Navigation Links
Intercept Pharmaceuticals Announces Positive Phase II Results for Obeticholic Acid (INT-747) as Monotherapy in Primary Biliary Cirrhosis
Date:3/31/2011

NEW YORK, March 31, 2011 /PRNewswire/ -- Intercept Pharmaceuticals, Inc., today announced positive results from a 59 patient, placebo controlled, double-blind  Phase II clinical trial of obeticholic acid (OCA) given as monotherapy to patients with primary biliary cirrhosis (PBC).  The study evaluated the effects of 10 mg and 50 mg of OCA compared with placebo in patients with elevated alkaline phosphatase (AP).  AP is a liver enzyme routinely used to evaluate the clinical status and disease progression of PBC patients.

At the end of the 12 week treatment period, both doses of OCA produced statistically highly significant reductions in AP, the primary endpoint, compared with the patients receiving placebo (changes: 10mg:  -45%; 50mg:  -38%; placebo:  0%; p < 0.0001 both doses versus placebo). There were also significant improvements in other liver enzymes, including gamma-glutamyl transferase. In addition, serum markers of inflammation and immunity also improved with significant reductions of C-reactive protein (CRP), and immunoglobulin M (IgM), which is closely associated with the autoimmune dysfunction in PBC.  Pruritus (itch) was seen more commonly in the OCA treated patients and increased with dose; otherwise, all other adverse events were generally similar across the groups.

PBC is a chronic autoimmune disease of the liver marked by the slow progressive destruction of the small bile ducts within the liver which may lead to liver failure and the need for liver transplantation. PBC primarily afflicts women with up to 300,000 patients estimated in developed countries.  There is only one drug approved to treat the disease, ursodeoxycholic acid (UDCA), and up to 50% of PBC patients on UDCA therapy continue to be at significant risk of progression to cirrhosis.

Kris V. Kowdley, MD, Director of the Center for Liver Disease at Virginia Mason Medical Center, in Seattle, Washington and a princ
'/>"/>

SOURCE Intercept Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Dainippon Sumitomo Pharma and Intercept Pharmaceuticals Announce Agreement to Develop and Commercialize Obeticholic Acid (INT-747) for Chronic Liver Disease
2. Initiation of FLINT Announced by NIDDK: Study of Intercept Pharmaceuticals Obeticholic Acid (INT-747) in NASH
3. Intercept Pharmaceuticals to Collaborate With NIDDK on Study of Obeticholic Acid (INT-747) in Nonalcoholic Steatohepatitis (NASH)
4. Intercept Pharmaceuticals Raises $25 Million Series B Financing
5. Intercept Pharmaceuticals Announces Positive Phase II Results for INT-747 as a Treatment for Primary Biliary Cirrhosis
6. Intercept Pharmaceuticals FXR Agonist INT-747 Meets Primary Endpoint in a Phase II Clinical Trial in Type 2 Diabetic Patients with Nonalcoholic Fatty Liver Disease
7. Reportlinker Adds Top 500 Pharmaceuticals Industry Report (Global)
8. Reportlinker Adds Top 200 Biopharmaceuticals Industry Report (Global)
9. Syndax Pharmaceuticals Announces Entinostat Data at 102nd Annual American Association for Cancer Research Meeting
10. Vanda Pharmaceuticals to Evaluate Tasimelteon in Major Depression
11. Pacira Pharmaceuticals Reports Fourth Quarter and 2010 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a specialty ... disease and overall health is pleased to provide you with ... outlook for 2015 from the CEO, Mr. Eugene Bortoluzzi ... like to take this opportunity to share with you the ...
(Date:1/22/2015)... MINNEAPOLIS , Jan. 22, 2015  Bio-Techne Corporation (NASDAQ: ... launched Ella, the first member of the new Simple ... ProteinSimple brand.  This launch represents the re-branding of the ... The Simple Plex platform is a transformative immunoassay technology ...
(Date:1/22/2015)... 2015 Increasing sophistication among enterprise buyers of language ... in 2015, says Moravia CMO, Renato ... by market research firm Common Sense Advisory, 15 percent ... translation and localization needs. "From a language industry perspective, ...
Breaking Medicine Technology:Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7Bio-Techne Launches Simple Plex Platform 2Bio-Techne Launches Simple Plex Platform 3Moravia Sees Single-Sourcing as Key Localization Trend in 2015 2
(Date:1/22/2015)... The federal court overseeing thousands of vaginal mesh ... District of West Virginia has upheld a $2 million verdict ... trial. In an Order dated January 21st, the Court denied ... C.R. Bard had not proven a miscarriage of justice. (Cisson ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Autocarinsurancebest.com has released ... purchasing a commercial auto insurance policy . , Auto ... their vehicles. It is no longer necessary to call an ... are now available online on a single website: http://autocarinsurancebest.com/ ...
(Date:1/22/2015)... New York, NY (PRWEB) January 22, 2015 ... American College of Sports Medicine flagship journal Medicine ... supplementation with L-Citrulline before exercise may help reduce ... strenuous exercise. 1 , Participants in the ...
(Date:1/22/2015)... Boulder, Colorado (PRWEB) January 22, 2015 Four years ... is Queen – which coincided with the marriage of Avasa & ... album, THE ROAD, which is scheduled for release through White Swan ... heartfelt message that there is a sacred path available to all ...
(Date:1/22/2015)... JJsHouse.com is a famous dress online store ... announces its latest collection of wedding dresses , and ... issue is the wedding dress on your big day; the ... life. Every bride wants to find the most suitable wedding ...
Breaking Medicine News(10 mins):Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2
... announced an agreement with Schwarz Pharma AG under which it ... drug that can be a treatment option for an overactive ... affects up to 100 million people around the world," said ... Human Health. "We are excited about the potential of this ...
... time researchers have studied deeply about fat cells, called adipocytes ... .Research has now revealed that these Fat cells around coronary ... University of Iowa researchers have revealed that fat cells release ... upon a time, were thought to have a role of ...
... government a confirmed case of mad-cow disease in a cow ... case was of a 6-year-old dairy cow which was identified ... for mad-cow disease. ,In a written statement, "This finding ... which BSE is known to concentrate in infected animals are ...
... wildlife rescue group has raised concerns over swans and other wild ... fear //. Despite pleas from wildlife rescue groups, Canada geese, peregrine ... ,The attempts of Salisbury Wildlife Rescue workers to save a swan ... ended up in vain. The bird had to be eventually destroyed ...
... country focuses on headline-grabbing diseases, hemophilia, a little known blood ... over 50,000 people affected. // ,World Hemophilia ... effort to secure appropriate care and treatment for a disease ... a defect in the genes. ,"The disease might ...
... palmetto, commonly used for treatment of enlarged prostate is nothing ... Francisco VA Medical Center and the Northern California Kaiser Permanente ... published in the New England Journal of Medicine. ... is a very common condition that leads to urinary problems ...
Cached Medicine News:Health News:Fat cells lethally connected to heart disease 2Health News:Saw Palmetto Extract No Good In Improving Prostate Health 2
... introduces new high precision femtosecond laser technology ... opportunity to offer their patients a safer, ... creating the corneal flap. By using ... IntraLASIK software, surgeons may avoid the complications ...
... Teco Diagnostics manufactures fine urine chemistry ... urine chemistry reagent strips from start ... offer more economical prices compared to ... quality. Teco Diagnostics urine reagent strips ...
... Long term complications associated with diabetes ... the health and quality of life of ... costs. These complications are known to be ... The discovery that the level of haemoglobin ...
The Lifestream Plus Cholesterol Monitor provides you with a comprehensive tool to help you monitor your cholesterol as part of your wellness program....
Medicine Products: