NIDDK Terminates Cell Cept Study

[icnmgrjill]

In a move that has caught the IC patient community by surprise, the NIDDK has terminated the clinical trial of CellCept for the treatment of refractory Interstitial Cystitis/Painful Bladder Syndrome. This action was taken upon the recommendation of the Data Safety Monitoring Board which reviewed interim data at their meeting on January 23, 2008. Early results found a "lack of efficacy of the drug vs. placebo" suggesting that it would be futile to continue the trial.

Cellcept created early excitement as a possible new therapy for IC, particularly for patients who had more severe IC. Unfortunately, it was learned that Cellcept contributed to a high rate of fetal defects in patients who became pregnant, resulting in the FDA safety alert issued in the past few months. Sadly, the data was not promising as well. More research results will be published shortly to discuss, in depth, what occurred.

[stacym]

I am quite surprised about the results of the study. I have studies here (let me know if you need the reference point to them) that say about 50% of people with IC responded to methotrexate (chemo/immunosuppresant) and even better percentages for cyclosporine (although side effects are really tough!). It doesn't make sense to me that they didn't see about the same improvement with Cellcept.

Any thoughts?

Stacy

[icnmgrjill]

He wouldn't share the results in detail so I guess we'll just have to wait to see what the published studies say. It's DEFINITELY a mystery and surprise.

Jill :)

[ejovan]

could you tell me about the familial tremor and neuromas. what is that. it sounds so neurological to me. thank you for your time so much

[SoTiredofIC]

This is very upsetting! I had heard about such great results from Cellcept! My doctor wouldn't prescribe it for me but I figured if my IC ever got a lot worse...

I don't see why the drug couldn't come with a strong warning like my Cytotec does, it has a large red ring around the top that says that pregnant women must NOT take this drug. I seem to recall another drug recently that required a negative pregnancy test before starting it.

When I found out that antibiotics lessened the efficiency of birth control pills, every time I had to take them, I continued on my pills, used a spermicide and made my husband wear a "raincoat".

Pity it can't continue to be used, I'll bet if folks found out that Cialis, Levitra or Viagra caused men to grow a third eyeball we'd see men walking around with an eye patch on their forehead!!!!! If it works for you and you are informed of the risks, you should be able to take it.

There was a drug used for IBS that had a lot of negative publicity and it was taken off the market. The folks who used it went crazy and demanded that they be able to use it no matter what the risks and the FDA did a reversal and now it can be prescribed for people suffering from IBS as long as they are willing to sign a statement holding their doctor and the drug company harmless if an adverse situation develops.

I guess we will all have access to the study and the results on medscape through the NIH website, I'm glad that the ICN is on top of this situation, I know that we will all get up-to-the-minute reports on future developments!