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05-08-2012, 10:00 PM   #1
crohnscoulton
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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.

Last edited by DustyKat; 05-22-2014 at 08:19 PM. Reason: Reason for sharing added to title.
05-08-2012, 10:07 PM   #2
David
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I've talked to the doctor who invented SSIs. It's an interesting treatment.
05-08-2012, 10:11 PM   #3
kiny
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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?
05-08-2012, 10:13 PM   #4
David
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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?
You're not going to find much information out there. It is definitely not a TNFa blocker.
05-10-2012, 09:57 AM   #5
Igor_Passau
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Could you provide any link regarding this treatment?
05-10-2012, 10:18 AM   #6
Igor_Passau
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http://www.youtube.com/watch?v=uKTq00hxEHc
05-10-2012, 10:37 AM   #7
Jobell
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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.
05-10-2012, 12:48 PM   #8
kiny
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Isn't anaphylaxis a minute risk with any injection?
It differs what the injection is though, the chance of anaphylaxis for an iron injection exists too, but the chances are incredibly low.
05-16-2012, 05:12 AM   #9
Igor_Passau
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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
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887 Great Northern Way, Suite 138
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T. 604.734.1450
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www.qubiologics.com
05-18-2012, 04:47 AM   #10
Igor_Passau
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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





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05-18-2012, 04:48 AM   #11
Igor_Passau
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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.

Last edited by Igor_Passau; 05-19-2012 at 04:25 AM.
05-18-2012, 04:50 AM   #12
Igor_Passau
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I plan to participate in this study!
05-19-2012, 04:22 AM   #13
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Good news! Follow this subscribe !
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05-23-2012, 04:34 AM   #14
Igor_Passau
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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
05-23-2012, 09:19 AM   #15
David
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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.
05-23-2012, 10:33 AM   #16
Igor_Passau
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I hope they will invite me! thank you the information!
05-23-2012, 11:17 AM   #17
Igor_Passau
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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?

Last edited by Igor_Passau; 05-24-2012 at 07:54 AM.
05-24-2012, 07:53 AM   #18
Igor_Passau
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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/re...sonId=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/ne...unnLecture.pdf

Mr. Salim Dhanji
Head of Pre-Clinical Research
http://investing.businessweek.com/re...onId=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/re...onId=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/
05-24-2012, 08:02 AM   #19
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Can anyone see how it should work for crohns? What do they target - a particular bacteria?
05-24-2012, 05:07 PM   #20
David
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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.
05-25-2012, 09:39 AM   #21
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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!
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06-05-2012, 10:52 AM   #22
Igor_Passau
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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 [email protected]
http://www.qubiologics.com/archives/1211
06-13-2012, 07:00 AM   #23
Igor_Passau
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Hi all!
I found another SSI - http://www.ssi.dk/English/Vaccines/T...023%20SSI.aspx
could you explain me SSI ?
06-26-2012, 04:24 PM   #24
apogee91
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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.
06-28-2012, 02:14 PM   #25
Mark in Seattle
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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.
06-28-2012, 05:57 PM   #26
apogee91
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I found this by simply searching "Crohns Cure" in youtube and found Tyler Wilson's video.
06-28-2012, 06:31 PM   #27
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I admit I haven't read the entire thread, however I am interested in getting on the trials list.

How do I do this??
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06-28-2012, 07:50 PM   #28
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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.
06-28-2012, 07:58 PM   #29
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I sent them an Email asking for information, and to be included in the trials loop.
06-28-2012, 08:05 PM   #30
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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?
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