Thursday, 7 January 2016

Cladribine4MS


Today I launched a new project on the Blog, called Cladribine4MS (see the project button).

As you know ProfG was chief investigator of the CLARITY trial, that showed the efficacy of Movectro (oral cladribine) in relapsing MS.

In 2011 Merck terminated their respective programme and the drug was withdrawn from the market across the Globe, despite having been licensed in Australia and Russia.

Later that same year we (excluding ProfG because he was conflicted) began a process to try and develop generic Cladribine for people with relapsing MS. We identified generic companies willing to hold the license, obtained the full CLARITY phase III data set following request to the EMA, and planned a second phase III multi-centre trial to satisfy the UK regulators (MHRA) to support licensing.

In 2014/2015 the National Institute of Health Research indicated that they are not interested in developing anything new for relapsing MS.

In 2015 Merck announced their intention to relaunch Movectro with the EMA.

As a result, we put our attempts to develop generic Cladribine for people with relapsing MS in the UK on hold and went public.

 We believe Cladribine has a future as a treatment for pwMS beyond relapsing MS, and are willing to try again.

13 comments:

  1. Thank you for you persistence. Shall we start a political campaign? Let's take on the man!

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    1. Thanks. Politicial campaign sounds like a huge mountain to climb, but I'd definitely be a supporter. From our end we're planning a trial for people with advanced MS (EDSS 6+); these are the neglegted thousands, and there is preliminary evidence that Cladribine may make a difference even at this stage.

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    2. It would be amazing if someone can get to engage owith a politician our attempts failed but we were spread too thin. It need a team todo this.

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    3. Political campaigns only need to be started and journey of a thousand miles begins with the first step and all that. If you clarify the aims then I'll start a petition on 38 Degrees. I talked to my MP the other day about the MS Society campaign on benefits / cuts to working families tax credits and he was quite interested for a Tory. ;)

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  2. Project button doesn't work on my phone, might explain why only three comments?

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    1. Thanks i dontknow much about the coding but we will be posting the contents again next week and we will just use the project as a storage for old posts anyway.

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  3. This comment has been removed by a blog administrator.

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    1. in my haste to respond I accidently depleted your comment if you want repost if you have it but caldribien is very good a depleting B cells and therefore it removes the EBV reservoir

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    2. MD Thank you, no problem. I'll post at the end of my question, I have it well in mind because it was a question I had. This is excellent news, plus a super vantage point the Cladribine. o//

      "Since the dose of Cladribine administered in MS is not the same for the cases of hairy cell leukemia (superiomente the dose is larger), you would have some "reverse" action on EBV? Because the stories of leukemia treated with Cladribine (high dose) of the side effects is precisely the EBV infection".

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    3. Post any immunosuppressive drug there is a chance of increased infection

      http://www.ncbi.nlm.nih.gov/pubmed/15291365. A case report of post clad EBV lymphoma.

      Where is you information source as there is no doubt an inhibtory effect of cladribine in MS.

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  4. Could you please post the URL as mentioned before the banner does not work on my phone either...

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    1. http://multiple-sclerosis-research.blogspot.com/2015/12/cladribine4ms.html

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