Friday, 30 October 2015

History of Clear MS Coming Soon

        The History of CLEAR MS  

                         Coming Soon

Thursday, 29 October 2015

Re-purpose Cladribine !

Here's the email I sent Chuka Umunna on 18 Oct: 

Dear Mr Umunna

I am contacting you about the drug re-purposing Bill to ask for your support to see it become Law. I believe it comes before the house on November 6. I attach some documents setting out the case for the Bill and please excuse me if you are already familiar with the arguments.

Breakthroughs in research have meant that several existing drugs have been found to be effective in treating conditions other than the ones they were originally made and patented for. They are referred to as “off patent” drugs. Repurposing these could have potentially huge benefits for many people suffering from conditions like multiple sclerosis (MS) and Cancer. They can be supplied at low cost by Generic Drug companies. The annual treatment for a patient may be less than £1,000 versus over 20x the cost for patented alternatives if in fact they exist. The savings would be of great benefit to patients, the NHS and the taxpayer, and could lead to treatment for many people whose treatment is denied by NICE on the grounds of cost.

However, drugs need to be licensed and approved for their new uses in order to be made available and there is little commercial incentive for pharmaceutical companies, who normally sponsor this process, to do so for off patent treatments. This is largely because prices generally fall a great deal once the patent has expired. There is no mechanism in place to enable licensing of drugs for uses other than their original purpose. Even if a doctor can refer to strong evidence in support of prescribing an off-patent drug to a patient, they would likely be put off by the potential personal liability they may face in doing so. 

There are thus political, legal and commercial barriers in place to prescribing off patent drugs. The Bill seeks to overcome these barriers by obliging the Government to act in the public interest through the process of the Medicines and Healthcare Regulatory Agency (MHRA) to license and approve off-patent, repurposed drugs for use on the NHS. 

The Bill is strongly supported by medical charities and specialists in the NHS, including myself - I am a Reader in Clinical Neurology at Queen Mary University of London & Consultant Neurologist at Barts Health NHS Trust.  As a clinical academic with an interest in MS, I know that early effective treatment of people with MS is key for a beneficial long term outcome.  I therefore have a particular interest in the re-purposing of Cladribine, a drug licensed in the UK for patients with hairy cell leukaemia.  There is evidence from phase III trials that Cladribine is highly effective and safe for people with MS.  The annual cost of Cladribine treatment in MS would be under £1,000 compared to licensed drugs of lesser efficacy that cost 20x or more.  I would be very happy to expand on this example further if you are interested and have the time; just call me on my mobile xxx.

For now, I do hope you are able to support the Bill. Please let me know if there is anything further I can do to promote it.

With best wishes

Sincerely Yours,
Klaus Schmierer
I'll keep watching out for comments by my MP, over and above his auto-reply...

Thursday, 22 October 2015


Cladribine (trade names Leustatin, Litak and Movectro) is a drug used to treat hairy cell leukemia (HCL, leukemic reticuloendotheliosis) and multiple sclerosis. Its chemical name is 2-chlorodeoxyadenosine (2CDA).


As a purine analog, it is a synthetic anti-cancer agent that also suppresses the immune system. Chemically, it mimics the nucleosideadenosine and thus inhibits the enzyme adenosine deaminase, which interferes with the cell's ability to process DNA. It is easily destroyed by normal cells except for blood cells, with the result that it produces relatively few side effects and results in very little non-target cell loss.

Cladribine was designed by Dennis A. Carson as an anti-lymphocyte compound, while he was at The Scripps Research Institute in La Jolla, California. It was first synthesized at Brigham Young University.The pharmacology and clinical applications were researched by scientists at Johnson and Johnson, which filed the New Drug Application and launched the drug in 1993.

Cladribine was designed based on information about an immune deficiency disease called adenosine deaminase deficiency. Carson described it as "a targeted agent directed against lymphocytes at a time when there was no such thing as targeted agents".

In 2008, Ernest Beutler of The Scripps Research Institute won the Wallace H. Coulter Award for Lifetime Achievement in Haematology from the Coulter Foundation and theAmerican Society of Hematology in part because of the clinical trials he ran, which established cladribine as the most effective treatment for hairy cell leukemia (HCL).

Thursday, 1 October 2015

Unrelated Blogger Comments


  1. Address: Dr Klaus Schmierer, Neuroscience Clinical Academic Group, Barts Health NHS Trust, The Royal London Hospital, Whitechapel, London E1 1BB,
  2. Patient pathway coordinator: Patricia Willams-Falokun, Neuroscience Clinical Academic Group, Barts Health NHS Trust, The Royal London Hospital, Whitechapel, London E1 1BB,
  3. Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D, 11th Floor, Central Tower, Whitechapel, London, E1 1BB, Switchboard: 020 3594 0000Direct Dial Ward Number: 0203 5940637/0638, Ward Manager: Maria Espasandin
  5. The Royal London Hospital Mapclick here for map
  1. Address: Dr Klaus Schmierer, Blizard Institute, Queen Mary University of London, 2 Newark Street, Whitechapel, London E1 2AT.
  2. Laboratory Manager: David Holden,for laboratory related issues and queries in relation to grant budgets: Tel: +44 20 7882 2327, Email:
  3. Neuroscience & Trauma Centre Administrator: Jyoti Salhan, for issues related to Blizard Institute and the Neuroscience & Trauma Centre, Tel. +44 20 7882 8605, Fax. +44 20 77882 2180 Email:
  4. Blizard Institute Mapclick here for map

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      General Disclaimer: Please note that the opinions expressed here are those of the individual bloggers and do not necessarily reflect the positions of the Barts and The London School of Medicine and Dentistry or Barts Health NHS Trust.

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      As a principle we will attempt to declare all relevant conflicts of interest in relation to our postings.

      However, we have many conflicts of interest and therefore read this information with this in,and an open,mind.

      Klaus Schmierer is a principal investigator of trials sponsored by Novartis, Roche and Teva. He is also involved in trials sponsored byBiogen, Genzyme, BIAL, has revieced speaking honoraria from, and/or served in an advisory role for, Biogen, Novartis, Teva, Merck Inc., and travel support from Genzyme to attend AAN 2014.  Klaus and his group have received research grant support from Novartis, the WellcomeTrust, the National MS Society (US), the MS Society of Great Britain & Northern Ireland, the Royal College of Radiologists, and Barts Charity. 
      We have received grant support from companies and Aims2cure; The National Multiple Sclerosis Society, The Multiple Sclerosis Society, The Wellcome Trust; The Medical Research Council; Innovate UK; Fastforward and others, for which we are very grateful.

      Updated, October 2015

      Blog Authours

      DrK (Klaus Schmierer PhD FRCP)
      Multiple sclerosis has been DrK's clinical and research focus from the beginning of his training in neurology at the Charité Hospital (Humboldt University), which followed undergraduate studies in Berlin and Jerusalem. In 2001 he moved to London to pursue a career in academic neurology, initially as a Research Fellow, and from 2005 as a Wellcome Intermediate Clinical Fellow at the UCL Institute of Neurology, and a Consultant Neurologist (Hon) at The National Hospital for Neurology & Neurosurgery, Queen Square. Here, he investigated the histo-pathological correlates of quantitative MRI using standard and high-field MR systems to improve disease monitoring in people with MS. Following appointment in 2009 at Queen Mary, where he is a Reader in Clinical Neurology, his clinical-academic work now includes (i) quantifying the pathological substrate of disease deterioration in pwMS using MRI and quantitative histology; (ii) further developing the BartsMS Database (the MS Trust's QuDos runner up 2015!); (iii) in vivo MRI studies to improve the early diagnosis of MS, and (iv) investigator-led and commercial clinical trials.  DrK considers Cladribine the best
      currently available 'allround drug' for people with MS.

      MouseDoctor. Has an ology.
      The MouseDoctor spent his academic career based at different places of the University of London . He was awarded a BSc (Hons) in Zoology from Bedford College in 1983 and was awarded a PhD from London University in Immunology/Pathology in 1987 for work at the Institute of Basic medical Science on immunological tolerance induction in delayed hypersensitivity of the skin. He then spent six years as the Angela Limerick lecturer, for multiple sclerosis research at the Hunterian Institute, The Royal College of Surgeons of England working on delayed hypersensitivity in the brain, where he developed an active research interest in multiple sclerosis. He took a 5 year Principal Fellowship to the Institute of Ophthalmology , University College London in 1994 and became the first Senior Fellow of the Multiple Sclerosis Society and moved to the Institute of Neurology , University College London in 1999. He became a senior lecturer in 2003 and got a personal chair in 2004 as Professor of Neuroimmunology. He moved to Queen Mary in the autumn of 2006. 

      Canned Pictures is a journalist with experience as a script writer for an Ex Prime Minster and worked on Newsnight for the BBC. They have MS.

      BartsMSBlog a cyborg collective
      This is a lab portal for anyone (shy members) in the group to use

      About this Blog

      Cladribine is an anti-Cancer drug that is used to treat hairy Cell Leukaemia.

      This is available as a generic drug that is injected either via the subcutaneous route under the skin or as an intravenous infusion.

      In 2010 an oral Produg of Cladribine called Movectro was Shown to be Effective in the Control of Multiple Sclerosis.

      Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg Sørensen P, Vermersch P, Chang P, Hamlett A, Musch B, Greenberg SJ; CLARITY Study Group.
      A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.N Engl J Med. 2010 Feb 4;362(5):416-26.

      BACKGROUND:Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes. We report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing-remitting multiple sclerosis.
      METHODS:We randomly assigned 1326 patients in an approximate 1:1:1 ratio to receive one of two cumulative doses of cladribine tablets (either 3.5 mg or 5.25 mg per kilogram of body weight) or matching placebo, given in two or four short courses for the first 48 weeks, then in two short courses starting at week 48 and week 52 (for a total of 8 to 20 days per year). The primary end point was the rate of relapse at 96 weeks.
      RESULTS:Among patients who received cladribine tablets (either 3.5 mg or 5.25 mg per kilogram), there was a significantly lower annualized rate of relapse than in the placebo group (0.14 and 0.15, respectively, vs. 0.33; P<0.001 for both comparisons), a higher relapse-free rate (79.7% and 78.9%, respectively, vs. 60.9%; P<0.001 for both comparisons), a lower risk of 3-month sustained progression of disability (hazard ratio for the 3.5-mg group, 0.67; 95% confidence interval [CI], 0.48 to 0.93; P=0.02; and hazard ratio for the 5.25-mg group, 0.69; 95% CI, 0.49 to 0.96; P=0.03), and significant reductions in the brain lesion count on magnetic resonance imaging (MRI) (P<0.001 for all comparisons). Adverse events that were more frequent in the cladribine groups included lymphocytopenia (21.6% in the 3.5-mg group and 31.5% in the 5.25-mg group, vs. 1.8%) and herpes zoster (8 patients and 12 patieTreatment with cladribine tablets significantly reduced relapse rates, the risk of disability progression, and MRI measures of disease activity at 96 weeks. The benefits need to be weighed against the risks. ( number, NCT00213135.)

      Giovannoni G, Cook S, Rammohan K, Rieckmann P, Sørensen PS, Vermersch P, Hamlett A, Viglietta V, Greenberg S; CLARITY study group. Sustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis. Lancet Neurol. 2011 Apr;10(4):329-37

      Cook S, Vermersch P, Comi G, Giovannoni G, Rammohan K, Rieckmann P, Sørensen PS, Hamlett A, Miret M, Weiner J, Viglietta V, Musch B, Greenberg SJ; CLARITY Study Group.Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study.Mult Scler. 2011 May;17(5):578-93.

      Comi G, Cook SD, Giovannoni G, Rammohan K, Rieckmann P, Sørensen PS, Vermersch P, Hamlett AC, Viglietta V, Greenberg SJ.MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study.J Neurol. 2013 Apr;260(4):1136-46

      However following the request of the the Regulators for more data the Company manufacturing the drug stopped production and ceased interest 

      What happened next. Read this Blog.