flosz schreef:
[quote=ronbanged2]
POC stands for "Proof of Concept"
It means you are going into the Clinic soon
Laughing my ass off
I just went back to the August 2008 press release, the CC where Ronald Brus announced the POC for
Factor V. It has been altered...this is now the blurb for Factor V
"Blood Coagulation Factor VL/C: Preclinical work on this program continues but conclusive proof of concept is not expected in the near future."
Ronald, I do not forget. I remember complaining that they had said they had achieved POC, but gave no date as to when they would enter Phase I
If you need any more proof of the dishonesty of this Management team...this is it.
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Ik geloof niet dat je begrijpt wat ik zeg. Ik zeg veranderden ze het persbericht van 2Q 2008
Het citaat gaf ik was niet wat ze zeiden in de oorspronkelijke release van augustus 2008 ... in dat release ze zei: "ZIJ had gekregen EEN POC voor factor V"
Ze loog over de POC, en hebben de originele PR deze BS zeggen veranderd. Ze heeft gelogen, en nu hebben gelogen over liegen.
Neem niet mijn woord te geloven ... Vraag het aan de andere oldtimers als ze niet verkondigen zij hadden POC voor Factor V in augustus 2008.
Ze veranderde het persbericht om hun sporen uit te wissen ... ze gelogen en zijn nu liegen over liegen.
Verachtelijk!
I don't believe you understand what I am saying. I am saying THEY CHANGED THE PRESS RELEASE FROM 2Q 2008
The quote I gave was not what they said in the original release from August 2008...in that release they said "THEY HAD GOTTEN A POC FOR FACTOR V"
They lied about the POC, and have changed the original PR to say this BS. They lied, and have now lied about lying.
Don't take my word for it...ask the other old timers if they didn't proclaim they had POC for Factor V in August 2008.
They changed the Press Release to cover their tracks...they lied and are now lying about lying.
Despicable!
[/quote]
Natuurlijk, dit alles na MAART...12 MAART 2008!!!
First of all, we produced it in PER.C6, which went okay. And then -- and maybe we underestimated it to some extent,we had to set up models for it. So you have mice models, you have also a lot of others, but the easiest and most established in
models of hemophilic mice.
And I show you here in this slide, which is now in front of you, you can clearly see that if you deplete a normal serum from Factor VIII, so there's no Factor VIII in that serum left. And if you subsequently start to supplement or compliment, so to speak, what you see in this slide to the blue column at the left, and you see the same at the right, so you could look at these two plasmas, what you see is that when you have no Factor VIII in this experiment, which is an in vitro experiment, you see a very long clotting
time. In other words, it takes a very long time to clot blood. And as you know, there are two ideas about the blood stream, one is blood should flow in the blood stream and when you get wounded it should clot. Very simple strategy.
Now what you see is that you add Factor VIII, what you see is that reduces your clotting time in vitro. And Factor V Leiden, to our happiness and delight, actually reduced it even better. When we confirmed that experiment into a plasma from a severe hemophilia A patient, you saw exactly the same. So in vitro, we had to prove that it worked in the sense of reducing the ability to reduce the amount of blood. Now the next question you will immediately ask is does this work also in vivo? In other words, in real life situations?
When we did this experiment and we reported to you the first experiment -- and then the scene at the left. What we observed in that experiment and we had to set up these mice models, which is quite hard to do, it took us about a year to get all the tools in place. And we maybe looked upon that a little lightly, but we got it working quite beautifully, even better than many others.
What you can see at the left is an interesting observation we had about end of last year, I think, or the middle of last year. We observed that Factor VIII is very well able to reduce blood loss in such a mouse. And subsequently we observed that the combination of Factor VIII and Factor V, the two things to show you here, first of all, it reduced the amount of Factor VIII that
was needed. And secondly, you saw a kind of synergistic effect.
We said, now this is a very interesting observation. And then came somewhat of a disappointment to us. The disappointment
was, we hoped, of course, because if you want to have a general bleeding indication, we hoped, of course, that Factor VIII -- Factor V Leiden Cambridge would have this effect also on its own. Now very obvious from the right panel is in this particularmodel, which are very difficult to set up, it was not the case.
This had an enormous consequence on our thinking and still has, because we are working on that. First of all, we had to ask ourselves, is this the right model. But that's the easy out for a scientist, you say, okay, [reduce] the right model and it's not the science I favor. So you would say you need a better explanation to say the model is not good if you first set it up for a whole
year and say it is the right model. So accept the model.
And then you have to say, okay, what does this mean. Now it means for sure that it is very hard to move this project at this point
on into development, because if Factor V in this model does not work on its own, it essentially means that the main indication, those are the hemophiliac patients with antibodies to Factor VIII, does not -- do not benefit from it.
And the second point is that, in general, it cannot compete in the situation where you need it as a stand-alone product. So we were very disappointed. We're still working in that area. We think it is an important area to work in. However, if we look at what we have to conclude for it, it's guess PER.C6 produced protein can, in vitro, work, and particularly even in this concept.
Second, in vivo, in the best model we could use and we could make, we needed still Factor VIII and that means to us that the consequences that you cannot use Factor V Leiden Cambridge alone, at least we didn't feel comfortable by doing so. And we keep on working now by improving that situation. But it really -- it means to us that we cannot move this into development.
Now what does that mean? That's the bottom panel you see here, it's essentially we moved it back to research, discovery and innovation. However, we are planning to stay active in the area of hematology.
hugin.info/132631/R/1317501/307347.pdf