Navigation Links
Preliminary Phase 2 Data of Ocera Therapeutics' OCR-002 for the Treatment of Liver Cirrhosis and Upper GI Bleeding Show Potent Ammonia Reduction

BARCELONA, Spain and SAN DIEGO, May 29, 2012 /PRNewswire/ --- Hospital Universitari Vall d'Hebron Research Institute in Barcelona and Ocera Therapeutics, Inc. announced today preliminary data from an open label phase 2 study evaluating the overall effectiveness and safety of OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis of the liver and upper GI bleeding. An interim analysis of the first cohort of patients demonstrated that OCR-002 is well tolerated and provided a rapid and durable ammonia reduction after 36 hours of treatment. The data were presented at the 15th International Symposium for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN) in Grenaa, Denmark.

OCR-002 is a novel injectable agent that removes toxic, circulating ammonia from the blood. In patients with severe liver impairment, ammonia and other toxic substances that are normally removed by the liver accumulate in the blood and impair the function of brain cells. By removing circulating ammonia, OCR-002 may treat or prevent hepatic encephalopathy (HE), a neuropsychiatric complication of acute liver failure associated with increased levels of circulating ammonia. Signs of HE include impaired cognition, uncontrolled movements and decreased levels of consciousness leading to coma and even death.

"These early data demonstrate that OCR-002 is well tolerated, rapidly normalizes hyperammonemia and has the potential to prevent the development of hepatic encephalopathy," said Dr. Juan Cordoba of Hospital Universitari Vall d'Hebron and the lead investigator of the study. "Cirrhosis patients that present with acute upper gastrointestinal bleeding have a 30% chance of developing hepatic encephalopathy and require intensive care. A medicine that can quickly remove the toxic ammonia may help prevent or reverse this life-threatening condition, minimize the need for intensive care and shorten hospitalization."

The data presented today from the study of Upper GI bleed in patients with liver cirrhosis (n=10) shows that OCR-002 is well tolerated up to 10g/24h and provides a significant, rapid and durable ammonia reduction to normal levels after 36 hours of treatment.  All patients tolerated study drug well for 5 days. There were no severe toxicities associated with the treatment and no incidence of HE, with patients doing well at the 30 day follow up. A rapid drop in ammonia from 80.01+/-13.44 uM at baseline to 41.95+/-4.99 uM was observed at 36 hours (ANOVA, p<0.05).

The Phase 2 clinical trial is ongoing and will enroll 48 patients with cirrhosis of the liver. The first part of the trial recently completed was an open-label study to confirm the safety and tolerability of OCR-002 seen in earlier clinical trials. The second phase is a double-blind, placebo-controlled study and will measure as the primary endpoint ammonia plasma concentration and improvement in HE as a secondary endpoint.

OCR-002, developed by Ocera Therapeutics, has received Orphan Drug designation in the U.S. and Europe and has fast track status in the U.S. OCR-002 is also being evaluated as a treatment of acute liver failure in the U.S. It is estimated that there are up to 1 million cirrhotic patients in the U.S., of which 150,000-200,000 patients are hospitalized due to complications of encephalopathy costing the healthcare system over $1.2 billion every year.

About OCR-002
Ocera in-licensed OCR-002 (ornithine phenylacetate), an ammonia scavenger designed to rapidly lower systemic hyperammonemia and treat hepatic encephalopathy (HE) in patients with liver cirrhosis and acute liver failure from University College of London. OCR-002, through its novel mechanism of action, directly lowers circulating blood levels of ammonia by enabling alternate metabolic pathways in the muscle and kidney in patients with liver failure and is patent protected until 2031. OCR-002 is being developed as an injectable for hospitalized patients and as an oral formulation to treat HE in patients with chronic liver cirrhosis. Ocera has completed studies in healthy volunteers and cirrhotic patients and phase 2 studies are ongoing. For more information: (OCR-002)

About Hepatic Encephalopathy (HE)
HE is an often reversible neuropsychiatric complication observed in patients with acute liver failure or chronic liver cirrhosis in whom the metabolic conversion of ammonia to urea in the liver fails.  With severe liver impairment, toxic substances that are normally removed by the liver such as ammonia accumulate in the blood.  Elevated ammonia levels can impair the function of brain cells, cause cerebral edema and may elevate intracranial pressure. Signs and symptoms of HE include impaired cognition, confusion and a decreased level of consciousness, which can progress to coma and ultimately death. 

SOURCE Ocera Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ampio Announces Positive Preliminary Update on the Optina™ Clinical Trial to Treat Diabetic Macular Edema and Decision to Conclude the Study Ahead of Schedule
2. Cardinal Health Statement in Response to Preliminary Injunction Hearing February 29, 2012
3. Vermillion to Report Preliminary Results for Fourth Quarter and Fiscal Year 2011 on February 23, 2012
4. Watson Confirms Court Stays Preliminary Injunction
5. Watson Announces Preliminary 2011 Non-GAAP Earnings of $4.75-$4.77
6. Hill-Rom Announces Preliminary Fiscal First Quarter Financial Results; Updates 2012 Financial Outlook
7. Volcano Corporation Announces Preliminary Fourth Quarter 2011 Revenues
8. CareFusion Announces Preliminary Second Quarter Results
9. Sanofi Announces Court Ruling Granting Preliminary Injunction Against Synvisc-One® Competitor Product
10. InterMune Reports Preliminary Fourth Quarter 2011 Esbriet® (pirfenidone) Revenue and Other Recent Business Highlights
11. PDL BioPharma Announces Expiration and Preliminary Results of its Exchange Offer
Post Your Comments:
(Date:11/25/2015)... , November 25, 2015 ... Investors"), pursuant to which BioLight and the New Investors ... Ltd. subsidiary ("IOPtima") via a private placement. The financing ... its innovative IOPtimate™ system used in the treatment of ... pathway process for the IOPtimate™ system with the U.S. ...
(Date:11/25/2015)... 25, 2015 --> ... eine Lizenz für das Patent über eine neue Hepatitis-B-Behandlung, ... ENS-Lyon innehaben, an Enyo Pharma vergeben haben. ... Leben gerufenen und von Edelris gemeinsam mit seinen Partnern ... Behandlungsziel für HBV identifiziert, und es wurden neue Inhaltsstoffe ...
(Date:11/24/2015)... Calif. , Nov. 24, 2015 /PRNewswire/ ... leader in non-invasive genetic testing and the ... that it will present at the 27 ... York on Wednesday, December 2, 2015 at 1:00 p.m. ET.  Matthew Rabinowitz, ... Company,s financial results, business activities and financial ...
Breaking Medicine Technology:
(Date:11/25/2015)... Missouri (PRWEB) , ... November 25, 2015 , ... ... HEAL, will provide scholarships for people struggling with eating disorders as a result ... from the second annual event, held at Fox Run Golf Club in Eureka, ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely combination of recycled ... way for homeless people to have a more dignified and comfortable night’s sleep. ... they are repurposing plastic bags into sleeping mats for the homeless. The ...
(Date:11/25/2015)... Mateo, CA (PRWEB) , ... November 25, 2015 , ... ... in prizes were awarded to winners of the Create Real Impact awards. California ... creative expression to help stem the tide of distracted and reckless driving, the number ...
(Date:11/24/2015)... GA (PRWEB) , ... November 24, 2015 , ... Dr. ... to now offer laser services to many of his patients. Dr. Afferica now uses ... designed to reduce the amount of time the doctor uses other traditional cutting tools, ...
(Date:11/24/2015)... SAN FRANCISCO, CA (PRWEB) , ... November 24, ... ... launched half-cup sizes, has launched their Black Friday sale a week early, offering ... ThirdLove continues to transform the intimate apparel industry through both mobile fit technology ...
Breaking Medicine News(10 mins):