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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

al 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 patie
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