Prochymal not as promising as we thought?

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Reef08
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Date Joined Dec 2005
Total Posts : 267
   Posted 3/27/2009 12:25 PM (GMT -7)   

jmiller056
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Date Joined Feb 2009
Total Posts : 57
   Posted 3/27/2009 12:59 PM (GMT -7)   
What a downer.... I was and I'm still looking forward to Prochymal. From what I gathered from the article, it sounds like the problem isn't that Prochymal is not effective, but the trial design is the problem. If Prochymal still proves to be an effective treatment, then this is just a minor setback, but it will be so devastating if we find out that it never actually worked....
Dx Crohn's Disease in 2001 at age 14. Lost 3 inches of colon and 7 inches of ileum in 2004 bowel resection.

CD returns in October 2008 at age 22.

Current meds: Pentasa: 3000 mg; Fibercon: 2 pills 3x; Imodium: 2 pills 3x

Ineffective Drugs: Imuran, Entocort, Remicade


goldy3
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Date Joined Feb 2009
Total Posts : 139
   Posted 3/27/2009 1:48 PM (GMT -7)   
I saw that article today...very disappointing....
 


pb4
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Date Joined Feb 2004
Total Posts : 20576
   Posted 3/27/2009 2:15 PM (GMT -7)   
Hopefully it's nothing more than a few glitches that need to be worked out.

:)
My bum is broken....there's a big crack down the middle of it! LOL :)


ivy6
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Date Joined Sep 2005
Total Posts : 10404
   Posted 3/27/2009 2:44 PM (GMT -7)   
Oh, no! That is heartbreaking. I hope it truly is a logistical glitch, and not a problem with the drug itself.

:-(

So many people have pinned their hopes on that drug...
Co-Moderator Crohn's Forum.


Rider Fan
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Date Joined May 2008
Total Posts : 1445
   Posted 3/27/2009 2:48 PM (GMT -7)   
They make it sound like Osiris is some kind of spin shop, fly by night operation. Kind of glad they rejected me from the trial.

I thought it was fishy when they weren't taking on Kasper either. I wonder what's really going on over there....
32 y/o male. Dx'ed in 1999. No surgeries.

Current meds: Humira 2/27/09. 17.5mg prednisone. Udo's Choice Probiotics (30 billion). Can't tolerate any iron supplements.

Tried SCD, didn't work, now avoiding gluten and dairy.


mtgman
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Date Joined Mar 2005
Total Posts : 1289
   Posted 3/27/2009 3:56 PM (GMT -7)   
wow. that sucks. sounds like a shady co.
that looks like it's a lot more than a logistical glitch.

ivy6
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Date Joined Sep 2005
Total Posts : 10404
   Posted 3/29/2009 4:59 PM (GMT -7)   
Wow. Interesting. Thanks for that.

Who are you, BetterIdea? Were you connected with the trial in some way?
Co-Moderator Crohn's Forum.


SydneyJo
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Date Joined Mar 2006
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   Posted 3/29/2009 5:25 PM (GMT -7)   
Great! Now I have nothing drugwise to look forward to :(

ivy6
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Total Posts : 10404
   Posted 3/29/2009 5:52 PM (GMT -7)   
Jo, the Aust Crohn's Assn recently advertised for people who hadn't take Rem or Humira, to trial a new investigational drug. Don't know what it is, but that might be something to look forward to?
Co-Moderator Crohn's Forum.


Rider Fan
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Date Joined May 2008
Total Posts : 1445
   Posted 3/29/2009 5:58 PM (GMT -7)   
BetterIdea said...
Osiris Therapeutics is an extremely reputable company. They discovered that the patients who had received the Placebo were lying about their results. Why would Placebo patients do that? Follow this:


The Prochymal trials were set up as a two step trial. The first step was designated as trial S-603 and was the introductory step. Patients were split into 3 groups. A High Dose Group, a Low Dose Group and a Placebo Group. The next follow-on trial was designated as trial S-610 and was a maintenance step. Most of the Patients were begging for the Prochymal because they knew it was working. Wanting to help these people, Osiris told all three groups in the S-603 trial that if their CDAI score dropped by 100 points or more then they would be eligible to participate in the S-610 trial. 210 people were enrolled in the S-603 trial.



The CDAI score is a subjective measure based upon the patients statements on how they say they felt. At about the mid-point of the S-603 trial, the control board discovered that most of the Placebo patients were fudging their CDAI score, just so they would qualify for the next S-610 trial. They thought that there would be a 50-50 chance of them getting the real Prochymal in the next trial.



Being a reputable company, Osiris decide to stop the trial and to redesign a new trial that doesn't have an implied incentive to cheat on the numbers. Prochymal was working for those who got it and it was the Placebo group who screwed the test up. That's too bad because it will delay Prochymal from getting on the market for Crohns for at least another year...and that's really is bad, because it works.



Most of you are probably not aware that Prochymal has already been approved by the FDA, but only for critical life threatening GvHD patients. That's Graft versus Host Disease. It's been FDA proven that it is 100% safe with no adverse side effects and has already been used on over 3,000 patients. That's how Osiris discovered that Prochymal works on Crohns, because GvHD is so similar to Crohns. Unfortunately, the FDA rules require Trials for each disease.



Prochymal is not just a maintenance "feel better" drug. It actually cures. Don't beat this drug up, it will probably be the answer to your prayers, but now it will take a little longer to get here.


How do you know it works? The phase III data have not been published. The phase II study included only 10 people. I'm not beating the drug up, I would like it to work as much as anyone. Also, I would wait a while before calling a drug that hasn't even been approved yet a "cure".
32 y/o male. Dx'ed in 1999. No surgeries.

Current meds: Humira 2/27/09. 17.5mg prednisone. Udo's Choice Probiotics (30 billion). Can't tolerate any iron supplements.

Tried SCD, didn't work, now avoiding gluten and dairy.


Reef08
Regular Member


Date Joined Dec 2005
Total Posts : 267
   Posted 3/29/2009 6:49 PM (GMT -7)   
BetterIdea said...
Osiris Therapeutics is an extremely reputable company.  They discovered that the patients who had received the Placebo were lying about their results.  Why would Placebo patients do that?  Follow this:
 
The Prochymal trials were set up as a two step trial.  The first step was designated as trial S-603 and was the introductory step.  Patients were split into 3 groups. A High Dose Group, a Low Dose Group and a Placebo Group.  The next follow-on trial was designated as trial S-610 and was a maintenance step.  Most of the Patients were begging for the Prochymal because they knew it was working.  Wanting to help these people, Osiris told all three groups in the S-603 trial that if their CDAI score dropped by 100 points  or more then they would be eligible to participate in the S-610 trial.  210 people were enrolled in the S-603 trial.
 
The CDAI score is a subjective measure based upon the patients statements on how they say they felt.   At about the mid-point of the S-603 trial, the control board discovered that most of the Placebo patients were fudging their CDAI score, just so they would qualify for the next S-610 trial.  They thought that there would be a 50-50 chance of them getting the real Prochymal in the next trial. 
 
Being a reputable company, Osiris decide to stop the trial and to redesign a new trial that doesn't have an implied incentive to cheat on the numbers.  Prochymal was working for those who got it and it was the Placebo group who screwed the test up.  That's too bad because it will delay Prochymal from getting on the market for Crohns for at least another year...and that's really is bad,  because it works.
 
Most of you are probably not aware that Prochymal has already been approved by the FDA, but only for critical life threatening GvHD patients.  That's Graft versus Host Disease.  It's been FDA proven that it is 100% safe with no adverse side effects and has already been used on over 3,000 patients.  That's how Osiris discovered that Prochymal works on Crohns, because GvHD is so similar to Crohns.  Unfortunately, the FDA rules require Trials for each disease.
 
Prochymal is not just a maintenance "feel better" drug.  It actually cures.  Don't beat this drug up, it will probably be the answer to your prayers, but now it will take a little longer to get here.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sounds like you have a financial interest in Osiris' stock, being that this is your first post.  I hope you're right, but where are you getting the idea that this cures Crohn's?  Many people on this forum have been in the trial and as far as I know, none have have been cured.  I think most of us expect this drug to keep us in remission as long as we keep taking it (at best).

lovepink
Regular Member


Date Joined Sep 2007
Total Posts : 182
   Posted 3/29/2009 7:02 PM (GMT -7)   
Wow, this is very sad. I actually just made my FINAL decision to not participate in this study in SEATTLE! I have heard nothing but good things about this. Is this about the study as a whole? Yuck. Bad news to me. It looks great to me. Something I am really looking forward to for when it is finally FDA approved. Let's all keep in touch about this please! Thanks for the info. I love this forum.

Gosh being so sick is so hard, but I will keep going one day @ a time, one symptom and disease @ a time!!!!

LOVEPINK
I have had Crohn's since I was 21 years old and I am now 28!!
Unfortunately, nothing has worked for me. But I will keep on going and trying everything possible!


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 3/29/2009 7:28 PM (GMT -7)   
Well, that article was not exactly neutral either. For a person who did NOT fudge the 603 results, and can say with NO doubt that Prochymal led to a 50% healing (based on video taped colonoscopy results), I can fully understand BetterIdea's reasoning. I can see why someone would misrepresent their 603 results in order to get a new randomization in hopes of receiving the real cells in 610.

I am still keeping my eye open and my hopes up. I know what I experienced with no question. It's the only drug, aside from steroids, that have helped me.
--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
--Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08 => STOPPED 10/3/08 - now 2 months into it & it was the right decision
--currently taking budesonide suppositories, 3mg at night.  SLIPPING big time.  Started Cimzia first dose 2/10/09.  cipro/flagyl cocktail 3/25/09  Dx Osteoporosis 10/08 started Forteo 1/27/09
--single mom to 11-yr-old girl


lovepink
Regular Member


Date Joined Sep 2007
Total Posts : 182
   Posted 3/29/2009 7:36 PM (GMT -7)   
Oh okay! I was recently taken off of all medications and have been on everything available for Crohn's so that is why I am so excited for this to become FDA approved. I have read and heard great things about it, so this most recent "yucky" article was weird and not expected to me. So really, how are you doing on the Study?! I would like to know everything! I am so happy for you if it is helping @ all.

LOVEPINK!!
I have had Crohn's since I was 21 years old and I am now 28!!
Unfortunately, nothing has worked for me. But I will keep on going and trying everything possible!


sr5599
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Date Joined Aug 2007
Total Posts : 1202
   Posted 3/29/2009 8:34 PM (GMT -7)   
I'm a year and a half out of 603. I heard a rumor that there would be on open-label and I might be eligible at my 2-year marker date. The effects from the first round of infusions (603) lasted about 3 months. So it's not as if Prochymal can be touted as a cure but it was quite effective for me.

I am not the only person who was in the trial on this forum. I believe NorthernGuy was also in it.
--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
--Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08 => STOPPED 10/3/08 - now 2 months into it & it was the right decision
--currently taking budesonide suppositories, 3mg at night.  SLIPPING big time.  Started Cimzia first dose 2/10/09.  cipro/flagyl cocktail 3/25/09  Dx Osteoporosis 10/08 started Forteo 1/27/09
--single mom to 11-yr-old girl


lovepink
Regular Member


Date Joined Sep 2007
Total Posts : 182
   Posted 3/29/2009 8:39 PM (GMT -7)   
Wow, well that is amazing! Yes, I was told that Rumor is for sure TRUE! So good for you huh? Fabulous. @ the 2 year mark. I thought that was sorta cool. So that would be only 6 months for you? Wow- I would love to hear more....

NorthernGUY: are you on this study to? I would love to hear what you think! I will also start a Post to NorthernGuy! Thanks so much!

LOVEPINK!!
I have had Crohn's since I was 21 years old and I am now 28!!
Unfortunately, nothing has worked for me. But I will keep on going and trying everything possible!


MMMNAVY
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Date Joined Jul 2006
Total Posts : 6927
   Posted 3/29/2009 9:38 PM (GMT -7)   
BetterIdea,
Please understand that while we are hopeful for a "cure," but until it is used in medical textbooks, it is not a word we use.
I have to agree with you that it sounds like a pretty poorly designed study. Besides who uses CDAI as marker? (well besides me...lol? it is not the most reliable of markers) I imagine that is would be pretty difficult to get funding for something that you could not prove concretely, like by blood test? To rely on symptomology vs signs makes an inherently flawed study. I have to admit I get a giggle out of a drug company named for the god of the dead/afterlife.
 

I hope you understand that we have been burned badly in the past and just want to protect ourselves from people trying to sell us...rattlesnake oil vs sea snake oil.  The suspicion is not meant as a personal offense.
 


Forum Co-moderator - Crohn's Disease:_All comments have the caveat contact your local health care provider.

I will find a way or make one. –Phillip Sidney 1554-1586

All that I am and all that I shall ever be, I owe to my Angel Mother.

The Bucket List- Have you found joy in your life?  Has your life brought joy to others?

Make sure your suffering has meaning…

Post Edited (MMMNAVY) : 3/29/2009 10:42:02 PM (GMT-6)


sr5599
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Date Joined Aug 2007
Total Posts : 1202
   Posted 3/29/2009 10:44 PM (GMT -7)   
Every study I have enrolled in (or tried to enroll in) has used CDAI as a marker... Not only for eligibility but for response.

While the C-reactive protein level does accurately indicate inflammation in some patients with Crohn's, that is not a reliable source of data either. They did test for CDAI and they tested the white blood cell count.

The Osiris study had a handful of trial sites which were designated colonoscopy centers. (As was the office I participated at.) Those sites video taped the scope at day 0 and day 30. And even a colonoscopy is not 100% indicative of results. They'd have to do that and an upper scope.

All if all, clinical trials rely upon the honesty of a number or participants. I can't imagine what a person who misrepresents their condition is thinking. But, to get into this trial one has to have failed pretty much every other approved treatment. That makes it understandable that every person is at the end of their rope and desperate for a treatment that works.

I'm not entirely sure that Prochymal has been approved for GVHD yet, though. I think it's been submitted? Not sure on that one.
--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
--Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08 => STOPPED 10/3/08 - now 2 months into it & it was the right decision
--currently taking budesonide suppositories, 3mg at night.  SLIPPING big time.  Started Cimzia first dose 2/10/09.  cipro/flagyl cocktail 3/25/09  Dx Osteoporosis 10/08 started Forteo 1/27/09
--single mom to 11-yr-old girl


onebloodonelife
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Date Joined Feb 2006
Total Posts : 842
   Posted 3/30/2009 3:05 AM (GMT -7)   
Well, after seeing this last night, I was absolutely crushed.

I've been off of all Crohn's meds for close to 75 days now, after failing Tysabri, in order to become eligible for this trial. This was essentially my last shot...I have the option to possibly try Cimzia, but with maybe a 20-30% chance at remission, according to my doc, because I've been on and failed three of the four biologics on the market now.

It's incredibly disappointing to see a promising trial like this one get completely thrown out the window because of patients' misrepresenting their relief. I understand why the patients would do it, they're just as at the end of the line as I am...and it becomes a desperate situation to find relief anywhere.

Is it typical for a trial to promise entry into a second-stage trial if the patient's CDAI drops by a certain amount? That seems to me where Osiris went wrong...if they had said you would be considered for the second trial after reviewing your progress or something, I think they could've avoided this problem.

Really though, it's the patients who are going to suffer greatly from this, especially if FDA approval does get pushed back a couple years because of it.



Also, that article makes the whole thing sound incredibly sinister, when I hope and think it probably wasn't. Osiris has the official press release up on their site, I'd suggest reading over it, at the very least to gain another perspective on the whole thing...
http://www.osiristx.com/
Crohn's Disease diagnosed March 8th, 2006
Failed medications: Prednisone, Imuran, Remicade, Humira, Tysabri
Hoping to get into the Phase III Prochymal trials

Post Edited (onebloodonelife) : 3/30/2009 4:09:28 AM (GMT-6)


MMMNAVY
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Date Joined Jul 2006
Total Posts : 6927
   Posted 3/30/2009 6:05 AM (GMT -7)   
For right now everyone it just means there was a poorly designed study and do not draw any conconclusions until this has past the FDA process.
Forum Co-moderator - Crohn's Disease:_All comments have the caveat contact your local health care provider.

I will find a way or make one. –Phillip Sidney 1554-1586

All that I am and all that I shall ever be, I owe to my Angel Mother.

The Bucket List- Have you found joy in your life?  Has your life brought joy to others?

Make sure your suffering has meaning…


aoccc
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Date Joined Feb 2005
Total Posts : 455
   Posted 3/30/2009 7:04 AM (GMT -7)   
any old school daytrader knows never to trust an article from thestreet.com...the writers are amateurs and they only have their short term greed in mind, including that loser Cramer.
SCD since 01, remission since 01, occasional Arby's breaks :)


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 3/30/2009 2:58 PM (GMT -7)   
If anyone wants details, you can listen to the webcast replay: http://investor.osiris.com/eventdetail.cfm
 


--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
--Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08 => STOPPED 10/3/08 - now 2 months into it & it was the right decision
--currently taking budesonide suppositories, 3mg at night.  SLIPPING big time.  Started Cimzia first dose 2/10/09.  cipro/flagyl cocktail 3/25/09  Dx Osteoporosis 10/08 started Forteo 1/27/09
--single mom to 11-yr-old girl

Post Edited (sr5599) : 3/30/2009 10:08:32 PM (GMT-6)


northernguy
Regular Member


Date Joined Oct 2007
Total Posts : 39
   Posted 3/31/2009 8:33 PM (GMT -7)   
Hey guys- I was crushed too when I heard this news. I was in this trial and my doc and I both felt that it did wonders for me. At the time of this news I was in the process of setting up my one year follow up with the trial coordinator at the University of Minnesota. I guess now all I can do is wait and see what Osiris will do. Hopefully it is just a minor setback towards FDA approval , but who knows. If they decide to do another phase III trial I will definetely try and get back into it. Kinda makes me mad that if I person is as sick as some of us are that they cant make some exceptions and just give you the darn stem cells so that you can get on with your life and not basically be a lepper. UGH!!!

Nanners
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Date Joined Apr 2005
Total Posts : 14995
   Posted 4/8/2009 9:13 AM (GMT -7)   
Bumped up for britt1449
Gail*Nanners* Co-Moderator for Anxiety/Panic Forum
Been living with Crohn's Disease for 33 years. Currently on Asacol, Prilosec, Estrace, Prinivil, Diltiazem, Percoset prn for pain, Zofran, Phenergan, Probiotics, and Calcium and Xanax as needed. Resections in 2002 and 2005. Also diagnosed with Fibromyalgia and Osteoarthritis and Anxiety. Currently my Crohns is in remission.
*Every tomorrow has two handles.  We can take hold of it by the handle of anxiety, or by the handle of faith"*
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