Thursday, November 13, 2014 1:10:31 PM
Tom: My two cents...The main other drug candidate for liver fibrosis is Gilead (Simtuzmab). Its a monoclonal aintibody against LOXL2 (which is involved with cross-linking of fibrosis.) I believe that Gilead acquired the drug when they purchased Solvadi (their hep C treatment). They are in a phase 2 clinical trial for 96 weeks of treatment (1.84 years). The trial is for advanced liver fibrosis with NASH (but not cirrhosis).
The trial that Galectin has announced is for NASH with Cirrhosis (or a later stage) closer to death. It is a first and it would end up becoming the gold standard for cirrhosis treatment with NASH if GRMD02 is found to be effective. It could become a breakthrough therapy and if it does a phase 2 approval could be possible as there are other recent examples (cancer drugs).
My thoughts (and hopes) are that GRMD02 is going to be active a lot sooner than 96 weeks of treatment. Hopefully it will be more like weeks to a few months. That would end up being a major catalyst.
Also, keep in mind that monoclonal antibody treatments are expensive. The cost should be slightly less than a liver transplant but likely not by much for a 96 week (IV) treatment. No pricing has been announced for Simtuzumab so I am just taking a guess here. GRMD02 should likely have the edge for treatment time and cost of treatment.
GRMD02 and Simtuzmab should end of being complimentary to each other as they involve different mechanisms of action (1+1) would likely equal 3 or 4 for treatment results. I don't really have answers to any of your other questions. I am in the dark like the rest of us. Please make your own investment decisions.
The trial that Galectin has announced is for NASH with Cirrhosis (or a later stage) closer to death. It is a first and it would end up becoming the gold standard for cirrhosis treatment with NASH if GRMD02 is found to be effective. It could become a breakthrough therapy and if it does a phase 2 approval could be possible as there are other recent examples (cancer drugs).
My thoughts (and hopes) are that GRMD02 is going to be active a lot sooner than 96 weeks of treatment. Hopefully it will be more like weeks to a few months. That would end up being a major catalyst.
Also, keep in mind that monoclonal antibody treatments are expensive. The cost should be slightly less than a liver transplant but likely not by much for a 96 week (IV) treatment. No pricing has been announced for Simtuzumab so I am just taking a guess here. GRMD02 should likely have the edge for treatment time and cost of treatment.
GRMD02 and Simtuzmab should end of being complimentary to each other as they involve different mechanisms of action (1+1) would likely equal 3 or 4 for treatment results. I don't really have answers to any of your other questions. I am in the dark like the rest of us. Please make your own investment decisions.
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