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Thought I would share this…SSI Vaccines

Thought I would share this…SSI Vaccines

There is a new therapy for crohns called ssi vaccines. They have no extreme or deadly side effects. In a recent clinical study there was 100% remission in 6 out of 8 patients. The other 2 showed improvement. Look up tyler wilson 100% remission crohns on youtube, he was one of the patients in the study. Also read the video description it has a link to the companies website that does the ssi vaccines. Currently they are only being usef for cancer but this might be a potential treatment for crohns, maybe even a cure. I heard they are doing a larger trial soon and they will post info on their website june 1st.
 
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It does say there is the potential side effect of anaphylaxis, which is deadly in some cases.

I honestly can't find what this thing is, is it another TNF-alpha blocker?
 

David

Co-Founder
Location
Naples, Florida
It does say there is the potential side effect of anaphylaxis, which is deadly in some cases.

I honestly can't find what this thing is, is it another TNF-alpha blocker?
You're not going to find much information out there. It is definitely not a TNFa blocker.
 
Isn't anaphylaxis a minute risk with any injection? I also want to hear about the science behind this... what it is supposed to do? What is their claim (other than bringing on remission)? Could a 'cure' be at hand? So far all I see are anecdotal stories of symptom relief (which I would welcome), but nothing that explains the conceptual basis of the treatment.
 
Dear Mr. ХХХХХХ,

I have responded to your gmail address, but I will also respond to this address as well.
Thank you for your inquiry re: clinical trial for Crohn's disease, which I understand, is subsequent to you having seen a patient (Tyler Wilson's) testimony video. I expect that you have also reviewed our website (www.qubiologics.com). Although the information provided is cancer-focused, we believe that the basic principles likely also apply to other inflammatory conditions such as IBD.
Site-Specific Immunotherapy (SSI) is not currently approved for use in Canada or the U.S., as it is still in development. However, we are actively planning a small-scale (60 patients) randomized placebo-controlled clinical trial (RCT) to be registered with Health Canada and run here in Vancouver for the use of SSI to treatCrohn's disease. We anticipate that the trial will begin enrolling patients in Fall 2012.
If you would like, I would be happy to add your name to our growing list of Crohn's patients interested in participating in the trial.
We are still working out the details of how the clinical trial will be run, but we plan to put together an information website in the next few weeks answering many FAQ's and clearly delineating the eligibility requirements for participation in our RCT, which I would be happy to direct you to, once it is ready. In the meantime, please don't hesitate to contact me again should you have any specific questions.

Cordially,
Gillian
__________________________________________________ ______________

Gillian Vandermeirsch, Ph.D.
Operations Manager

887 Great Northern Way, Suite 138
Vancouver, British Columbia
Canada V5T 4T5
T. 604.734.1450
F. 604.676.2235
www.qubiologics.com
 
Dear Igor,


Thank you for your enthusiasm, we too are really excited about this trial. Those are all really good questions. I can give you a few quick answers, but we are still in the process of finalizing our study protocol, and we are setting up a website for interested participants that we hope to have online in June, and that will address all of your questions in detail, and allow patients to learn more and self pre-screen for the study.


In the meantime, please see my answers below in green.


Kind regards,
Gillian





________________________________________________________________


Gillian Vandermeirsch, Ph.D.
 
1.Duration of clinical study?
24 weeks (6 months) + 6 months follow-up for safety monitoring purposes

2.Duration of course of therapy for one patient? 16 weeks Number of course of therapy. single course (i.e., 1 x 16 weeks) Intervals between courses? N/A

3.Will be this treatment inpatient or outpatient care? outpatient care - there will be one week of training that will require 5 office visits, and then the patients self-administer the treatment at home, every 2nd day by subcutaneous injection (similar to insulin injections)

4.Please provide me detailed list of examinations for participants in this study? not yet available - there will likely be standard hematology, serum biochemistry, urinalysis and immunological tests as well as stool sample analysis. There will not be any invasive procedures/imaging.

5.How you will plan to control the effectiveness of treatments?
We will be using the Crohn's Disease Activity Index (CDAI) score and the Harvey-Bradshaw Index (HBI) score

6 During the study should I refuse from standard treatment (budenofalk, antibiotics) ? We are still finalizing the list of acceptable concomitant medications - most medications, with the exception of biologic therapies, will be acceptable as long as the dose is stable

7 Could you inform me about negative side effect of this treatment? This will be explained in the Informed Consent Form What kind of medical actin should be done in this case? This will be explained in the Informed Consent Form

8 Cost of study for me? All study-related costs (lab work etc.) will be paid for by Qu Biologics. The only costs for the participants will be travel and accomodation. Patients will need to come for three in-person visits over the 24 week period (one visit (10 days) at baseline, one visit (one day or one week) at 8 weeks and one visit (one day) at 24 weeks.

9. Could you also clarify me about method of study! Is this possible that I can be in group of patient where will be only placebo? The study will be a phase 1/2 double-blind randomized control trial for 60 patients. Patients will be randomized 1:1 at baseline (i.e., 30 get placebo, 30 get SSI drug). Patients will be assessed at 8 weeks and "responders" will continue their current therapy for an additional 8 weeks while "non-responders" will be given "open-label" SSI for an additional 8 weeks. All patients will therefore be treated for 16 weeks, and all patients will get a minimum of 8 weeks on the SSI drug, unless they have responded to placebo.
 
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Dear Igor,


Please see my answers to your queries below:


On Mon, May 21, 2012 at 8:26 AM, XXXXX> wrote:

Dear Dr. Gillian,

Thank you for the quick respond! Could you also answer for few next questions:

1.Should I need additional care during treatments? For example, family care in your hospital?


No, you should not need any hospital care during your visit. You will need to have blood drawn and provide a urine sample, and meet with the physician for a routine office visit, that is all.
1.2.Could you inform me about specific of health insurance during this study? I have local – Ukrainian assurance.


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.
1.2.Is this possible for me to be directly in group with SSI drug? I understand that this is not honestly to another patients but I will travel for long distance and with CD this is difficult.


The nature of the trial is "randomized 1:1 double-blind placebo controlled" which means that neither the physicians nor the patients will know who is in what group, and that you will have a 50% chance of receiving SSI. Having said that, the trial is designed such that after the first assessment at 8 weeks, any patient who has not responded to their current treatment (placebo or SSI) will then receive "open-label" SSI for the next 8 weeks. This means that if you were on placebo for the first 8 weeks, and you have not improved, then you will get SSI treatment - so all patients will have access to SSI during the trial - either at baseline or at 8 weeks (unless you have had a response to placebo).
1. Waiting from You more details (Especially interesting to see information about side effects)!


SSI have an excellent safety profile to-date. With over 250 patients in our Austrian Compassionate Use program, we have only seen mild side effects, such as a larger than normal local skin immune reaction (red spot) at the injection site, and in rare cases where patients have self-administered a larger than normal dose, flu-like symptoms (fever, chills) which resolve within a few days.
Regards,

Igor
 

David

Co-Founder
Location
Naples, Florida
Since they've giving out more info now, I want to come out and say that I am super excited about the potential of SSIs and plan to be actively involved spreading the word about this trial once they put their informational site up.

I've talked back and forth a lot with the CEO of the company and he's an amazing doctor and person. Everyone who participates will be in good hands.
 
Hi,
Could somebody help in information research about this company?
• How many drugs produce this company ? I found only SSI for cancer. Is this SSI for cancer approved by FDA?
• Whether this company have any articles regarding IBD?
 
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Qu Biologics Inc., a biotechnology company, provides site specific immunotherapy for the treatment and prevention of cancer. The company was founded in 2007 and is based in Vancouver, Canada.

Dr. Hal Gunn
Chief Executive Officer
http://investing.businessweek.com/research/stocks/private/person.asp?personId=49276771

Hal Gunn, M.D., founded Qu Biologics Inc., in September 2007 and serves as its Chief Executive Officer. Dr. Gunn is a Co-Founder and Chief Executive Officer of InspireHealth. He is a Co-founder and Chief Executive Officer of the Centre for Integrated Healing, Vancouver, BC, a non-profit organization funded in part by the Medical Services Plan of BC, the Canadian Cancer Society, and the BC Cancer Agency. He is recognized nationally as a leader in integrative cancer care. Dr. Gunn has used bacterial vaccines in the treatment of cancer, and has a clinical appointment with the University of British Columbia School of Medicine. He serves as a Member of Clinical Advisory Board at MBVax Bioscience Inc. In 2009, Dr. Gunn was awarded the Dr. Roger's Prize in Alternative and Complementary Medicine for vision, leadership and integrity in the field of Integrative Medicine. He has a clinical appointment with the UBC School of Medicine. Dr. Gunn obtained his Doctorate of Medicine from the University of B.C. (1981).

http://intlhealth.med.utoronto.ca/newsfiles/19102007GunnLecture.pdf

Mr. Salim Dhanji
Head of Pre-Clinical Research
http://investing.businessweek.com/research/stocks/private/person.asp?personId=109639138
Salim Dhanji, Ph.D. serves as Head of Pre-Clinical Research at Qu Biologics Inc. Mr. Dhanji has done extensive pre-clinical animal study cancer research, including immunological mechanism of action studies and cancer therapeutic studies. He received 7 awards and scholarships for his graduate work and post-doctoral research, and published a number of articles on his work. Mr. Dhanji has a Ph.D. in microbiology from the University of British Columbia, where he studied the innate immune response to infection. Following this, he completed a 3 year post-doctoral fellowship at the Ontario Cancer Institute, researching the immune response to cancer, including the immune response to cancer vaccines.
Dr. Jerry Calver
Vice President of Chemistry & Manufacturing
http://investing.businessweek.com/research/stocks/private/person.asp?personId=109639091
Jerry Calver, Ph. D. serves as a Vice President of Chemistry & Manufacturing at Qu Biologics Inc. Dr. Calver is the founder and serves as the President of Calver Biologics Consulting. Dr. Calver worked at Health Canada for 31 years, most recently as the Head of the Bacterial and Parasitological Vaccines Department. He was involved with the regulation, research, testing, lot release, review of drug submissions and inspection of production and testing facilities of vaccines and other biological products. Dr. Calver's major expertise lies in the evaluation of quality, chemistry and manufacturing, preclinical aspects of production of biologics and site inspection. He specializes in reviewing vaccine files and Good Manufacturing Practices (GMP) inspections. He oversees the development and production of the site specific immunotherapies and will oversee the manufacturing and production aspects of Qu's clinical trial applications and product approval of the SSIs
Scientific Advisory Board

Brian Bressler, M.D.
Dr. Bressler is a Clinical Assistant Professor of Medicine, in the Division of Gastroenterology at the University of British Columbia’s Department of Medicine. Dr. Bressler received his MD from the University of British Columbia and completed his residency in internal medicine and gastroenterology at the University of Toronto. He received an MS in Epidemiology from the Harvard Public School of Health and completed an advanced fellowship in Inflammatory Bowel Disease at Massachusetts General Hospital, Harvard Medical School. Dr. Bressler is a recognized expert in inflammatory bowel disease. His research interests include population based studies, classic clinical epidemiology studies and clinical trials in inflammatory bowel disease. He is an invited reviewer for many medical journals including Gastroenterology, Clinical Gastroenterology and Hepatology, and American Journal of Gastroenterology

http://www.bridgeibd.com/brian-bressler-md

Articles
Оhttp://thischangedmypractice.com/author/bribre/
 

David

Co-Founder
Location
Naples, Florida
SSIs don't target a particular bacteria. They actually stimulate the immune system to do what it's supposed to do :)

And yes, I can absolutely see how it would work for Crohn's Disease and I'm very excited about it.

I occasionally get something called "prolotherapy" for some inflammation in my chest area called costochondritis. It's basically injections in my chest joints and it stimulates the immune system to properly deal with the damage. I remember talking to my doctor wishing there was an equivalent for IBD. Next thing I knew I was being contacted about SSIs which I consider to be that equivalent. :)
 

JDTM

OMG LDN BBQ
David, this is so freakin' cool. I'm psyched to hear more about SSIs as the trials progress, and I'm happy to hear that the prolotherapy is working for you too buddy!
 
Qu Biologics closes another angel financing round bringing recent funding to $2.8M
Qu Biologics recently closed a new round of funding that will be used to move our clinical trials programs forward in inflammatory bowel disease (IBD: Crohn’s Disease and ulcerative colitis) and cancer indications (lung, pancreas, colorectal), bringing the total funding raised in the last six months to $2.8M and the total to-date to over $5M. The round was backed by multiple individuals from a network of angel investors that Qu has established in Ontario.

“We are really inspired by the overwhelmingly positive response that we have received from potential investors as we have laid out our plans to move forward quickly in the IBD space. This additional funding will allow Qu to progressively initiate all of our currently planned clinical trials over the next year or so, and, more importantly, to see our first clinical trial in Crohn’s Disease through to completion” said Hal Gunn, M.D., Chief Executive Officer of Qu Biologics.

If you are interested in learning more about investment and/or partnering opportunities with Qu Biologics, please contact Dr. Hal Gunn directly at 604.734.1450 ext. 1 or hal@qubiologics.com
http://www.qubiologics.com/archives/1211
 
If there aren't any major side effects why can't we all simply buy it and have a doctor inject it to us? Why wait so long? Trials.. etc.. why? if this had 6 out of 8 patients totally cured / remission why not sell the vaccine? why not spread the word out asap? I don't mind trying this on my own and having a private Dr. injecting this to me.
 
I looked on the Qu web site. It talks a little bit about how it works, and has some pictures of macrophages. It's talking about how it works for cancer, so I don't know if the same process would hold true for Crohn's or not, but here it is. Pretty interesting.

I emailed the company asking if Americans like myself can drive up and participate in the trial. I wonder how safe it really is though....

Anyway, this is awesome that you found this & shared it crohnscoulton. How did you happen to find this?

http://www.qubiologics.com/technology/how-it-works


How SSIs Work
Substantial historical and published evidence shows that acute bacterial infection may reverse cancer development, even in advanced stages. Anecdotally, many clinicians dating back to the time of Hippocrates have observed that people who developed cancer had rarely experienced colds, flus or infections earlier in life. Simply put, by stimulating the immune system’s natural surveillance and defence actions, acute bacterial infection may enable the immune system to stop a tumour from growing, and thus reverse cancer development.

SSIs were developed as a treatment to mimic acute infection allowing the development of an anti-tumour immune response. In order to better understand how Qu Biologics’ SSIs harness the immune system to treat cancer, it is helpful to become familiar with one of the key components of the innate immune response – the macrophage cell.

Macrophages are a type of white blood cell which perform two essential roles in the human body: tissue repair and immune response. In cancer, these roles are opposing. Macrophages functioning in their “tissue repair” mode can stimulate cancer growth (M2 macrophages), while those functioning in their “tissue defense” role can inhibit and destroy tumour cells (M1 macrophages).



During wound healing, M2 macrophages act as sentinel cells that coordinate the tissue repair process. When functioning in their tissue repair role, M2 macrophages actively support cancer growth by releasing cytokines that suppress the immune response within the tumour microenvironment. In the case of cancer, the tissue repair response is actually detrimental, as rather than attacking the defective cancer cells, it favours the conditions necessary for their proliferation, leading to tumour formation.

In sharp contrast, an acute bacterial infection, acting as a strong antigenic stimulus, can activate M1 macrophages, inducing a cascade of cytokines/chemokines that results in tumour regression, and eventually, destruction.

Qu Biologics hypothesizes that treatment with the appropriate SSI mimics an acute bacterial infection in the cancerous organ/tissue, stimulating macrophages to perform their essential role in defence against foreign pathogens, as opposed to tissue repair. In agreement with this, Qu Biologics’ research team has demonstrated that SSI therapy shifts macrophage dominance from M2 to M1 within the tumour microenvironment in a mouse model of lung cancer. Further, this important shift in macrophage function is associated with tumour regression in these mice.



From a clinical perspective, the expression profile of immune cells within the tumour microenvironment is highly correlated with prognosis – more highly correlated than any currently used prognostic indicator, including tumour grade, presence or absence of lymph nodes, or use of chemotherapy. Not surprisingly, the greater the density of M1-type macrophages, the better the prognosis. Targeting and harnessing the tumouricidal activity of M1 macrophages therefore holds significant promise as an innovative approach to treating cancer.
 

David

Co-Founder
Location
Naples, Florida
The trial is not yet open and won't be for awhile yet. They're working hard to get ready though. It's amazing how much logistics goes into a trial like this.
 

KWalker

Moderator
This interests me. I've always kind of looked at medicine like somewhat of a waste if it couldn't actually cure you but it sounds like this might have the potential. If you guys were closer to me I would jump all over the opportunity for the study.

Do you think there will ever be different means of getting the medicine such as syringe vs. Epi pen?
 
Question for David - as I read the writeup from the Qu web site about how this SSI works, it does not sound like the kind of immunotherapy a person does when they go to their allergist to be treated with SCIT (subcutaneous immunotherapy) for allergies, such as dust mites, pollen, etc., where the idea is to reduce the allergic reaction by creating tolerance. I'm understanding that the Qu theory believes that the immune system is misguided in perpetually trying to repair the tissues that the microbes are tearing down, rather than marshalling macrophages to eliminate the microbes. In a way, this theory differs from the conventional "overactive immune response" theory because it blames inflammation on the microbes rather than on the immune response. Am I understanding this correctly or am I mixed up?

Also, it does mention using bacteria in the injections (bacteria specific to lungs for lung cancer, bacteria specific to the gut for gut cancer, etc.). I emailed them asking if they could tell me which bacteria they use for the Crohn's Trial. We'll see what they say.

You sound pretty positive on this trial/approach - why? I'm thinking about applying since I'm pretty close to Vancouver. I'd sure like it if they would disclose more info about what's in the vaccine and what the results have been to date for other Crohn's patients who have tried it.
 
I received a reply to my email, and the trial happening this fall is going to be in Canada. :( So I wouldn't be able to participate.

Best of luck to you Canadians!
 

David

Co-Founder
Location
Naples, Florida
Mark in Seattle,

I'm covered by an NDA and don't want to risk violating it. As such, I'm going to wait for Qu Biologics to provide more information before I discuss specifics.

There's a variety of reasons I'm excited about it. One being that my sister (the Crohnsforum.com Science Advisor) was conducting research for cancer that does almost the exact same thing and had amazing results. I understand the basic premise and it makes sense to me that it would help with IBD. Judith and I have been in contact with Qu Biologics and have been learning the finer details of their approach. Once they're ready to proceed, we'll be providing our opinions on the positive and negative aspects as we see them in an effort to provide CF members with as much information as possible so anyone interested can make an educated rather than emotional decision.

For transparency sake, neither of us is in any way being compensated by Qu Biologics. There is zero bias or conflict of interest.
 
От: Gigi Cheung <gigi@qubiologics.com>
Тема: Ответ: Experimental SSI Treatment for Crohn's
Дата: 9 июля 2012 19:07:29 Восточноевропейское летнее время
Кому: Igor <igorpassau@gmail.com>

Dear Igor:

We wanted to let you know that we are busy working towards our goal of having the trial approved by Health Canada to start in Fall 2012. We are also working on a patient recruitment website which we hope to have up and running in late August. This site will give you more information about the trial, including a self-screening questionnaire and a FAQs page.

In the meantime, there are a couple of key points that we would like you to be aware of:
As you may or may not be aware, the trial will be run out of a single centre here in Vancouver, British Columbia, Canada. As such, all trial participants will be required to travel to Vancouver three times, to be seen at our clinical trial site in downtown Vancouver, once at the start, once at 8 weeks, and once at trial end, at 24 weeks. Your travel to and from Vancouver, and your accommodation, transportation and meals while in Vancouver will be your responsibility (i.e., these expenses are not reimbursed by the trial sponsor).

It has just been brought to our attention that non-Canadian residents may not be able to participate in our trial due to a lack of medical coverage valid in Canada. If you are a non-Canadian resident interested in participating in our trial, could you please contact your health insurance provider(s) to see if your regular and/or travel medical coverage will allow you to participate in a clinical trial outside of your home country. Please make sure that there are no exemption clauses re: pre-existing medical conditions and/or receiving an investigational drug, therapy or treatment.
We would greatly appreciate hearing back from any non-Canadian residents with regards to the medical coverage issue, as this will have important implications as to who we can invite to participate in our clinical trial.

Please don't hesitate to contact us should you have any further questions.

Sincerely,

Gigi Cheung, BBA
Administrative Assistant

887 Great Northern Way, Suite 138
Vancouver, B.C. V5T 4T5
Tel: 604-734-1450 ext. 0 | Fax: 604-676-2235
www.qubiologics.com
 
От: Gigi Cheung <gigi@qubiologics.com>
Тема: Ответ: Experimental SSI Treatment for Crohn's
Дата: 12 июля 2012 00:30:26 Восточноевропейское летнее время
Кому: Igor <igorpassau@gmail.com>

Dear Igor:

Thank you for your response. I have forwarded your inquiries to our Clinical Trials Team, and they are working hard to finalize the answers for you.

Thank you for your patience. Have a lovely day.

Sincerely,

Gigi Cheung, BBA
Administrative Assistant

887 Great Northern Way, Suite 138
Vancouver, B.C. V5T 4T5
Tel: 604-734-1450 ext. 0 | Fax: 604-676-2235
www.qubiologics.com


On Wed, Jul 11, 2012 at 7:01 AM, Igor XXX <igorpassau@gmail.com> wrote:
Dear Gigi,

Thank you for the important e-mail. I am appreciating of your support.

I will cover all traveling, accommodation, visa and etc. cost.

As you know I am non- Canadian resident, I am from Ukraine (CIS country). My current Ukrainian health insurance doesn’t cover USA and Canada only Europe and CIS. For additional payment I can cover also Canada, but my existing policies did not cover any clinical study. Could you provide me with insurance or not? If no, should I try to find international insurance for this case?

As a rule I will need invitation for clinical study with the purpose to receive a long term visa in Canada (for minimum 24 weeks). Could you provide this invitation (letter)?

I should be able to take SSi vaccine\ treatment throw customhouses of Canada and Ukraine. Will you provide me any official therapeutic indications for SSi vaccine?

Regards,

Igor XXX

Mobile
 

David

Co-Founder
Location
Naples, Florida
I don't think they forgot you, they're just crazy busy. I know if I was sent a letter like you did, my initial thought would be, "Oh crap, I didn't think of that!" And because I'd already be super busy with other things, your letter would sit on my desk and I'd stare at it every day knowing that it was going to require serious time/research and wanting to do it but getting pulled away by other things. They're really good people who want to help as many people as they can and they're having to focus their time in an effort to get as many people who need help into the trial as possible.

I am NOT speaking for Qu Biologics here, just thinking out loud. If I was you, I'd fill out the trial info on their website when it goes live in an effort to get accepted. And I'd also be researching EXACTLY what I'll need if I do get accepted into the trial so I could provide real world examples to Qu Biologics when that time comes to make their lives easier. For example, "I need an invitation letter for a long term visa. Here is an example..."
 
Dear Igor,

Thank you for your e-mail of July 11, 2012 inquiring about the Qu Biologics product, site-specific immunotherapy (SSI), and the proposed clinical study for subjects with Crohn's disease. I am replying in my role as Chief Medical Officer for Qu Biologics. The following points are relevant for your further consideration of the study:


Eligibility for the study: Although the study protocol and informed consent form are not yet finalized, the eligibility requirements for the study will be based upon:


a. Provision of voluntary informed consent.
b. Age >18 years and <80 years.
c. Established diagnosis of Crohn's disease, sustained at least 6 months prior to enrollment in the study and substantiated by a histopathology report, or corroborating evidence to support the diagnosis of Crohn's disease and exclude other potential diagnoses of inflammatory bowel disease.
d. Active, incompletely controlled disease at the time of enrollment. This would be established according to the Crohn's disease Activity Index (CDAI) and/or the Harvey-Bradshaw Index (an aggregate score based upon clinical symptomatology, physical findings and corroborating investigations, including imaging and/or endoscopies).
e. Willingness to practice contraception during, and for 2 months post-completion, of SSI therapy.
f. Use of medications, including oral steroids is permitted. Subjects are ineligible if they have received cyclosporine (Gengraf, :Neoral®, Sandimmune®) or thalidomide (Thalomid®), investigational/experimental therapies, or adalimumab (Humira®) within 30 days of enrollment, or infliximab (Remicade®) or certolizumab (Cimzia®) within 60 days of enrollment.


Exclusion from the study:


a. Infection and/or treatment for Clostridium difficile or other intestinal pathogens within 30 days of enrollment.
b. Currently require, or are anticipated to require, major surgical interventions for Crohn's disease during the study (at least up to 4 months from enrollment in the clinical study).
c. Other co-existing inflammatory bowel disorder diagnoses e.g. ulcerative colitis.
d. Any identified congenital or acquired immunodeficiency state e.g. HIV/AIDS, organ transplantation etc.
e. Other co-existing or prior diagnosis of cancer, other than non-melanoma skin cancer.
f. Co-existing illicit drug or alcohol abuse or dependency.
g. Inability to comply with the required presence for the study in Vancouver.
These criteria are absolute requirements. Enrollment cannot take place if these conditions are not met. Qu Biologics would be in breach of ethics and regulatory permissions if these conditions were to be ignored or contravened.
Procedures conducted as per the protocol, including availability of SSI product and its administration, would be fully funded by Qu Biologics i.e., there would be no charge to subject or insurance carrier for these procedures or the product for any enrollee, Canadian or foreign.
Medical complications or interventions (emergency medical care) by health professionals or institutions, will not be paid for by Qu Biologics. These costs would be borne by the insurance carrier providing coverage for the non-Canadian citizen requiring healthcare services in Canada. The responsibility for ensuring appropriate and adequate insurance coverage is a direct subject responsibility. Qu Biologics cannot and will not, arrange insurance coverage for non-Canadian citizens enrolling in the trial. Entrance into Canada should not be undertaken unless appropriate and adequate health insurance coverage through your own insurance provider (in the Ukraine) has been assured.

All travel, hospitality, meals and personal costs are the responsibility of the enrolled subject.
Qu Biologics cannot issue an invitation to participate in the trial. This would violate Ethics Review Board understandings. Qu Biologics can advise you of the trial, direct you to publicly available information, outline the general eligibility requirements, provide an indication of your eligibility (subject to on-site confirmation) based on medical documentation provided by you, and indicate that the protocol procedures, including drug supply and administration, are provided free of charge to the subject enrolled in the study. However, the responsibility for obtaining a visa to enter Canada to participate in the clinical trial lies with the subject /enrollee.


Participation in the study requires that you be on-site in Canada on three (3) occasions during the 16-week induction therapy component of the study. This would require a total of approximately 20 to 30 days in Vancouver.

Currently, there are no official therapeutic indications for Qu Biologics SSI treatment. The clinical trials are being conducted to seek regulatory approval and establish defined indications for clinical usage.


Qu Biologics is enthusiastic to initiate this trial and welcomes subject participation. However, for foreign nationals, it is essential that adequate insurance to cover medically necessary care whilst in Canada is in place prior to entry into Canada.


I hope this addresses your questions satisfactorily.


Yours sincerely,


Simon Sutcliffe,
M.D. F.R.C.P.C.
Chief Medical Officer, Qu Biologics
 
.............Qu Biologics cannot and will not, arrange insurance coverage for non-Canadian citizens enrolling in the trial. Entrance into Canada should not be undertaken unless appropriate and adequate health insurance coverage through your own insurance provider (in the Ukraine) has been assured...............

:((((((((((
 
So, I found in internet that insurance for clinical trials have to be covered by arranger of this trial! I cannot obtain such insurance, only companies. My ukrainian insurance will not cover this study! My insurance does not cover IBD…. !You will never find any insurance in CIS that will cover IBD! In Russia this is covered directly by GOVERNMENT!
 
I had some correspondence with Qu as well. Here is some of it. Gigi inquired with me about my insurance coverage. I told her I was covered for emergencies while in Canada. Her response:

Yes, you are correct. If an unwanted reaction occurs and causes the participant to seek for extra medical treatment, the sponsor will not cover the medical cost. Similarly, if the participant's Crohn's disease worsens and requires additional medical intervention while in Canada, Canadian participants will be insured by their own provincial medical plan, but this does not apply to participants coming from out of Canada. Not limited to our trial treatment, if a non-Canadian participant suffers an injury (e.g., breaks a leg) during his/her time in Vancouver, it is very important for us to make sure that he/she has medical insurance coverage outside of his/her home country.

Gigi seemed to indicate that having insurance that covers emergencies in Canada would suffice for their concerns.

Also, I saw a video of someone named Tyler Wilson who claims to have done the treatment for Crohn's. Do you have any other info regarding anyone else who has done the treatment for Crohn's and/or what the results have been for all the people who have tried this treatment for Crohn's (how many people have tried it & how many have had success or not)?

We have used SSI treatment in eight (8) people with Crohn's disease through our small clinical trial in the Bahamas. All eight (8) patients have had a therapeutic response with substantial improvement in symptoms. Five (5) of the eight (8) patients are in clinical remission with full resolution of clinical symptoms. Two (2) patients had follow-up colonoscopies, and in both cases, full remission was confirmed. Seven (7) of eight (8) patients are now off all other medications.
Also, I noted on the Qu Biologic website that it says that for intestinal problems, the vaccine that is used targets a single bacteria that is unique to the gi tract. Can you tell me what bacteria that is? I'm curious because I've read that there are a great many kinds of bacteria living in the intestines?

Yes, there are many different species of bacteria living in the intestines - collectively these are called microflora. The bacteria used to create this investigational treatment is Escherichia coli, commonly known as E. coli. The product is made from killed E. coli so it cannot cause infection.
Finally, if my doctor signs off on the paperwork stating that I have active Crohn's which has been visualized via colonoscopy, will that satisfy the sponsors so that I don't have to do more invasive testing to demonstrate my situation?

The study doctor may require additional evidence to determine whether your disease is active at the time of enrollment. Once the study doctor reviews your medical records, you may or may not be required to submit other medical documents in addition to your colonoscopy results.
 
I asked some follow-up questions of Gigi, and they were answered by Hal Gunn:

1) Can you say what particular strain of E. Coli is used in the vaccine? I've heard there are a number of varieties of E. Coli, such as adherant-invasive and many types that go by alpha-numeric labels.

The specific strain used to create the SSI is proprietary.

2) Is there, or will there be any writeup of the Bahamian trial in any journal or published document that I could read? Also, is there a particular reason it was done in the Bahamas rather than in North America?

It was done in the Bahamas the investigator there was very interested in SSI and obtained approval. We won't be publishing the results of the trial. We intend to publish the results of our upcoming Canadian trial.

3) So I should just monitor the Qubiologics web site to see when the trial opens, correct? And then when I see it listed on the web site, I can apply at that time? Yes, that is correct.

We are currently targeting early November as the start date. Any more specific timeline at this point, or still just sometime in the fall?
4) Finally, would you have any concerns or objections if I were to share the content of our email correspondence on thehttp://www.crohnsforum.com/ web site? This is a web site where folks with IBD and/or an interest in IBD share information & stories with one another. There is a subforum on the site where some folks are interested in knowing about this trial.

Yes, you are welcome to share this information. Thank you for your interest in SSI treatment.
 
I asked some follow-up questions of Gigi, and they were answered by Hal Gunn:

1) Can you say what particular strain of E. Coli is used in the vaccine? I've heard there are a number of varieties of E. Coli, such as adherant-invasive and many types that go by alpha-numeric labels.
So the Strain of E.Coli is Patented?
Another 10 year drug in the making. Theyve had this for over 4 years. Better
than nothing.:medal1:
 
Hi Igor,


Thank you for contacting your medical insurance provider. I'm sorry that your medical insurance does not cover insurance outside of Ukraine.


I wish you the best in your Crohn's care journey.


Sincerely,



Dear Simon,

Thank you for the e-mail.

I contacted https://www.travelunderwriters.com/ regarding necessary medical insurance for non resident of Canada. But the is one of the main condition of this insurance – «the unchanged use of prescribed drugs or medication for a Stable condition, symptom or problem». In the case of clinical study this is a case of changes.

Regarding Ukrainian insurance, as I mentioned below – does not cover clinical study.

As a result I could not find appropriate medical insurance.

Sorry that I spend you time. I hope you SSI technology will be successful and in the near future (4-5 years) I will be able to buy it.

Regards,

Igor


Gigi Cheung, BBA
Administrative Assistant
 
I would be interested in updates as far as the results of the trials and when it will be available to all.
 
Do you where I could obtain more information on the 240 people in Austria who received the SSI Vaccine?
Regards,
Traci Richard
Cola SC
Dear Igor,


Please see my answers to your queries below:


On Mon, May 21, 2012 at 8:26 AM, XXXXX> wrote:

Dear Dr. Gillian,

Thank you for the quick respond! Could you also answer for few next questions:

1.Should I need additional care during treatments? For example, family care in your hospital?


No, you should not need any hospital care during your visit. You will need to have blood drawn and provide a urine sample, and meet with the physician for a routine office visit, that is all.
1.2.Could you inform me about specific of health insurance during this study? I have local – Ukrainian assurance.


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.
1.2.Is this possible for me to be directly in group with SSI drug? I understand that this is not honestly to another patients but I will travel for long distance and with CD this is difficult.


The nature of the trial is "randomized 1:1 double-blind placebo controlled" which means that neither the physicians nor the patients will know who is in what group, and that you will have a 50% chance of receiving SSI. Having said that, the trial is designed such that after the first assessment at 8 weeks, any patient who has not responded to their current treatment (placebo or SSI) will then receive "open-label" SSI for the next 8 weeks. This means that if you were on placebo for the first 8 weeks, and you have not improved, then you will get SSI treatment - so all patients will have access to SSI during the trial - either at baseline or at 8 weeks (unless you have had a response to placebo).
1. Waiting from You more details (Especially interesting to see information about side effects)!


SSI have an excellent safety profile to-date. With over 250 patients in our Austrian Compassionate Use program, we have only seen mild side effects, such as a larger than normal local skin immune reaction (red spot) at the injection site, and in rare cases where patients have self-administered a larger than normal dose, flu-like symptoms (fever, chills) which resolve within a few days.
Regards,

Igor
 
Hi,
I couldn't find issuance! So I could not participate in this study. I try to by insurance in Canada but no chance. So I was able cover all accommodation cost and etc. but ...
 
Sorry I have to ask a few questions.
1 when there is 100% remission is that permanent?
2 If approved how long before this becomes available for others (im in UK).

Thank you for your help, it looks an exciting possible cure.
 
It differs what the injection is though, the chance of anaphylaxis for an iron injection exists too, but the chances are incredibly low.
That's what epi-pens are for. A shot of epinephrine in the thigh, and anaphylaxis goes away, pretty much immediately. I carry one in my purse. I used to get anaphylaxis in a regular basis before I got my allergies under control.
 
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
 
Great questions everyone.

SpinnyChick - Thank you for your warm welcome to the forum. Travel and accommodations are at the participants' expense.

Ya noy - I encourage you to complete the questionnaire on the trial website and apply. We do have a wait list for non-Canadian residents.

Igor_Passau - Very happy to hear your update.

Best regards and thank you for your questions,
Hal
 
Hi everyone,

We have reserved a discount for participants at a hotel nearby in Vancouver - Ramada to assist with travel costs. Please see attached.

This information is now posted on Qu Crohn's Trial website so that other's will be able to see this and benefit.

Best regards,
Hal
 

Attachments

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
 

nogutsnoglory

Moderator
When do you expect to offer a trial in the U.S.? If everything is successful, what is your earliest projection of this hitting the market?
 
Hi nogutsnoglory, it is still too early to know when it will hit the market. We are working towards offering the trial to US residents.

If you are a non-Canadian resident and would like to assess your eligibility for the Qu Crohn's Trial, please complete the self-assessment questionnaire and pre-register on our website so we may place you on our priority waitlist for international participants.

Thank you for your question,
Ashley
 
Hi nogutsnoglory,

I have more information for you: Qu Biologics is aiming to enroll international (including US) residents this summer. Stay tuned for more updates on this.

I would recommend you complete the self-assessment questionnaire and pre-register on our website so we may place you on our priority waitlist as soon as this becomes available.

Thank you and best regards,
Ashley
 

Trysha

Moderator
Staff member
Thank you Tyler for sharing this encouraging information
Your baby is adorable with your charming supportive wife.
Hugs and best wishes
Trysha
 
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
 
I think the hypothesis that Qu is working on sounds more plausible than a lot of others I've heard, and I think the approach of solving an underlying problem sounds much more appealing than fixing its symptoms.

I'm in the US, so unfortunately I can't participate, but I'm excited for the results of this trial!
 
I live in Sweden and filled out the form. I would love to try this, looks promising. Anything that´s not remicade or humira is welcome.
 
Hi Igor_Passau,

If you have submitted a completed registration form, you will be contacted as soon as the trial becomes available to other countries. Thank you for your continued interest.

Best regards,
Ashley
 
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
 
Hi nogutsnoglory,

Great question.

Ten (10) patients with uncontrolled persistent moderate to severe Crohn's Disease were treated with QBECO SSI treatment through the 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 SSI 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 SSI treatment. - See more at: http://www.qucrohnstrial.com/ssi-intro/qbeco-ssi-efficacy-and-safety/#sthash.XzelULDh.dpuf

The total number to be enrolled in this trial is 60 participants. - See more at: http://www.qucrohnstrial.com/quicklinks/frequently-asked-questions/#sthash.MdqPjMhm.dpuf

Thank you,
Ashley
 
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
 
Last edited:
Ashley: Could you please let me know if there´s any progress in the international-side of the study?

I got an mail från Hal Gunn on the 2 of Aug.

"We are still working on obtaining insurance for international patients. We should know whether we are able to achieve this in 2-3 weeks and then it will take another month or so (if successful) before international patients could start the study."
 
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
 
Hi Everyone,

I currently have no new updates on the trial as of yet. Stay tuned!
Hi Everyone,

Feel free to also direct questions to the Qu Crohn's toll-free line:
1.855.209.9680.

Ashley
 
I signed up for the US trial on last Friday and I was contacted yesterday. The young lady on the phone was very informative and even gave me a document to show to my GI. Unfortunately I do not qualify because I just started Remicade after my revised resection. She exclaimed that the trial would be going on for awhile and that if the Remicade isn't working for me that I could contact them again.
 
This trial is suuuper interesting, i really look forward to seeing the result of their clinical trial - the initial 10 people 'trial' results make it sound very promising, i hope it's as good as they make it seem.

The only bad thing is that that guy who has been in remission for 3 years since taking the treatment was on it for 11 months. That's quite a difference when compared to the 8 - 16 weeks that the people in the trial will be given.
 
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