Summary of the pipeline

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Postby dignan » Sat Nov 26, 2005 9:21 am

I'm adding glucosamine to the pre-clinical stage. Looks interesting and it's readily available and doesn't have serious side-effects, so I hope they can dig up some funding to get a human trial together.
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Postby bromley » Sat Nov 26, 2005 9:33 am

Dignan,

What's glucosamine? Have I missed something?

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Postby dignan » Sat Nov 26, 2005 11:11 am

Yeah, check out my post on glucosamine in "Natural Approach".
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Postby bromley » Sat Nov 26, 2005 12:00 pm

Thanks I don't usually check natural approaches. When you say it's readily available, does it come as a supplement?

I'm becoming confused about all the things I should / should not be taking for this disease - at least next summer I can sit in the deckchair without sun cream while eating lots of turkey sandwiches. I don't think my MS will kill me it will be skin cancer or heart disease - but at least I can go happy.

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Postby dignan » Sat Nov 26, 2005 2:46 pm

Yes, it's a supplement that's often used by people with joint pain/arthritis. It's supposed to be an anti-inflamatory I think...

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Postby gibbledygook » Sun Nov 27, 2005 3:54 am

It also doesn't taste too bad. It comes in a powder which you can mix with water or juice and is actually quite agreeable.

Bromley, I too, am completely lost in a sea of vitamins and amino acids and harder drugs! Oh for a vaccine!
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Postby bromley » Sun Nov 27, 2005 7:52 am

Gibble,

I too, am completely lost in a sea of vitamins and amino acids and harder drugs


I'd throw you a life jacket to help if I could.

This really is a joke disease.

Ian
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alferon

Postby DS » Wed Nov 30, 2005 2:13 am

Here's an update:

http://europa.eu.int/comm/research/conf ... ill_en.pdf , see p 17

Alferon N, or interferon alfa N-3, is in phase IIa testing by Hemispherx Biopharma. This form of interferon is derived from human leukocytes and contains at least 14 alpha interferon molecules. In a retrospective, uncontrolled study, brain MRI with gadolinium contrast enhancement was performed in 69 patients treated with MS, including 38 who declined treatment with interferon alfa-n3, and 31 who were treated with subcutaneous interferon alfa-n3 for three to six months. MRI revealed gaolinium enhanced lesions in two of 31 patients (6%) treated with interferon alfa-n3, and in 14 of 38 patients (37%) in the untreated group. During a mean follow-up of 11 months, mean Expanded Disability Status Scale (EDSS) score decreased in the interferon alfa-n3 treated group from 4.8 to 3.4, reflecting less disability, but mean mean score in the untreated group increased from 3.8 to 4.5. However, prospective, controlled trials are needed to obtain regulatory approval.

I was wondering, are there MS drugs on the market where they didn't look at the amount of flare-ups patients experience in those clinical trials?
MRI tests are crucial in my opinion but the the primary endpoint in the trials isn't that the amount of flare-ups?

Dignan, make sure you take a look at the pdf, MS starts on p 15 and there's a very nice overview of what's in trials right now! Enjoy.
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Postby dignan » Wed Nov 30, 2005 9:26 am

Thanks for the update. I think this means Alferon should stay in Phase II for now...
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candidate drugs in MS

Postby TIB » Thu Dec 01, 2005 8:49 am

your summ up of drugs is very updated : nice job; just to add that Gemacbio is developper of MS drug GEMSEP mentioned in your list; good day
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Postby dignan » Thu Dec 01, 2005 3:49 pm

TIB,
Thanks for the info. I will add it.
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Re: alferon

Postby NHE » Fri Dec 02, 2005 3:37 am

DS wrote:I was wondering, are there MS drugs on the market where they didn't look at the amount of flare-ups patients experience in those clinical trials?
MRI tests are crucial in my opinion but the the primary endpoint in the trials isn't that the amount of flare-ups?

I believe that the reason MRI activity is used for the clinical trials and not flare-ups is that there is a great deal of subclinical activity that occurs in MS. Much of this activity does not actually produce symptoms as the brain can compensate for some of the damage that occurs from the inflammation.

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Postby dignan » Wed Dec 07, 2005 8:29 am

Based on a post by Bromley today I'll add CT301 to preclinical.
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Postby dignan » Mon Dec 12, 2005 3:49 pm

I wonder if they will eventually pile up enough evidence for azathioprine to make it an approved MS med and not just an off-label option...



Immunosuppressive Drug Reduces New Brain Lesions in MS Patients
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December 12, 2005 - Newswise - A medication that reduces relapse rates in patients with multiple sclerosis (MS) appears to be effective in reducing new brain inflammatory lesions and is well tolerated, according to a study in the December issue of Archives of Neurology, one of the JAMA/Archives journals.

The drug is azathioprine, an immunosuppressive agent that is well tolerated, easy to administer and monitor, and has been used for many years in the treatment of transplant rejections and autoimmune diseases. Azathioprine reduces relapse rates in MS patients, but its effects on the frequency and accumulation of new brain inflammatory lesions has not been studied in MS, according to background information in the article. MS is a disease of the central nervous system, marked by numbness, weakness, loss of muscle coordination, and problems with vision, speech, and bladder control.

Luca Massacesi, M.D., and colleagues at the University of Florence, Italy, conducted an open-label treatment study to evaluate the effect of azathioprine therapy on new brain lesion suppression in MS. They used magnetic resonance imaging (MRI) to evaluate brain lesions of 14 patients with relapse-remitting MS (RRMS) of short duration. RRMS is a form of the disease characterized by relapses, when new symptoms can appear and old ones resurface or worsen, followed by periods of remission, when the person fully or partially recovers from the deficits acquired during the relapse. The patients were evaluated for six months before and six months during treatment with azathioprine, and new lesions were evaluated during the same periods and after an additional six months.

“The results of this study show, for the first time, that the immunosuppressive agent azathioprine suppresses new brain lesions evaluated using MRI in patients with RRMS,” the authors report.

“Indeed, the treatment induces remarkable new brain lesion reduction, stable for 12 months,” they write. “This activity was obtained at doses that can be well tolerated and that are associated with low circulating lymphocyte numbers.”

Adverse events were observed in six patients, mainly at the beginning of the evaluation period, but they were transient or reversed after dose reduction and no patient interrupted therapy. Neurologic disability was stable, and the relapse rate decreased consistently with the new brain lesion rate.

“If considered in the context of previous clinical trials, the present study indicates that azathioprine may represent an alternative to immunomodulatory medications specifically approved for RRMS,” the authors conclude.

(Arch Neurol. 2005;62:1843-1847. Available pre-embargo to the media at http://www.jamamedia.org.)

http://www.newswise.com/articles/view/516687/
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Postby Brownsfan » Mon Dec 12, 2005 7:55 pm

Isn't FTY720 also used, or being tested, for transplant rejections?
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