Friday, 24 September 2010

Oral Cladribine turned down by the European Medicines Agency

Despite evidence that oral cladribine is effective in relapsing-remitting MS the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion regarding the marketing authorization for Cladribine Tablets. The CHMP have concerns about the long-term safety of Cladribine.

In my opinion, long-term safety data can only be obtained from post-marketing surveillance studies and the extension study of the pivotal clinical trial. Unfortunately, there are probably not enough patients in the latter study to answer this question. It is a good thing that the drug is licensed in Russia and Australia.

Click here for press release from Merck-Serono

Click here for Bloomberg's press release

Click here for the abstract of the CLARITY study

Wednesday, 22 September 2010

Fingolimod - first oral drug for MS in the United States

The FDA has licensed Fingolimod as a first-line therapy for people with relapsing-remitting MS. Let's hope it passes through the European Medicine Agency (EMA) with the same ease as the FDA and NICE gives it the thumbs up in the UK; the pessimist in me expects not. I predict that its use will be handcuffed in Europe for patients with highly-active disease (similar to Natalizumab) and for patients intolerant of first-line injectable therapies. I also suspect NICE will make it second-line; however this will depend on how much Novartis charge for the drug.

Click here for Bloomberg's Statement

To see how the drug works please see the following YouTube video:

Click here for YouTube video on Fingolimod's mechanism of action

Wednesday, 8 September 2010

Vince Cable's "Science, Research and Innovation" Speech

Apologies about politicising this blog, but what happens to investment in science in the UK will eventually impact on the lives of people with MS and their families. The only way to limit the impact of this devastating disease is through scientific research. The unmet need in MS is massive:

1. We have yet to optimise disease-modifying therapies. Is expecting a cure too much?
2. What about restorative therapies?
3. Symptomatic MS therapies are dismal; too many side effects and limited or suboptimal efficacy.
4. What about prevention? Preventative strategies are just beginning to emerge as potential option.

Without investment in research how are we going to address these needs?

You may find Vince Cable's speech interesting.

Click here for his speech

Sunday, 5 September 2010

No association between allergies and multiple sclerosis

Different types of inflammation are defined by immunologists by the type of cells and the mediators used by these cells.

The current dogma: inflammation in MS is mediated by either T-helper one (Th1) or T-helper 17 (Th17) cells. In comparison, allergies are due to a T-helper two (Th2) immune response, which may be protective in MS.

A large analysis of all published studies on allergic disease and MS provides no evidence of a positive or negative association between the allergic diseases asthma , allergic rhinitis and eczema.

Implications: this analysis challenges the current dogma and also raises questions about the treatment strategy of trying to stimulate Th2 immunity in PwMS; e.g. by promoting parasitic infections of the gut.

Click here for abstract: Monteiro et al. Acta Neurol Scand. 2010 Apr 29 (Epub ahead of print)

Thursday, 2 September 2010

Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis

Does low does naltrexone (LDN) improve quality of life in PwMS?

A study in 80 PwMS was performed to evaluate the effect of 8 weeks of treatment with LDN (4.5mg taken at night). Although LDN was associated with significant improvement in some mental health quality of life measures, the trial was too small to draw definitive conclusions.

Interpretation: this study was too small to be definitive. However, it provides further support for a large definitive study of LDN in MS. Unfortunately, the current "Big Pharma" business model does not support investigating drugs that are off patent. May be "Big Pharma" will now try and develop a follow-on me-to drug to test in PwMS.

Cree et al. Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis. Ann Neurol. 2010 Aug;68(2):145-50.

In memory of her mother; J K Rowling's £10m for MS

Good news for MS Research in the UK. The Edinburgh team are leading the field on neuro-restorative therapies in MS.

Click here to read article

A personal account of living with MS: further motivation to prevent this disease.

Cathy John: My diagnosis with MS has taught me the wisdom of 'gathering ye rosebuds while ye may'

Click here to read article