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Sorbent Therapeutics' CLP1001 Improves Heart Failure Symptoms In Phase 2 Clinical Study
Date:5/22/2012

SUNNYVALE, Calif. and BELGRADE, Serbia, May 22, 2012 /PRNewswire/ -- Sorbent Therapeutics, Inc. a biopharmaceutical company developing therapies for cardiovascular and renal diseases, presented positive data from its Phase 2a clinical study of CLP1001.  In the study of 111 heart failure patients with chronic kidney disease, CLP1001 demonstrated improvement in heart failure symptoms as compared to placebo.   

Data from the randomized, double-blind Phase 2a study were presented in an oral session at the Annual European Society of Cardiology Heart Failure Congress 2012 in Belgrade, Serbia.  A manuscript detailing the results of the Phase 2a clinical study, titled "A Double-Blind, Randomized, Parallel, Placebo Controlled Study Examining the Effect of Cross-linked Polyelectrolyte (CLP) in Heart Failure Patients with Chronic Kidney Disease," will be published in the June 2012 issue of the European Journal of Heart Failure.

"Addressing the symptoms of heart failure is critically important to patients' quality of life.  The beneficial effects of CLP1001 represent a meaningful improvement in heart failure signs and symptoms in a difficult-to-treat patient population," said Maria Rosa Costanzo, M.D., F.A.C.C., Medical Director of the Edward Center for Advanced Heart Failure in Naperville, Illinois and member of Sorbent's Medical Advisory Board.  "I am excited by the data obtained from this trial and look forward to CLP1001's continued clinical development in heart failure."

"Despite available therapies, heart failure is the most common cause of hospitalizations in patients 65 years and older in the U.S.  The positive findings from this Phase 2a clinical study of CLP1001 are highly promising with regard to reducing fluid retention and shortness of breath, which are considered critical measures of success in the treatment of heart failure patients," said Howard C. Dittrich, M.D., F.A.C.C., Sorbent's Chief Medical Officer.  "CLP1001 could ultimately be used alongside standard medications to improve the physical functionality and overall quality of life of these heart failure patients."

About the Phase 2a Study
The double-blind, randomized, parallel, placebo-controlled study examined the effect of CLP1001 over eight weeks in 111 heart failure patients with chronic kidney disease (CKD). 

CLP1001-treated patients achieved significantly greater weight loss – an accepted measurement of fluid retention – as compared to placebo over the first two weeks of treatment.  This trend continued through the end of the study.  After eight weeks of treatment, a greater number of patients experienced marked or moderately improved breathing in the CLP1001 group and the average distance walked in the 6-Minute Walk Test was larger in patients receiving CLP1001 versus the placebo population.  CLP1001 improved functional heart capacity as assessed by the New York Heart Association (NYHA) classification by at least one class compared to the placebo group (48.8% vs. 17.4%; p=0.002).  Similar results favoring the CLP1001 group were seen when examining quality of life.

These data were presented by Dr. Costanzo during the Late-Breaking Trials 2 Special Session at the ESC Heart Failure Congress in a talk titled "A Double-Blind, Randomized, Parallel, Placebo Controlled Study Examining the Effect of Cross-linked Polyelectrolyte (CLP) in Heart Failure Patients with Chronic Kidney Disease – Sorbent  CTST-21." 

About Heart Failure
Heart failure is a progressive condition in which the heart muscle becomes weakened after it is injured, most commonly from heart attack or high blood pressure, and gradually loses its ability to pump enough blood to supply the body's needs.  Many people are not aware they have heart failure because the symptoms are often mistaken for signs of getting older.  Heart failure affects approximately 5.8 million individuals in the United States annually.  Demographic and clinical evidence strongly suggests that the prevalence of heart failure will increase throughout the next decade.  Ten to fifteen years ago heart failure was considered a "death sentence"; however, recent advances in treatment have shown that early diagnosis and proper care in early stages of the condition are key to slowing, stopping or in some cases reversing progression, improving quality of life, and extending life expectancy.

About CLP1001
CLP1001 is a non-absorbable, super-absorbent cross-linked polyelectrolyte polymer that acts by removing sodium and fluid along 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.  CLP1001 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.


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