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:2/8/2016)... , ... February 08, 2016 , ... ... only four states in the U.S. require dental technicians to be certified or ... the dental industry, NADL created the “What’s In Your Mouth?” campaign to inform ...
(Date:2/7/2016)... ... February 07, 2016 , ... Women's Excellence staff, in all four locations, wore ... Wear Red Day is the first Friday each February and a day to bring ... in 3 deaths among women each year – more than all cancers combined. Go ...
(Date:2/7/2016)... ... February 07, 2016 , ... ... Plastics, has added Kybella® to his medical and surgical expertise. Technically known as ... FDA injectable medication used as a non-surgical alternative for reduction of fat below ...
(Date:2/6/2016)... San Rafael, CA (PRWEB) , ... February 06, 2016 , ... ... 2016 Youth Ultimate Coaching Conference (YUCC) . This event brings together top non-profit leaders, ... is “Gender Equity and Girls Ultimate”. Valerio Iani, Bay Area Disc Program Director of ...
(Date:2/6/2016)... ... 06, 2016 , ... Shark Finds and Kevin Harrington, along with ... DRTV campaign with Belly Bands. , Having a dog is great—except when it wets ... and find nothing works, get Belly Bands, the easiest way to stop dogs ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... Feb. 8, 2016 ... of the "Label-Free Detection Market by ... 2020" report to their offering. ... addition of the "Label-Free Detection Market ... to 2020" report to their offering. ...
(Date:2/8/2016)... , Feb. 8, 2016  Unilife Corporation ("Unilife" or "Company") ... of injectable drug delivery systems, today announced that it will ... ended December 31, 2015 after market close on February 9, ... conference call to discuss these financial results.    ... --> About Unilife Corporation ...
(Date:2/8/2016)... Calif. , Feb. 8, 2016  Sangamo ... in therapeutic genome editing, announced that the U.S. ... Company,s Investigational New Drug (IND) application for SB-318, ... life-long therapy for Mucopolysaccharidosis Type I (MPS I). ... enables Sangamo to initiate a Phase 1/2 clinical ...
Breaking Medicine Technology: