High Dose Cyclophosphamide (Revimmune)

A board to discuss Revimmune as a potential therapy for multiple sclerosis

High Dose Cyclophosphamide (Revimmune)

Postby Lyon » Sun Oct 14, 2007 8:12 pm

American Autoimmune Related Disease Association article from 1995
http://www.aarda.org/infocus_article.php?ID=11

"Rebooting" - A Promise For Autoimmune Diseases?
Johns Hopkins University researchers have developed a new technique in treating autoimmune disease patients which reboots the immune system with results that have cured some patients while dramatically improving the health of others. This is a new approach to the use of stem cells in treating autoimmune disease.

Autoimmunity occurs when the blood lymphocytes, which are designed to defend the body against infections and foreign agents, actually attack one or more of the body organs. Researchers in the past have focused on ways to destroy the disease-causing lymphocytes and replace them with normal ones. That attempt has not been successful. Bone marrow transplantation is now being used by many medical institutions worldwide. One attempt to get rid of the misdirected lymphocytes has been the use of high doses of cyclophosphamide, a chemotherapeutic drug. This method also calls for a blood stem cell transplant since it has been thought, incorrectly, that cyclophosphamide in high doses is destructive to the bone marrow ability to make new blood cells.

Stem cells, present in both bone marrow and blood, regenerate marrow and blood after chemotherapy. In stem-cell transplants, stem cells are harvested before chemotherapy by drawing some of the patient own blood or bone marrow. After the chemotherapy, the blood or marrow stem cells are returned to the patient body. However, patients who do go into remission after the procedure usually relapse after a time. This is thought to be the result of the "bad" lymphocytes returning to the patient along with the stem cells. How can pure stem cells be isolated from other blood cells?
Now Johns Hopkins researchers have found a way to circumvent the problem.

According to Robert A. Brodsky, M.D., assistant professor in oncology and medicine at the Johns Hopkins University School of Medicine, "...stem cells contain an enzyme, called aldehyde dehydrogenase, which detoxifies cyclophosphamide. Like most blood cells, lymphocytes have very low levels of this enzyme, so cyclophosphamide destroys them but not the stem cells. That means it is not necessary to do a transplant to preserve the stem cells." He further states, "Studies have shown that after chemotherapy--as the stem cells turn into the specialized blood cells that have been destroyed--those that become lymphocytes are normal and do not attack the body. The immune system has been repaired."
This system was first tried with aplastic anemia patients. Seven out of the first ten patients treated by this method have remained disease-free for 10 years--and, in some cases, more than 20 years. The system was later tried with 27 other patients with autoimmune diseases, the majority of whom were lupus patients. Dr. Brodsky reports, "Most are still in remission, and some are off medications two and three years later." He continues, "All the patients weve studied have, at the very worst, remained stable: Virtually all have had major reductions in their immunosuppression medications." Dr. Brodsky cautions that, before this can be called a cure, the patients must remain disease-free for ten or more years.

Dr. Brodsky offers the comment that "When we have more information about the long-term effects of this treatment, and as more physicians and patients learn about it, the technique could well become standard protocol for autoimmune conditions soon after they are diagnosed and well before the diseases progress or become debilitating."

Excerpted from Johns Hopkins "Health Insider," interview with Robert A. Brodsky, M.D., Johns Hopkins University School of Medicine.
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Postby MaggieMae » Mon Oct 15, 2007 5:40 am

If they knew this back in 1995, why are we still waiting? I can't understand this. Why? Why?
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Postby Lyon » Mon Oct 15, 2007 6:27 am

Until a month or so ago I was absolutely convinced that when something presented itself as seeming to be a vast improvement for MS patients, it would quickly be recognized and fast tracked.

In the last month or so I've seen signs on several fronts that my conviction was probably unjustified and for so many reasons that it wouldn't be easy to name them all.

In this particular case regarding HDC I think, despite the favorable results found, the legal and financial risk of such an aggressive treatment has kept a damper on things.

I don't have MS so it's easy for me to talk, but the other side of the coin is that I can't think of anything riskier or with a worse possible outcome than for someone with mild disability to allow MS to run rampant with the hope that their MS will remain mild or that currently accepted treatments will always keep it at bay.

Bob
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Postby MaggieMae » Mon Oct 15, 2007 9:37 am

Do you think I am correct in my assumption that no drug company would fund a clinical trial for HDC and MS because it is not a "new" drug, so where is the major profit?

And you know, without a clinical trial, most doctors would never recommend the treatment.

Twelve years - so unfair.
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Postby Lyon » Mon Oct 15, 2007 2:55 pm

MaggieMae wrote:Do you think I am correct in my assumption that no drug company would fund a clinical trial for HDC and MS because it is not a "new" drug, so where is the major profit?
Hi Maggie,
I'm not a lawyer but from what I can tell, Accentia buying the exclusive rights to use HDC for any and all of the "autoimmune" seems that they will be able to make a profit from it. Whether or not Accential has the money to fund clinical trials, I have no idea.

At any rate, it seems that HDC has been studied against MS a bit and it seems that Accentia stands to make a profit. Since Cyclophosphamide has long been FDA approved and used against MS as a suppressing agent, I'm not sure what, if any, clinical trial process would be necessary to use it in higher dose against MS in the "rebooting" process?

MaggieMae wrote:Twelve years - so unfair.
At this point I'm sorry I worded my last post the way I did.

Something I need to keep in mind is that the situation for those with MS hasn't always been the way that it is now.

With the benefit of hindsight it's obvious that in the past there weren't clinical trials worthy of getting excited about. In hindsight it's obvious that they involved facing risk for minuscule or no benefit.

In the past the internet didn't exist or didn't provide the wealth of information it does now. I have no idea how a layman would even find out about the existence of interesting clinical trials, much less be able to do the necessary research to assess the risk/benefit ratio.

It does seem to be a terrible shame but remember that regardless of what "seems" to be the situation with HDC and MS there is a lot we don't know and is still a lot which needs to be proven.

I personally find "rebooting" the most interesting and hopeful thing in the history of MS research but things are slow and deliberate in the world of MS research.

Bob
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