SIMTUZUMAB, AN ENIGM !


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Regarding the incoming trial results for SIMTUZUMAB (GILEAD), I have a bad feeling and stay very cautious in front of a smoke screen



During the last interview (Well Fargo) Norbert Bischofberger was very cautious mentionning simtuzumab 

"you know the simtuzumab, you know all the, looking at the biology, the mechanism of action, the preclinical data this compound should be an antifibrotic. Now having that said, we had disappointing data on the same compound previously in IPF. We stopped the study because there was no evidence of any efficacy and it also didn’t show any efficacy in two oncology application. So that somewhat dampens my enthusiasm honestly for simtuzumab but we will learn later in the year what it really does."


and when you look at the trials on simtuzumab you can understand him:

  • Pancreatic Cancer (Failure)
  • Idiopatic Pulmonary Fibrosis (Failure)
  • Primary myelofibrosis (PMF) and Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis (Results not published since the end of the study in 2014 - in a black hole)
  • Simtuzumab With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma (Results not published since the end of the study in 2015 - in a black hole)


GILEAD argued that hepatic fibrosis mechanisms  were very differents than Pulmonary one and that they were optimistic in NASH induced fibrosis and NASH induced cirrhosis.

but when you look at this small 2a study on hepatic fibrosis 

  • Simtuzumab in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis (2a) 


And look for a publication on the results (HERE) , you discover it was again a failure !

Moreover, I scanned all the abstracts of presentations and poster to be presented at the AASLD meeting in Nov 2016 .. i found no any one on simtuzumab !! the communication is focused on GS 4774 and GS 9674 . 

To my opinion a smoke screen is in place , and Analysts stay on the wrong side of it .

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