure is the most common cause of hospitalizations in patients 65 years and older in the U.S.

About CLP-1001
CLP-1001 is a first-in-class, non-absorbable, superabsorbent cross-linked polyelectrolyte polymer that acts by removing sodium and fluid via the gastrointestinal tract.  There is a significant need for agents other than diuretics to treat fluid overload associated with heart failure.  Each year there are approximately one million hospitalizations plus re-hospitalizations in the US alone due to fluid overload.  A majority of hospital admissions occur in patients already being treated with optimal medical therapy, including diuretics.  CLP-1001 has the potential to provide additional sodium and fluid removal independent of the kidneys, making it an attractive alternative therapy.

About Sorbent
Sorbent Therapeutics is a private biopharmaceutical company developing therapies for patients requiring targeted cation and fluid removal from the body.  The company is focused on the development of non-absorbed polymeric drugs to satisfy unmet clinical needs in large cardiovascular and renal markets such as heart failure, end-stage renal disease, chronic kidney disease and hypertension.  Sorbent is headquartered in Sunnyvale, California.  For more information, visit www.sorbent.com.


'/>"/>
SOURCE Sorbent Therapeutics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sorbent Therapeutics CLP1001 Improves Heart Failure Symptoms In Phase 2 Clinical Study
2. Sorbent Therapeutics Presents CLP1001 Phase 2a Study Results at the 16th Annual Meeting of the Heart Failure Society of America
3. Sorbent Therapeutics Appoints Jason Levin Chief Business Officer
4. CytoSorbents Receives Approximately $400,000 in Non-Dilutive Capital from the Sale of Net Operating Loss Carryovers
5. Cell Therapeutics, Inc. (CTI) to Report First Quarter Financial Results on April 20
6. Faruqi & Faruqi, LLP Encourages Investors Who Suffered Substantial Losses Investing in Chelsea Therapeutics International, Ltd. to Contact the Firm
7. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
8. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
9. Zacks Industry Outlook Highlights: Eli Lilly, Forest Labs, ViroPharma, Novartis and United Therapeutics
10. Oxford BioTherapeutics Appoints Senior Industry Leader to Head its New Clinical Development Operations in Basel, Switzerland
11. Nektar Therapeutics Reports Financial Results for the First Quarter of 2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... 10, 2016 /PRNewswire/ - The President of New Venture ... release of an anti-radiation product from their Research ... in the treatment of cancer using radiation and ... assist in the healing of radiation burns, even ... protect only the healthy cells from radiation damage. ...
(Date:2/10/2016)... , Feb. 10, 2016  Silicon Biosystems ... and products that help uncover the biological complexities ... Biosciences Inc., a developer of innovative technologies for ... co-marketing partnership aimed at enabling translational researchers to ... a couple hundred tumor and normal cells in ...
(Date:2/10/2016)... Fla. , Feb. 9, 2016  Until recently, ... were surgery or liposuction. Thankfully, the FDA approved the ... them to death. Coolsculpting was originally approved in 2010 ... the thighs and now the chin. With this add-on ... Center can use a smaller applicator, the CoolMini, to ...
Breaking Medicine Technology:
(Date:2/10/2016)... PLAINSBORO, N.J. (PRWEB) , ... ... ... J. Hennessy Associates, Inc. , a full-service health care communications company offering ... integrated digital news resource for practitioners and specialists working in infectious diseases. ...
(Date:2/10/2016)... ... February 10, 2016 , ... As part of its ... in February 2016. Each webinar features a dynamic expert and thoughtful presentation to ... athletes, patients and facilities. Both events are free to attend, but registration ...
(Date:2/10/2016)... ... February 10, 2016 , ... Compliancy Group LLC ... of medical professionals throughout the country. The Guard was specifically designed to handle ... procedures, employee training, regulatory updates, and compliance coaching. , In addition to meeting ...
(Date:2/10/2016)... ... 2016 , ... 10 Best Water is excited to announce a ... owners that topped the list as a result of their commitment to offering clients ... was Tibet 5100, a top notch water company that specializes in providing the public ...
(Date:2/10/2016)... ... ... Ongoing news of the ravages of traumatic brain injury (TBI) among former ... takes a closer look at cases of TBI being managed by their members. The ... the aging population, and identifies the challenges associated with their care. , During the ...
Breaking Medicine News(10 mins):