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I Want a New Drug, II

Dexpramipexole

Cover of Huey Lewis’s single ’I Want a New Drug’In an earlier post, I linked to a couple of articles about the testing of a prospective new ALS drug, “dexpramipexole,” and plans to move to phase III trials of it.

The phase III trial announcement was posted on the NIH’s clinical trials website on February 10, 2011. Apparently, the hoped-for “fast-tracking” is happening, though the study’s estimated completion date is February of 2013. Not such a fast track, then, ALS timeline-wise.

Results from the phase two study of this drug are published on-line in Neurology Today.

Neuraltus’s “NP001”

Another drug in the testing pipeline is known only as “NP001” and is being developed by Neuraltus Pharmaceuticals. This drug is just entering a phase II trial (announced on the NIH clinical trials site on January 17, 2011). It’s very early on this one, but some of the doctors involved are very well-regarded, and the phase I results appear to be encouraging. Here’s an excerpt:

Robert G. Miller, M.D., the study’s principal investigator and Medical and Program Director of the Forbes Norris MDA/ALS Research Center, commented, “NP001 appears to have affected the level of a biomarker directly related to ALS pathogenesis in a dose-dependent manner. This is extremely promising and is virtually unprecedented in ALS research. In addition, the safety profile of NP001 is very reassuring and gives us confidence going into the Phase 2 clinical study.”

Still, the expected end date of this trial is October of 2012 (and it’s only phase II)—so a long time out, unfortunately.

Other Studies

There are a few other studies—none that are particularly exciting—listed on the NIH Amyotrophic Lateral Sclerosis Open Studies page. One of possible interest is the study of a High Fat/High Calorie Diet in ALS patients. I’m already conducting my own independent test of this one. :-)

None of the drugs or treatments in clinical trials aim to “cure” ALS or to reverse its effects. Slowing or halting its progression is the best that is promised at this point.

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