Parkinson Pipeline Project-treatment development database, research, FDA drug approval, PD clinical trials and sponsors, patient involvement

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“Fluid convection within the brain” is important because if the fluid moves, it can penetrate much larger distances than the diffusion of a large protein molecule would and consequently can be used to reach and saturate a biologically-interesting part of the brain.

Let me show you what this so-called convection looks like in agar. (video)

When it works like we would like it to work, as the first and the second from the left, we get a spherical distribution of the agent. When the flow conditions are not right, the fluid clings to the outside of the cannula and creeps up. This is known as a backflow.

With that as a background, the surgeon involved in the open-label trial and the surgeons involved in the multi-site control trial thought that they were doing convection enhanced delivery. The first clinical results in the open-label trial look pretty good.

The Phase II trial does not look as good. The first thing you notice is that the results are scattered, like a bunch of peas thrown against a wall. Unfortunately, the way the investigators looked at it, they compared the average of the left side to the average of the right side and the results were something like a 20 percent improvement – but less than the completely arbitrarily-picked target of 30 percent. And consequently it was a failure, trial halted, let's go home.

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