Navigation Links
Ocera Therapeutics Announces Positive Results with AST-120 in Pouchitis
Date:10/15/2007

- Data Presented at the American College of Gastroenterology Annual

Scientific Meeting -

PHILADELPHIA, Oct. 15 /PRNewswire/ -- Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases announced today that data from the first cohort of patients from an exploratory Phase 2 study evaluating the efficacy and safety of AST-120 in patients with active pouchitis was presented in a poster presentation at the American College of Gastroenterology Annual Scientific Meeting.

"A four-week treatment with AST-120 in patients with active pouchitis led to a significant decrease in symptoms of pouchitis and endoscopy scores in the first ten patients enrolled in the study," said Dr. Bo Shen, principal investigator at the Center for Inflammatory Bowel Disease, Cleveland Clinic. "These results were impressive with 44.4% of the patients achieving clinical remission and 55.6% achieving a clinical response."

"These promising results warrant the further evaluation of AST-120 for the treatment of pouchitis in controlled randomized studies," added Laurent Fischer, M.D. president and CEO of Ocera Therapeutics. "We are encouraged by these findings which further support our strategy of exploring AST-120 as a platform drug with the potential to address multiple gastrointestinal and liver diseases."

Patients who suffer from Ulcerative Colitis often require a resection of the colon to reduce the risk of cancer. A J-pouch is created to collect stools and the pouch often becomes inflamed, a condition known as pouchitis, which is associated with diarrhea, abdominal cramps, fever and dehydration. Pouchitis occurs in up to 40% of patients with a J-pouch and there are no treatments currently approved for this indication. An estimated 80,000 patients in the United States suffer from this condition, which qualifies as Orphan Drug. The current standard of care for pouchitis includes treatment with antibiotics such as ciprofloxacin and metronidazole and relapse is common.

In vitro adsorption studies have demonstrated that AST-120 has a high adsorption capacity for bile acids and bacterial toxins and is expected to protect the intestinal mucosa of the pouch from inflammation.

AST-120 was in-licensed from Kureha Corporation, Japan in 2005. Ocera announced last week that it completed enrollment in FHAST1, the Fistula Healing with AST-120 Phase 3 pivotal trial in Crohn's disease conducted in North America, Europe and Israel. Ocera also recently initiated proof-of-concept trials with AST-120 in Irritable Bowel Syndrome and Hepatic Encephalopathy.

About the Pouchitis Phase 2 Study

The proof-of-concept study conducted under investigator IND at Cleveland Clinic is evaluating 20 patients with active pouchitis treated with open label AST-120, 2 grams tid. The Primary efficacy endpoint is remission as defined by a Pouchitis Disease Activity Index (PDAI) less than 7 points which includes clinical, endoscopy and histology scores. Secondary endpoints include safety, clinical response measured by a decrease of PDAI of a least three points and Global Quality of Life score.

About Ocera Therapeutics, Inc.

Ocera Therapeutics, Inc. is a privately-held biopharmaceutical company focused on the licensing, development and commercialization of proprietary compounds to treat a broad range of gastrointestinal and liver diseases. Ocera Therapeutics is based in San Diego and is pursuing the development of AST-120 in Crohn's disease and other gastrointestinal and liver diseases including Pouchitis, Hepatic Encephalopathy, Irritable Bowel Syndrome and Proton Pump Inhibitor-resistant Gastroesophageal Reflux Disease. Ocera Therapeutics has raised $26.5 million dollars in venture financing from Domain Associates, Sofinnova Ventures and Thomas, McNerney & Partners. Additional information on the Company can be found at http://www.oceratherapeutics.com.

For more information on Pouchitis and Inflammatory Bowel Diseases, visit the Crohn's and Colitis Foundation of America website as http://www.ccfa.org.


'/>"/>
SOURCE Ocera Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Canadian firm buys Proventiv Therapeutics, makes ex-Bone Care exec CEO
2. Speaker announces business members of IT Task Force
3. Doyle announces technology tax credits for Berbee
4. Doyle announces new energy, global warming policies
5. Doyle announces $80M renewable energy strategy
6. GE announces first installation of Discovery VCT
7. UWM announces winners of RGI awards
8. Third Wave announces two senior management appointments
9. Mirus announces new method for making antibodies
10. Merge announces sofware updates, upcoming acquisition
11. Small Tree announces ethernet solution for Apple Xserv G5
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... 11, 2016  Wellcentive today announced it has ... Oregon -based community care organization (CCO) with ... analytics, quality reporting and care management solutions and ... team of quality managers, analysts and care managers ... groups serving FamilyCare members. ...
(Date:2/11/2016)... Feb. 11, 2016  Dovetail Genomics™ LLC today announced ... program for a planned metagenomic genome assembly service. ... metagenomic genome assembly method in a talk on Friday, ... & Technology conference in Orlando, Fla. ... complex datasets is difficult. Using its proprietary ...
(Date:2/11/2016)... --  BioInformant announces the February 2016 release of ... Tools, and Technologies – Market Size, Segments, Trends, and ... The first and only market research ... has more than a decade of historical information on ... cell type. This powerful 175 page global strategic report ...
(Date:2/11/2016)... ... , ... Global Stem Cells Group, a world ... Cells Network (GSCN) to distribute exosome injection and other biological products to stem ... Dominican Republic, Colombia, Argentina, Nicaragua, Panama, El Salvador, Venezuela, Peru, Ecuador, Paraguay, Puerto ...
Breaking Biology Technology:
(Date:2/2/2016)... , Feb. 2, 2016 This BCC ... bioinformatic market by reviewing the recent advances in ... that drive the field forward. Includes forecast through ... Identify the challenges and opportunities that exist in ... software solution developers, as well as IT and ...
(Date:2/2/2016)... , Feb. 2, 2016  Based on ... Frost & Sullivan recognizes US-based Intelligent Retinal Imaging ... & Sullivan Award for New Product Innovation. IRIS, ... North America , is poised ... rapidly growing diabetic retinopathy market. The IRIS technology ...
(Date:1/28/2016)... SYNA ), a leading developer of human interface solutions, today ... --> --> Net revenue ... to the comparable quarter last year to $470.5 million. Net income ... $0.93 per diluted share. --> ... 2016 grew 9 percent over the prior year period to $60.3 ...
Breaking Biology News(10 mins):