Important new low side effect treatment option in clinical trial you may be eligible for (or help others learn about)

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David

David

Co-Founder
Joined
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Location
Naples, Florida
Hey Everyone.

You may or may not know about the "Site Specific Immunomodulation" (SSI) treatment by Qu Biologics which they are testing in people with Crohn's disease. They are currently in their phase I/II clinical trial and I just got word that they recently not only received approval to allow US residents into it, but THEY HAVE A STIPEND TOWARDS YOUR TRAVEL EXPENSES THAT SHOULD COVER MOST PEOPLE 100%!. What's amazing about SSI and why I really want this community to help them fill their trial is:

1. The treatment appears to have very little in the way of side effects. Mostly soreness at the injection site or occasionally flu-like symptoms.
2. The treatment seems to work VERY well to the point of putting some people into sustained remission and off all their medications.
3. The company is a small startup and is led by a super cool doctor/CEO (read his interview here: http://www.crohnsforum.com/showthread.php?t=43965)

Now, will it definitely work for you or is it the best option for you? I don't know. That is a conversation for you and your doctor and questions you should pose to Qu Biologics if you're interested. But it's an exciting new option and the more options people have, the better.

Here's where we come in. Not only do I think some of you would potentially benefit from this treatment, but because they're such a small company, they don't have the millions of dollars and connections with doctors around the world that big pharmaceutical companies do to make sure their trials get filled with people. Yet here they have this potentially highly effective treatment with very little side effects. How big of a tragedy would it be if the trial doesn't get filled (they have a lot of spots to fill yet) and this would have been a great treatment option? As such:

A. If you are looking for a new treatment for your Crohn's disease, please check out their website at http://www.qucrohnstrial.com/
B. If the trial is not right for you, please consider putting a link to this thread in your signature so we can get the word out to others who might be interested and qualify.

To put a link to this thread in your signature, do the following:
1. Go here: http://www.crohnsforum.com/profile.php?do=editsignature
2. Copy this and edit however you want:

-Are you looking for a new treatment option for your Crohn's disease? If so, I suggest you look into the ongoing clinical trial by Qu Biologics for their SSI treatment. [URL="http://www.crohnsforum.com/showthread.php?t=60661"]Click here for more information or to help spread the word[/URL].
Click to expand...

3. Save your signature.

PLEASE help spread the word about this clinical trial. It's time for people with Crohn's disease to have access to a potentially remission inducing treatment with what appears to be few side effects. Let's show the power of this community!

A crohnsforum.com member by the name of Trevor is in the trial. You can follow his experience here: http://www.crohnsforum.com/showthread.php?t=58980

This is an interview with Tyler Wilson who has Crohn's disease and was able to utilize SSI:
[youtube]TEFrrAxAP6I[/youtube]

If you join the trial and start a diary thread, please let me know so I can link it here.
 
I'd love some constructive feedback as to how I can more effectively spread this message. I just think this is so important and exciting but I must not be articulating myself very well. Any help on that front would be greatly appreciated!
 
Ha, I just logged in to update my own SSI thread and saw this.

All I would add is that they are super nice! So friendly and helpful and honestly concerned about people. I've mostly spoken with the admin person and a study nurse, both have been great to deal with.

David, maybe re-post some of the videos/interviews/news spots? It was a radio interview with Dr. Gunn on "The Natural Health Show" that got me to give them a call.

Oh and I guess the other thing I can offer is local help, born and raised Vancouverite here so if anyone is thinking about coming from far away and has questions about that side of things I'm your guy :)
 
Hi david, Im not eligible for the trial, but I was wondering about including this information in a blog post with a link to this thread for more information if you think that would be okay?
 
Trevor, do you mind if I link to your thread in the first post?

Thanks to all in this thread who have put a link to this in their signature! :heart:
 
Trevor said:
Absolutely! Anything I can do to help, David.
Click to expand...
Thank you :) I've edited it into the first post.

I hope the trial works for you. But even if not, you're doing a great service to people with Crohn's just for trying. Science like this is so very important. I commend you for your bravery and willingness to give an experimental treatment a try.
 
CLCH87 said:
I would be interested if it weren't so far away.
Click to expand...
You only have to go to Canada once and they have a travel stipend that should cover your expenses. If you're looking for a new treatment option, I'd suggest at least giving them a call and seeing what you think after talking with them.
 
I completed the pre-screening and will see what they say when the call. Per the video, though, you have to make three trips to Vancouver. The travel stipend seems fair, though, and appears to be what I would pay to travel and stay in Canada.
 
That's great ruhereyet! Out of curiosity, which video? As I am pretty sure it's just one trip now and want to either bring the error to their attention or be corrected myself.
 
There's a four minute video from the CEO of the company. He outlines the three trips. First one is 9 days. Second is 3-9 days (depending on how well the trial is working). Third is three days. I'm not on my PC, or I'd link it. It's definitely more do-able if only one trip is required. I wasn't sure how I was going to manage three trips to Canada. Please let me know what you find out. Thank you.
 
I got a call today from Qu. They said that since I was currently taking a biologic, I was ineligible to participate. I was given a letter, though, to give to my GI that explains the trial so he can make an informed decision whether to take me off my current drugs. The folks there were so very nice. I'm still keeping my fingers crossed since I've had no relief from Humira.
 
I watched the video as well which says 3 trips. I'd be interested if it was one trip and I can stay on Remicade. I hope it proves to be positive.
 
I was mistaken. It IS three trips to Canada. Sorry about that. I got my wires mixed somewhere along the lines. But they do provide the travel stipend which is great.

Trevor, I hope you told them they need to improve their toilet paper? If not, let me know and I will.
 
Haha, I didn't mention it. It's in the same office as my GI and I am sure it's been pointed out to them before, what with the hundreds of IBD patients that cycle through that floor every day. My guess is that it's provided by the building and they don't want to fork out for nice stuff for the whole floor.

Don't worry :p I am a byotp (bring your own tp) expert.
 
I was lucky enough to participate in the QuBiologics SSI Crohn's trial. Let me tell you, it changed my life in so many positive ways!

I was diagnosed with Crohn's in the summer of 2009 and have now been Crohn's free since September 2012, thanks to the SSI treatment.

I am happy to answer any questions privately or publicly about my experience before and after the treatment.
 
I can validate that Colleen was in the compassionate use trial they did. Thanks for your willingness to share with others Colleen :)

Colleen, what were your symptoms like before the trial and what are they like now? Are you on any medications?
 
Before explaining my symptoms, I feel it necessary to explain a little bit of how I became diagnosed with Crohn's disease. Some of the information below may be too detailed...I've lost all sense of shame after dealing with this disease.

My diagnoses came following a surgery to drain a perianal/perirectal abscess. This surgery was an emergency procedure and the doctor performing it said he had never seen an abscess like it.

At the time of the surgery, I was 21 years old. Call me naive, but it had never dawned on my that most people do not experience 10-20+ bowel movements and/or severe cramping before a BM.

After my surgery/recovery and diagnoses I started on remicade and Imuran. I chose to refuse prednisone, after doing intense research of the options my doctor presented me with. Remicade helped with most of my symptoms, however I continued to experience constant drainage. Gross - I know. But for a 22 year old, having to always be concerned about your next BM is easier than dealing with non stop abscess drainage.

So other than still having a movement after each meal, that was my biggest pain AND embarrassment.

That was then. NOW, I have completely recovered from the abscesses, I have zero pain, and have (on average) one BM per day. This treatment literally changed everything I dealt with every day. I never have to worry about travelling distances, what I eat, when I eat, or any other things I had to plan every day.
 
For the record, I have reached out to a few people who were in the compassionate use trial like Colleen. I hope others will chime in with their experiences as well.
 
Like Colleen, I was also fortunate enough to have the opportunity to participate in the QuBiologics SSI Trial. An amazing decision in my life that has essentially left me symptom free for the past year.
I was diagonosed with UC in Nov. 2010, after previously being told I had IBS years before. I have been symptom and medication free since Dec. 2012.
I too would love to discuss life before and after the trial, or anything treatment related.
 
Just wanted to say that I just filled out the pre-screening questionnaire, so we'll see what happens. Thanks for the information! I am not on any medications except LDN, so that shouldn't be a problem, but I am one of the Crohnies who does not have multiple BMs per day - I tend to be on the constipated side in between diarrhea episodes. So maybe my symptoms aren't bad enough for me to be considered. I have freedom to travel as much as necessary (I work for myself), and I find the whole idea of clinical trials fascinating, so I hope they're willing to take me!
 
B.Elligsen I'd be very interested in symptoms before and after as well as how your SSI treatment progressed.

Glad it worked so well :-D
 
Hi guys,

My name is Adrienne. I was diagnosed with UC 10 years ago. 2 years ago flew down to Bahamas to receive this treatment (as the trial was not yet available in Canada) and was on the treatment for approx. 1 year. I was in full remission after 2 months of starting the injections, and have remained so since stopping (1 year).

I had no side effects, other than the redness at the injection site.

In addition to being in remission, it has also helped my immune system in general. I used to get every common cold, and after the treatment, I found I rarely get sick.

Let me know if you have any questions about it. I was done with suffering, so I gave this treatment a chance, and I am so glad I did.
 
Here's an interview with Tyler Wilson who also took part in the compassionate use trial and has Crohn's Disease:

[youtube]TEFrrAxAP6I[/youtube]
 
I applied to Qu Biologics and they responded with a phone call within 48 hours. I have all of the forms to complete the process but have not followed thru yet. The multiple connecting flights I would have to make and standing in security lines, it would be a troublesome task considering I have up to 15 + urgent D events per day. And now after a small bowel follow through and colonoscopy this week, my doc says I need to immediately address a stricture in the ileum at the ileocecal valve. I have a history of stenosing Crohn's that perforated, hence the urgency. I wonder how long the door is open for this trial? And if I will still be qualified after surgery? I had over 40cm taken from the ileum last go round and don't know how much will go this time, along with the valve. I will call them and post their answers for others who may be in the same condition.
 
Hi David,

I just responded about my experience with the SSI treatment in another thread, but just to get the message out there as much as possible, I'll add my two cents in here as well!

SSI is a vaccine that you administer yourself, every other day; the method is similar to insulin injections commonly used for diabetes for example. Prior to going on the vaccine you are trained by a health professional on how to administer the vaccine properly. The vaccine is composed of dead bacteria - it's all natural and there are no side effects as a result (at least I never experienced any while I was on the vaccine, nor did the patients that I spoke with who were also on it). The vaccine activates the body's immune system by targeting the organs affected by the disease, thereby reversing the chronic inflammation associated with Crohns, Colitis, and other autoimmune diseases. I was on the vaccine for just a little under a year (July 2011 to June 2012). It literally changed my life. I was originally diagnosed with Crohn's in November 2009 and for the first year after the diagnosis I was in excruciating pain, probably because I refused to take all of the crazy drugs that were being pushed my way by my GI specialists. But I was always a firm believer in taking the natural route so I saw a natural path and focused on trying to get better through a better diet, herbs, probiotics, digestive enzymes, the list goes on. And although that did help a little, the pain remained. I ended up in the hospital with a bowel obstruction June 2011 and it was shortly after that, that my natural path told me about the clinical trial for SSI therapy, originally started by Dr. Gunn, a doctor from BC. Since SSI therapy was still in its beginning stages at this point, I actually flew all the way to the Bahamas to participate in the trial since it had not been approved in Canada yet. But now it is, because they have seen so much success with it! I am no longer on the vaccine, and have been symptom free (knock on wood) for almost two years. Following a colonoscopy from March of last year, I was told that I am 100% in remission. I can't stress enough how different my life is now. And that, coming from someone who wasn't even able to get out of bed for days to go to work, is saying a lot. I noticed a difference in my symptoms within 48 hours of taking the vaccine. I would strongly, strongly, recommend this treatment to anyone. Let me know if you have any other questions!
 
Hey everyone, I just wanted to thank you all for sharing your stories. I have been fighting Crohn's for a year now. I refused biologics and have been pursuing holistic and alternative treatments. I have progressively gotten worse and was unsure where to turn when I heard about Qu and the SSI vaccine. I actually got into the study!!!! I am scheduled for my first visit to Vancouver next week. I am praying that this is an answer to my prayers. I am encouraged reading all of your posts. I get very anxious and depressed thinking that at some point I'll have to either have surgery or go on a biologic, but I have some hope restored that the pain and agony of this disease can be helped with this new treatment. So, again, thank you for your posts! Those of you who have been through it, any advice? Were the benefits from the treatment quick? I'm so nervous about everything. Any info you can give would be appreciated!
 
That's awesome Wendsjoy! Thank you so much for having the courage to go through this. I am excited for you and hope that it ends up being the answer you've been looking for. Either way, know that you're advancing the body of knowledge so that we're one step closer to finding better treatments for people with Crohn's.

And is your avatar purposely sideways looking? If not, want me to fix it?
 
I have called them too. They have specific tests they want to confirm diagnosis. I will call my doctor again, if he's talking to me! Thanks for commenting. I will try harder!
 
David, I clicked my post while I was listening to that video with Tyler, and it clicked off my page, even though I hadn't finished it. What can I do to hear it?
 
David said:
That's awesome Wendsjoy! Thank you so much for having the courage to go through this. I am excited for you and hope that it ends up being the answer you've been looking for. Either way, know that you're advancing the body of knowledge so that we're one step closer to finding better treatments for people with Crohn's.

And is your avatar purposely sideways looking? If not, want me to fix it?
Click to expand...

Hey David! Thanks! Yes, fix it. I couldn't figure out how to change it.
 
I started my treatment in this study last month and I'm starting to feel major improvement, pretty sure I'm not in the placebo group :)

I feel like with remicade, my gut healed first, and then my BMs became normal, where with the qbeco treatment my BMs became normal first and my gut was too sore to deal with it. This caused an increase in pain at the start, which has since subsided. This could also just be because my intestines are more damaged this time around.

The staff running this trial is superb, I rarely get such great service at a gastros office. My gastro always yells at me for suggesting alternate therapies but when I mentioned that this study is being done by Dr. Brian Bressler he was willing to listen, Dr. Bressler has built up some respect in the community it seems.

I also feel way more comfortable injecting myself with inoculated e.coli because it's a very simple bacteria that has been around longer than us, our bodies know how to deal with it and it's not some new chemical that was developed recently.

Help spread the word about this treatment so that these folks can complete their study and bring this treatment to market.
 
Hi bees, that's awesome that you're feeling improvement! Can you share what specific improvements you're noticing and how long it took?

And thank you for having the courage to take part in this trial!
 
I started having solid BMs on the 3rd week of the treatment, and every day since then has been better and better, healing seems to be happening nice and quickly now that proper digestion has been restored. I don't think I woke up once last night from pain, which used to wake me up a few times a night since my Crohns returned half a year ago.

There's still some mild tenderness when I push on the diseased parts of my gut but it's not nearly as bad as it was just a few weeks ago and should go away. For now I'm feeling great and have my life back again.

I think those of us taking remicade and getting surgeries are much more courageous, I haven't found a single negative comment regarding this treatment and would really like to know if there is any evidence of side effects or dangers.
 
Hi all I am too on humira, do they say how long that you have to be off the humira before you can commence the trial? Because I am not having great success with the humira :(
 
But did David say that they are looking at taking international patients now aswell, it also says it on their website?
 
I'm a pretty open book and I have a lot of free time this week hanging out at the clinic so ask away :) anyone who would like to.

I did send you an e-mail as well, Sebastian, maybe check your spam or just PM here.
 
Sorry Alison yeah kind of private questions - if you ahve any questions for me though I'd be happy to answer
 
ruhereyet said:
I got a call today from Qu. They said that since I was currently taking a biologic, I was ineligible to participate. I was given a letter, though, to give to my GI that explains the trial so he can make an informed decision whether to take me off my current drugs. The folks there were so very nice. I'm still keeping my fingers crossed since I've had no relief from Humira.
Click to expand...
Do you know how long you have to be off your biologic for in order to participate?
 
Hi Poppysocks

I looked around and couldn't find a written answer anywhere for you. If you're interested and it's a concern just call, they're super friendly :) or, if I remember, I'll ask the study nurse when she calls me in a week or two.
 
Maybe I'm underestimating the travel issue, but I find this shocking.

4 out of 5 digestive tracts recommend SSI's.

If anyone is worried about travel or being in a strange city or anything give me a shout and I'll do whatever I can to help :) Vancouver is a great place to visit.

Let's not let some other disease beat us to market! If there's one thing Crohnies aren't it's quitters :p
 
Trevor said:
Maybe I'm underestimating the travel issue, but I find this shocking.

4 out of 5 digestive tracts recommend SSI's.

If anyone is worried about travel or being in a strange city or anything give me a shout and I'll do whatever I can to help :) Vancouver is a great place to visit.

Let's not let some other disease beat us to market! If there's one thing Crohnies aren't it's quitters :p
Click to expand...

I traveled from Philadelphia for this study! If I can do that than anyone can go :)
And yes, Vancouver is amazing! Loved it there.
 
My gastro discouraged me from going ahead with any trials, I'm glad I went against his advice. The truth is, the Qu folks don't have a marketing budget to spread the word about this treatment, it's up to us to document our success and recommend it to others.

I've been trying to spread the word as much as I can on facebook groups, reddit, and in person. Most people don't know about alternative options, and trust that their doctor is making the right choices. Mistakes and bad choices happen all the time in health care, don't be afraid to question your doctor to ensure that your treatment choices are in your best interest, and not just the safest option for your doctors career.

My doc even made sure to document in my file that I am starting this treatment against his advice to avoid any liability.
 
bees said:
My gastro discouraged me from going ahead with any trials, I'm glad I went against his advice. The truth is, the Qu folks don't have a marketing budget to spread the word about this treatment, it's up to us to document our success and recommend it to others.

I've been trying to spread the word as much as I can on facebook groups, reddit, and in person. Most people don't know about alternative options, and trust that their doctor is making the right choices. Mistakes and bad choices happen all the time in health care, don't be afraid to question your doctor to ensure that your treatment choices are in your best interest, and not just the safest option for your doctors career.

My doc even made sure to document in my file that I am starting this treatment against his advice to avoid any liability.
Click to expand...


Good for you!!!! Well said! I am the same way. My doc is still trying to get me to drop out of the study and start remicade and pred. Even though I am making more progress with this than anything else. You have to stand up for what you know is best for your body and not blindly follow what is 'standard'!
 
I tried to get into the trial, but my fecal calprotectin and CRP levels were not "bad" enough. I hope the change the inclusion criteria for phase 2.
 
I found I was eligible for a different trial by Pfizer, which I'm now testing for eligibility. The wash-out period for meds was six weeks. My CRP, CT Scan, X-Rays, and stool tests have tested at the appropriate levels. Now I just wait for my colonoscopy to finalize the eligibility. To answer Poppysocks question, I think that the Qu Trial was also six weeks of biologic wash-out, although I don't know for certain.
 
My gf's best friend got turned down because his CRP was too low as well. They met in nursing school and both smoke :ybatty: which leads nicely into my rant about doctors and how many of them are horribly incompetent...

I don't even mind the incompetence so much but their just so arrogant while being incompetent.

Dr. Bressler at the trial is great though :)
 
I find this new treatment very encouraging. I've watched one of the videos and the doctors mention the treatment can help for UC and auto-immune arthritis as well. Hopefully it will be soon accepted as a treatment.

so for those who went to the Bahamas, the treatment is available there? or its still for study purposes?
 
ruhereyet said:
I found I was eligible for a different trial by Pfizer, which I'm now testing for eligibility. The wash-out period for meds was six weeks. My CRP, CT Scan, X-Rays, and stool tests have tested at the appropriate levels. Now I just wait for my colonoscopy to finalize the eligibility. To answer Poppysocks question, I think that the Qu Trial was also six weeks of biologic wash-out, although I don't know for certain.
Click to expand...
What is Pfizer testing?
 
People, do you have any idea when will the phase 1/2 study result? I want to see published results of this exciting therapy very soon.
 
Crohn2357 said:
People, do you have any idea when will the phase 1/2 study result? I want to see published results of this exciting therapy very soon.
Click to expand...
It's going to be a long time unfortunately. :(

They haven't even filled half the slots for the study. Only after all the participants finish and they crunch and compile and present the data will we get the results.
 
David said:
It's going to be a long time unfortunately. :(

They haven't even filled half the slots for the study. Only after all the participants finish and they crunch and compile and present the data will we get the results.
Click to expand...
I'm trying to get into the study, it's taking forever to get my medical records though.
 
I wish this trial will become available for global crohn's patients very soon. This has a potential for becoming groundbreaking crohn's treatment and other immune related diseases like HIV and Cancer. I wish it will work for colitis and other IBD too. Thanks for showing us the updates and supporting this trial.
 
Hi
I really dont understand why people in Canada and America with crohns are not dying to be a part of this trial. I live in Ireland and have put my name down for when they can take international patients.
 
Chron2357 it does work for Colitis - I have it, and took the treatment and have been in remission since. I am also surprised that people are not knocking down the door to be part of the trial.
 
Nosebag said:
I really dont understand why people in Canada and America with crohns are not dying to be a part of this trial. I live in Ireland and have put my name down for when they can take international patients.
Click to expand...
Everyone has their reasons and it's not my place to judge. The ones I'm focused on are those that simply don't know about it. If you're game, please do what you can to spread word about this trial. Even putting the info in your signature like I outline in the first post can help a LOT. :)

The sooner we get the trial filled, the sooner it can end. And if the data is good, then we'll be one step closer to widespread usability.
 
People are generally scared of the 'unknown'. It's a scary thing to jump into a new drug that hasn't been proven yet.
Also, you can't be on biologics to be in the study so I am sure that alone excludes many many IBD patients.
Personally, I jumped at the shot to be in and feel extremely privileged to have been accepted. I hope that this helps many people in the years to come!
 
I will definitely be giving it a shot once I get my darn medical records. Been waiting for like 2 weeks. :ymad:

They pay you a pretty nice stipend to participate. That, plus it's harmless from what I understand. No side effects. There is literally no reason people shouldn't be going crazy about this. I just don't think anybody knows about it.
 
Everyone who is attempting to join the trial, I congratulate you for your patience and efforts! It will all be worth it in the long run! I hope more Americans and Canadians will take the opportunity they're presented with.

How are current trial patients feeling? All good news?! I'm going on 2 years of remission. Everyday I'm so grateful for this treatment.

Stay healthy and stay positive!
 
David, have you ever think about making a visible sticky announcement about this trial in forum? Would that be appropriate with forum rules and principles?
 
Next time I see my GI I will bring him the information about the trial. I am so excited about this new treatment understanding (if im correct) its mechanism of action is to boosting the immune system instead of supressing it like the other meds we take like anti-TNF or immuno-supressors. Its finally a mode of action I agree with, feel confident about and in respect with my logic. This new treatment makes me dream and feel so much joy, hopefully it will be a reality for us soon. Thanks to all of you for receiving the treatment and sharing with us. thank you David for being our intermediate and reference. Im so happy to be part of the forum and to have access to such priviledged information. THANK YOU!!!
:ghug:
 
I had an appiontment with my GI today. I was on Humira and had to come off because of severe joint pain and migraines. The next step was to put me on Remicade. I showed him this study and he basically brushed it off and said it's such a small study and that this had been tried before. Has anyone else had this kind of feedback from their GI?
 
mousesjca said:
I had an appiontment with my GI today. I was on Humira and had to come off because of severe joint pain and migraines. The next step was to put me on Remicade. I showed him this study and he basically brushed it off and said it's such a small study and that this had been tried before. Has anyone else had this kind of feedback from their GI?
Click to expand...
60 participants for Phase I/II isn't a small study. And could you ask them for details on when this was tried before as I'm not aware of such data.

Many doctors will brush off that which they don't understand or is different from what the mainstream doctrine prescribes. Frankly, I can't blame them as they are usually so busy that it is hard to find the time to understand the theory behind this treatment. And even then, it takes an open mind.

The thing is, what if this treatment IS efficacious? I can't say for sure that it will prove to be, but what if it is? That will mean a new treatment option with what appears to be minor side effects compared to traditional treatments. How amazing would it be if doctors had a first-line treatment that had very little side effects and was shown to be statistically efficacious? And then only use treatments like biologics with their side effects in refractory disease? As such, I feel it is imperative that we ensure that this treatment is thoroughly and properly investigated thus my passion for getting the word out.
 
That was my thought David. My GI has had me on Imuran and Humira. I had a small reaction to Imuran and a huge reaction that i'm still trying to get over with Humira. He is still pushing Remicade or Vedolizamab. One side effect just as scary and the next.

He didn't go into huge detail of the study but it had something to do with pigs and worms. If you google that treatment it was stopped in 2013.
 

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