Nuvion (therapy in trials) discontinued

That's too bad... any new drug would be an additional weapon against colectomy.


Nuvion (visilizumab) Pivotal Program Termination

Following review of data communicated by the Nuvion DMC this past Friday, August 24, PDL has decided that it will no longer pursue its phase 3 program of visilizumab in IVSR-UC, including both the RESTORE 1 and RESTORE 2 studies. The DMC interim evaluation included data from 91 patients in the RESTORE 1 trial at the 45-day primary endpoint. The analysis showed insufficient efficacy and an inferior safety profile in the visilizumab arm compared to IV steroids alone. The company is currently reviewing whether to continue the ongoing dose-ranging trial while it thoroughly evaluates the broader implications of these very recent results to the overall visilizumab program.

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Dx:

Left-sided UC, Jun 2005. Flex-sig only... clear for first 20cms, then inflamed through next 30cms.

Therapies:

Pharmaceutical: Pentasa 3G/day, hydrocort 1x every 7 days
Probiotics: Acidophilus Pearls, Primadophilus Bifidus
Naturals: Caprylic Acid, Methylated B-12, Vit ACDE, Zinc (w/copper), Selenium, Turmeric, Bromelain, Luteolin
Killer Foods: Soda, Fried Food (especially french fries!), Beer, Red Wine, Pepperoncinis

KB5: Did you ever follow up on that treatment on your own? I'm doing my own treatment (lidocaine enemas) based on somebody's dormant patent and it's working great--better than anything else I've tried. Can you give me the name of the trial drug and anything else you know about it? That would be cool. Thanks!

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Disease History:
1999: Ulcerative proctitis --> 2002: pancolitis --> 2006: 40cm left-sided colitis.

Current meds:
Lialda-4 pills in the am, Immodium-no longer needed, Lidocaine enemas-3oz/400mg twice a day.

Current condition:
Getting much better ...