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News RoundUp 34

as at 26 November 2007

Minocycline shown to be harmful

Initial research has shown that the drug minocycline may be an effective treatment in delaying the progression of MS for people in the early stages of the condition.

But recent research published in the journal The Lancet Neurology has now shown that minocycline may have a harmful effect in people with Amyotrophic Lateral Sclerosis (ALS), commonly known as motor neuron disease.  A late-stage trial carried out in 412 people with ALS showed people treated with minocycline deteriorated at a 25 per cent faster rate.

Minocycline can be used to treat bacterial infections, such as pneumonia, acne and urinary infections. It has been shown to have a neuroprotective effect in animal models of stroke, trauma, and neurodegenerative disorders. Phase II trials suggested that minocycline could be taken safely by people with ALS. On the basis of these positive results, plans were made for many further trials of minocycline in other neurodegenerative conditions, such as MS.

However, the most recent trial data has implications for several trials that are planned or in progress for minocycline in patients with Huntington's disease, stroke, dementia, and multiple sclerosis.  A clinical trial involving 200 participants across Canada has subsequently been planned.

 

Updates on MS treatments

The UK MS Society has useful information posted on its website spotlighting emerging MS treatments, as well as reviewing the progress on the development of potential treatments.

They are providing evidence-based information to people affected by MS regarding possible therapies so that PwMS can make appropriate choices, and know the relevant research background. This includes information about LDN (low dose naltraxone), stem cells, cannibis, Aimspro (goat serum).

“It is important to the MS Society that we address the questions and concerns raised by people with MS by focusing on relevant topics within this section.” We agree.

“Often the media inadvertently over-hype certain treatments or therapies. Equally there are no controls over what is posted on the internet and no regulations over the validity of information written there. This section aims to give people affected by MS clear and accurate information regarding issues related to MS which are often in the media.”

Also, in recent years there has been exponential investment into research into potential drugs and treatments for MS. Pages about potential treatments are designed to give you more information about the progress on current experimental treatments and clinical trials, such as fingolimod, cladribine and breakthroughs in genetic research.

Bookmark these two pages to keep up-to-date on key developments:

http://www.mssociety.org.uk/research/in_the_spotlight/index.html

http://www.mssociety.org.uk/research/potential_therapies/index.html

 

Daval International Limited gains approval for Phase IIB Trial of AIMSPRO

Last week, Daval International Limited, a UK company, announced approval of a London based Phase IIB trial of AIMSPRO®, its hyperimmune goat serum derivative.

It will be double-blind placebo-controlled cross-over study seeking to detect a beneficial effect on bladder function in patients with Secondary Progressive Multiple Sclerosis, following open-label observations over several years in a number of informed consent, “compassionate basis” patients.

AIMSPRO is a frozen medication, given as a 1ml sub-cutaneous injection every 4 days. It is believed to have a pronounced and sustained anti-inflammatory action with an associated, novel effect of lowering sodium channel triggering voltages in nerve fibres.

Applications for two further clinical trials are to be lodged within the next 3months.

Daval International Ltd. has recently been accepted as a member of the Association of the British Pharmaceutical Industry. “APBI”

Downlaod and read page 7 of the August 2007 issue of MS Voice at http://www.msnz.org.nz/resources/msvoice.html for an article on the history of this treatment.

 

Breakthrough drug for MS

A recent feature on the news website Scoop, talked about a new MS drug, recently approved for use in New Zealand. “[It] has been heralded by one of the country’s leading experts as a “substantial step forward” in the treatment of a debilitating disease.

The article states: “TYSABRI® is a new treatment for relapsing remitting MS. Dr Ernest Willoughby, a neurologist at Auckland City Hospital, is in charge of a trial of Tysabri in Auckland, involving five patients with MS.”

“Dr Willoughby says Tysabri is one of the biggest advances in MS treatment yet, and has sparked considerable interest among neurologists.”

“It has the potential to help everyone with relapsing remitting MS,” he says.

“Data, published in the New England Journal of Medicine, showed that over two years Tysabri treatment reduced relapses by 68% and reduced disability progression by 42%”

“Other treatments such as beta-interferon and glatiramer acetate reduce relapses by around one third.”

“According to Dr Willoughby, neurologists in New Zealand already have restricted access to MS treatment compared to other western countries, and if Tysabri is not funded there is a risk of the country falling even further behind.”

“In New Zealand, to qualify for treatment, it is necessary to have frequent relapses and moderate residual disability, so most people early in the course do not qualify.”

“Dr Willoughby says it is now widely accepted that starting patients on treatment early offers the best chance to prevent patients with relapsing remitting MS from progressing to the most disabling form of the disease—secondary progressive MS.”

“About 50% of patients with relapsing remitting MS develop secondary progressive MS within 10 to 20 years.”

“Although there is controversy concerning how the residual damage from relapses relates to the gradual decline in the secondary progressive phase, the belief is that by cutting the number of relapses, Tysabri could help prevent MS worsening later in the course.”

“However, it cannot fix damage which is already done –highlighting the need for early treatment.”

“While Tysabri was approved by Medsafe in September (2007), the issue of funding the drug is complex.”

“Unfunded, a patient would have to pay about $41,000 a year for treatment, a financial burden very few could even consider.”

Dr Willoughby says: “Funding is a complicated process. Tysabri is an infused drug, which would normally be given in a hospital setting, and we’re currently looking at the issue that the treatment may be potentially approvable by individual DHBs or hospitals.”

“His concern is that, if it is up to individual hospitals to decide whether to fund the drug, and what criteria to place on its use, we will end up with the situation where treatment for MS patients will vary, depending on where they live.”

“In a bid to prevent this, he says a group of interested neurologists has discussed making an approach to all DHBs in New Zealand to provide limited access to treatment with Tysabri”

“However, this in itself is complicated and time-consuming, with each hospital having its own particular processes to go through in such situations.”

“We’ve no idea how it will go. But we think it’s appropriate to try and get a consistent national policy on this, which may be difficult.”