# Interview with Dr. Hal Gunn, the Founding CEO of Qu Biologics and Developer of "Site Specific Immunomodulation" (SSI)



## David

Crohnsforum.com was lucky and managed to (virtually) sit down and have an interview with Dr. Hal Gunn, the founding CEO of Qu Biologics.  Qu Biologics is a Canadian company developing an exciting potential treatment for Crohn's disease called, "Site Specific Immunomodulation" (SSI).

*David Chapman:*  Dr. Gunn, can you please tell us a little about yourself, your medical training, how long you've been a doctor, and areas of practice/research?

*Dr. Gunn:*  I’ve always been interested in health and supporting the body’s own capacity to heal.  I graduated from University of British Columbia medical school 30 years ago and, 15 years ago, co-founded InspireHealth, Canada’s leading integrative medical centre, which we founded to help integrate the concepts of health and immune system support into the treatment of disease.  InspireHealth, a not-for-profit, has been funded by the BC government to expand across the province to provide integrative care to British Columbians diagnosed with cancer.  My primary interest in practice/research is understanding how to optimally support the body’s own capacity for health and healing.  

*David Chapman:*  Please tell us what SSIs are, how SSIs were developed and why you are now looking to treat Crohn's Disease with them.

*Dr. Gunn:*  A large body of research across a number of disease areas shows that the more acute infections you get, the less your risk of cancer and autoimmune diseases such as Crohn’s disease and ulcerative colitis.  Acute infection stimulates the body’s innate immune system.  There is growing evidence that a defect or deficiency of the innate immune system may be an important underlying cause of both cancer and autoimmune diseases such as Crohn’s disease. We’re developing drugs with the potential to simulate acute infection without actually causing infection, using Site Specific Immunomodulators (SSIs), which appear to stimulate innate immune system function in the targeted organ or tissue, for example, the gastrointestinal tract.  

*David Chapman:*  How many patients with Crohn's Disease have been treated with SSIs and how are they doing?

*Dr. Gunn:*  We treated 10 patients with moderate to severe Crohn’s disease in a small clinical study.  All 10 patients showed improvement in symptoms and 7 of the 10 patients had clinical remission of their disease.  4 of the 10 patients have had sustained clinical remission and are off all medications, including SSI therapy.  The longest sustained remission is 2.5 years.  This is a small study and wasn’t a randomized controlled trial, so we can’t make any definitive conclusions.  We will soon be starting a larger randomized controlled trial with our investigational treatment to assess the benefits and risks of SSI therapy for Crohn’s disease.  

*David Chapman:*  What side effects have patients experienced thus far with SSIs?

*Dr. Gunn:*  We have treated more than 270 patients with cancer and 15 patients with autoimmune disease (including 10 patients with Crohn’s disease) through compassionate use (‘Named Patient Use’) programs and small clinical studies.  To date, the safety profile has been very good and the drug has been well tolerated, however, as this is an investigational drug, the full safety profile has not yet been established..  A few patients have had transient fever, likely as a result of stimulation of the immune system, lasting 6 – 24 hours, which resolved with ongoing treatment.  

*David Chapman:*   For the doctors and researchers out there, can you explain the science behind how you think SSIs work?

*Dr. Gunn:*  Macrophages are important cells of the body’s innate immune system.  One of their primary roles is to engulf (through phagocytosis) dying or dead cells, in order to clear/recycle these dead and dying cells.  The cells of the tissues in our body have a natural life cycle, measured in days, weeks or months depending on the tissue.  When a cell reaches the end of its natural life cycle, it signals to macrophages that it is dying, a process called apoptosis, inviting macrophages to engulf and recycle the cell.  When this happens, the macrophage engulfs the cell and sends out anti-inflammatory and ‘tolerance’ signals so that the adaptive immune system (the other major arm of the immune system) doesn’t react against the antigens of the dying cell.  

However, if there is a defect or deficiency of macrophage function (i.e., innate immune system), especially if there is an environmental trigger such as stress or chronic infection that overwhelms macrophage function, macrophages don’t clear dying or dead cells efficiently.  As a result, not all dying or dead cells are cleared by macrophages and, when they aren’t cleared, these dead cells necrose (i.e., break apart) releasing their internal antigens to which the adaptive immune system reacts, resulting in antibodies against these self-antigens and autoimmune disease (such as Crohn’s disease).  In other words, while symptoms of autoimmune disease are generally understood to be a result of an over-reactive adaptive immune system response, we hypothesize that the underlying trigger/cause may be a defect or deficiency in the innate immune system (macrophage function).  

Based on our preclinical research, we’ve found that SSI treatment results in recruitment of macrophages to the targeted organ or tissue (for example, the gastrointestinal tract) with stimulation of their phagocytosis function, which we believe relieves the defect or deficiency that may underlie Crohn’s disease.  SSIs are made from killed bacterial components.  Injected subcutaneously (i.e., just under the skin), we’ve shown that SSIs stimulate an innate immune response in the organ or tissue in which the bacteria commonly causes infection.  An SSI made from E. coli stimulates an innate immune response in the gastrointestinal tract and thus, we are using an E. coli derived SSI in our Crohn’s disease clinical trials. 

*David Chapman:*  When should SSIs enter phase I/II clinical trials and who will be eligible?

*Dr. Gunn:*  Our 60 patients phase I/II randomized trial is planned to begin in January or February.  Patients with active moderate/severe Crohn’s disease will be eligible for the trial.  Half the study patients will be randomized to SSI treatment in addition to their usual treatment, the other half to placebo in addition to their usual treatment.  After 8 weeks of treatment, all patients who have not responded to treatment will begin SSI treatment for 8 weeks, so patients who are initially on placebo treatment will have the opportunity to be on SSI treatment.  The trial will be conducted in Vancouver, Canada.  Patients can fly in to start treatment for the trial and continue treatment at home, returning to Vancouver for reassessment twice as the trial progresses.  Initially, Canadian patients will be eligible for the study.  We may expand the study to American and international patients if the necessary measures for treating foreign patients in Canada can be put in place.

*David Chapman:*  If someone with Crohn's Disease is interested in the upcoming trial, what should they do?

*Dr. Gunn:*  We welcome patients interested in our upcoming trial, especially Canadian patients, to visit our trial website www.qucrohnstrial.com, which will be launched shortly.  The website will provide information about the trial and eligibility criteria.  Patients will be able to answer a questionnaire on the site to assess their eligibility for the trial.  

*David Chapman:*  If you have good results with the trial, what happens after that?

*Dr. Gunn:*  If our upcoming trial is successful, we will initiate a larger multi-centre trial to further study the efficacy and safety of the treatment in Crohn’s disease and as a further step towards drug approval.

*David Chapman:*  Do you have any parting words for the members of Crohnsforum.com?

*Dr. Gunn:*  I’ve had a long-time interest in patient advocacy and empowerment.  I applaud the work of David and all the patients and family members at Crohnsforum.com for everything that you are doing to empower, educate and engage people with Crohn’s disease and am grateful for the opportunity to inform the membership about SSI treatment and our upcoming trial.  Thanks so much.

*** Added 02/27/2013 - A new video interview with Dr. Gunn:*
[youtube]JC6U83EgYAI[/youtube]

**** Added 05/31/2013 - See videos of Crohn's patients who have already taken SSI: http://www.crohnsforum.com/showpost.php?p=657979&postcount=59*


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## Igor_Passau

David thank you!


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## sid

That is so exciting...I pray that Dr. Gunn is successful in this Site Specific Immunomodulation project. All the best to him and his team.


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## Glenda

This is really exciting news and hopefully will benefit other autimmune disorders. My son has Moderate to severe Crohns and my husband has Myosythenias Gravis. They are both taking LDN. My son has been taking LDN since September and has been doing well. He developed a rash and thought it was the LDN so stopped taking it. He had also weaned off Entocort around the same time that the rash developed. We have since heard that a rash can be a side effect of Entocort. When he stopped the LDN he had a flare. He has restarted the LDN and is going to see a dermatologist for the rash. Anyone else with a rash that is in patches on the wrist elbow and other places. It is red and moderately itchy.


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## Crohn's Mom

Thanks David ! 
Exciting stuff


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## deontas

Brilliant theory and good luck.  Seems to me that many diseases, including CV disease, have inflammation at their heart.  Wouldn't it be great if it was so simple as the innate system not carrying its weight, and the auto-immune system being called upon unnecessarily, making it so hyper-reactive it destroys all in its way.


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## Jmrogers4

Glenda, 
You might want to post your questions about LDN under the the LDN section of treatments that way it wont get accidently passed over.  My son takes LDN as well and we have not had any problems with rashes while on it, but there are others on here who have been taking it a lot longer then he has.
Here is the link to the LDN forum
http://www.crohnsforum.com/forumdisplay.php?f=32


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## my little penguin

Thanks David


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## moogie

Finally something concrete that will actually fight the cause of this plague. great interview.


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## AckMac

WOW!  This is incredibly exciting.  Great results so far and the worse side effect is FEVER?!  If this scales to your larger trial, this is going to be SO HUGE for people with IBD.

I'll definitely help spread the word once your website goes live.

How do I give up my US citizenship and become Canadian in time for this trial?  :lol:


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## Barnacle

I'm glad stuff like this is in the pipeline.  What makes me sad is I know it will be at least 3-5 years before I'm able to try it, even if it works really well.


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## sid

Barnacle said:


> I'm glad stuff like this is in the pipeline.  What makes me sad is I know it will be at least 3-5 years before I'm able to try it, even if it works really well.


still i think we are lucky..3-5 years isnt big deal....especially when you imagine how people have suffered for decades even when there was no internet, n info on crohn's , and no drugs like pentasa,etc...I think the phase we are in is phase of researchs..and the next gen will be the one who will benefit more.


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## levi

http://www.crohnsforum.com/showthread.php?t=36119

Here's an older thread on this as well. I thought seven out of 10 going into remission was great but could be a fluke...but then read on this other thread which mentions another trial whre six out of eight went into remission. I wonder what the duration was. 

Anyway, if this were avialable in three to five years that would be great!


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## Glenda

My son has just started LDN ( 3 months) so I am wondering if anyone else who is on LDN would consider participating in the study.  We THINK the LDN is working but can't be sure with it being such a short time.  So should we stay with the LDN or try to be a participant in this study?


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## Igor_Passau

Glenda said:


> My son has just started LDN ( 3 months) so I am wondering if anyone else who is on LDN would consider participating in the study.  We THINK the LDN is working but can't be sure with it being such a short time.  So should we stay with the LDN or try to be a participant in this study?


why you posted LDN here?


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## Glenda

Sorry I wasn't very clear in my question. The study I was talking about is the SSI taking place in Canada for moderate to severe Crohn's patients. (hence why i posted this reply on this thread) Should my son take the chance with volunteering for this study or continue with the LDN which he has been on for only a short time. He is doing well on it but we are still not sure that it is the reason for him doing better.  He had 1 flare but that could be because he stopped the LDN for 5 days because of a rash he has developed he has been under a naturopaths care as well so it is hard to know what is working and what is not


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## David

Glenda,

Taking LDN is not an exclusion for this study.  Meaning he could do both at the same time


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## BobbyM

I hope this gets opened up to US residents.  My meds don't seem to be working anymore...


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## AnnieInside

Good interview.

Is this like a vaccine?  I have two kids, one has Crohn's, one does not.  The one who does not has some gene that makes their doctor worried.  Could this be given to stop the onset of Crohn's?


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## David

Sorry nobody has responded Annie.  I saw your post and left it in an open tab to respond to later and it got lost in a sea of open tabs 

Anyway, I like the way you think!  Unfortunately I don't know but I think the first step is to see how well SSI do at the trial and what kind of side effects people experience.  How amazing would it be though if they do great, have few side effects, and maybe one day can be used prophylactically in people at high risk for developing IBD.  One can certainly wish!    One step at a time though


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## mf15

Here is one of their patents,it also mentions oral delivery.  Wonder if that would work. Hopefully the link works,if not go to google patens and search QU Biologics.
Old Mike
https://docs.google.com/a/google.com/viewer?url=www.google.com/patents/US8034359.pdf


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## David

The website for the clinical trial is now live at http://www.qucrohnstrial.com


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## Tesscorm

Thanks for organizing the interview and keeping us all up-to-date!


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## happy

Thanks David. And also for sending the email message to Canadians to let us know that the website was live. I really appreciate all the hard work you do in getting informative and reliable info to us, in a manner that is understandable.


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## happy

By the way David, if you come back to this page soon could you please tell me how to get rid of the box and question mark where an avatar could go on my profile. I don't want anything there. Thanks.


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## Trysha

Thank you David for all the hard and dedicated work
 you are doing for all of us on the forum
This work on Site Specific Immunomodulation is very exciting and I think holds great promise in  the future treatment of Crohn's.
If I was not a member of the Crohn's Forum I doubt if I would have been aware of it.
You have given so much to us all.
Thank you again
Trysha


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## SkinnyNinny

Been meaning to read the book 'Bad Pharma'....something about clinical trial design....


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## David

Dr Gunn recently did another interview.  Here it is in video format:

[youtube]JC6U83EgYAI[/youtube]


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## kiny

Can critique because I don't agree with hygiene hypothesis part.

I think people take this hygiene theory for granted without much evidence, bacterial load in urban areas is just as high as in rural areas I read, in fact urban city rats in Germany are the major contributors to infections, it's still the same story as the plague in the middle ages, hospitals in urban areas, major contributors to infections because urban buildings shut out nature by keeping the building airtight, refrigerators (sp?) and frozen foods in urban areas harbour listeria and yersinia much more than in rural areas. What about all the vaccinations they give people in the West, measles, tetanus, hepatitis, polio. 

How does the hygiene theory explain that people from Asian descent in Canada or Moroccan descent in Western Europe get more crohn's disesase than the Canadians and Western Europeans, shouldn't they be protected since they have lived without proper hygiene? How come they tend to get more crohn's disease than people who have been living in Urban areas all their lives by simply moving to the West? This completely contradicts the hygiene theory.

How about farmers who come into contant with bacteria all the time, they don't have any less crohn's disease. They don't have more, but also not less. According to the hygiene theory these people should be protected from getting crohn's disease, they do not live in an urban environment and come into contact with bacteria non-stop, but these farmers in the West develop crohn's disease just as easily as everyone else.

And the cold to protect us, why would viral infections help us at all if the issue is macrophage deficiency through autophagy, that's not viral, that's bacterial. The WHO said no one can use antibody tests for TB anymore.

The idea that it's an autoimmune disease. How come the inflammation isn't everywhere but is localised in the form of patches in the intestine? An autoimmune disease would manifest itself everywhere in the intestine, it would be like UC, but it's not, crohn's disease is patchy in skip lesion patterns, that's not autoimmune.


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## Igor_Passau

Hi,
Please send your quetions to Qu Biologics!

It will be more efficient than only posted it on this forum. Send e-mail! Or you can call. I think you will open something new for all on this forum.

Regards,


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## snowwhite

Kiny, doesn't this hypothesis run in tandem with the recent Japanese study on MAP that you recently posted? Dr Gunn thinks that the innate immune system is failing at clearing out the dead bacteria. If I remember correctly that Japanese MAP study linked Crohn's to dead MAP floating around in the bloodstream.


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## spinnychick

Got an email this weekend, they have selected 60 people to participate and I made the invite list!!!  Not sure what I will do as I don't much want to travel out to BC three times, but am researching and considering it.  Don't know if my doctor would approve either.


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## David

I understand your predicament Spinny.  But if there was one clinical trial I would want to be a part of and do everything I could do participate, it would be this one.


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## spinnychick

I don't know much about it to be honest and need to do some research over the next couple days.  I'm also nervous to ask my doctor for his approval, I almost feel like I am "second guessing" his treatment plans, although he doesn't have me in remission yet since being diagnosed last May.  I trust your judgment and since you seem keen on this I will def give it serious thought.  I know 30/60 people will be on placebo, so only half will actually reap the possible benefits of this new wonder drug.


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## kiik

Actually spinnychick from what I read everyone gets the medication. What happens is for the first 8 weeks half of the people get placebo and half get medication and then after that the ones on placebo will be switched to the treatment. At least I think, someone correct me if I'm wrong!

On another note, does anyone know if it's too late to participate in this? I live about half an hour outside of Vancouver when not at university, the only thing is I don't think my parents would be too keen on an experimental treatment!


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## killcolitis

I was in contact with Dr Gunn this past summer as we were considering this for our daughter (aged 6) with UC.  I spoke to him and the CMO and I have to say they were incredibly generous with their time, honest and kind.  They spoke to us for probably more than an hour on several occasions.  At the time there was a pretrial in the Caribbean and our daughter was too unstable for us to feel comfortable traveling there with her.  Now they are only trialing the treatment on adults but hope to have a pediatric trial in the future. I'm in Ontario and would be happy to travel to Vancouver with this (I would have traveled to the Caribbean if it had been me and not my daughter without too much of a second thought).  I'd love to hear how it goes for those who are participating.  I wish you the best of luck, this seems like such a promising treatment to me.


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## David

kiik, I would definitely contact them.  And once your parents see all the data surrounding the existing patients, I think the might end up as excited as I am about the potential of this treatment.


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## VICTOR

Thank you David


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## kiik

Thanks David, I went to fill out the form and got error messages so I emailed them. They are emailing the programmer so hopefully I will be able to participate! I am only in Vancouver from April - August, although if it was really worth it I could fly back for the checkups. Is there any particular reason you are so excited about this treatment? I think my parents are mainly worried about the number of people they've tested it on.
Kiera


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## David

A combination of reasons.  Three of the big ones are how well it has worked thus far, the lack of side effects, and the fact that, in theory, there should be very minimal side effects for the vast majority of people.

They've actually given the same general type of treatment to tons of people with cancer so it has been widely used.  They simply changed it up a little for people with IBD.  My point being, it has a long history of use in human subjects.


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## kiik

Well I did the pre-screening questionnaire and am currently on the list! They said that they  will ask for medical records to determine eligibility once everything is ready to go. Hopefully I am eligible/will be in Vancouver at the time!


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## kimmidwife

Thanks for this interview. I had not heard about this new treatment and it sounds very exciting. Especially for those who have failed many treatments already or are allergic to them.


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## Hal Gunn

Hi everyone, 

I wanted to update you with 2 new video's that have just been released to Qu Biologics YouTube page to give you a better idea about the Qu Biologics Crohn's Disease Trial process. 

1) Study Treatment Injection Training for Qu Biologics' Crohn's Disease Trial

2) Stool Sample Collection Training for Qu Biologics' Crohn's Disease Trial

Happy to answer any questions you might have about Qu Crohn's Trial.

Kind regards, 
Hal


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## sid

welcome to the forum Dr Gunn. really glad to see you here...your new study has given us a lot of hope..all the best with the SSI trials.


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## spinnychick

My GI hasn't yet approved me doing this but they called and I am supposed to let them know asap.


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## Igor_Passau

Welcom! I posted a lot of information about your innovation in IBD. But in other part of forum. 
By the way I was in the list to participate in clinical study but I could not formalized issuance for this study ;(((( but I hope the further stages of studies will be more open for not citizent of Canada. I could participate and other


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## Hal Gunn

Thank you everyone for your comments and updates. This is much appreciated. 

If you do not live in Canada, I encourage you to fill out the questionnaire on the website. You will be put on a wait-list and we will be able to contact you if there is an opening or opportunity.


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## Igor_Passau

I registered on the web but I failed pre-screening Questionnaire – «I am not a Canadian resident with valid health insurance coverage that meets one your criteria». I was in the list of first 60 patents for the clinical study but this did not work… Sorry, but I posted mails on this forum, with the purpose to find any solution. http://www.crohnsforum.com/showthread.php?t=36119&page=2 

Last e-mail from 8th of September 2012:

«Dear Igor,

Our clinical team has reviewed the insurance policy provided in your last email and it was very helpful for us - it looks promising, but to be 100% certain, we have decided that it would be preferable to have the individual insurance companies acknowledge our conditions, instead of us reviewing different insurance policies from different companies. Qu Biologics has decided to supply a letter of explanation and an attestation to all potential clinical trial participants so that they can obtain written confirmation from their insurance provider.

Could you please provide this letter (attached) to your insurance provider and ask them to review it to make sure your insurance policy fits with the terms & conditions stated in the letter. After they have reviewed it, please kindly inform us if the letter is acceptable or if they have any problems with the terms. Their feedback is very important to us because it will help us to determine whether or not we can accept non-Canadian residents like yourself into our clinical trial.

Kind regards,
Winnie Lim

Clinical Trials Assistant»
Summary:

1.	I have my local issuance and I also have international police.
2.	I could obtain Canadian issuance for non-resident of Canada.
3.	I try to find international company to cover my study but the work only corporate clients. 
None of above could cover clinical trial! If you will arrange study for non – resident of Canada please include me in list of patients and give advice regarding the issuance. 


Regards,
Igor


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## spinnychick

I live in Ontario and have been selected and am trying to find out if travel and accomodation expenses are covered.


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## Igor_Passau

spinnychick said:


> I live in Ontario and have been selected and am trying to find out if travel and accomodation expenses are covered.


Qu Biologics will pay for any testing that is required as part of the clinical trial (lab tests etc.), and we will provide the drug for free. All other expenses (travel, accomodation, food etc.) will be the responsibility of the patient.


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## spinnychick

Yikes, that's a pricey trial for us then.  Three flights there, plus 3 nights hotel stay twice and a week another time.  will have to ponder this, we're talking thousands of dollars.


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## Igor_Passau

spinnychick said:


> Yikes, that's a pricey trial for us then.  Three flights there, plus 3 nights hotel stay twice and a week another time.  will have to ponder this, we're talking thousands of dollars.


For me it is the same  one flight about 1000 USD! But this is nothing if this SSI will give remission ))


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## spinnychick

I know we can't put a price on our health but being able to afford something is a completely different story.  Here in Ontario, we have help to cover humira and remicade, provincial grants, sponsors, etc.


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## Igor_Passau

I need only advice about issuance! All cost I will cover ... I also start thinking to live in Canada  my company Deloitte offer me such possibility


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## Hal Gunn

Great questions everyone. Thank you for sharing these. 

We have reserved a discount for participants at a hotel nearby in Vancouver - Ramada. Please see attached. This information will be posted on Qu Crohn's Trial website shortly so that other's will be able to see this. 

Best regards, 
Hal


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## ashleyanderson

Hi Everyone, 

I am the Social Media Coordinate at Qu Biologics and am happy to answer any general questions you might have about the trial. 

I would also like to hear your thoughts about the trial. 

Looking forward to hearing from you!

Kind regards, 
Ashley


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## David

SkinnyNinny said:


> What kind of legitimate research organization holds clinical trials in the Caribbean?


Qu Biologics is a very small startup company, they're anything but Big Pharma and are operating on an extremely limited budget.  Taking a medication from research through three clinical trials costs millions and millions of dollars.  The caribbean offered them a means of offering their medication on a compassionate use basis for a low cost and to allow them to showcase that there does appear to be efficacy AND few side effects.  I personally applaud them for trying to bootstrap their medication through the clinical trial process instead of selling out to a huge company.

I'm sorry the form didn't work for you but software bugs happen.  While it was no doubt frustrating, the mature thing to do would have been to contact them privately, not attack them here.  I'm going to give you 24 hours to cool down and rethink the conduct of your post.  Feel free to respond to this thread if you want to apologize to our guests.  They deserve better.


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## ashleyanderson

Hi SkinnyNinny, 

Please contact us here: http://www.qucrohnstrial.com/contacts/request-to-speak/ . We would like to call you and answer all of your questions. 

Thank you for letting us know that the form didn't work for you. In the contact form, could you provide the date and time you tried to complete the form and what happened when you tried to submit the form (e.g. did you receive an error message)? This will help us pin-point the issue so that  we can ensure this doesn't happen to others. 

Thank you, 
Best regards, 

Ashley


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## tylerthorndale

Hi everyone, my name is Tyler Wilson and I created a video testimonial of my experience using QBECO SSI therapy for Crohn's Disease. It has changed my life and I wanted to share my story with you: 
[youtube]kC_OM8O5Y4w[/youtube]

2 other participants in the trial also shared their experiences. Here are the links to their videos:

Natalia

[youtube]P-rd5zYEFU8[/youtube]

Colleen 

[youtube]EjvDkduWZxE[/youtube]

I hope this helps, 
Tyler


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## Twiggy930

Thanks for posting those testimonials Tyler.  This give me so much hope for the future.


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## gerrard

This sounds promising. May I ask when the trial is due to start?
Also, is there a particular reason why the results of the carribean trial have not been released? 

Thanks.


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## Twiggy930

News story on Qu Biologic's Crohn's trial.

http://globalnews.ca/news/606100/new-clinical-trial-for-Crohn's-disease/


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## ashleyanderson

Thanks Twiggy930 for posting the news release! 

Qu Biologics' Dr. Hal Gunn was interviewed in a Global TV news health segment about the Qu Crohn's clinical trial. Dr. Gunn talks about the immune system and how it relates to Crohn's disease. 

We've also posted this interview on Global TV in Qu Biologics YouTube channel: http://www.youtube.com/watch?v=KPoIg9bR9PA

I hope this helps,
All the best,

Ashley


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## ashleyanderson

Great questions, gerrard. 

The trial has begun!  If you are interested, you can complete the pre-screening questionnaire to see if you are eligible by clicking here: https://www.qucrohnstrial.com/securequestionnaire/

Here is information about the compassion use program that you were asking about: 

Ten (10) patients with uncontrolled persistent moderate to severe CD were treated with QBECO through a compassionate use program. Patients may have continued to receive conventional medical treatments and/or complementary therapies in addition to the SSI treatment. Seven of the ten patients reported full resolution of clinical symptoms with a course of QBECO treatment of three months or more.  Four of these patients have had sustained clinical remission after discontinuing all medications including SSI treatment. The longest case of clinical remission reported is still ongoing, after almost 3 years. Three of the seven patients reporting full remission had follow-up colonoscopies or CT scan with confirmation of full remission. Nine of the ten patients were able to discontinue all other medications at some point while on QBECO treatment. (More information here: http://www.qucrohnstrial.com/ssi-intro/qbeco-ssi-efficacy-and-safety/).

I hope I answered your questions. 
Thank you and all the best, 
Ashley


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## ron50

In 1998 I had chemotherapy for stage 3 colon cancer. The primary agent was 5 flurouricil and it was enhanced with a drug called levamisole. It was mainly used in veterinary work as an anti-parasitic. It is an immunomodulator.  It was banned around 2000 because of side effects some fatal .  For me it was a nasty drug and I suspect it as the cause of some of my on going neurological problems. Ron.


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## Igor_Passau

ron50 said:


> In 1998 I had chemotherapy for stage 3 colon cancer. The primary agent was 5 flurouricil and it was enhanced with a drug called levamisole. It was mainly used in veterinary work as an anti-parasitic. It is an immunomodulator.  It was banned around 2000 because of side effects some fatal .  For me it was a nasty drug and I suspect it as the cause of some of my on going neurological problems. Ron.


What are you talking about!!!??? Look on current treatment of IBD and side effect!!!


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## gerrard

ashleyanderson said:


> Great questions, gerrard.
> 
> The trial has begun!  If you are interested, you can complete the pre-screening questionnaire to see if you are eligible by clicking here: https://www.qucrohnstrial.com/securequestionnaire/
> 
> Here is information about the compassion use program that you were asking about:
> 
> Ten (10) patients with uncontrolled persistent moderate to severe CD were treated with QBECO through a compassionate use program. Patients may have continued to receive conventional medical treatments and/or complementary therapies in addition to the SSI treatment. Seven of the ten patients reported full resolution of clinical symptoms with a course of QBECO treatment of three months or more.  Four of these patients have had sustained clinical remission after discontinuing all medications including SSI treatment. The longest case of clinical remission reported is still ongoing, after almost 3 years. Three of the seven patients reporting full remission had follow-up colonoscopies or CT scan with confirmation of full remission. Nine of the ten patients were able to discontinue all other medications at some point while on QBECO treatment. (More information here: http://www.qucrohnstrial.com/ssi-intro/qbeco-ssi-efficacy-and-safety/).
> 
> I hope I answered your questions.
> Thank you and all the best,
> Ashley


Thanks Ashley! 
I live outside of Canada so I don't think I am eligible. Is the trial due to finish in 16 weeks time then? I'm looking forward to the results.


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## ashleyanderson

Hi Gerrard, 

Even though you live outside of Canada, I would recommend you complete the pre-screening questionnaire so that if you are eligible, we can call you when it becomes available in your country. We are working hard to make this available to countries outside Canada. You can also speak with one of our representatives and share your interest in the trial so that we can stay connected with you. 

Here is a link to speak with a Qu Crohn's Trial representative: http://www.qucrohnstrial.com/contacts/request-to-speak/

The 60-participant trial will not be complete in 16 weeks, as we are still recruiting. Stay tuned 

All the best, 
Ashley


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## ashleyanderson

Hi ron50, 

I am very sorry to hear about your experience. I am not sure how this might relate to the Qu Crohn's Trial. The therapy you used sounds very different from SSIs used in Qu Crohn's Trial. 

I would be happy to answer any questions you might have about SSI's as it pertains to Qu Crohn's Trial. 

Best and kind regards, 
Ashley


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## Pointy_ears

Thanks David this study looks very hopeful!


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## ashleyanderson

Hi Everyone, 

Here are some new videos created by Qu Biologics providing further information and details pertaining to the Qu Crohn's Trial:

Qu Crohn's Trial Participant video:
http://www.qucrohnstrial.com/trial-info/about-this-crohns-disease-trial/


Qu Crohn's Trial Treatment Information and Training Videos:

Treatment Injection Training:
http://www.qucrohnstrial.com/trial-info/about-this-crohns-disease-trial/
http://www.qucrohnstrial.com/ssi-intro/qbeco-ssi-efficacy-and-safety/

Stool Collection:
http://www.qucrohnstrial.com/trial-info/about-this-crohns-disease-trial/

Please let me know if you have any questions. It would be a pleasure to assist, 

Best regards, 
Ashley


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## ashleyanderson

Hi Everyone, 

I have some very exciting news to share: 

To minimize the financial burden of travel expenses incurred while participating in the trial, Qu Biologics is pleased to provide a travel allowance to trial participants living 150 kilometres or farther from the trial site. - See more at: http://www.qucrohnstrial.com/trial-info/travel-allowance/

Have a great day!
Ashley


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## spinnychick

ashleyanderson said:


> Hi Everyone,
> 
> I have some very exciting news to share:
> 
> To minimize the financial burden of travel expenses incurred while participating in the trial, Qu Biologics is pleased to provide a travel allowance to trial participants living 150 kilometres or farther from the trial site. - See more at: http://www.qucrohnstrial.com/trial-info/travel-allowance/
> 
> Have a great day!
> Ashley


Ashley, if we were selected and turned it down due to the high expense/travel costs associated with it, are we now able to reverse our decision and be considered?


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## rollinstone

Is there any news on how the trial is coming along?


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## joe-swift

This is very promising for lots of people. Any people at all that can achieve remission without any side effects is a good thing. I'm open to taking anything that can help me so its good to see that there are companies out there that are aiming to help us treat the disease   Thanks for getting the interview for us David


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## rollinstone

Just wondering if any has talked to dr gunn recently? David? I'm super interested in knowing how the trials are going


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## ashleyanderson

Hi Everyone!

I will keep everyone updated with how the trial is going as news comes out. Stay tuned 

Spinnychick: absolutely! Please contact Qu directly: http://www.qucrohnstrial.com/contacts/


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## ashleyanderson

Hi everyone,

We wanted to inform you that the videos from patients who took part in our compassionate use program for Crohn’s disease have been removed.  While we recognize that these patients are happy to share their personal stories of their SSI treatment experience, we also respect the regulatory requirements that ensure the public is given information that is evidence-based and proven through controlled clinical trials. 

The compassionate use program, which involved 10 patients with Crohn’s disease, demonstrated promising results that supported further research in a larger-scale, formal clinical trial, which we have now begun.

We are excited about the potential of SSI treatment for Crohn’s disease and look forward to sharing the results from our clinical trial. 

Sincerely,
Ashley


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## rollinstone

Hi Ashley, will progressive results be released? Or only after the trial is completely finished?


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## ashleyanderson

Hi Joshuaaa, 

Thank you for your interest in the Qu Crohn's Trial. We expect to release results after the trial is complete.  We do not plan to release preliminary results.

Thanks, 
Ashley


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## rollinstone

Thanks Ashley, the trial is supposed to be complete at the end of next year right? Also, any more word on insurance for international patients?


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## ashleyanderson

Hi Joshuaa, 

The total duration of the study is 24 weeks. In addition, participants will receive follow-up calls from the study nurse for a period of one year from the time of their last dose of study treatment, for safety monitoring purposes. 

I have no new updates for you as of yet for insurance for international patients. Stay tuned!

Take care, 
Ashley


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## ashleyanderson

Hi Joshuaa, 

The expected time to finish the current trial is August 2015. This is the date projected to finish the 12-month follow up period of the last enrolled subject. 

I hope this helps!
Ashley


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## ashleyanderson

*Qu Crohns Trial Update*

I'd like to update everyone on our clinical trial and let you know that we hope to be able to accept American residents within the next few weeks. We are finalizing the logistical details with our laboratory testing service.

A maximum of 30 U.S. and international participants will be allowed into the Qu Crohn's clinical trial.  U.S. and other international participants who take the pre-screening questionnaire and register through the www.qucrohnstrial.com website are placed on a waitlist. Applicants on the waitlist will be contacted first once international participants are officially welcomed into the clinical trial.
Thank you for your patience.

Ashley


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## ashleyanderson

Hi Everyone, 

I wanted to share with you an audio interview and a video interview featuring Qu Crohn's Trial.

The first one is a podcast from the interview that Qu Biologics did with The Natural Health Show which aired this past weekend.  We had the opportunity to talk about the trial.  Dr. Hal Gunn and our Principal Investigator, Dr. Brian Bressler, were interviewed. Dr. Kevin Glasgow from the CCFC was also on the show. Click here to listen to the podcast ---> http://thenaturalhealthshow.ca/listen.html

The second is a video. Our IBD advisory team sent us some questions they felt would be helpful to answer. The panel video includes Dr. Hal Gunn, Dr. Brian Bressler and Dr. Simon Sutcliffe.  Click here to watch the video ---> https://www.youtube.com/watch?v=q6tIytz9ZAM

Have a great day!
Ashley


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## David

Thanks for taking the time to share all of this Ashley


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## Reef08

ashleyanderson said:


> The second is a video. Our IBD advisory team sent us some questions they felt would be helpful to answer. The panel video includes Dr. Hal Gunn, Dr. Brian Bressler and Dr. Simon Sutcliffe.  Click here to watch the video
> Have a great day!
> Ashley


Hi Ashley,

I have a few questions:

1. In the video, the Chief Medical Officer says that he believes that 4 months of treatment are needed for permanent change to the immune response. Why is the trial only 8 weeks long? It doesn't seem like patients will get any long-term relief from the trial. 

2. How long were the 4 patients that had sustained remission treated for?

3. If you take part in the trial, are you allowed to take part in future SSI trials (Phase2/Phase 3)?

Thanks!


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## Igor_Passau

Нi, you have to read the information the web about trial.


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## David

Ashley, I was thinking about you guys today and reread through everything you've been saying.  A couple questions:

1.  I see that you are now allowing Americans in the trial (awesome).  Posts above that you mentioned that there is now a travel stipend.  Does the travel stipend cover Americans?  And if so, is there a cap?  For example, if someone is coming from Florida and has an expensive ticket, will it be covered?

2.  You're trying to recruit 60 patients, correct?  Are you allowed to share how many are currently enrolled?


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## rollinstone

Also wondering if the travel subsidy covers international patients? Thx!


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## Reef08

Reef08 said:


> Hi Ashley,
> 
> I have a few questions:
> 
> 1. In the video, the Chief Medical Officer says that he believes that 4 months of treatment are needed for permanent change to the immune response. Why is the trial only 8 weeks long? It doesn't seem like patients will get any long-term relief from the trial.
> 
> 2. How long were the 4 patients that had sustained remission treated for?
> 
> 3. If you take part in the trial, are you allowed to take part in future SSI trials (Phase2/Phase 3)?
> 
> Thanks!


I should clarify that patients on placebo will only receive 8 weeks of actual treatment. Why not allow them to also get 16 weeks of treatment after the initial 8 weeks on placebo? It would be really disappointing to end up in placebo and miss out on potentially being cured or receiving a sustained remission.


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## ashleyanderson

Hi Everyone, 

Great questions! Please call the Qu Crohn's toll-free line to have these questions answered:
1.855.209.9680. 

Thanks
Ashley


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## ashleyanderson

Qu Crohn's Trial is now open to Americans!

There is a travel subsidy --> http://www.qucrohnstrial.com/trial-info/travel-allowance/

-Ashley


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## DustyKat

I see that Qu has been granted a second patent for targeted treatment of multiple cancers in Australia. 

Has the government been approached about the use of SSI’s in Crohn’s disease and if so what was their response?


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