Sunday, 15 November 2015

Barts Health is Now a Recruting Site in A Spasticity trial

Recruitment for a Spasticity trial with VSN16R is now occurring and both UCLH 

and now Barts Health are open and actively recruiting.

More sites across the UK will be opening

Details can now be found on clinical trial.gov. NCT02542787

Detailed Description:

Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.


VSN16R (Canbex name for molecule) oral capsules, daily or twice daily, total exposure 26 days.


Eligibility
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:
Have a confirmed diagnosis of MS
Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening. Spasticity due to MS of at least 3 months duration with minimum mean score of >/=2 mASH

Exclusion Criteria:
Acute MS relapse requiring treatment with steroids within 30 days of screening.
Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening.
Receiving medications that would potentially interfere with the actions of the study medication or outcome variables
Significant renal and hepatic abnormalities
Previous history of other significant medical disorders

If are interested you need to get your GP/neuro to contact the trial centre.

VSN16R is the sixteenth drug made by a chemist called Cristina Visintin and is an R enatiomer compared to an S enantiomer (meaning a side chain can point forwards or backwards). 


This has a unique mechanism of action, unlike any current anti-spastic drug.

Trial is called 


A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis.

or the CANBEX trial.


Canbex is a University College London Spin-Out Company aiming to develop VSN16R.

CoI: We are founders and consultants for Canbex

11 comments:

  1. If the drug is a success and gets licensed, will you be millionaires? If so, will you give up research? Will you feel differently about the huge sums paid to big pharma executives?

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    Replies
    1. "If the drug is a success and gets licensed, will you be millionaires? "

      Lets hope so:-)....but what's the currency?. When we go on holiday many of people become millionaires:-). Howeer, I am not at liberty to discuss this from a contractual point of view.

      But to get licenced implies the drug works and is safe in humans, as an interim I will take that as the most important thing. We will get a good publication and we will have discovered a new biology and will be the first people in a few decades to invent a new symptomatic treatment.

      Virtually no scientist these days ever has the experience of seeing a project through from invention to humans treatment. All I can do is try push the science of the project forward, I have no control of any financials.

      "If so, will you give up research?"

      Not the plan at the moment...there is still life in the old dog yet. Money is not the driving force for academics, although who would not want some if it is being handed out:-).

      Will you feel differently about the huge sums paid to big pharma executives?

      "No not at all...as I already know how they will shaft the people at the coal face and have had a few tastes of this from unexpected sources already".

      Do you no wonder if any of the 11% of people being canned from Biogen invented any thing that George Scangos is not profiting from. Viagra was invented in Sandwich in Kent this facility has long been closed.

      You can take this to show that my view is that I am against the excessive sums that they are taking. However should they be rewarded for their endevours...yes absolutely They are at the peak of their profession.

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    2. What is meant by Previous history of other significant medical disorders?

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    3. I'll have to ask what they actually meant when they wrote this

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  2. Is this Trial available in USA? or is Canbex available to try?

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  3. Oh, and screening for the study is restricted to the UK, and will open at some point to other countries?

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    Replies
    1. Dear Joey and Cinara
      At present the plans are to recruit totally from within the UK, because it would add so much to the cost of the study if we go overseas. But if this changes I will let you know as new sites are opened. There will be more I believe.

      However ,if the phase II is positive I am sure the phase III will be multi national.

      Delete
  4. Dear Poster
    I think I deleted a comment on this post by mistake , so if you posted something please post again.

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    Replies
    1. Thanks MD
      Here it is again. And despite the link being to one of the alternative dietary approach to MS websites, there are no hidden marketing nasties lurking - it is a review of B12 research and MS and a most interesting read (it is the only online version of this article I have been able to find).

      Dear MD
      The significance statement might make sense to you, but a plain English version would be handy for those of us who are not scientists........

      While on the subject of Vit B12 - there are many PwMS who are quite adamant that B12 supplementation does make them feel better - especially in relation to fatigue. At least B12 is non-toxic and if you take "too much" of it, you just piddle it out of your system.

      And the following article provides quite a bit of food for thought on B12 and MS - I found it most interesting that apparently IFN-B-1A has negative impacts on B12 levels for PwMS. The article also raises some interesting points about MS and B12 levels similar to the "reverse causation" questions/issues around MS and Vit D3.
      http://www.direct-ms.org/pdf/NutritionMS/B12%20and%20MS.pdf

      Delete
  5. I think that was my comment: "MD do not give up the search even if you become a millionaire, and not this blog !!! Will that VSN16R has positive properties in addition to the spasticity ..."

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    Replies
    1. Many Thanks. Once the manuscript on VSN16R is published we can talk about properties

      Delete

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