Crohn's Disease Relief

Interesting Theory on Prochymal Study Placebo Effect

After yesterday's blog post about Osiris, I received a very interesting email from Lorie in Texas whose son was part of the Prochymal trials.  She posits that the people receiving the placebo may have reported a lessening of symptoms due to an anti-inflammatory property of the medium the stem cells is frozen in for stability which is called Dimethyl Sulfide (DMS for short.)  Because the stuff has a strong smell (like corn, I have heard people say) they also gave the placebo infusions in the same medium.

This is a very interesting idea to me.  Lorie also reported that her son had great results from the infusions he received.  Of course they do not know if he was on Prochymal or the Placebo, but they are very dissapointed that he has to wait to have further treatment. 

Considering the growing concerns about the downsides of the other biologic treatments currently used to fight severe Crohn's, I feel that the Prochymal trials should be put on as much of a fast track as is safe and appropriate.

The OSIRIS, Prochymal story just keeps getting more and more interesting, doesn't it.  It's a great story - it has a potentially life saving drug, questions about why the study ended early, a law firm nosing around, and angry patients accusing the FDA of killing Crohn's patients...  Top that off with the US Department of Defense stockpiling the medication for a purpose not yet needed.  It sounds like a mixture of Erin Brockovich, X-Files, House, and Boston Legal.

Here is the text of the email I received, which Lorie has given me permission to reprint for you.
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From: Lorie Conn
Date: Thu, 28 May 2009 13:34:08 +0000
To: Marianne Case
Subject: OSIRIS

I can give you a little bit of insight on the Prochymal Study, since my son was in the study for almost a year.

It is likely that the solution that they freeze the stem cells in to keep them stable,  (something called DMS (Dimethyl Sulfide), and it smells like fresh shucked corn) & which is also an anti-inflammatory agent in itself; if everybody is feeling better, it could be that the solution itself triggered a body response – with or without the stem cells in it.

However, if you DID get cells (it was a blind study, so who knows?) it was likely that you got better pretty fast – and that you KEPT getting better over time.

 I was really bummed that they stopped the study when they did, but I agree with you that if you find out something is wrong with your study you should stop it, redesign it & start over.  A clean study is needed for FDA approval!

 My son was in this study, and he changed from going to the bathroom 18 times a day,  down to 5 times – and boy what a change in his life! 

 I keep thinking, though, if they had given him more cells at one time that perhaps this could have been a permanent cure.  When they use Prochymal for the Graft vs Host infusions that’s what they do – one BIG infusion.  For some odd reason in the study for the Crohns patients they decided to only do a series of smaller infusions over a period of two weeks.   I think they’ve got a lot of testing yet to do – there will probably be no standard fix for every person. But the good news is it does seem to work! 

Lorie Conn

RICHARDSON, TEXAS

Osiris Therapeutics, Inc. OSIR - (NASDAQ)

I was laid off in December, after 10 years of working at the same company.  I had accumulated some money in my 401k there, and rolled it over into a rollover IRA.  My mom (the family investment maven with a proven track record) has been advising me on what to buy.  I asked her to check out Osiris for me, as I have been following the company's Crohn's Disease treatment trials for the stem cell product Prochymal.  When I read that Osiris had sold large amounts of Prochymal to the US Department of Defense for possible future use in case of a radiation emergency, I was intrigued.  That is an acutal sale, right?  My brain's wheels started clicking. 

Although it may be years before a new Crohn's Disease pahse III trial is completed and the drug approved, I still think that they may have something there.  Considering that the trials were scrapped because TOO MANY of the participants felt better, that is sure better than bad side effects, or it not working at all.  (Unfortunatelly almost all of the study participants reported feeling better - even the ones on the placebo.  They may have been effected by knowing that if they were on the drug and were doing better they would have a chance to continue taking it)  Also since Crohn's has a emotional component to it, they may have also had a feeling of elation at being part of the study and that may have made their symtoms get better for a time.  Anyone with Crohn's can tell you its an up and down situation.

Anyway, I bought just a little bit of Osiris, at about 12.15 a share earlier today.  I am a little bit excited and now I will be following them for the site as well as for myself.

I will still report negative as well as positive news about them.  By the way, there is a legal firl trying to investigate them for investor fraud due to the mishandling of the research trial.  (KaplanFox)  Seems kind of iffy to me, I don't think the company screwed up on purpose.  Not really in their best interests to do that.  The science of the study has to be clean.  If it was not set up properly, it has to be redone.  That is that.

Stock Information

OSIR - (NASDAQ) $12.15           - 0.17

Funny For the Day

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Learn More About Crohn's With Webcasts

In the last two days I received two press releases about Crohn's Disease related webcasts.  One is being sponsored by the CCFA and the other by Patient Power.  Here is more information about these webcasts where you can learn about some of the cutting edge Crohn's research and treatments being done today.

National Expert Addresses Inflammatory Bowel Disease Risks and Treatments During Crohn’s & Colitis Foundation Interactive Teleconference/Webcast

June 9

Dial-in from any phone to hear the presentation and participate in an interactive question-and-answer session, or log on to any computer to hear the presentation, see the program slides and submit questions.

Registration is available at no cost to participants via an online portal at www.ccfa.org/webcasts/risksandbenefits and by phone at 877-547-5641, ext. 312.

 

The Crohn's & Colitis Foundation is hosting an interactive educational teleconference/webcast, supported by an educational grant by UCB. Balancing the Risks and Benefits of Treatment for Inflammatory Bowel Diseases has been developed to meet the needs of patients seeking answers to questions regarding treatment.

·        What are the side effects of IBD medications?

·        When should surgery be considered?

·        How can I decide on the treatment that is right for me?

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Patient Power Webcast:

Leading-Edge Inflammatory Bowel Disease Therapy

8:00 pm Eastern (5:00 pm Pacific) on May 26th 2009

This will feature Dr. Terrence Barrett from Northwestern Memorial Hospital, discussing state-of-the-art management of inflammatory bowel disease. Learn when the top-down therapy approach, the early intervention of intensive therapies, can be appropriate for the management of Crohn’s disease. Non-surgical treatments will be highlighted, including how dietary management can enhance therapy. Cancer prevention and early detection also will be discussed.

Track the Progress of the IBD Bill

Here is a great page for keeping track of the status of the new proposed legislation to improve research and awareness for IBD.

Open Congress page for the Inflammatory Bowel Disease Research and Awareness Act S.981

Scroll back a post to read more about how you can contact your local representatives to help promote this great legislation.

Funny for the Day

Sometimes you just have to laugh.  Happy Mother's Day to all the Moms, Grandmas, and even the Dads and honorary Aunties and Uncles out there.  We would't be anywhere without your support.

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It's time to write your local Congressman and Senator

I just received word from the CCFA (Crohn's and Colitis Foundation of America) that there is new legislation in the US House of Representatives and Senate that would increase research and awareness for Inflammatory Bowel Diseases such as Crohn's and Ulcerative Colitis. 

I just sent a note to my Congressman telling him about the bill and how it is important to his constituents.  I ask you to do the same.

Write Your Representative - Via the US House Web Site.  The bills are H.R. 2275 (House bill number) and S. 981 (Senate bill number).

Here is more information from the CCFA.

We need your help to advocate for passage of the IBD Research and Awareness Act and to address the needs of the 1.4 million Americans with IBD.

This crucial legislation builds upon similar legislation from the 110th Congress, and would:

• Express the Sense of Congress that the National Institute of Diabetes and Digestive and Kidney Disease at NIH should expand research on IBD.
• Authorize for five years an IBD Epidemiology Program at the Centers for Disease Control and Prevention (CDC).
• Authorize the establishment of a Pediatric IBD Patient Registry at the CDC.
• Authorize the establishment of an IBD Awareness Program at the CDC.

Please contact your legislators now and ask them to cosponsor H.R. 2275 (House bill number) and S. 981 (Senate bill number). In just a few sentences, you can share your personal story and show how important this legislation is to you.

Here is what I wrote:

Dear Congressman Price,

I would like to write to about the H.R. 2275 bill which will increase and expand research for IBD diseases which are Crohn's Disease and Ulcerative Colitis.  Many of your constituents suffer from these two terrible diseases, including me.  I write the web site crohnsdiseaserelief.com and write about how the disease has effected my life.  There are many people who have Crohn's worse than I do, and I really feel for them, especially children and teens with this rather embarrassing disease.  We need to get over the embarrassment factor and find a cure!  I do not like having an incurable disease - lets find a cure already.  :-)

Thanks for listening and representing the great state of Georgia.

Marianne

Virtual IBD March on the Hill via Facebook

Facebook users - click this link to join the "Virtual March on the Hill." http://apps.facebook.com/supportccfa Shire will donate $1 per footstep to CCFA for research, education and support initiatives for each of the first 30,000 steps taken.