Rituxumab Study for PPMS (OLYMPUS Trial): When will we know?

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

Postby Elin » Tue Jan 22, 2008 7:46 am

This may be a silly question, but. . . can anything be done when the interferon-gamma level rises? Is this where the "wash-out" is appropriate?

Thanks much.

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Postby gwa » Tue Jan 22, 2008 9:23 am

NHE,

Glad that you found the article because about how Tysarbi is upping the toxic affects in MS brains, I had did not kept the link.

At the time Biogen bought out the company last year that was working on a cure for PML, its seemed almost humorous to me. They can make MS'ers sick with their new treatment and then bail them out with a new med. Wonder what is in their pipeline to treat toxicity in MS brains from Tysarbi.

The fact that the Biogen CEO and other upper management have sold most of or all of their Biogen stock shares would make me think twice about taking any of their "fixes". I am getting more cynical in my old age.

The FDA has now approved Tysarbi for Chron's disease, so it will be interesting to see what the side effects will be for those patients.

Medicalnewstoday.com had an article about the dangers of taking Vit D supplements and how they make people with immune disorders sicker. I spent several hours reading more on this topic and am now trying to decide whether to continue with my D regimen. I didn't post the article because I knew the Vit D lovers would impale me on a pole.

I believe researchers can slant any paper to further their own beliefs, so it is difficult to find out what is truly helpful and what is junk science.

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Postby gwa » Tue Jan 22, 2008 2:15 pm

Bob,

The report states that 2 people died of PML, but the scientists cannot relate their deaths to Rituxan usage. These patients had lupus. I didn't see anything about length of time or dosage for the patients before death.

The main group of patients in trials are suffering from rheumatoid arthritis. Rituxin is apparently very helpful in about half of those people in trials.

One hundred RRMS patients are now in preliminary trials using Rituxan. It didn't say how long they will be trialled.

These researchers are convinced that rogue B cells are the culprit in autoimmune diseases. Why the treatment just works in about half the patients is unknown. However, this is basically the same figure given out for the CRABS too, which still puts it not too far ahead of placebos.

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Postby Lyon » Tue Jan 22, 2008 3:45 pm

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Postby CureOrBust » Wed Jan 23, 2008 2:46 am

gwa wrote:Medicalnewstoday.com had an article about the dangers of taking Vit D supplements and how they make people with immune disorders sicker. I spent several hours reading more on this topic and am now trying to decide whether to continue with my D regimen. I didn't post the article because I knew the Vit D lovers would impale me on a pole.
I think I found it... and now to get impaled. 8O
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Postby gwa » Wed Jan 23, 2008 8:16 am

COB,

So what did you think about the article? It is a little scary to me. One thought I have is that I don't believe that there is anyone that really knows anything FOR SURE about vitamins and supplements.

For every good report about a vitamin, there is another report that casts a negative light on the vitamin.

I have long thought that most supplements go in one end and out the other relatively unchanged, but that is from reading reports from sewer workers talking about having to break up sewer "log jams" that are clogged with vitamins.

If you follow the researcher in the article, there is a lot to read from his site and blogs. At this point I don't know if he is just another nutcase or a legitimate researcher that goes against the crowd.

There was another article on medicalnewstoday last week that discussed research showing that calcium supplements had no effect on osteoporosis for older women. So if I got rid of my calcium, magnesium and Vit D supplements then I could save more money to go to London and see Ian for lunch.

What do you think?

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Biogen execs

Postby Elin » Wed Jan 23, 2008 8:50 am

gwa (and all)


Can you give me more info about the Biogen execs dumping stocks? I know that they tried to sell the company (which may reflect simply profit-taking, rather than uncertainty). They had no buyers. I take it that Carl Icahn scared some people off with his entry into Biotechnology. Like you, I'm rather cynical about Big Pharma.

But let me nag you all by returning to my previous question of --

What happens to people after when their immune systems are so diminished with drugs?

What has been the long-term experience with other "nuke"-drugs? Novantrone has the two year limit (although because of cardiac toxicity). But what has been the long-term experience with Cytoxan (cyclophosphamide)? Isn't that also a short-term fix? Are there other protocols that so completely devastate the immune system the way Rituxan, Cytoxan, and Novantrone do? Does anyone have figures on the progression of the disease and the life expectancy of folks after they have taken these "nuke"-drugs?

I've not done enough research on this topic to have a sense of the answers and greatly appreciate your help. Thanks.

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Postby gwa » Wed Jan 23, 2008 9:09 am

Elin,

I am not sure if any of the people that have taken the immune drugs have had the process long enough to show side effects or wear and tear on their bodies after the process.

Bromley is a lab rat for Campath, so he would be one person to contact about his ordeal. He seems to be better physically, mentally it is still up in the air with him.

Another person on this site, Chrishasms, is about to start the procedure with Revimmune, so watch his blog on the Revimmune forum.

I don't think anyone here is ignoring your question, it is just that there is not a lot of experience with these cancer drugs being used in MS and we don't know much about how they work in the long term.

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Re: Biogen execs

Postby gwa » Wed Jan 23, 2008 9:15 am

Elin wrote:gwa (and all)


Can you give me more info about the Biogen execs dumping stocks? I know that they tried to sell the company (which may reflect simply profit-taking, rather than uncertainty).


Elin,

There is more to the story than profit taking. The CEO sold ALL his shares and he and others are being investigated by the SEC. Something smells here with these activities.

It is anyone's guess as to why so many bailed out of their shares. The public will find out the story eventually since they are being investigated.

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Re: Biogen execs

Postby Lyon » Wed Jan 23, 2008 1:53 pm

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Re: Biogen execs

Postby NHE » Wed Jan 23, 2008 9:13 pm

Elin wrote:gwa (and all)

Can you give me more info about the Biogen execs dumping stocks? I know that they tried to sell the company (which may reflect simply profit-taking, rather than uncertainty). They had no buyers. I take it that Carl Icahn scared some people off with his entry into Biotechnology. Like you, I'm rather cynical about Big Pharma.


I posted some links to a few articles covering this information in a series of posts on the General forum. Here are links to the posts.

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Re: Vitamin D article

Postby NHE » Wed Jan 23, 2008 10:33 pm

CureOrBust wrote:
gwa wrote:Medicalnewstoday.com had an article about the dangers of taking Vit D supplements and how they make people with immune disorders sicker. I spent several hours reading more on this topic and am now trying to decide whether to continue with my D regimen. I didn't post the article because I knew the Vit D lovers would impale me on a pole.
I think I found it... and now to get impaled. 8O

I don't wish to impale anyone either as I believe that a scientific based discussion benefits all of us. I read the article, New Research Challenges Concept Of Vitamin D Deficiency. What I found interesting is that it seemed to be linking the prevalence of many chronic diseases to an apparent lack of efficacy in vitamin D supplementation.
Molecular biology is now forcing us to re-think the idea that a low measured value of vitamin D means we simply must add more to our diet. Supplemental vitamin D has been used for decades, and yet the epidemics of chronic disease, such as heart disease and obesity, are just getting worse.

Now I personally have never heard of a suposed benefit of vitamin D on obesity (in my opinion, people should eat less, more healthily, and get more exercise). But this statement did get me interested enough to persue the investigation further. At the bottom of the article are some links to more information. One is a link to a paper published in the journal Bioessays. I wasn't familiar with the journal, but it appears to be something like the Medical Hypotheses journal. A description of the journal states...
BioEssays is a review-and-discussion journal publishing news, reviews and commentaries in contemporary biology that have a molecular, genetic, cellular, or physiological dimension. The journal is divided into two main sections, Reviews and Features. The Reviews consists of both short articles highlighting issues of interest and broader review articles that have a wider scope and attempt to give rounded pictures of particular subject areas. The Features focus on subjects of special interest, including novel hypotheses, discussions of difficult issues in biology, presentations of molecular or cellular model systems, specific advances in genomics, first-hand accounts of discoveries of importance, or subjects in applied biological science, particularly medicine. What's New Articles, commentaries, meeting reports, book reviews, and a page of extracts of stories in the news complete the coverage provided by BioEssays. The journal's insightful analysis makes it essential reading for professional researchers, as well as an invaluable tool for classroom instruction.

... which doesn't sound too bad but it still leaves room for articles which might contain more hypothesis than data. My local research university does not subscribe to BioEssays so I cannot access the full content to read T. G. Marshall's paper. However, the other link http://autoimmunityresearch.org/ goes to T. G. Marshall's site which appears to be promoting the "Marshall Protocol" which sounds similar in some ways to the antibiotic protocol used by some members of ThisIsMS. I then found this document which describes the "Phase I" treatment plan of the Marshall Protocol. In it, I found the following passage confusing...
If the level of 1,25-D is elevated (above 45pg/ml) and/or the 25-D depressed (below 20ng/ml), a Th1 infection should be suspected. Remember, however, that as the level of 25-D rises above 20ng/ml
(usually due to artificial supplementation) it is providing an mmunosuppressive action. High levels of 1,25-D are often not evident until the 25-D drops to a therapeutic level (under 15ng/ml). If D-metabolites
tests do not indicate Th1 inflammation but clinical observation suggests Th1 inflammation, the MP may be used as a therapeutic probe.

...which seems to be saying that vitamin D is a problem and an indicator of a Th1 infection if it is either too high or too low.

Anyways, I have yet to come to a conclusion on the benefits, or lack thereof, of the Marshall Protocol. Perhaps people more familiar with long term antibiotic use could offer some comments on it. I did find this statement from T. G. Marshall with regards to a lipid he calls capnine...
I had thought of making a big song and dance and trying to persuade a journal to publish this stuff. But that would be a complete waste of our time. At this point we have to start focusing on 'saving the world' not on being ''first to publish."

... and I can only say that I've never thought publishing data to be a waste of time. If the data from a study is good, and other people can reproduce it in the case of controversial or new research, then it should be published so that the scientific community can evaluate it. But then, that's just my personal view. Hmmm. I just noticed that there were several articles published on capnine back in the 1980's and the full papers are freely available through PubMed.

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Postby SarahLonglands » Tue Jan 29, 2008 4:51 pm

NHE, I agree with you totally on this, so will David when I snd him the link!

Sarah :wink:
An Itinerary in Light and Shadow Completed Dr Charles Stratton / Dr David Wheldon abx regime for aggressive secondary progressive MS in June 2007, after four years. Still improving with no relapses since starting. Can't run but can paint all day.
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CD20 questions

Postby Elin » Thu Jan 31, 2008 11:20 am

Dear All,

What wonderful news about antibiotic therapy! I wish I had that option in Boston.

I'm still trying to figure out how rituxan works. Unfortunately, my knowledge of the immune system is primitive. (Nor does it help that more and more T and B cells variations are discovered every year. Back in dinosaur days, when I was an undergraduate, we only learned of T and B cells, period. Grumble, grumble.)

Can someone tell me whether or not every B cell has a CD20 integral membrane protein? If so, it would explain why rituxan succeeds in reducing the B cell population by 90%.

But, in the study by Stuve, et al., "Clinical Stabilization and Effective B-Lymphocyte Depletion in the Cerebrospinal Fluid and
Peripheral Blood of a Patient With Fulminant Relapsing-Remitting Multiple Sclerosis, " Arch Neurol. 62(2005):1620-1623, they conclude "that a complete depletion of CD19+ B lymphocytes is obtainable in PB and CSF samples within 8 weeks after rituximab administration," with results lasting 6 months or longer. If this is the case, what other B lymphocytes are left and are they of a sufficient number to constitute a some sort of immune system?

The notion of "rebooting" the immune system is attractive. But if this is the case, why is rituxan administered again in six months? Maybe "rebooting" is an expression best left with computers.

Thanks.
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Re: CD20 questions

Postby Lyon » Thu Jan 31, 2008 1:49 pm

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