DewDiligence, you wrote "Can you cite a single HCV thought leader not affiliated with PPHM who thinks this is a realistic possibility?"
That leaves me wondering about what is your point?
Do you consider Dr. Godofsky a thought leader? Yes, IMO.
Is Dr. Godofsky "affiliated" with PPHM because his clinic has been facilitating the 1b repeat dose trials? Yes, IMO.
Are you suggesting that the medical community that has affiliated themselves with PPHM by being on the PPHM science advisory board or assisting with trials have compromised their professional integrity? No way, IMO.
The announcements heard today, IMO, are a reinforcement of what PPHM already delivered last March, along with PR about PPHM's business plan to pursue development of the value indicated by the 1b study. I observed nothing new beyond PPHM giving information that should bring closure to some of the critical comments about the 1a trials played out over these last several months since March. PPHM did not announce that a single dose of Bavi was an HCV cure. They did repeat announce a "promising" "first in class" treatment that is proceeding through follow on trials.
Is a two log reduction in repeat dosing 1b trials necessary to affirm Bavi success? Only if Bavi is to be cited as a solo treatment, IMO. Maybe the 1b will show a 2 log reduction with Bavi's solo administration, maybe not. If Bavi is to be used as a combo treatment, as PPHM has indicated to be the case in their business plan, "safe and well tolerated" and a signficant viral resposne at all dose levels is enough to bring forward from the 1a trial to support PPHM's pursuit of Bavi as being a world class drug. The development train moves along, LOL.
One can simplify the Bavi viral development as a three step process:
1. demonstrate safety and indications of some efficacy (after all, a saline IV should also show it is safe and well tolerated. Bavi needed to show its administration was showing some sort of beneficial response, and it did.
2. demonstrate optimal dose and pharmokinetics while being administrated as a solo therapy (the 1b trial currently underway)
3. demonstrate efficacy as a combo treatment either displacing a component or enhancing results, improving effectiveness in the standard of care HCV treatment.
If PPHM "hits a home run" with the 1b trial by showing Bavi can be a solo treatment, that would be nice, but demonstrated performance with the combo treatment is what is critical for Bavi's anti-viral future, IMO. And it looks like PPHM is planning to resolve that issue in 2007. Presuming PPHM continues to show Bavi is performing and on track for development in their business plan, at what point does "Mr. Market" step in and bring realization to shareholder value?
I look at what Vertex just reported about their Vx-950 trials. My observation was that the Vx-950 sped up or invigorated the patient's responsiveness to the SOC pegylated interferon plus ribavirin treatment, but still left the residual of nonresponders at a percentage comparable to the SOC results. While speeding up the viral reduction time under the SOC, the need to administer interferon or ribavirin was not shown to be no longer necessary with Vx-950. Rather, 24 to 48 weeks of Peg-interferon plus ribavirin was demonstrated as being needed ON ALL the patients in the trial for the Vx-950 to achieve the same statistical proportion of HCV RNA "none detected" as was achieved by the SOC with no Vx-950 administered.
What will Bavi show as a combo treatment? Will there still be that persistent 20% +/- of nonresponders? If Bavi can match current SOC performance while enabling elimination of or greatly reducing the administration of pegylated interferon, it will have outperformed Vx-950, as Vx-950 was reported out yesterday. If Bavi can achieve getting that last 20% being "cured" of HCV (no detectable HCV RNA after six months) while administered in a combo treatment, with or without interferon administration, Bavi will have outperformed all HCV treatments currently available. So, what if Bavi just does what Vx-950 was reported to have demonstrated yesterday, that is, it helps speed up viral reduction, but there is no change in SOC but for the addition of Vx-950 to the mix and there is no statistically significant reduction in the nonresponders population?
Best wishes and IMO.
KT
AI
