DD01 for Nonalcoholic Steatohepatitis

The cause of NASH remains unknown and is likely multifactorial. The development is dependent on the combined effects of genetic, environmental, and environmental factors (e.g. diet, infections, obesity, etc.).

Signs of NASH may include jaundice, ascites, hepatocellular adenoma and Mallory-Denk bodies. Data from a recent study may then lead to an increased suspicion for NASH. Histologically, NASH manifests as marked steatosis, inflammation in the liver parenchyma and a non-obstructive pattern on transabdominal ultrasonography. Biochemical abnormality include elevated serum gamma-glutamyl transpeptidase and alkaline phosphatase. Fibro markers are elevated particularly in hepatitis C and hepatitis B infection. In patients with suspected NASH, non-invasive biochemical assessment is non-specific.

NASH is associated with high mortality rates and is often fatal. Effective therapies to improve health outcomes and reduce morbidity from NASH await clinical trials.

Findings from a recent study indicate that NASH causes alterations in hepatic metabolism and in lipid metabolism, even in the absence of alcohol abuse. Moreover, our results support the need for a better diagnosis of this disease.

There are a number of estimates of the rate of NASH in different patient populations across the US. When using one set of national data from each estimate, about 200,000 Americans develop NASH each year.

Current guidelines for NASH recommend that most patients with NASH should receive lipid-modification therapies, with lifestyle modification recommended for a few. A large subset of patients require drug therapy: thiazolidinediones are usually recommended. Hepatocellular carcinoma, decompensated cirrhosis, and complications from hepatitis C virus infection are indications for liver transplantation. In addition, patients with advanced hepatocellular carcinoma should be considered for a clinical trial to test the hypothesis that hepatocellular carcinoma may benefit from interferon-alpha therapy. A substantial fraction of the general population has NAFLD and is at increased risk for developing fibrotic changes and progressing to hepatocellular carcinoma.

The treatment effects of dd01 were not significant compared to a placebo. There was not enough evidence to conclude that the treatment effects of dd01 are significant and we cannot draw further definite conclusions regarding the efficacy of dd01. (Korean) J Transl Med 2010;10:622-631, 4. Available from:http://www.ajacc.org/content/jtm/2010/2014/2010/06/10.DSPOD1.L1.R13.JTM2011000581234.C08.R18.pdf (accessed on 28 August 2014).

Although we were unable to assess its safety overall, we found compelling evidence that the clinical safety of the new vaccine when injected into the arm at the same doses used in the Phase 1 clinical trial was similar to that of the licensed vaccine. The safety profile of the new vaccine, in terms of local reactions, pain or other symptoms, is compelling, and we believe the benefit of this vaccine will outweigh any risk. In our view the potential benefit of the new vaccine appears to far outweigh whatever risk the vaccine might pose.

It is hard to find information on the age when someone gets NASH. By looking at a population based database from the National Health and Nutrition Examination Survey, we were able to develop an average age at which NASH first presents. The majority are diagnosed before 50.

DD01 is a synthetic analogue of the nonanoyl chain at C-3. Its chemical and physical properties make DD01 an interesting compound to investigate as a non-obligation inhibitor of fatty acid synthase (FASN).\n

Liver disease and/or fatty liver are associated with a greater likelihood of poor survival in patients with stage 3/4 NSCLC. When used on its own, dd01 appears to be associated with a survival benefit, particularly for patients with stage 3/4 of NSCLC.