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Another T-cell vaccination, this time in Russia


http://www.transplantation.ru/multiple- ... atment.php

Hi Milica,

Sounds like a small trial for a Tovaxin-like drug to me. After a quick read I didn't see any mention of large, double-blind trials...did I miss that?

Dom.

Hi Dom,

It looks like they use it as a treatment. I might send them an email and ask the question.


Milica

Hi Dom,


I received this email today from Novosiborsk:

I guess will have to wait until their paper is published to find out more

Dear Milica,

The information on treating MS patients at our Center is presented in our paper that will be published in Russian soon. The manuscript in English will be prepared later.

I answer your questions one after another.

1) No control patients were followed up in our own study.

2) No adverse reactions were noticed so far.

3) All patients enrolled in the study underwent a medical examination at 6-to-8 months intervals.

4) Now nearly 80 MS patient are under our observation.

5) Actually, there are no contradictions to such treatment

6) Nearly 300 ml of blood is sufficient for preparing T-cell vaccine.

7) I have no detailed information on the mentioned studies.

8) We are treating both Russian and foreign patients.

9) For the preparation of T-cell vaccine a patient should arrive at our Novosibirsk's clinic. This procedure takes nearly 12 days. A quantity of the prepared vaccine is usually sufficient for the treatment of duration of 7-to-9 months. The overall cost of the treatment is nearly 4000 Euro.

Kindest regards,

Victor I. Seledtsov
Professor


Вы писали 24 февраля 2007 г., 8:01:36:

Your line of reasrch with T cell vaccinatin is extremly important
to MS sufferes around the world.I would like to ask several
questions in that regard:

1.I noticed that published results from T cell autovaccination state
about follow up of 28 patient over 2 years. Was this conducted as a
small clinical trial with matching contols( double blind placebo
trial), or it was conducted as treatment?
2.Did you notice any site injection,alergic, adverse
reaction?( redness, irritation)
3.What follow up was done on the patients over the treatment
period and how often ?( phyisical, MRI, blood tests)
4.Are You still treating patients (how many )and what are your latest results
5. What are the inclusion and exclusion criteria to get the
vaccine(age, EDDS score, what other therapies are
contraindicated)?
6.How much blood is needed for the preparation of the
vaccine, how many vaccinations can be done with one blood drew,
how long a patient should be getting montly vaccinations?
7.What are the differences and similarities between your T
cell vaccination and -TOVAXIN (phase II clinical tral)
http://www.tovaxin.com/ OPEXA and
-SHEBA from ISRAEL (phase III clinical trial)
http://www.clinicaltrials.gov/ct/show/NCT00228228
8.Is your centar open to take patients from other countries,
what is the cost of the treatment. Is it
possible to take 12 monthly supply of the vaccine( after the
initial preparation ) to be administered overseas and come back 1 year later for the second batch of 12?

Best regards,

Milica K.

Hi Milica,

Thank you for that information, you asked some very important questions and I think it is great that you asked the professor directly. I'm a little bit concerned about some of his answers though: first, from his answer to question one, this wasn't a double blind clinical trial with controls, and he doesn't suggest that there has EVER been a trial with this procedure.
Second, Question 5: they appear to give the vaccine to anyone with MS, whatever the type of MS they have and whatever their level of disability. This might be a really good thing, or it might mean they just don't care who they take the money from.
Third, Question 7: although you provided him with some Web links, he doesn't seem particularly interested in people who are working in the same direction.

Perhaps I'm being too hard on him -- maybe he just didn't want to give too much away until the paper is published. As you said, we'll just have to wait and see,

Dom.

and don't forget this answer:
3.What follow up was done on the patients over the treatment period and how often ?( physical, MRI, blood tests)
3) All patients enrolled in the study underwent a medical examination at 6-to-8 months intervals.

Just on how they are looking?[/b]

I think is not enough clear...

Actually the fact that Russia is kind of it's own little world makes the situation more interesting. Despite his feigned naivete regarding what we are doing in T cell vaccination. There is no doubt that they are well aware and drew at least part of their knowledge from us.

While it doesn't seem that Russian medicine is as advanced, refined or has the tools that we do, they also don't have to follow nearly the procedural and safety restrictions and some interesting things might be learned from them.....although with caution.

While everything they do seems kind of course, probably dangerous and not terribly accurate, there must be some small amount of truth involved and I find it interesting that their graph of results does show a decent amount of effectiveness even in the later stages.

No real lesson to be taken from it with confidence, but interesting.

Bob

Hey there

I've kept my eye on this forum since it began, and the progress of Tovaxin for a longer while still. I thought I'd register and post because I thought you are being a bit unfair on the Russian Academy of Medical Sciences...

Lyon wrote:Despite his feigned naivete regarding what we are doing in T cell vaccination. There is no doubt that they are well aware and drew at least part of their knowledge from us.

Perhaps there was no deception and they genuinely have access no to more data or information from Opexa than you or I and therefore he wasn't in a position to comment. I think this might well be the case since I'm sure that Opexa regards its methods as private.

It's an assumption to say that the Russian scientists took their knowledge, albeit in part, from Opexa. I vaguely remember reading that the doctor who heads the program for Opexa began his work, for the first few years, in China. The events that led to current research are clearly complex and must have built upon many achievements by many scientists in many countries. It may be the case, it may not be the case that the Russian scientists found their inspiration in the work of PharmaFrontiers, but to make the assumption with no evidence strikes me as wrong.

Lyon wrote: While everything they do seems kind of course, probably dangerous and not terribly accurate, there must be some small amount of truth involved and I find it interesting that their graph of results does show a decent amount of effectiveness even in the later stages.

Again, to say that the procedure is 'probably dangerous' (on the basis that, I presume, it is not American, or rather, it is Russian) seems quite rash. And to admit that there must be 'some small amount of truth involved' in their work sounds to me like a silly, patronising understatement.

You did touch upon the fact that the Russian system has less safe guards. Tovaxin may be available to the general public in the Western world by 2010/2012, right? Personally I believe that it is a great shame that a treatment with a proven track record for safety (I don't know how many people have been treated by Opexa to date but I do know it is a significant number) is not available to the general public. I understand the relationship between finance and pharmaceutical companies and research and safety and it's clear that the same financial interests which delay the marketing of drugs also promote research, but wouldn't it be a better world if people who needed a drug could be trusted to make a balanced decision as to the risks involved, and take it if they wished. I know that I would have dearly loved to have been included in the Tovaxin trial. Who knows how much worse my MS will be by the time Tovaxin has been approved? I speak reasonably good Russian, I really like the place, so I plan to go there for a therapeutic holiday.

Incidentally, there was mention in your post too of the state of advancement of Russian medicine. Looking at the other achievements of the Academy in Siberia, I'm pretty impressed by the list. An effective treatment for children with cerebral palsy, to name but one, seems pretty advanced to me.

Rita wrote:and don't forget this answer:
3.What follow up was done on the patients over the treatment period and how often ?( physical, MRI, blood tests)
3) All patients enrolled in the study underwent a medical examination at 6-to-8 months intervals.

Just on how they are looking?[/b]

I think is not enough clear...

Hey Rita,

They don't have access to MRI, they used tomographies.