"PRINCETON, N.J., Nov. 10 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News), Roche (SWX: ROG - News) and InterMune, Inc. (Nasdaq: ITMN - News) today announced that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus (HCV). The trial (run in centers in Australia and New Zealand) is the first to investigate the combination of two oral antiviral molecules "
What is more interesting is what may happen if the INFORM trial is good and things progress and telaprevir is approved in its current regimine. On the Biotech Confab presentation Dan Welch indicated if things progress without delay in the results of the INFORM study (and follow up studies) continue to look positive there could be full SVR data from a Phase 2 study before telaprevir would be approved. This could present an interesting situation for a good deal of patients awaiting treatment. We are a way off but this could be quite interesting!
This is very interesting news. But, we have to be clear, this is just a very early safety trial. We measure RVR at four weeks but they are only dosing the protease and polymerase for 2 weeks, because of the unknown affects. After the 2 weeks they are giving the trial participants 48 weeks of SOC for 'ethical reasons'; i.e they don't want to leave them high and dry after 14 days of completely novel and potentially insufficient treatment.
Any suggestion that definitive information will be available from the Inform trials by the time telaprevir is approved is based on very pessimistic estimates for telaprevir and very optimistic views on these protease/polymerase trials.
I listened to the conference call with Dan Welch from Intermune and I think he gave away his own views on this trial when he answered a question on whether his company should be valued on its' HCV work or on the IFP work. He responded by being very high on the IFP work and then stating almost as a throwaway, - "unless this Inform thing works out." Listen for yourself, it comes a minute or two after the 30 minute mark.