Prochrymal news

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mtbcubs2004
Regular Member


Date Joined May 2008
Total Posts : 25
   Posted 6/5/2008 10:22 AM (GMT -7)   
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.

 


Jason D in MN
Regular Member


Date Joined Jun 2008
Total Posts : 54
   Posted 6/5/2008 11:31 AM (GMT -7)   
can you toss a link to the article, and also to an abstract for the study referenced? (NIH usually has these)
-- Jason
Diagnoses? Crohn's in 1983; Kidney Stones in 1997; Reactive Airway Syndrome in 2002; Major Depression and GAD in 2003; Migraines in 2006; ADHD and IBS in 2007.

Current Meds? 6MP; Adderall; Wellbutrin; Zoloft; Albuterol (emergencies only); Fexofenadine; and Epidrin or Imitrex (depends on migraine severity...etc)

Overall: Things are So-So. In other words "It could be worse. It could be raining."


mtbcubs2004
Regular Member


Date Joined May 2008
Total Posts : 25
   Posted 6/5/2008 11:52 AM (GMT -7)   
 
[*I just activated the link - C2]

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


ivy6
Elite Member


Date Joined Sep 2005
Total Posts : 10404
   Posted 6/5/2008 4:23 PM (GMT -7)   
Shari, a member of this forum, has been on Prochymal. You can find the link to her thread where she discusses her experiences in the New Meds thread .

Ivy.
Co-Moderator Crohn's Forum.


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 6/5/2008 8:42 PM (GMT -7)   
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.
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--stuck on methylprednisolone, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08, started Xifanan 5/24/08 
--single mom to 10-yr-old girl


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 6/6/2008 9:05 AM (GMT -7)   
It's true that the tests are extensive for Prochymal. For me it was, without question, worthwhile. It's mostly that first week, before you get to start the infusions that's hard. But, it's over before you know it and if you get the real cells, it is likely worth the effort.

If you've been approached to enter the trial, you have failed most every other treatment. I would say to seriously consider the trial. But, that's just me!

Stem cells are very exciting from my perspective. From what I experienced with Prochyal, if it's any indication, the are very, very promising!

If you decide to join the trial, I'd love to know how it goes!
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--stuck on methylprednisolone, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08, started Xifanan 5/24/08 
--single mom to 10-yr-old girl


Jason D in MN
Regular Member


Date Joined Jun 2008
Total Posts : 54
   Posted 6/6/2008 9:38 AM (GMT -7)   
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...
-- Jason
Diagnoses? Crohn's in 1983; Kidney Stones in 1997; Reactive Airway Syndrome in 2002; Major Depression and GAD in 2003; Migraines in 2006; ADHD and IBS in 2007.

Current Meds? 6MP; Adderall; Wellbutrin; Zoloft; Albuterol (emergencies only); Fexofenadine; and Epidrin or Imitrex (depends on migraine severity...etc)

Overall: Things are So-So. In other words "It could be worse. It could be raining."


Puccini
New Member


Date Joined Jun 2008
Total Posts : 5
   Posted 6/9/2008 10:59 AM (GMT -7)   
I'm to hear from NIH shortly about participating in the Phase III trial which has been fasttracked by FDA.  I'm hoping I am eligible as what I've read about Prochymal sounds really good.
 
 
Diagnosed in 1978 - 5 resections of terminal illeum - currently on AZA - out of remission
 
Puccini

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 6/9/2008 10:00 PM (GMT -7)   
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.
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--stuck on methylprednisolone, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08, started Xifanan 5/24/08 
--single mom to 10-yr-old girl


Puccini
New Member


Date Joined Jun 2008
Total Posts : 5
   Posted 6/10/2008 6:10 AM (GMT -7)   
Looks like I am not eligible as I am having possible fistula surgery late June. Would have to wait 6 wks post op. Also, they want people who would have a lot of symtoms for the CDAI and currently I do not have many. Priase God. So, I hope the drug will be on the market early '09. I was scheduled for Humira but my GI was afraid I'd go into "shock" as I had a reaction to Remicade. He does not see many crohns patients so I am switching to one that works closely with my surgeon. Right now, I plan to just stick with AZA as I am afraid of the biologics right now.

Thanks for the support.

Puccini

sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 6/10/2008 9:44 AM (GMT -7)   
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?
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--stuck on methylprednisolone, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08, started Xifanan 5/24/08 
--single mom to 10-yr-old girl


Puccini
New Member


Date Joined Jun 2008
Total Posts : 5
   Posted 6/10/2008 10:06 AM (GMT -7)   
My current GI is concerned that I might react to what Remicade and Humira have in common rather than the fact that one is mouse protein and the other human synthetic. I've a history of allergic reactions to numerous drugs. Will be seeing a new doc. after my surgery to explore this issue more.

Re Prochymal - It was hopeful thinking. I spoke once again to the NIH rep. this a.m. and asked her just that question. She said it is fast tracked for GVHD not crohns and her guess is it will take longer than a few years to get on the market. Too bad as it seems so promising.
 
 
 
 

Post Edited (Puccini) : 6/10/2008 11:12:38 AM (GMT-6)


map lady
Regular Member


Date Joined Feb 2008
Total Posts : 154
   Posted 6/10/2008 11:14 AM (GMT -7)   
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...

Puccini
New Member


Date Joined Jun 2008
Total Posts : 5
   Posted 6/10/2008 12:03 PM (GMT -7)   
GVHD stands for graft vs. host disease. In a nutshell, it is a serious complication that children with cancer get from having bone marrow transplants. Prochymal is saving their lives. I, too, was so excited when I found the drug info. on the net. My husband has heart disease and prochymal has been shown to reduce inflammation in the heart as well. Let's hope the regulatory system moves quickly for us all!

Post Edited (Puccini) : 6/10/2008 1:08:06 PM (GMT-6)


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 6/10/2008 1:45 PM (GMT -7)   
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.
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--stuck on methylprednisolone, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08, started Xifanan 5/24/08 
--single mom to 10-yr-old girl


Reef08
Regular Member


Date Joined Dec 2005
Total Posts : 267
   Posted 6/10/2008 4:33 PM (GMT -7)   
It's being fast-tracked for Crohn's too. It should be out by 2009, 2010 latest.

Puccini
New Member


Date Joined Jun 2008
Total Posts : 5
   Posted 6/10/2008 5:19 PM (GMT -7)   
Sounds good to me -thanks for the info.
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