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Crohn's Disease Forum » Ask the Experts » Interview with Dr. Hal Gunn, the Founding CEO of Qu Biologics and Developer of "Site Specific Immunomodulation" (SSI)


 
12-01-2012, 08:06 PM   #1
David
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Interview with Dr. Hal Gunn, the Founding CEO of Qu Biologics and Developer of "Site Specific Immunomodulation" (SSI)

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:


*** Added 05/31/2013 - See videos of Crohn's patients who have already taken SSI: http://www.crohnsforum.com/showpost....9&postcount=59
12-02-2012, 03:58 AM   #2
Igor_Passau
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David thank you!
12-02-2012, 04:04 AM   #3
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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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12-02-2012, 01:35 PM   #4
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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.
12-02-2012, 02:00 PM   #5
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Thanks David !
Exciting stuff
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12-02-2012, 03:26 PM   #6
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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.
12-02-2012, 06:48 PM   #7
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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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12-02-2012, 08:19 PM   #8
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Thanks David
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12-03-2012, 09:54 AM   #9
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Finally something concrete that will actually fight the cause of this plague. great interview.
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12-04-2012, 10:52 AM   #10
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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?
12-05-2012, 12:38 PM   #11
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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.
12-05-2012, 01:31 PM   #12
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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.
12-05-2012, 01:56 PM   #13
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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!
12-05-2012, 02:15 PM   #14
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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?
12-05-2012, 04:19 PM   #15
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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?
12-05-2012, 04:30 PM   #16
Glenda
 
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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
12-05-2012, 07:37 PM   #17
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Glenda,

Taking LDN is not an exclusion for this study. Meaning he could do both at the same time
12-09-2012, 02:50 PM   #18
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I hope this gets opened up to US residents. My meds don't seem to be working anymore...
12-12-2012, 03:32 PM   #19
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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?
12-14-2012, 04:10 PM   #20
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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
01-14-2013, 07:30 PM   #21
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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.../US8034359.pdf
02-06-2013, 09:38 AM   #22
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The website for the clinical trial is now live at http://www.qucrohnstrial.com
02-06-2013, 11:35 AM   #23
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Thanks for organizing the interview and keeping us all up-to-date!
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02-06-2013, 12:48 PM   #24
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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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02-06-2013, 12:50 PM   #25
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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.
02-06-2013, 02:38 PM   #26
Trysha
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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
02-07-2013, 10:37 AM   #27
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Been meaning to read the book 'Bad Pharma'....something about clinical trial design....
02-27-2013, 12:47 PM   #28
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Dr Gunn recently did another interview. Here it is in video format:

02-28-2013, 02:48 AM   #29
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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.

Last edited by kiny; 02-28-2013 at 03:25 AM.
02-28-2013, 09:13 AM   #30
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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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Crohn's Disease Forum » Ask the Experts » Interview with Dr. Hal Gunn, the Founding CEO of Qu Biologics and Developer of "Site Specific Immunomodulation" (SSI)
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