Navigation Links
New phase II study supports potential of gs-9450 as new treatment option for steatohepatitis

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
European Association for the Study of the Liver

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:
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
(Date:6/24/2016)... TX (PRWEB) , ... June 24, 2016 , ... People ... part in Genome magazine’s Code Talker Award, an essay contest in which patients and ... an award to be presented at the 2016 National Society of Genetic Counselors (NSGC) ...
(Date:6/24/2016)... Las Vegas, Nevada (PRWEB) , ... June 24, ... ... their Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and ... The Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Venture Construction ... Classic Tournament held on June 20th at the Woodmont Country Club at 1201 ... Wings, an organization dedicated to helping service members that have been wounded in battle ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... OAKLAND, N.J. , June 24, 2016 /PRNewswire/ ... in the design, development and manufacturing of collagen ... and regeneration announced today that Bill Messer ... Sales and Marketing to further leverage the growing ... surgery medical devices. Bill joins the ...
(Date:6/24/2016)... Mass. , June 24, 2016   ... Spaulding Rehabilitation Network,s Dean Center for Tick ... Physical Medicine and Rehabilitation, MIT Hacking Medicine, University ... for Innovation, today announced the five finalists of ... for Lyme disease.  More than 100 scientists, clinicians, ...
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
Breaking Medicine Technology: