I include Stanley's comments from December 7 conference call and information from the website regarding drug....most notably the 20 million people that can benefit from the drug and a drug application with FDA in the beginning of 2013:
Stanley Crooke - Chairman of the Board, President, Chief Executive Officer
It will be a little while. By the way, DGAT2 has an early clinical trials yet but we really are quite excited about it and we just need to get it into clinical trials and have that money to develop all these drugs and what's exciting about it in particular, is the fact that we now know, thanks to the work with KYNAMRO, that we can pretty easily measure pretty modest changes in liver fat over a short periods of time using MRIs. So that’s another drug that will populate our metabolic pipeline over the bit.
ISIS-DGAT2Rx is an antisense drug that specifically reduces the production of diacylglycerol acyltransferase-2, or DGAT-2, a key component in the synthesis of triglycerides. By reducing DGAT2, ISIS-DGAT2Rx should reduce liver fat in patients with NASH, a common and often asymptomatic liver disease that can cause irreversible damage to the liver, and lead to liver cirrhosis and cancer. The National Institutes of Health, or NIH, estimates that NASH affects more than 20 million people in the United States and expects the number to increase as the rate of obesity rises. There are no effective therapies available for patients with NASH and current treatments consist only of lifestyle changes. In addition, because clinicians associate increases in liver fat with insulin resistance, ISIS-DGAT2Rx could also benefit patients with type 2 diabetes who are insulin resistant.
We plan to conduct preclinical studies to support an investigational new drug application for ISIS-DGAT2Rx in 2012 or early 2013.