New Crohns study coming

[Guest guest]

For Crohn's Disease

PRECISE-1 and PRECISE-2. Celltech has announced two pivotal studies to test CDP870, an antibody that targets TNF-alpha, a protein that contributes to the intestinal inflammation in Crohn's disease. CDP870 is a biologic drug therapy that is administered by subcutaneous (under the skin) injection. The PRECISE trials are large, international studies that will involve more than 1,300 patients to assess how well CDP870 induces and maintains remission in people with moderate to severe Crohn's disease. PRECISE stands for Pegylated antibody fRagment Evaluation in Crohn's dIsease: Safety and Efficacy, a new technology developed for delivering this biologic drug to the TNF-alpha target. Recruitment for the trials is expected to start in January 2004.

Arne

52 - UC 9/77 - PSC 4/00

Alive and (mostly) well in Minnesota

[Guest guest]

Arne;

Thanks for your post about the CDP870 trials for Crohn's disease.

Unfortunately, CDP870 seems to have been a little disappointing in

peliminary phase II trials:

BiotechTracker - Disappointing Data for CDP571 and CDP870 in Crohn

Disease Trials

http://www.bioportfolio.com/news/biotracker_123.htm

Best regards,

Dave

(father of (18 yr); dx PSC 07/03; dx UC 08/03)

[Guest guest]

Dave,

Although at first glance it appears that

the trial was less than successful keep in mind they are still working out dosing

and such. There is a similar TNF-a inhibitor on the market (see email

below) and it is administered bi-weekly not every 4 weeks as in the

study. As for its use in Crohn’s, UC or PSC we really cant say

either way just yet. These drugs are relatively new and given the level

of understanding about the cause of these diseases (none at all) it is hard to

say how successful these drugs will be. They are however very effective

in rheumatoid arthritis, another autoimmune disease. I am very hopeful

that we are very near an improved therapy that will actually do something for

people like us.

Mark

Dear Mark:

Thanks

for your interest in Celltech's studies. My hat is off to you for

following the field so closely. There may indeed be utility for CDP870 in UC.

We have chosen Crohn's to study first in our Phase III trails as our Phase II

was in Crohn's. It has the clearest entry and endpoint criteria of the two

diseases. It may be that Celltech will choose to move ahead in UC as well but

those studies are not planned as yet. There are other anti-TNF agents out there

right now, such as Humira. While not approved for Crohn's or UC at this point

you might explore this with your physician. The biggest issue you will face is

that since it is not approved for UC, your insurance probably won't cover it's

use in UC; Humira is quite expensive.

I wish you the best of luck,

Randy Schatzman

Re: New

Crohns study coming

Arne;

Thanks for your post about the CDP870 trials for

Crohn's disease.

Unfortunately, CDP870 seems to have been a little

disappointing in

peliminary phase II trials:

BiotechTracker - Disappointing Data for CDP571 and

CDP870 in Crohn

Disease Trials

http://www.bioportfolio.com/news/biotracker_123.htm

Best regards,

Dave

(father of (18 yr); dx PSC 07/03; dx UC

08/03)

[Guest guest]

Thanks Mark;

I appreciate your clarification of the CellTech's studies. I also am

very hopeful that this new generation of TNFa inhibitors will prove

useful for UC and Crohn's. This area of research is certainly very

promising, and has given me reason to be optimistic about eventually

finding a cure or more effective treatment for these inflammatory

bowel diseases. I've been trying to read up on the various results

with different TNFa inhibitors. It is curious that Infliximab has

shown very promising results for Crohn's, but Etanercept is

apparently not effective in this disease:

Sandborn WJ 2003 Strategies for targeting tumour necrosis factor in

IBD. Best Pract. Res. Clin. Gastroenterol. 17: 105-117 (PMID:

12617886).

Sandborn WJ 2003 Optimizing anti-tumor necrosis factor strategies in

inflammatory bowel disease. Curr. Gastroenterol. Rep. 5: 501-505.

(PMID: 14602060)

Maybe Etanercept or one of these newer TNFa inhibitors will prove

useful for UC?... I certainly hope so!!

For this reason I was interested in the following trial at NEMC:

Primary Sclerosing Cholangitis: An Open-label Pilot Study of Enbrel ®

(Etanercept) in the Treatment of Primary Sclerosing Cholangitis

http://www.tufts-nemc.org/medicine/gastro/gastroclinicaltrials.htm

I wondered whether anyone has heard anything about this trial?

Best regards,

Dave

http://home.insightbb.com/~rhodesdavid/