Combo treatment

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Combo treatment

Postby bromley » Tue Jul 18, 2006 5:34 am

Dear all,

Saw this and couldn't resist posting despite saying I'd take a 3 month break.

There is one school of thought that if you treat the early stages of this disease aggressively that you might prevent / significantly delay the progressve stage of the disease. Campath is currently in trial to test this theory and another approach is showing some success. Dr Mike Boggild is a very well respected neuro with a specific interest in MS.

Ian


New hope for patients with aggressive multiple sclerosis


A new combination treatment regime, for patients with aggressive forms of multiple sclerosis (MS), is offering new hope to a group of patients who would otherwise be at high risk of early disability according to British research due to be published in the Journal of Neurology.
The treatment regime, consisting of a limited course of mitoxantrone (an immunosuppressant normally used to treat cancer) followed by long-term glatiramer acetate (Copaxone - one of two classes of disease modifying drugs for use in relapsing-remitting multiple sclerosis), has proven so successful in this early trial that a full controlled study is now being initiated at 10 centres across the UK to examine the combination further. Investigators are now looking to enrol suitable patients with MS.

In this 'open' trial the combination was found to provide a rapid and sustained suppression of relapses in MS patients experiencing frequent, recurrent and disabling attacks (90% reduction in annualised relapse rate maintained, to date, for a mean of 36 months). It was also shown to improve, or at least stabilise, existing levels of disability in the 27 patients who had extremely active forms of the disease. Follow up in early patients now extends to over 5 years.

The patients treated with this new protocol, developed by a research team at the Walton Centre for Neurology and Neurosurgery in Liverpool, had all been diagnosed with Relapsing Remitting MS for less than 5 years and showed clear signs that their disease was likely to progress quickly producing early and severe disability.

Dr Mike Boggild, Consultant Neurologist at the Walton Centre and principal investigator of this research commented: ' This novel treatment regime has proved remarkably effective in a group of patients with early MS and a poor prognosis. Though there are certain risks, associated particularly with the use of Mitoxantrone, we have been able to limit these by using this agent for just a short 'induction' period and, balanced against the high risk of early disability for these patients, the outcomes we have seen appear to justify this approach. The effect is so striking that we suspect the two drugs may be acting synergistically'

Karen Ayres, 28 from Warrington is a patient who has benefited from the new treatment protocol. She said: 'Lying paralysed in hospital, I truly believed that I would never get the chance to travel again, let alone go back to university to study. Without mitoxantrone and Copaxone treatment, I simply don't think it would have been possible - it is not an exaggeration to say that I feel as though the treatment has given me my life back. I have been able to take up my beloved backpacking again and I am currently studying for a PhD. MS really doesn't spell the end of your life'

Mitoxantrone, the first immunosuppressant to be approved by the United States Food and Drug Administration (FDA) for use in MS, has previously been shown in randomised controlled studies in the US to reduce relapses in MS, but due to its potential toxicity its use is limited. Previous attempts to extend its effectiveness with subsequent use of interferon-beta have been disappointing, so researchers at the Walton Centre decided to use the alternative class of disease modifying drug, glatiramer acetate (Copaxone).

Source: News-Medical.Net ©2006 News-Medical.Net
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Postby Brainteaser » Tue Jul 18, 2006 7:45 pm

Everything that goes around, comes around.............No wonder there are a few sceptics out there (Hi Harry :) )

In Oz there have been various attempts at combo treatments, with mixed results. About 5 years ago there was the promotion of Imuran & Copaxone/Betas(f)eron by a Sydney neuro, Dan Milder.
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Postby HarryZ » Wed Jul 19, 2006 6:31 am

Hi Brainteaser,

Brainteaser wrote:Everything that goes around, comes around.............No wonder there are a few sceptics out there (Hi Harry :) )


Ever notice how heavy duty chemo drugs sometimes end up being used on MS patients? Betaseron didn't work for cancer so it ended up getting approved for MS. Campath is another one being tested. Novantrone got approved for SPMS....shakes up the immune system big time but a patient can only use it so long because of the danger of serious heart damage. As well, they have recently been testing Copaxone at a double dose and the newest trend is to combine these drugs. A friend of mine is in a Daclizumab clinical trial and she continues to use Avonex....hmmm, still combining a monoclonal antibody with a immune system altering drug!!

I sure wish the researchers and drug companies would spend this much effort into looking into what "causes" the disease as opposed to simply throwing another heavy duty cancer drug at it.

Take care.

Harry
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Postby bromley » Wed Jul 19, 2006 7:44 am

Brainteaser / Harry,

I agree that they need to find the cause - until then, drugs which substantially reduce relapses and stabilise or improve disability levels are our best bet. Although, these drugs are chemo drugs they are given in much lower doses than for a cancer treatment. Mitoxantrone needs to be carefully monitored because of possible damage to the heart.

Dr Mike Boggild has a very good reputation with his patients and his fellow MS doctors in the UK. The results of the smallish trial look promising and I hope that the results can be replicated in a larger trial.

In this 'open' trial the combination was found to provide a rapid and sustained suppression of relapses in MS patients experiencing frequent, recurrent and disabling attacks (90% reduction in annualised relapse rate maintained, to date, for a mean of 36 months). It was also shown to improve, or at least stabilise, existing levels of disability in the 27 patients who had extremely active forms of the disease. Follow up in early patients now extends to over 5 years.


Many are of the view that treating aggressively early may stop or significantly delay the disease moving to the progressive stage. This is what the Campath trial is testing. I hope it can deliver this expected effect.


Ian

PS Harry, is your friend seeing any benefit from Daclizumab?
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Postby HarryZ » Wed Jul 19, 2006 5:36 pm

Ian,

PS Harry, is your friend seeing any benefit from Daclizumab?


Spoke to her a couple of weeks ago and she told me that she hasn't noticed anything different at all. Then again, she said she could be on the placebo.

I was really surprised to hear that she was allowed to continue on the Avonex at the same time after what happened in the Tysabri trial. Obviously the docs don't seem to think there is a similar type potential problem.

Harry
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Postby Dunmann » Fri Jul 21, 2006 5:48 am

Here is another article about the success of these combinations.


'Miracle' drug to help MS sufferers

Jul 21 2006

EXCLUSIVE by Deborah James Daily Post Staff

LIVERPOOL doctors have discovered what may be a "miracle treatment" for the muscle wasting disease Multiple Sclerosis.

Scientists say the treatment, pioneered at the Walton Neurological centre, could herald a major breakthrough for the UK's 85,000 MS sufferers.

Patients who were all severely disabled, including some who were confined to wheelchairs and others who went blind, last night described how they regained the ability to walk and see.

Doctors at Walton began treating patients with a combination of a chemotherapy drug normally used to treat cancer called mitoxantrone, with an MS anti-relapse drug Copaxone, in 2001.

An official, but unfunded, trial on 27 patients over the last year was so successful the treatment is now being introduced at 10 centres across the UK to test its effectiveness more rigorously.

It comes after a damning report by the MS Trust and the Royal College of Physicians yesterday found the NHS was failing MS sufferers with a "low quality and inadequate quantity" of services.

Last night the country's largest MS support group said thousands of lives could be changed if the larger trial echoes the "fantastic" Walton results.

Walton patient Karen Ayres, diagnosed in 2002 after she fell in a nightclub, said: "I really do see it as a miracle cure."

The 28-year-old travel agent from Newton-Le-Willows spent three months paralysed in hospital and thought she would never walk again.

But four years after starting the treatment she has regained the full use of her body, finished a Masters Degree in psychology, backpacked across five continents, and returned to work.

"It's no exaggeration to say I feel as though the treatment has given me my life back."

Another patient, mother-of-two Jayne Clarke, suffered extreme fatigue and balance problems when her MS reached aggressive levels in 2003.

After a short course of mitoxantrone she started treatment with daily Copaxone injections. She is now relapse free, and recently ran the 5km charity Race for Life.

Alun Games from Runcorn suffered partial blindness and spinal problems, but is now back on his feet, with greatly improved vision.

And motorbike enthusiast Joe Stevens from Bootle was left in a wheelchair for a year when in 1999 a relapse left him unable to walk or control any movement of his body.

Now the 38-year-old says the treatment has completely turned his life around, he said: "I'm not the party animal I used to be.

"I'll never be back to full physical peak, but I can ride my bike again, I'm happy and I'm back in work.

Initially the new combination has only been used on the most severe cases of degeneration, which worsen with each relapse.

But consultant neurosurgeon Dr Mike Boggild who led the Walton trial, said newly diagnosed cases could also benefit.

He described the results as "striking". He said: "This is not a cure, it can't reverse damage caused by MS, but it effectively halts the degeneration in its tracks.

"We are learning the earlier we can start treatment the more chance people have of living a normal life.

"Every time they have an attack their condition degenerates a bit more, and what this does is stop it developing any further.

"The question now is not whether this works on the most severe cases, but whether we should be using it for all forms of MS."

Doctors do not know precisely what causes MS but it affects twice as many women as men, and is more common in the north of the country.

It is a chronic neurological disease which destroys protein layers (called myelin) between the nerves in the brain and spinal chord.

MS stops brain impulses being carried to other parts of the body, causing muscular weakness, loss of coordination, slurred speech and visual blurring which can lead to blindness.

It mostly affects young adults and in a very few cases it can be terminal, but more often shortens life expectancy by around six years.

Existing anti-relapse drugs have proved only temporarily effective, and steroids are used to relieve inflammations and pain, but cannot stop the degenerative effects of the disease.

All the patients in the Liverpool trial showed clear signs their disease was likely to progress quickly producing early and severe disability.

Most rapidly showed signs that their attacks were happening around 90% less often.

Only two patients had relapses while in Copaxone therapy for up to 40 months after they stopped taking the mitoxantrone.

But there are risks with the new treatment, as mitoxantrone is highly toxic and cannot be used for long periods of time.

One patient developed therapy-related acute leukaemia nine months after comple treatment - which is a known side effect of mitoxantrone in about one in 300 patients.

The patient is now in remission from the leukaemia, diagnosed 12 months ago, and his MS is stable and relapse-free.

One patient dropped out of the study because of allergic reactions where they had their injections, but still remained relapse-free without further treatment for 26 months.

A spokesman for the MS Society said yesterday the new regime could herald a "fantastic breakthrough" that could change the lives of MS sufferers.

Dr Boggild said: "We have been using this treatment for quite some time now at Walton, but we don't have funding and no-one takes much notice of uncontrolled trials.

"We are telling people about it now because we need to recruit volunteers to help us conduct a full scale clinical trial."

The research is due to be published in the August edition of the Journal of Neurology.

deborahjames@dailypost.co.uk

Volunteers needed to take part in study

DOCTORS are now looking for volunteers to take part in the wider study. The centres taking part in the new trial are:

The Walton Centre for Neurology and Neurosurgery, Liverpool

Hope Hospital, Manchester St James's University Hospital, Leeds

The Royal Hallamshire Hospital, Sheffield

Queen's Medical Centre, Nottingham University Hospital, Nottingham

The Radcliffe Infirmary, Oxford

Southern General Hospital, Glasgow

The Royal Free, London Charing Cross Hospital, London

University Hospital of North Staffordshire, Stoke on Trent

Anyone who is interested can get more information by visiting: www.mxga-mstrial.co.uk
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Postby bromley » Fri Jul 21, 2006 6:20 am

Patients who were all severely disabled, including some who were confined to wheelchairs and others who went blind, last night described how they regained the ability to walk and see.


This looks like something from the new testament. Dr Mike Boggild is no Jesus but a consultant neurololgist with MS as his main specialism.

My MS nurse has seen some good results from Mitoxantrone and described one case as a miracle. As with most things MS, results will vary.

When I last spoke to Dr Coles he said that Campath trial results would be out in 2007. This is another trial to assess whether early aggressive treatment can stop further damage and allow the body to undertake some repair.

Fingers crossed that some of these trials come good or at least throw more light on this wretched disease.

Ian
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Postby HarryZ » Fri Jul 21, 2006 6:30 am

Dunman,

LIVERPOOL doctors have discovered what may be a "miracle treatment" for the muscle wasting disease Multiple Sclerosis.


Gee...I sure wish that newspaper reporters would take a little more care when writing about possible new treatments for MS....or any disease! While hope is a very important aspect for MS patients, inferring that a "miracle treatment" may have been found after treating only 27 patients is stretching things just a bit.

While Novantrone has had some success for more advanced forms of MS, the drug has limited term usability due to its possible serious effect on the heart. Let's give the scientists some time here to conduct proper trials and evaluate the situation of combining it with Copaxone. We don't need another "rushed" treatment into the world of MS medicine.

Newspaper reporters often look to create sensationalism as opposed to writing objectively. MS patients need good science working for them...not creative reporters.

Harry
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Postby bromley » Sat Jul 22, 2006 3:17 am

This story has travelled the world. An example is attached.

Recruitment is taking place for a larger trial.

Given that this disease appears to involve several mechanisms, combo treatments may well be the approach in the future.

As the experts better understand what's going on (and they are beginning to), it should become easier to identify the combinations of drugs which will have the optimal effect.

Ian


http://c.moreover.com/click/here.pl?j590182757&w=464753
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Postby Lyon » Sat Jul 22, 2006 7:19 am

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Postby bromley » Sat Jul 22, 2006 7:48 am

Bob,

The risks associated with Mitoxantrone are known and have to be carefully monitored.

I think Dr Boggild tried beta-interferon initiallly but did not see good results. Then he and his team tried copaxone. Recent evidence suggests that copaxone may increase T-Reg cells which may explain the good results in the trial of 27 on this combo.

The set up is very different in the UK to the US. Dr Boggild works for the National Health Service, which is funded by our taxes. Visits to GPs, consultants, operations and drugs are free (on the whole). I do not pay for my Rebif or the services of the neurologist or MS nurse. These types of trials are not sponsored by drugs companies. I understand that Dr Boggild has been using Mitoxatrone since the mid 1990s, and has been interested in combination therapies for some time.

Stoping the immune system from doing damage has been the main focus of many MS doctors, they now know that demyelinated nerves need to be protected. In the future, drugs to promote nerve regrowth and re-myelination will also form part of the armoury against this disease. I think the general consensus is that it is better to stop / limit damage than try to repair it. That's why more powerful drugs such as Mitoxantrone and Campath are being used. The aim is to wipe out the white cells which are doing the damage.

Ian

Here is a presentation given by Dr Boggild on combo treatments which I posted a few months ago - you need Powerpoint to access it

http://www.mssociety.org.uk/document.rm?id=1407
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Postby Lyon » Sat Jul 22, 2006 9:12 am

oo
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Postby bromley » Sat Jul 22, 2006 10:37 am

Bob,

I'll take something for the pain :lol:

My research has identified the following drugs which appear to drastically dampen down inflammation and allow some repair to take place - mitoxantrone, campath, rituxan and tovaxin. The last three are in trial. Other treatments which offer improvements in EDSS are HSCT and Bone Marrow Transplantation.

I imagine that re-myelination takes place or nerve fibres are rescued from an inflammatory environment. Campath is very effective at stopping attacks / inflammation, but those on the trial are told that any repair will depend on the individual.

Of course the bigger the benefits the bigger the risks as has been seen on several of these drugs. The risks are something that each individual will have to consider. Hopefully as the researchers learn more some of these treatments can be made safer.

Professor Compston at Cambridge thinks that there could be big breakthroughs might be seen in the next 12 months - fingers crossed.

Earlier this year I had some correspondence with the NMSS - some are not fans but the head of research impressed me with his detailed response to my e-mail . I have posted the final bit of the response before but post again as it is very hopeful.

the recent advances in molecular biology, cell culture techniques, and in deciphering the human genome provide unprecedented opportunities to tackle MS, TODAY. With our current technologies, new therapies abound in various stages of development. I am convinced that technology will enable us to stop this disease well before we know how to prevent it. Those involve different “cures”. But it is our responsibility to vigorously tackle each of the three cures: stopping disease activity/progression, repairing the nervous system, and preventing the disease altogether. These will require different strategies and different technologies. We are aggressively pursuing all three and I am certain that you will be impressed as you witness the developments of the upcoming years.


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Postby HarryZ » Sat Jul 22, 2006 11:04 am

Bob,

That's pretty spectacular but something obvious has to be going on.....reduced inflammation, remyelinating, lesion reduction..something.


I'm thinking it is a reduction in inflammation.

Back in the 60's, my uncle had a serious exacerbation. This came some 8 years after his initial attack. He was bed ridden. About two months later he was playing golf again!!! At that time there was nothing they gave for MS other than vitamin B 12 shots which seemed to help the patients to some degree.

A number of months later, he suffered another attack and although he recovered somewhat, it was not to the level of his previous recovery. I don't think that myelin can repair itself that quickly but who knows. I'm thinking that the attacks created the inflammation, caused the problems and then when it was reduced, a level of improvement occurred.

You would have thought that after all these years of research the docs would have learned what was going on...but sadly they still don't know.

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Postby Lyon » Sat Jul 22, 2006 12:06 pm

oo
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