Replies to post #83101 on Innovation Pharmaceuticals Inc (IPIX)

[Astavakra]

Dr. J,
I know that you've posted about Vanco before. Why do you think they chose Dapto as the comparator and not Vanco in the first place?

[MinnieM]

The FDA wanted Brilacidin tested against Daptomycin in the 2B since Daptomycin was used in the 2A. We basically did a dose optimization study. The drug had to be the same.

Here's the 2A:
https://clinicaltrials.gov/ct2/show/NCT01211470?term=pmx30063&rank=1

We should be finding out about the phase III and what the FDA wants soon enough. It may end up comparing Brilacidin to Vancomycin. ;)





In Reply to 'Dr Jerry'
Market makers cleaned out all the stop loss orders today cleaning up on another million shares at bargain prices.
Leo will release phase 2b bottom line data on monday, mark this post.
The man will also probably announce mechanics of the phase 3 trial.
I think the delay is because the FDA would like to compare Brilacidin to the current drug of choice Vancomycin.
If B can take on and out perform Vancomycin it would guarantee a Fast Track designation.
Daptomycin is not the current drug of choice and people here forget to check the facts.
Leo and Menon must go toe to toe in phase 3 with Vancomycin.
They will beat V hands down...

[CallMeCrazy]

In a study, daptomycin was found to be noninferior to vancomycin for absssi and csssi infections:

Daptomycin has rapid concentration-dependent bactericidal activity against Gram-positive pathogens.[80,81] Its tissue penetration supports its use in the treatment of ABSSSI, and daptomycin was shown to be 'noninferior' to vancomycin and semisynthethic penicillins.[

http://www.medscape.com/viewarticle/827923_6

Since it appears that daptomycin and vancomycin are nearly equally effective against absssi, would not the insurance companies require that the cheaper vancomycin be used instead of the more expensive daptomycin (all other things being equal)?

If this is true, then when you call vancomycin the "drug of choice" don't you really mean the insurance companies drug of choice?

Why would the FDA hold-up Brilacidin's P3 so that it can be studied against vancomycin when it has not been fully tested against dapyomycin. This doesn't seem to make sense.

Anyone who can make some sense of this or tell me where my thinking is flawed, please feel free to respond.

[sox040713]

According to one of the slides on the CTIX website, "Zyvox and Vancomycin are discontinued ~40% and ~46% respectively over time, due to tolerability issues, non-response and side effects."

I think the delay is because the FDA would like to compare Brilacidin to the current drug of choice Vancomycin.