Prochrymal news

Has anyone been reading about Procryhmal?  Here's some info

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A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.

PROCHYMAL[tm] adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.

Osiris Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.

Outcome Measures for this Clinical Trial

Primary:

• Disease remission (CDAI at or below 150) 28 days

Secondary:

• Disease improvement (Reduction by at least 100 points in CDAI) 28 days
• Improvement in quality of life (IBDQ) 28 days
• Reduction in number of draining fistulas 28 days

There was an article in the Chicago Tribune a couple weeks ago that Prochrymal was approved by the FDA to treat terminally ill children with cancer.  It has also been made fast track status by the FDA.  Apparently from what I read the Phase 3 testing is coming to and end in the next couple of months and if all goes well look for FDA approval at the end of this year or beginning of 2009.   there's a ton of info about this online.  Not trying to get anyone's hopes up but looks very promising to take the place of some of the harsher treatments we have.

http://clinicaltrials.gov/ct2/show/record/NCT00482092

[*I just activated the link - C2]

Post Edited By Moderator (CrohnieToo) : 6/9/2008 6:07:58 PM (GMT-6)

The results for me were amazing. I won't retype all that I did before, especially since the link was posted in the Meds thread.

Personally I had great results personally while an Antegren... It was a Phase IV study med at the time... Then it got pulled... A couple people (MS patients) developed a life threatening condition (PML) ... I'm hopeful for Procryhmal, but not holding my breath for it either.

As for "lots of tests" being a deterrant for joining a study med or not, I'd caution against that being the reason. If you've been asked to join your Crohn's is in a state that might require lots of tests and monitoring anyway. If I were asked to join I would likely join as Phase III meds tend to have established *at least* a good amount of short term safety. (I'm not a likely candidate as Crohn's stays too close to remission for me to qualify for much in the way of study meds... but just far enough out to be a royal pain in the butt... pun intended...)

From what little I read on this study last night, I'm *guessing* it won't have any more risk than current therapies.

Will the prep tests be rough... Possibly... but by the sounds of it, Procryhmal did for Shari what Antegren did for me. Despite the risk with Antegren, I'd conditionally go back on it again if Crohn's got that bad again! Not being avaliable for Crohn's anymore makes that a pipedream... but hey it's a nice dream...


just my half-cent worth...

Good luck with it! I am always so excited to hear how it's going for others with Prochymal.

I agree that anyone who qualifies for the Prochymal trial should consider that they will benefit from all the screening tests. I was at a center that did colonoscopies at day 0 and day 28. In the beginning I cringed at 2 colonoscopies in a month. But, they're really not all that bad and it was fascinating to see the results in such a determinate manner. It was not just about how I felt or what boxes I checked for my CDAI score. There was concrete evidence of healing through the scopes.

There are many people who have reactions to Remicade and do fine on Humira. From what I understand, most of the Remicade reactions have to do with the fact that it's made from mouse antibodies. It's foreign to our systems. Humira does not have that problem.

RE Prochymal coming out. It's true that it's on fast track, but it still needs to complete the trials before being submitted. I figured it would be much later than '09. Did you hear that from a trial coordinator? Or is it just hopeful thinking?

What is GVHD?  I was so excited about the fast-track status on Prochymal, thinking it might be available for us soon.  Maybe they'll fast-track it for Crohn's later this year...

From what I have been told, it has both fast track and orphan drug status for both GVHD and Crohn's. However, the GVHD started trials earlier. The fast track only says it gets through the approval/denial process within a designated timeframe... but that is *once it is submitted* for approval. And, it can't be submitted until the trials are complete.

I've also been told they are conducting both phase 3a and phase 3b trials for Crohn's. So, yes, it will be years. :-( I still hope it goes faster than expected! and, at least we know that once it's submitted it won't take too long.

Sounds good to me -thanks for the info.