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Crohn's Disease Forum » Books, Multimedia, Research & News » Thought I would share this…SSI Vaccines


 
06-29-2012, 03:20 AM   #31
Igor_Passau
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I sent them an Email asking for information, and to be included in the trials loop.
Hi, all possible information I have already posted! I am on the list of study. When I receive further information will post it!
07-05-2012, 07:08 PM   #32
Mark in Seattle
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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.
07-05-2012, 10:17 PM   #33
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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!
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07-07-2012, 08:04 PM   #34
CrohnsCHES
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Fascinating stuff! I hope it comes to the states soon, too!
07-07-2012, 08:10 PM   #35
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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.
07-10-2012, 01:56 PM   #36
Igor_Passau
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this study will run not late then August 2012
07-29-2012, 02:11 AM   #37
Igor_Passau
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От: Gigi Cheung <[email protected]>
Тема: Ответ: Experimental SSI Treatment for Crohn's
Дата: 9 июля 2012 19:07:29 Восточноевропейское летнее время
Кому: Igor <[email protected]>

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
07-29-2012, 02:14 AM   #38
Igor_Passau
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От: Gigi Cheung <[email protected]>
Тема: Ответ: Experimental SSI Treatment for Crohn's
Дата: 12 июля 2012 00:30:26 Восточноевропейское летнее время
Кому: Igor <[email protected]>

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 <[email protected]> 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
07-29-2012, 02:16 AM   #39
Igor_Passau
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No answers to my request! They forget me....
07-29-2012, 09:52 AM   #40
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Igor, what is the date you sent that message?
07-29-2012, 10:07 AM   #41
Igor_Passau
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11 and 12 July 2012
07-29-2012, 10:34 AM   #42
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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..."
07-29-2012, 12:28 PM   #43
Igor_Passau
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I understand you!
07-31-2012, 04:49 AM   #44
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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
07-31-2012, 05:25 AM   #45
Igor_Passau
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.............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...............

(((((((((
07-31-2012, 05:49 AM   #46
Igor_Passau
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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!
08-11-2012, 12:38 AM   #47
Mark in Seattle
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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.
08-11-2012, 12:40 AM   #48
Mark in Seattle
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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.
08-11-2012, 04:39 AM   #49
Igor_Passau
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where and how can I arrange insurance coverage for non-Canadian citizens enrolling in the clinical trial?
I try to contact http://www.torontovka.com/classified/business/165/158/
but without any answers!
08-11-2012, 09:59 AM   #50
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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.
08-16-2012, 10:41 AM   #51
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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
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09-23-2012, 01:55 PM   #52
mreyn
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I would be interested in updates as far as the results of the trials and when it will be available to all.
10-25-2012, 04:41 PM   #53
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Do you where I could obtain more information on the 240 people in Austria who received the SSI Vaccine?
Regards,
Traci Richard
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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
10-25-2012, 06:58 PM   #54
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Any update on this, is it still a promising?
10-26-2012, 02:13 AM   #55
Igor_Passau
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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 ...
10-28-2012, 05:37 PM   #56
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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.
12-01-2012, 09:49 PM   #57
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For those of you following this thread and SSIs progress, I interviewed the founding CEO and creator of SSIs here.
03-11-2013, 11:06 AM   #58
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Found out I've been selected to participate, 60 people chosen for the trial.
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03-11-2013, 01:52 PM   #59
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Please keep us informed of how it goes. I'm very interested in hearing. Thanks and good luck!
03-16-2013, 11:48 AM   #60
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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.
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