Navigation Links
Ocera Therapeutics Presents Data on AST-120 in Patients With Hepatic Encephalopathy at the European Association for the Study of Liver Disease Annual Meeting
Date:4/28/2009

The Company also Initiates the Phase 2b ASTUTE Clinical Trial for Mild Hepatic Encephalopathy

SAN DIEGO, April 28 /PRNewswire/ -- Ocera Therapeutics, Inc., a privately held biopharmaceutical company, announced that data from its phase 2 study of AST-120 for the treatment of patients with low-grade hepatic encephalopathy was presented April 25th at the 44th Annual Meeting of the European Association for the Study of Liver Disease (EASL) in Copenhagen. The study showed that AST-120 was better tolerated than lactulose, the standard of care in this population, with similar overall efficacy. An improvement on neurocognitive measures was also seen with AST-120. Based on these positive data, Ocera has initiated and dosed their first patient in the ASTUTE study, a phase 2b study of AST-120 in patients with mild hepatic encephalopathy (MHE).

The phase 2a study randomly assigned 47 patients with West Haven Scale (WHS) Grade 1-2 hepatic encephalopathy to 4 weeks of treatment with either AST-120 2g sachets (A) QID or lactulose (L) titrated to bowel movements. Forty-one patients were evaluable (n=21 A, 20 L) and 6 were excluded (n=3 L: non-compliance, n=3 A: other causes). Treatment response by WHS at Week 4 was similar between treatment groups (38.1% vs. 35.0%, A vs. L). AST-120 also produced an improvement in neurocognitive measures. A statistically significant reduction in pruritus, a secondary endpoint of the trial, was seen with AST-120 compared to lactulose. Adverse events related to diarrhea (p = 0.04) and flatulence (p = 0.02) were significantly less in patients treated with AST-120.

The improvement seen in neurocognitive measures is consistent with reports that neuropsychometric testing is required to truly measure deficits and detect changes in neurocognitive functioning in the MHE patient population.

"Patients with mild hepatic encephalopathy often don't comply with lactulose therapy because of the side effects," said Paul Pockros, M.D., division head of gastroenterology and hepatology at Scripps Clinic and the principal investigator of the study. "A safe, easily tolerated alternative such as AST-120 would be of great benefit in the management of these patients."

The ASTUTE Trial ("AST-120 Use for the Treatment of Hepatic Encephalopathy") is a Phase 2 multi-site, randomized, double-blind, placebo-controlled 8-week study in up to 150 patients with MHE. Patients will be evaluated on neurocognitive improvement at the end of the study, defined as the change in the global summary score of the RBANS or Repeatable Battery for the Assessment of Neuropsychological Status.

"The ASTUTE trial will use a battery of neuropsychometric tests to assess the efficacy of AST-120 in an MHE population," said Scott Harris, M.D., Ocera's chief medical officer, "Up to 60 percent of patients with cirrhosis have MHE and impaired neurocognitive function, a condition for which no drugs are approved."

About AST-120

AST-120 is a novel microspherical carbon adsorbent with a selective adsorption profile for a variety of unwanted substances in the digestive tract. These substances may be responsible for a number of conditions, including Hepatic Encephalopathy (HE), Irritable Bowel Syndrome (IBS), and pouchitis. They include ammonia, indoles (serotonin, octopamine), histamine, secondary bile acids, advanced glycation endproducts (AGE), and certain bacterial toxins. Ocera licensed the compound from the Kureha Corporation (Japan) in 2005.

About Ocera Therapeutics, Inc.

Ocera Therapeutics, based in San Diego, California, USA, is a privately held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic liver diseases and a broad range of gastrointestinal disorders. In addition to AST-120, Ocera is developing OCR-002 in hepatic encephalopathy due to complications of cirrhosis and acute liver failure. Ocera has raised $62.5 million dollars in venture financing from Domain Associates, Sofinnova Ventures, Thomas, McNerney & Partners, Montagu Newhall and InterWest Partners. Additional information on the company can be found at www.oceratherapeutics.com.


'/>"/>
SOURCE Ocera Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Ocera Therapeutics Announces Positive Results with AST-120 in Pouchitis
2. Ocera Therapeutics Closes $35.5 Million Series C Financing
3. M. Scott Harris, M.D., Joins Ocera Therapeutics, Inc., as Chief Medical Officer
4. Sir Richard Sykes Joins BioCeramic Therapeutics as Chairman
5. Dr Stephan Rietiker Joins BioCeramic Therapeutics
6. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
7. DJO Incorporateds Pending Merger With ReAble Therapeutics Clears U.S. Antitrust Review
8. PeriCor Therapeutics Announces Closing of Licensing Agreement for Acadesine with Schering-Plough Corporation
9. Systems Medicine (SM), a Subsidiary of Cell Therapeutics, Inc. (CTI), Announces Execution of CRADA with NCI/NIH to Develop Potential Cancer Treatments Targeting the Insulin Growth Factor (IGF) Pathway
10. Amsterdam Molecular Therapeutics to Release H1 2007 Results on August 29, 2007
11. Nektar Therapeutics Appoints Tim Harkness as Chief Financial Officer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample tracking software ... State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. , ... Tremblay, President and COO of STACS DNA. “In further expanding our capacity as a ...
(Date:6/23/2016)... 2016 Apellis Pharmaceuticals, Inc. today announced ... of its complement C3 inhibitor, APL-2. The trials ... dose studies designed to assess the safety, tolerability, ... in healthy adult volunteers. Forty subjects ... single dose (ranging from 45 to 1,440mg) or ...
(Date:6/23/2016)... Andrew D Zelenetz ... Published recently in Oncology ... touchONCOLOGY, Andrew D Zelenetz , discusses the ... is placing an increasing burden on healthcare systems ... With the patents on many biologics expiring, interest ...
(Date:6/23/2016)... CA (PRWEB) , ... June 23, 2016 , ... ... software, is exhibiting at the Pennsylvania Convention Center and will showcase its product’s ... conference. ClinCapture will also be presenting a scientific poster on Disrupting Clinical Trials ...
Breaking Biology Technology:
(Date:6/15/2016)... , June 15, 2016 ... report titled "Gesture Recognition Market by Application Market - Global Industry ... - 2024". According to the report, the  global gesture ... in 2015 and is estimated to grow at ... billion by 2024.  Increasing application of ...
(Date:6/2/2016)... , June 2, 2016 The Department ... has awarded the 44 million US Dollar project, for the ... Vehicle Plates including Personalization, Enrolment, and IT Infrastructure , ... in the production and implementation of Identity Management Solutions. Numerous ... however Decatur was selected for the ...
(Date:5/20/2016)... -- VoiceIt is excited to announce its new marketing ... working together, VoiceIt and VoicePass will offer an ... slightly different approaches to voice biometrics, collaboration between ... Both companies ... "This marketing and technology partnership allows VoiceIt ...
Breaking Biology News(10 mins):