KP-1461 - for Peter Staley

[leit]

Dear Peter,

I believe you know perfectly the whole Koronis' KP-1461 affair [ http://www.koronispharma.com/KP1461forHIV.html ] and its sad end.

As AIDSmeds/POZ, is there anything you could do to DEMAND an explanation about that (which, IMHO, looks really like a fraud)?

Thank you very much!

[keyite]

Isn't the purpose of fraud to gain some kind of advantage? Can't for the life of me think what that might be in this case - it isn't like it has improved Koronis' reputation and standing. Shit happens in science..

[leit]

Purposes and plans can go wrong, so please let's stick to the facts:

- Koronis claimed that, after 15 serial passages in vitro, KP-1212 (KP-1461 is a prodrug of it to be used in vivo) IRREVERSIBLY ESTINGUISHED HIV

- When, years later, FDA required Koronis to repeat the experiment, KP-1212 showed NO EFFECT WHATSOEVER.

How can you explain that, please?

[keyite]

plans can go wrong

You're so right.

[John2038]

Something smell bad
The problem in this the phase I have been validated by the fda and then unvalidated
It's not the same as if the Phase II have failed.

3 hypothesis :

1) koronis have fake it's report phase l
2) human error
3) interruption for any others reasons..

It would be nice to discuss  with a participant of this trial just to get the throughts of someone who was there

[leit]

plans can go wrong

You're so right.

 

[leit]

Something smell bad

Yes, VERY bad.

The problem in this the phase I have been validated by the fda and then unvalidated

A step back, please!

The problem is BEFORE any clinical trial (phase I, II and so). The problem is IN VITRO, where KP-1212 has shown to do nothing (AFTER FDA request!).

Anyway, the only documentation of some importance I have found is the following:

http://www.natap.org/2007/IDSA/IDSA_07.htm
http://www.natap.org/2008/Pharm/Pharm_24.htm
(Koronis in vitro and phase I bullshit)

http://www.projectinform.org/news/2008/061208.shtml
(FDA request / in vitro failure)

http://blogs.poz.com/paul/archives/2008/06/my_journey_with.html
(a declaration of absolute trust - don't understand why)

It would be nice to discuss  with a participant of this trial

It would be nicer to discuss with Koronis' Sirs, IMHO!

[Peter Staley]

I don't think we have to do anything.  If it's fraud, then I'm sure that would be uncovered during an SEC investigation and/or lawsuits by investors in the company's stock that feel ripped off.

As an activist, and as a person living with HIV, I don't personally feel ripped off.  I never got excited about the drug in the first place (I tend to withhold excitement until a drug proves itself in larger clinical trials).

But I kind of agree with keyite, that fraud seems pretty unlikely, since the drug would eventually have no chance of panning out.  More likely they just didn't know what they were doing the first time around (something went wrong in their lab).

[HIV? poz about being neg]

sorry to jump in but all this talk about phase 1 and phase 2 just how many phases are there anyway befor a drug proves itself ?

[Matty the Damned]

sorry to jump in but all this talk about phase 1 and phase 2 just how many phases are there anyway befor a drug proves itself ?

Generally there are 4 phases to a clinical trial.

MtD