Saturday, July 22, 2006 12:25:12 PM
It’s quite possible HCV Ph II will be done as a combination trial with Ribavirin. While there is some chance mono-therapy repeat dose trial could be sufficient to achieve SVR, Company suspects that Bavi AV will work better in combination with other drugs just as Bavi AC works better in combo. At least one preclinical study indicates that Ribavirin will upregulate Bavi in an anti-viral trial.
As stated by the Company, the combo trial will complete enrollment before year end. One has to assume it will start quite soon.
Obviously Company will compare carefully the pros and cons of HCV mono-therapy results against combo-therapy results before submitting Ph II protocol. Funding needed to run a Ph II trial will be about the same whichever way they go.
IMO, it would seem like the HCV Combo trial would be a good time to introduce the Humanized version of Bavi (90%H;10%M). This would seem especially true if there were a plan to develop Humanized Bavi as a drug for Co-infected HIV/HCV patients as part of a pricing strategy. This remark is purely my speculation.
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