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I spoke with my nurse as well. She said that Qu is putting an amendment on the protocol that weekly dose patients will be allowed to go back to every other day dosing if they flair. She is going to let me know once it has been okay'd by Health Canada. I think that Qu maybe has bowed to pressure as people were pretty upset(including myself) that we would not be allowed to return to the previous dose if we flared. It did seem odd that if you had been taken off you could go back on, but not from weekly. I didn't really see what the difference was.
 
Yeah, a little strange.

[edit] It sounds like it was an oversight on their part, not intentional. A detail that slipped through the cracks I guess.
 
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Since being reduced to the once a week dose, I've fluctuated in BM frequency quite a bit. For a few weeks my BMs were going between 13 - 17 per day. Then 2 weeks ago out of nowhere I went down to 5 one day, with the rest of the week at 8 per day. This past week it jumped around wildly between 6 and 18 BMs per day.

There was a pattern for a while, where a day or two after injection I'd see a dramatic increase in BMs, and then fall back to the week's norm. I'm not so sure I'm seeing that correlation lately though.

Also, no blood thus far. I'm not on anything else, including prednisone. Stool quality is usually soft and snakey looking. Not as much mucus as previous months. Rectal cramping is variable, but much better than before I started the trial still.

So, slight improvements, but one has to wonder if I'd be making faster progress on the alternate day dosing I was on before. October and November were still by far my best months as I was able to get out and get things done. Right now thats just not a possibility unless I pop some imodium (which would taint my numbers for a day or two), and even then that tends to make me feel pretty crummy.
 
Qu announced preliminary results today. No hard data, just that the treatment of 68 patients is shown to be safe and demonstrates consistent positive results at 8 and 16 weeks. The trials will continue to move forward and they expect to announce full results in the Fall.
 
NEWSLETTER:
Qu Biologics Announces Initial Results in Randomized, Placebo-Controlled Crohn's Disease Clinical Trial:

Vancouver, British Columbia - March 21, 2016 - Qu Biologics Inc.,

an immunotherapy company developing Site Specific Immunomodulators (SSIs) for cancer and other inflammatory diseases, announced initial results from the QBECO-01 study, a 68-patient randomized, placebo-controlled clinical study for the treatment of moderate-to-severe Crohn's disease.
Based on the Week 8 and preliminary Week 16 results, QBECO SSI appears safe and well-tolerated and demonstrates consistently positive trends throughout the treatment period of the trial, successfully establishing proof-of-concept in Crohn's disease and supporting continued development of QBECO SSI in inflammatory bowel disease.

Dr. Hal Gunn, CEO of Qu Biologics stated, "The positive trends observed across patient groups at Week 8 and Week 16 support the further assessment of SSIs as a therapeutic alternative to current treatments which suppress immune function."

Jim Pankovich, Qu Biologics' VP, Clinical Operations and Drug Development, added, "We are encouraged with the results of the trial, which will help to optimize the design and implementation of subsequent inflammatory bowel disease trials. Full results from the QBECO-01 study, including an assessment of the potential for sustained remission 8 weeks after completion of SSI treatment, are expected in the fall."

Qu Biologics' QBECO-01 study is a randomized, placebo-controlled, double-blinded clinical trial involving 68 participants with moderate-to-severe Crohn's disease. Participants were randomized (1:1) to treatment with QBECO SSI or placebo. The objectives of the study are to evaluate the safety and effectiveness of QBECO SSI for the treatment of Crohn's disease. The clinical study is taking place at four Canadian sites, in Vancouver, Edmonton, Calgary and Toronto.
 
Qu announced closing another $4 million in a new funding round. This will allow them to expand their CD and UC trials, and that's pretty great news!
 
I find the promotional picture from that announcement to be interesting - considering there happens to be an ingredients list for the SSI vaccine itself, minus the phenol. Oops.
 
Trevor said:
Oh boy. Not good news...

Crashed and burned about 8 weeks after the end of the trial. Actually pretty spectacularly. No more job, back on Pred and just waiting for the Humira :(

Sorry, guys.

If you're reading this and about to start or considering starting the SSI, it did some good stuff for me. It sucks it couldn't keep me where I was once I stopped taking it but this is where I was before so it's not that it made me worse.

I'll try and be around more. Been a rough go the last few weeks.
Click to expand...

Hi Trevor, I hope all has been well with you! I am sorry to hear what had happened. Did the onset happen gradually or right away and were you on anything for those 8 weeks?
 
Hi all. Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.
 
Wendy M said:
Hi all. Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.
Click to expand...

Hi Wendy,
Thanks for the reply! You are on this trial? Are you doing good on it at all?
 
Wendy M said:
Hi all. Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.
Click to expand...

Interesting that they're changing back. Did they say why?

Thanks for the update!
 
Scared1
Yes I have been on the trial since September 15. I have had good success in that my last scopes show no sign of disease. However I am still having some symptoms.
David
They haven't told me why but I will ask my nurse later today at my appointment.
 
Wendy M said:
Scared1
Yes I have been on the trial since September 15. I have had good success in that my last scopes show no sign of disease. However I am still having some symptoms.
David
They haven't told me why but I will ask my nurse later today at my appointment.
Click to expand...

Thank you Wendy - please keep us posted, I would love to hear more. This trial is under Bacterial Vaccines and I think the whole opportunistic infection type of premise for Crohn's would be validated even more based on the success of this trial amongst others (i.e. MAP stuff going on).

That's weird that you are having symptoms - did they do any biopsies at your last scope?

Thanks again for the info!
 
Thanks Wendy, we need more people like you stepping up for these tests to get through the murkiness! I hope things work out (for us all!)
 
I wish they'd hurry up - I went into one of my mini flares at work last night - and I was supervisor with 5 new people, so they were a bit uncomfortable with me walking around their desks checking their work holding an ice pack to my stomach to offset the swelling and since I was supervisor I couldn't go home sick since I was the senior in the entire building and everyone would have to go home haha. Better this morning though. No eating for a day or two. But yeah, they need to hurry up.
 
SauceySciencey said:
I wish they'd hurry up - I went into one of my mini flares at work last night - and I was supervisor with 5 new people, so they were a bit uncomfortable with me walking around their desks checking their work holding an ice pack to my stomach to offset the swelling and since I was supervisor I couldn't go home sick since I was the senior in the entire building and everyone would have to go home haha. Better this morning though. No eating for a day or two. But yeah, they need to hurry up.
Click to expand...

I am sorry Saucey, that really sucks. How long have you had Crohn's and what med's are you on? I can't imagine how horrible that must be - just doing your daily tasks and that in of itself is a struggle..:-( This year I think - honestly based on the timelines, we will get good information - either pro MAP (via Redhill studies should be presented end of the year at least interim) or show they failed (at least we will know) and the SSI is supposed to have something presented. I check these everyday - while my husband is asymptomatic. it breaks my heart reading all these struggles everyday:-(
 
Scared1 said:
I am sorry Saucey, that really sucks. How long have you had Crohn's and what med's are you on? I can't imagine how horrible that must be - just doing your daily tasks and that in of itself is a struggle..:-( This year I think - honestly based on the timelines, we will get good information - either pro MAP (via Redhill studies should be presented end of the year at least interim) or show they failed (at least we will know) and the SSI is supposed to have something presented. I check these everyday - while my husband is asymptomatic. it breaks my heart reading all these struggles everyday:-(
Click to expand...

Thanks, it's all good. The boss is very accepting of it - she knows sometimes I need to disappear and go into the shower (for some reason, cold showers have a nastily positive painkilling effect on me). Well, they could show that MAP has nothing to do with crohn's, but it could still turn out that the redhill clinical trial has positive results treatment wise. I'm leaning towards it being better than placebo - either way, it's another bullet in the arsenal for people :)

Currently 6 mg budesonide (roughly, it wavers), 100 mg azathioprine. And humira once fortnightly for the ankylosing spondylitis, which it does wonders for. I'm hoping a magic bullet comes along soon, I spent 8 years training to be a medical researcher, I'm supposed to be in a lab curing cancer, according to my mother :p

Hopefully your hubby can stay symptom free a little while longer :)
 
SauceySciencey said:
Thanks, it's all good. The boss is very accepting of it - she knows sometimes I need to disappear and go into the shower (for some reason, cold showers have a nastily positive painkilling effect on me). Well, they could show that MAP has nothing to do with crohn's, but it could still turn out that the redhill clinical trial has positive results treatment wise. I'm leaning towards it being better than placebo - either way, it's another bullet in the arsenal for people :)

Currently 6 mg budesonide (roughly, it wavers), 100 mg azathioprine. And humira once fortnightly for the ankylosing spondylitis, which it does wonders for. I'm hoping a magic bullet comes along soon, I spent 8 years training to be a medical researcher, I'm supposed to be in a lab curing cancer, according to my mother :p

Hopefully your hubby can stay symptom free a little while longer :)
Click to expand...


I really think we are close to a bullet of some sort, I honestly think the biggest hurdle to a cure or anything else is the Crohn's is an autoimmune mindset only. Being someone who I self diagnosed as OCD -and currently since my husband as been diagnosed (who has been asymptomatic always, as of last year before medicine - the basis of his diagnosis is the inflammation but that is another story), I have read soooo many articles, scientific journals and videos discussing the topic and then I read something about it being autoimmune and it annoys me because there is a clear difference between Crohn's and all these other autoimmune diseases, yet people disregard that for some reason. But honestly, I think within the next few years, something big will happen for sure - all thanks to researchers and people who are willing to think outside the box or popular conventions of that time....I hope in the meantime you feel much much better:) Hang in there!
 
So the SSI nurse says that the reason we get to go back to the original dosing is because patients were relapsing from remission when they were taken from every other day injections to once a week.
My symptoms are:
(Worst)is incomplete evacuation, which effects frequency. And makes for a lot of time spent in the bathroom.
frequency (2-4 times per day.) I know that's not bad for colitis but still not great. Unknown when etc so can't plan things without concern.
Still occasional diarrhea.
So similar symptoms as prior to Ssi. Very frustrating as I always seem to only get to a certain point and then no more improvement.
As I have said before the closest to remission I have come was on low dose naltrexone . I am still taking it but it definitely isn't working like it did for a while.
I had always stayed away from the Biologics but had decided to try entevyo if the ssi didn't work. But the doctor said because my last scope didn't show any signs of disease there was no point in trying it. So I'm not sure what to do now.
They did take biopsies on the scope but I haven't heard anything back.
I am scheduled for a colonoscopy in October.
 
Thanks Wendy for the update! I am so sorry you are still having symptoms:-(....Could food or some other reasons perhaps be causing this? That is so strange you have symptoms but no apparent active disease....do you think that the dosage - every day or every other day would affect how the long term impact is after the person stops SSI? Maybe your body just needs extra long to clear out the "infection" or pump your immune system so that it can handle it itself later on?

Sorry for the pain, please keep us posted...I hope it gets better for you soon!
 
I guess I'll give an update as well.

- Before starting SSI I was going between 15-18 times a day, with blood in my stool probably once a day and lots of painful rectal cramping. not the worst flare i've had, but the longest i've had.

- A month after starting I started to get better. after a month I was down to between 2-5 bowel movements a day that were much more solid than i've had in a long time. much less pain.

- A month after that I was reversing course back to around 10 urgent bowel movements a day. Shortly after I was randomized off of the alt day dose to once a week. Within a month and a half I relapsed and was hitting randomly between 12-18 BMs a day with blood here and there, lots of cramping, and mucus.

Having gone back to alt day dosing seems to have helped some what but its been a rocky road again and I've been told UC seems to be a rockier road than crohns with a lot of back and forth slow improvement. Unlike Wendy I never got rid of my inflammation though. Scopes showed less inflammation than when i started, but nonetheless it was a minor improvement. unfortunately that scope was also timed at a point where i had regressed so its hard to say what i looked like at the peak of my improvement.

In the last month I had gone down to about 5-8 BMs that were starting to look a bit more solid, but then it climbed back up to the 10 more urgent and mucus filled BMs with lots of cramping and gas and what not. One problem is that the SSI induces a type of inflammation to kill off any infection, so as a patient its really hard to know if this inflammatory response is my disease or the ssi doing its job. having lost several months to being on once a week was also a huge set back for me. it's hard to say whether or not that time off means i've essentially started from square one with the treatment again, and now with much less time than I initially thought I would have.
 
tongtol said:
I guess I'll give an update as well.

- Before starting SSI I was going between 15-18 times a day, with blood in my stool probably once a day and lots of painful rectal cramping. not the worst flare i've had, but the longest i've had.

- A month after starting I started to get better. after a month I was down to between 2-5 bowel movements a day that were much more solid than i've had in a long time. much less pain.

- A month after that I was reversing course back to around 10 urgent bowel movements a day. Shortly after I was randomized off of the alt day dose to once a week. Within a month and a half I relapsed and was hitting randomly between 12-18 BMs a day with blood here and there, lots of cramping, and mucus.

Having gone back to alt day dosing seems to have helped some what but its been a rocky road again and I've been told UC seems to be a rockier road than crohns with a lot of back and forth slow improvement. Unlike Wendy I never got rid of my inflammation though. Scopes showed less inflammation than when i started, but nonetheless it was a minor improvement. unfortunately that scope was also timed at a point where i had regressed so its hard to say what i looked like at the peak of my improvement.

In the last month I had gone down to about 5-8 BMs that were starting to look a bit more solid, but then it climbed back up to the 10 more urgent and mucus filled BMs with lots of cramping and gas and what not. One problem is that the SSI induces a type of inflammation to kill off any infection, so as a patient its really hard to know if this inflammatory response is my disease or the ssi doing its job. having lost several months to being on once a week was also a huge set back for me. it's hard to say whether or not that time off means i've essentially started from square one with the treatment again, and now with much less time than I initially thought I would have.
Click to expand...

Thank you for the update! This is very informative and very appreciated...do you feel there is a interim period where the vaccine is helping your body have a "normal" reaction meaning the inflammatory is killing off the bad bacteria if you will and so that is what you are experiencing? And in your opinion, do you think that the length of time you have had UC may also be a factor? Maybe longer = more time to adjust and work?
 
It's possible that the number of years I've had UC might be a factor. I had UC for 9 years and while it started as pan-colitis, most of my flares are located primarily in the rectum and sigmoid colon gradually tapering off in intensity.

As far as what I think is going on? its really hard to say, I'm not a doctor or researcher. I like to think that the amount of mucus I see is directly related to my body having an inflammatory response that is doing some good, but since we're in effect pioneers of this study there's nothing to compare to.

My guess is that the SSI triggers my body to look for something to kill, and when it finds it, I go into an inflammatory phase. When it finishes killing off that patch of infection, it goes back into a lull. The continued usage of SSI means my body continues to hunt for something, and when it finds another patch of infection it goes back into attack mode.

That's just a wild guess though. I have nothing to base that on really.
 
tongtol said:
It's possible that the number of years I've had UC might be a factor. I had UC for 9 years and while it started as pan-colitis, most of my flares are located primarily in the rectum and sigmoid colon gradually tapering off in intensity.

As far as what I think is going on? its really hard to say, I'm not a doctor or researcher. I like to think that the amount of mucus I see is directly related to my body having an inflammatory response that is doing some good, but since we're in effect pioneers of this study there's nothing to compare to.

My guess is that the SSI triggers my body to look for something to kill, and when it finds it, I go into an inflammatory phase. When it finishes killing off that patch of infection, it goes back into a lull. The continued usage of SSI means the body continues to hunt for something, and when it finds it again it goes back into attack mode.

That's just a wild guess though. I have nothing to base that on really.
Click to expand...

Thank you though - I am really interested in this trial and I really appreciate your first-hand experience. Please keep us posted, and I hope that your symptoms will subside....:-(
 
Thanks. It's been a 4 year run of constant flares for me, so I'm definitely ready to get my life back and maybe see some more sunshine!

Edit: What's most frustrating about this is that my Colitis never gets beyond "moderate", so it always seems treatable yet its bad enough that the urgency prevents me from going anywhere or concentrating on much of anything. Sadly one day ASAs stopped working, drugs like 6mp had no effect, and anti TNF drugs didnt do a thing for me either, so outside of entyvio, i'm not seeing a lot of options from a pharma perspective.
 
tongtol said:
Thanks. It's been a 4 year run of constant flares for me, so I'm definitely ready to get my life back and maybe see some more sunshine!

Edit: What's most frustrating about this is that my Colitis never gets beyond moderate, so it always seems treatable, but unfortunately one day ASAs stopped working, drugs like 6mp had no effect, and anti TNF drugs didnt do a thing for me either.
Click to expand...

That's the thing with this disease - I just don't believe it can be ONE underlying cause, waaay to much variability and too much differing patient reactions and successes with the drugs that are available. I mean, for diabetes I - you take insulin it works consistently, etc...yet for Crohn's or UC - just so frustrating and different. Have you tried diet changes maybe? 4 years of consistent flares, my heart hurts for you - that is horrible but it seems like you are pushing through - that will make your day in the sunshine when it arrives that much better:)
 
My GI told me that Crohn's and Colitis are more likely a spectrum of something like a 100 smaller diseases, with each person having a handful of those, which would explain the variability in effectiveness of treatment.
 
Wendy M said:
So the SSI nurse says that the reason we get to go back to the original dosing is because patients were relapsing from remission when they were taken from every other day injections to once a week.
My symptoms are:
(Worst)is incomplete evacuation, which effects frequency. And makes for a lot of time spent in the bathroom.
frequency (2-4 times per day.) I know that's not bad for colitis but still not great. Unknown when etc so can't plan things without concern.
Still occasional diarrhea.
So similar symptoms as prior to Ssi. Very frustrating as I always seem to only get to a certain point and then no more improvement.
As I have said before the closest to remission I have come was on low dose naltrexone . I am still taking it but it definitely isn't working like it did for a while.
I had always stayed away from the Biologics but had decided to try entevyo if the ssi didn't work. But the doctor said because my last scope didn't show any signs of disease there was no point in trying it. So I'm not sure what to do now.
They did take biopsies on the scope but I haven't heard anything back.
I am scheduled for a colonoscopy in October.
Click to expand...

Hi Wendy,
How are you doing? Any updates on your status?
 
So I have read on Qu Biologics website that Phase 1 for UC is closed for recruitment and that a Phase 2 will start...
Anyone with any other updates or any news from people on this trial???
 
I'll give my take on the trial. I think the treatment helped, but unfortunately due to the design of the study, I ended up being taken off the effective dose for several months and regressed close to pre-trial conditions. I was put back on the original dose because of this but had a much smaller window of opportunity to recover fully. That being said, I went from 18 bowel movements + cramping and blood per day to about 2-4 now, with the occasional 5. I'm definitely not in remission, but theres no blood, and the pain is basically not there anymore. just mild discomfort during the first few hours of the day typically.

So, I think there's promise, though it sounds like the treatment probably works better for crohn's than colitis considering how much faster the drug becomes effective for people. Also I think the reason for the trial closing and coming back with a phase 2 is to redesign a much more rigorous trial. I think perhaps its the kind of thing that might also be combined with another treatment, like say FMT, for a more guaranteed result, and perhaps a faster result.

Anyway, it was a long and rough journey. I went through repeated weeks long cycles of 2 steps forward, 1 step back, which got pretty discouraging since it makes positive progress seem so much less significant. It's hard to see the forest for the trees when you're parked on the porcelain throne for a year, but at least I no longer have to go to the washroom 18 times a day!
 
Thanks for sharing Tongtol. I am sorry you didnt get the full package treatment, seems like it helped in part though. 2/2 UC acheived continuing remission under SSI compassionate initial trial, so I am hoping it can work as much for CD and UC.
 
tongtol said:
I'll give my take on the trial. I think the treatment helped, but unfortunately due to the design of the study, I ended up being taken off the effective dose for several months and regressed close to pre-trial conditions. I was put back on the original dose because of this but had a much smaller window of opportunity to recover fully. That being said, I went from 18 bowel movements + cramping and blood per day to about 2-4 now, with the occasional 5. I'm definitely not in remission, but theres no blood, and the pain is basically not there anymore. just mild discomfort during the first few hours of the day typically.

So, I think there's promise, though it sounds like the treatment probably works better for crohn's than colitis considering how much faster the drug becomes effective for people. Also I think the reason for the trial closing and coming back with a phase 2 is to redesign a much more rigorous trial. I think perhaps its the kind of thing that might also be combined with another treatment, like say FMT, for a more guaranteed result, and perhaps a faster result.

Anyway, it was a long and rough journey. I went through repeated weeks long cycles of 2 steps forward, 1 step back, which got pretty discouraging since it makes positive progress seem so much less significant. It's hard to see the forest for the trees when you're parked on the porcelain throne for a year, but at least I no longer have to go to the washroom 18 times a day!
Click to expand...

Thank you for sharing, I really appreciate getting any information about this treatment - I am eagerly waiting for it for my husband to give it a try, hopefully within the next 5 years it will have passed all the phases.

If you don't mind me asking - are you still at 5 times a day even after you are done with the treatment? Are you taking any other medication?
 
I started entyvio about two months ago, about a month and a half after I stopped the trial. I feel roughly the same since I stopped the trial, and considering entyvio takes a minimum of 4 months to kick in for most people I'd say the trial must have had a lasting effect on me. Usually by this point I'm starting to flare pretty significantly. It's possible the entyvio is already doing something but it's quite rare for it to kick in so quickly (sometimes it takes up to 9 months for people), and like I said, it's not like I feel any different from when I exited the trial.

Hopefully the next trial gives them enough useful data that it can be the last trial, assuming its very effective at the dose and duration they administer it for. But yeah its probably at least 5 years away from coming to market, so I hope your husband is able to find something that works for him in the mean time!
 

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