Navigation Links
New phase II study supports potential of gs-9450 as new treatment option for steatohepatitis
Date:4/16/2010

Vienna, Austria, Thursday 15 April: Results from a multinational phase II study presented today at the International Liver CongressTM 2010 have shown that treatment with the caspase inhibitor GS-9450 can reduce markers of liver damage in patients with non-alcoholic steatohepatitis (NASH the most serious form of non-alcoholic liver disease) as demonstrated by reduced levels of alanine (ALT) and aspartate aminotransferases (AST), hepatic enzymes that indicate cell damage.

GS-9450, a potent inhibitor of caspases-8, -9 and -1, the intra-cellular proteins that initiate programmed cell death (or cell suicide, also known as apoptosis) in damaged cells, is a potential new treatment option for patients with NASH a disease characterised by fat build-up in liver cells with subsequent inflammation resulting in accumulation of scar tissue (fibrosis), cirrhosis and eventual liver failure.

Professor Fabio Marra of the EASL scientific committee commented: "It is encouraging to see that GS-9450-associated reduction of apoptosis and cell damage seen in animal models has translated to a significant patient population, and seems to be consistent with a good tolerability profile in patients from a variety of countries. Further studies are needed to evaluate the action of this therapy on histology and to confirm the drug's efficacy and safety in larger patient populations."

In this double-blind, parallel-group study, patients (n=124, principally male, mean age 45 years, with Body Mass Index (BMI) of >30kg/m2) with biopsy-proven NASH were randomised to receive 1, 5, 10 or 40mg GS-9450 or placebo once daily for 4 weeks. After 4 weeks on treatment, patients in the 40mg treatment group experienced the greatest reduction in ALT and AST levels.

At week four, linear regression of ALT versus GS-9450 dose was highly significant (p<0.0001) with 35% achieving ALT levels within the normal range (7-56 U/L ) compared to 0% at study baseline, and 48% achieving normal levels of AST (5-40 U/L1) compared to 20% at baseline. Placebo treatment showed no meaningful change for ALT or AST.

Additionally, the on-treatment measure of cytokeratin-18 caspase cleavage fragments (proteins that act as markers for liver cell death) declined in the 10 and 40mg dose groups (median baseline and week four values respectively were 540 and 445 U/L in the 10mg group and 562 and 386 U/L in the 40mg group), although no dose-related response was seen.


'/>"/>

Contact: Isabelle Scali
media.easl2010@cohnwolfe.com
44-771-743-5103
European Association for the Study of the Liver
Source:Eurekalert

Related medicine news :

1. NASA selects DNA Medicine Institutes Nanoscale Diagnostics Technology for Phase II SBIR
2. PRA International Rolls out Client Access to Oracle(R) RDC for Early Phase Studies
3. Treatment for chronic hepatitis C: A phase II study
4. New Pixantrone Phase III Data to be Presented at the 51st Annual Meeting of the American Society of Hematology
5. InstaMed Achieves Core Phase II Certification to Streamline Provider Access to Consistent Electronic Eligibility and Claim Status
6. Pharmacyclics, Inc. Announces Presentation of Interim Results From Phase I Trial of Its First-In-Human Btk Inhibitor PCI-32765
7. Aetna and WellPoint Achieve CORE Phase II Certification
8. Data from Phase 1 Study Confirm High Response Rate of Micromets Blinatumomab in Patients with Non-Hodgkins Lymphoma
9. Pharmacyclics, Inc. Reports Interim Safety and Clinical Data from a Phase I/II Clinical Trial of its Oral HDAC Inhibitor PCI-24781 in Lymphoma at the American Society of Hematology Annual Meeting
10. Hepregen Corporation Receives SBIR Phase II Grant from the National Science Foundation and Presents Corporate Update at OneMed Forum
11. Synomics Pharma and Bioscience Laboratories Announce Partnership to Provide Topical Clinical Phase 1 Study Services
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud ... and unique items from across the nation, this holiday-themed event will raise funds and ... the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual ... in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon ... fun run is geared towards children of all ages; it is a non-competitive, non-timed ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “The Journey: ... faced every danger possible to save lost souls in the Philippines. “The Journey: From ... Carole is a dedicated teacher of the Bible. She has taught all ages and ...
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... 11, 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), ... in Las Piedras, Puerto Rico , ... Following a ... sustained minor structural damage, temporary loss of power and ... been completed, manufacturing operations have resumed, and the company ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... Oct. 2, 2017  AllianceRx Walgreens Prime, the combined ... Walgreens and pharmacy benefit manager Prime Therapeutics LLC (Prime), ... which included the unveiling of new signage at its ... well as at a few other company-owned facilities across ... to patients, some of whom will begin to see ...
Breaking Medicine Technology: