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DewDiligence

06/08/11 12:23 PM

#121262 RE: oc631 #121247

It’s a feather in VRUS’ cap that the FDA is allowing one arm of the ELECTRON trial to test PSI-7977 monotherapy for as long as 12 weeks. Normally, the FDA limits monotherapy testing in HCV patients to very short periods (typically 3-5 days) to reduce the risk that patients will develop resistant mutations.

The fact that the patients in question have the comparably more treatable genotype-2/3 rather than genotype-1 surely played a role in the FDA’s willingness to allow 12 weeks of PSI-7977 monotherapy but, even so, the trial expansion announced today is a very impressive development, IMO.
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DewDiligence

06/22/11 5:59 AM

#122078 RE: oc631 #121247

JNJ/Medivir start phase-1b trial of HCV nuke, TMC649128:

http://finance.yahoo.com/news/Medivir-TMC649128-enters-bw-3338105057.html?x=0&.v=1

It is anticipated that TMC649128 will be used in combination with other HCV direct acting antiviral agents, given its high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.