Replies to post #102233 on Biotech Values

[Shengli]

IL28B polymorphism's effect on treatment response would have to be reevaluated for regimens including direct antivirals

Dew are you aware of any data with IL28B and any of the DAAs ?

Also if you were a CC and had an 80% chance of SVR would they even use a DAA ? MRK licensed the test and yet it could conceivably cut into Bocep profits ?? I know they have a medical obligation to advance science.This discovery came out of the IDEAL trial i believe.

[oc631]

LabCorp launches IL-28B gene test:

http://finance.yahoo.com/news/LabCorp-Enhances-HCV-Testing-bw-3886123465.html?x=0&.v=1

IL-28B variants have been found to be correlated to patient response to HCV drugs. Most, if not all, new efficacy trials of HCV drugs will likely have to stratify trial arms according to IL-28B variants.

LabCorp licensed IP from MRK in order to commercialize the IL-28B test (#msg-52716245).

Do you think the FDA will consider the IL-28B variant when reviewing the NDA for boceprevir and telaprevir? Could they require testing of prior test subjects for IL-28B? Diversifying the race of the subjects seems to address this issue indirectly without testing.

[oc631]

Most, if not all, new efficacy trials of HCV drugs will likely have to stratify trial arms according to IL-28B variants.

Case in point from todays PR from VRUS:


Patients will be stratified by IL28B status to ensure balance across cohorts.

[genisi]

A prognostic (a negative predictive biomarker for response to SOC therapy) test for HCV based on plasma protein - CXCL10. Not commercial yet. Full text:

http://www.jci.org/articles/view/40594?search[article_text]=+Plasma+levels+of+the+protein+IP-10+hcv&search[authors_text]=