Novartis trial is now in Phase II

[wilfried]

Nogo-A antibody in Phase II
http://www.ifp-zh.ch/index.php?id=353

In the summer of 2006 a clinical study with the Nogo-A antibody therapy was initiated. The study is coordinated and carried out by Novartis within the framework of a European network of rehabilitation centers - the sci-em project which was co-financed by the foundations of the IFP and IRP .

Patients with an acute spinal cord injury were treated with Nogo-A antibodies during one month. The interim results of Phase I (safety and toxicology study) are encouraging: so far, no adverse reactions occurred. Even high doses of antibodies, directly infused into the spinal fluid of the patients was well tolerated. Currently, a transitional Phase I/II group of paraplegic and tetraplegic patients has been started. The same standards of the ethics commission apply, concerning side effects and dosage. It will also be investigated whether the type of administering the antibody could be converted to individual injections, thus potential risks could further be minimized. We hope to finish this phase in early 2009, and to see the first signs of positive effects in some of the most severely injured patients.
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They are extending the trial to Spain:
http://clinicaltrials.gov/ct2/show/NCT00406016?term=Ati355&rank=1

[zepac]

The started with this in 2006 summer and still nothing? Not positive effects or negative? So its not working if its doing nothing.

[Wise Young]

The started with this in 2006 summer and still nothing? Not positive effects or negative? So its not working if its doing nothing.

In contrast, the fact that they are going ahead with a phase 2 trial is a good sign that the trial shows that the treatment is safe and may be showing some benefit as well. This is not a controlled trial and the treatment is being given early (first two weeks) after injury.

As you know, most people recover some function after injury. Even ASIA A patients usually get 2-3 levels of sensory function back and perhaps 1-2 levels of motor function. Occasionally (5%) ASIA A patients can get some motor function and return of anal function (resulting in ASIA C).

Without a control group to compare against, there is no way that they can tell whether there is a treatment effect versus a spontaneous recovery. There may also be too few patients to be able to detect a small change. I hope that they will present the results soon.

I am optimistic.

Wise.
Wise.

[KIM]

Control group? If no lesion is the same it is going to be difficult to compare. I think they might expect more recovery than average.

[Wise Young]

Control group? If no lesion is the same it is going to be difficult to compare. I think they might expect more recovery than average.

KIM,

There is some variability in recovery and you have to be careful to segregate complete and incomplete injuries. You only need 40-50 patients per treatment group so show a 20% neurological motor score difference.

In the NASCIS study to assess methylprednisolone, we detected a statistically significan effect of high-dose methylprednisolone therapy when we randomized 487 patients to placebo, methylprednisolone, or naloxone. We also segregated the patients by the time after injury (before and after 8 hours) and whether the injury was "complete" or not. This resulted in about 80 patients receiving the early treatment and about 40 patients that were complete or incomplete. With 40-50 patients per treatment group, it is possible to determine whether a treatment has a significantly better effect that a placebo group.

Wise.

[Leif]

But on these there are no studies, right? And to say CR overcomes to move his left finger is a bit vague. ASIA A or Z who actually cares. Aside, what are laboratories doing these days, as for SCIed, acute or chronic? Not much, can you list the Rutgers SCI program for SCI chronic cures for 2009? What are the Rutgers labs doing, how many are working on cures for chronic SCI, the technicality as for the programs and how long if/the programs will last, and what is to be the expected outcome due to this?

Placebo chronic SCI group, good one.