MS oral disease modifying drug soon available in Europe!!!

Medical News Today (27.07.2009):

Merck Serono announced that it is seeking a European license for cladribine, its oral therapy that is in late-stage clinical trials for relapsing remitting MS.

The announcement comes after results of a phase III clinical trial were reported in April at the annual American Academy of Neurology meeting in Seattle Washington.

If the application meets all of the regulatory hurdles, it is set to be the first oral disease modifying drug available to people with MS. If no delays are made, cladribine could be available as early as the middle of 2010, which could mean more choice for people with MS.


Pioglitazone, a diabetes drug, may be beneficial for MS patients

Yet more links between diabetes drugs and MS, as I mentioned in some of my previous posts. The amount of people tested was little but still… this drug might have some potential.

A small trial testing the benefits in multiple sclerosis (MS) of a drug used to treat type II diabetes, in combination with beta-interferon-1a, has been shown to potentially prevent brain cell loss.

The results of the trial in 21 people investigating the effects of pioglitazone (also known as Actos) were published last month in theJournal of Neuroimmunology.

Although the results of the trial showed some evidence of less damage in the brains of people with MS, there were too few people in the study to determine whether this effect was real.

A small trial testing the benefits in multiple sclerosis (MS) of a drug used to treat type II  diabetes, in combination with beta-interferon-1a, has been shown to potentially prevent brain cell loss.

The results of the trial in 21 people investigating the effects of pioglitazone (also known as Actos) were published last month in theJournal of Neuroimmunology.

Although the results of the trial showed some evidence of less damage in the brains of people with MS, there were too few people in the study to determine whether this effect was real.

For more information see under the Medical News Today link, date: 29.07.2009

Tysabri – 11th case of PML!

Yet again, from Medical News Today, today’s news:

An 11th patient taking Biogen Idec’s multiple sclerosis (MS) drug Tysabri has developed a potentially deadly brain infection.

In the latest confirmed case of progressive multifocal leukoencephalopathy, or PML, the patient took Tysabri for 29 doses, continuing the trend of the last six reported cases of the infection, where each patient had therapy for two years or longer.

The latest patient was located in the USA, the third American to have developed the infection. Of the 11 reported cases, one patient has died.

The PML incidence rate remains below the long-projected risk rate of one in 1,000 patients for those patients receiving the therapy for 12 months or 18 months.

Tysabri update – additional good news!

Another encouraging news regarding Tysabri :) taken from the Medical News Today (July 4th 2009) link:

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced results of a study demonstrating that TYSABRI® (natalizumab) promoted regeneration and stabilization of damage done to the myelin sheath, as measured by advanced MRI technology. Damage to the myelin sheath causes the symptoms of multiple sclerosis (MS). Additional posters will also be presented during the Congress highlighting the ability of TYSABRI, in some patients, to improve physical function and patient reported outcomes on cognition, quality of life, and fatigue. TYSABRI is the first approved MS therapy with reported data suggesting that some of the signs of disease progression can be stopped. The strong efficacy profile demonstrated in clinical trials is enhanced further from these data and may help redefine success in MS.

“What we have seen in these MRI data suggest that TYSABRI may have the capacity to repair and possibly restore some of the damaged myelin sheath that protects nerve fibers. Results from this study support the continued investigation of the potential effects of TYSABRI on this process,” said Robert Zivadinov, M.D., of the Jacobs Neurological Institute in Buffalo, N.Y., the lead investigator for the remyelination study.

“TYSABRI is changing the way neurologists and patients define success in the treatment of MS,” said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology, Biogen Idec. “These MRI data presented at AAN provide early evidence that TYSABRI may not just slow the progress of MS, but may also be able to reverse the damage inflicted by the disease.”

“Everyday, more patients understand that TYSABRI can represent a new way of looking at – and managing – their disease,” stated Carlos Paya, M.D., Ph.D., president, Elan Corporation. “These latest analyses further build on the impressive data we have seen to date with TYSABRI.”

TYSABRI helped stabilize and restore damage to the myelin sheath

The imaging study, which included a total of 110 subjects, used an advanced MRI technology called the Voxel-Wise MTR to measure lesions and normal brain tissue. The study showed that TYSABRI promoted remyelination when compared to those receiving interferon beta-1a IM and normal controls.

The effect of TYSABRI on lesions and NABT in relapsing MS was evaluated with a Voxel-Wise (VW) imaging method using magnetization transfer ratio (MTR). VWMTR is recognized as a powerful instrument for monitoring MS disease activity and effectiveness of therapeutic interventions in patients with MS.

In the study, 62 MS patients who received TYSABRI were followed for 12 months together with 26 MS patients who received interferon beta-1a IM and 22 age-matched and sex-matched normal controls. For each subject, baseline and follow-up MTR volume maps were placed in a common halfway-space. The resulting VW subtraction map was then enhanced via threshold-free cluster enhancement (TFCE) algorithm, and a significance threshold was determined based on subject-specific Monte Carlo simulation. Supra-threshold volumes (95th percentile) were quantified for both areas of increasing (remyelinating) and decreasing (demyelinating) MTR voxels, which represent a volume value.

There was no significant difference in decreasing VWMTR NABT volume over the follow-up between TYSABRI-treated and normal control groups. Relapsing-remitting patients on both therapies showed higher remyelination potential and less evident demyelination than relapsing secondary progressive patients. The volume of VWMTR changes in NABT (decreasing or increasing) was almost 3-5 times higher than the amount of changes observed for T2-lesion volume. This indicates that the VWMTR method might be a much more sensitive approach to capture demyelination/remyelination changes over time than the lesion-based volume measures.

The poster describing the study Natalizumab (Tysabri®) Promotes Remyelination in Patients with Multiple Sclerosis. A Voxel-Wise Magnetization Transfer Imaging Case-Control Study (P03.071) is available for viewing on Tuesday, April 28, 2009, at 4:00 p.m. PDT.

TYSABRI significantly increased the cumulative probability of achieving sustained improvement in disability in patients with relapsing MS.

To read the whole article and for more information see under the ‘Medical News Today’ link.


History of MS & understanding of the disease


After having done some research on the disease’s history…this is what I found, interesting:


Mulitple Sclerosis Historical Facts


1400 — the earliest written record of someone with MS-like symptoms was Lydwina of Schieden, Dutch patron Saint of Ice Skaters.


1838 — medical drawings clearly show what we today recognize as MS, but 19th Century doctors did not understand what they saw and recorded.


1868 — Jean-Martin Charcot, professor of neurology at the University of Paris, wrote the first complete description of MS and the changes in the brain which accompany it. 


1878 — Myelin was discovered by Dr. Ranvier. 


1919 — Abnormalities in the spinal fluid were discovered in MS, but their significance remained puzzling for decades.


1920 — Men were thought to be more susceptible to MS than women, because women were often mistakenly diagnosed with “hysteria”, and also because it seemed that MS symptoms used to flair each month for most female MSers.


1925 — Lord Edgar Douglas Adrian recorded the first electrical nerve transmissions, which helped prove demyelinated nerve cannot sustain electrical impulses.


1928 — The oligodendrocyte cell that makes myelin was discovered.


1935 — Dr. Thomas Rivers demonstrated that nerve tissue, not viruses, produced an MS-like illness. This animal form of MS, called EAE, or experimental allergic encephalomyelitis, paved the way to present theories of auto-immunity, for it demonstrated the body can generate an immunologic attack against itself.


1965 — White blood cells that react against a protein in nerve insulating myelin were discovered in MS.



History of Medicine’s Understanding of Multiple Sclerosis


1890’s — caused by the suppression of sweat, treated with herbs & bed rest, life expectancy after diagnosis was 5 years.

1910’s — caused by an unknown blood toxin, treated with purgatives & stimulants, life expectancy after diagnosis was 10 years.

1940’s — caused by blood clots & poor circulation, treated with drugs that improve circulation, life expectancy after diagnosis was 18 years.

1960’s — caused by allergic reaction, treated with vitamins & antihistimines, life expectancy after diagnosis was 25 years.

1996 — caused by autoimmune reaction possibly linked to virus, treated with steriods & immune system regulating drugs, life expectancy after diagnosis is essentially normal for most.

Fingolimod and Cladribine: Show promising clinical trial results for MS therapy

I previously mentioned under the post ‘new MS drug discoveries’ (Sept. 11, 2008) how oral treatments for MS are to be released within the next six months… 

Well here is what I just found is being done… (as reported in ‘Medical News Today’ :)

The results of current clinical trials on new substances for MS therapy are among the new research findings that are being discussed with particular interest at the ENS meeting. (…) An earlier study showed that oral fingolimod reduced the annualizied relapse rate in MS patients by more than 50 percent versus placebo. 

Professor Comi reports that “After four years, patients continuously treated with the substance had a low relapse rate, and 63% to 70% of these patients remain relapse free,” (…) “The majority of those patients treated also remained free from inflammatory activity and disability progression.” 

Another trial being presented in Milan by an international study group investigated the efficacy of a cladribine tablet therapy that is also in development. “Cladribine is a prodrug, and selective effects on lymphocytes provide targeted and sustained immunomodulation, permitting the investigation of an oral short-course annual treatment,” Professor Comi explained. The CLARTY study included 1,326 patients with relapsing remitting multiple sclerosis. The results, summarized by Professor Comi, are very promising: “Treatment with two different doses cladribine tablets in the CLARTY study resulted in a significant reduction in relapse rates (-58% for low dose and -55% for high dose) and significant reduction in disability progression relative to placebo with both doses. When taken alongside the MRI and safety data, the results provide clear evidence supporting the key role of the drug in the treatment of relapsing remitting multiple sclerosis.” 

As always… promising news :)