# Qu Biologics Cleared to Proceed with Crohn’s Disease Clinical Trial



## nogutsnoglory

*Qu Biologics Cleared to Proceed with Crohn’s Disease Clinical Trial*

"Qu Biologics a biotech company that specializes in formulating Site Specific Immunomodulators (SSI) for the restoration of normal immune system function, has just announced that a Data Safety Monitoring Committee (DSMC) has completed a review of one of their pipeline product’s safety data from a 30-patient (50% enrollment) clinical trial. The product, QBECO SSI, is indicated for the treatment of Crohn’s disease and has received clearance to proceed with further clinical research, which the committee will continue to monitor.

The company’s ongoing trial plans to recruit a total of 60 US- and Canada-based participants diagnosed with moderate to severe Crohn’s disease. The testing site will be situated in Vancouver, British Columbia, Canada, and is currently 60% enrolled. The DSMC is tasked with setting standards of safety, monitoring these standards’ implementation for the trial participants and treatment efficacy data, and acting on behalf of patients whenever necessary.

“We are pleased to learn that safety data collected to date in our clinical trial has passed independent DSMC review,” said Hall Gunn, Chief Executive Officer, Qu Biologics, Inc. “SSIs represent a new treatment approach by aiming to restore innate immune function in chronic conditions like Crohn’s disease and cancer. We believe that harnessing the body’s own immune response rather than blocking or disrupting a process may lead to safer and potentially more effective treatments.”

QBECO SSI employs elements of inactive bacteria, modified to induce a normal response from the body’s immune system, thereby reducing or inhibiting chronic inflammation in various diseases such as cancer, autoimmune conditions, and inflammatory bowel diseases like Crohn’s disease.

The ongoing Phase 1/2 clinical trial was preceded by a 10-patient compassionate use program, which revealed all participants experienced improvement of symptoms while receiving the experimental SSI. Additionally, 7 participants achieved remission while on the medication, while 4 of this program’s participants achieved sustained remission even without treatment. The record for the longest remission stands at 4 years.

While these are impressive findings, the company would like to clarify that the compassionate use program was not placebo-controlled, nor was it blinded. These findings are therefore inconclusive, and only serves as a preview of what one can expect upon proceeding with further, more substantial research.

The company also announced they are targeting the 2nd quarter of 2015 for this clinical trial’s completion and publication of findings. In the meantime, Qu Biologics is working on launching a Phase 2a clinical research of QBKPN SSI, indicated for lung cancer; and another Phase 2a trial of QBECO SSI for use in ulcerative colitis."

http://ibdnewstoday.com/2014/10/30/...o-proceed-with-crohns-disease-clinical-trial/


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## Lisa

Great news! I made this a sticky for now so it doesn't get lost!


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## DJW

Excellent news.


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## nogutsnoglory

So excited to see this progressing. I know our members make a big chunk of the research which is also cool to know


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## Igor_Passau

So what is the results? who understand what kind of E.coli they used?


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## xeridea

Qu has completed enrollment on their Crohn's trial and is expecting to unblind their top-line results by end of first quarter next year with full results coming by middle of 2016.  www.qubiologics.com/qu-biologics-completes-enrollment-of-randomized-clinical-trial-in-crohns-disease.


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## SauceySciencey

Igor_Passau said:


> So what is the results? who understand what kind of E.coli they used?


The strain of E coli they used was apparently derived from a patient with an active infection (essentially, a stool sample, and then various steps to isolate the species and tests to confirm)...basically they then boil it to inactivate (kill) it, put some Phenol in ..and bon appetit. I'm sure there are some other steps, but that's a general overview. You'll hear fancy words like site-specific immunomodulator, but to be honest that's just there for fancy, distinct and stand-out words, I do it myself when writing funding proposals, science papers etc. Still, it looks promising. 

I wished in the clinical trial that, apart from placebo and treatment, they added a non-gut related pathogen treatment, just to show the distinct novelty of "site specific immunomodulator"...there are case reports of people having febrile reactions (just a fancy word for appearing to have an infection (temperature, tiredess etc) without knowing what's causing it) and going into spontaneous remission from crohn's. Crohn himself and some others actually injected patients with serum taken from a patient with dysentery, and actually got good results - they gave it up thinking surgery to remove diseased portions would cure it, they didn't realise in those early days that remission from surgery didn't last, and would return. Pity. This type of therapy might have been available in the 1950s, instead of now. But, ce'st la vie.


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## David

Thread unstuck.


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## Scared1

So will results be coming soon? Looks like 2016 has some interesting findings - redhill, this study....hoping for more info if anyone has!


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## Scared1

I read a lot of forums comments about this and from people who underwent the treatment - I am excited about the results. Just a quick question if anyone knows - adter they take the vaccine or injections for 16 weeks I think, is that it? They remain in remission or they don't have to take anything else for a few years or mever again making them essentially cured?


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## eleanor_rigby

I think a couple of people on the SSI vaccine post in the treatment section relapsed after a few weeks after stopping the treatment?


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## Scared1

Thanks eleanor - do you know which thread that was? I would like to read more about it


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## David

Anyone out there who was on the treatment have time to update us as to how you're doing?


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## Scared1

Hi David - yeah, I would agree, I wish there were more updates. If people relapsed, I would love to hear their experiences....


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## eleanor_rigby

Hi scared you can find the thread here:

http://www.crohnsforum.com/showthread.php?t=58980

I believe it is page 13 where a couple of posters discuss their relapse after finishing the treatment but I believe while on the treatment they were doing well.


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## Scared1

So here is an excerpt from the CEO Qu Biologics - the creators of the SSI Vaccine, regarding the underlying concept of the SSI vaccine "clearing" out the bacteria/pathogenic trigger to Crohn's in susceptible individuals that he posted on an AMA on Reddit:

[–]HalGunn 1 point 1 year ago* 
"As we have treated only 12 patients with IBD (10 with Crohn's disease and 2 with ulcerative colitis) prior to our current clinical trial in Crohn's disease, the optimal length of treatment has not yet been determined. In these 12 patients who had active moderate to severe IBD, 4 remain in sustained remission off of all medications after a course of QBECO SSI treatment of 3.5 - 11 months. The longest sustained remission is 4.5 years ongoing. The treatment is designed to restore innate immune system function to clear chronic bacterial infection in the intestinal mucosa that may be the underlying trigger for the inflammation.* As such, we believe that sustained remission may be possible after a course of treatment to clear the chronic bacterial infection, but this is an unproven hypothesis at this point.* As above, 4 of the 12 patients with IBD treated in our compassionate use program are in sustained remission off of all medications, but this is far too small a sample size to draw any meaningful conclusions."

So here is my question that I would like to pose - assuming that MAP is an underlying cause or AEIC, would the SSI vaccine inadvertently clear out the MAP vaccine if his unproven hypothesis holds true? I would love to hear everyone's thoughts on this....


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## Scared1

temperance said:


> :dance: Excellent news.


I agree Temperance My thing is - like for Tyler Wilson, who is in remission still post 4 years. I wouldn't mind my husband taking this every 5-7 years to reboot his system! A million times better than the other drugs out there and their side effects. I am hoping that eventually, they will test for MAP or AIEC and treat you accordingly for those....wouldn't that be great knowing you are treating the disease instead of the symptoms? In my mind - not knowing the progression (because you are not treating the underlying issue) is probably something that a lot of Crohn's patient worry about and contributes to stress too.


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