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Genzyme Says Follow-up Data From Alemtuzumab Phase 2 Trial Continues To Show Lasting Benefits - Update
9/11/2009 1:32 PM ET





EnCana Revives Plan To Split Into Two Companies - Update
(RTTNews) - Friday, biotechnology company Genzyme Corp. (GENZ: News ) said that four-year follow-up data from its completed Phase 2 multiple sclerosis trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab. The accumulated four-year efficacy and safety data from the Phase 2 trial will be presented at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting in Germany today, the company noted.

The Phase 2 trial compared alemtuzumab to an approved multiple sclerosis therapy Rebif in early, relapsing-remitting multiple sclerosis or RRMS patients who had received no prior therapy. Three-year trial data were reported in the New England Journal of Medicine in last October.

In the trial, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three-times per week, every week for three years.

The four-year analysis of early RRMS patients from the trial found that patients taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 72% and the risk of sustained accumulation of disability by 73% compared to patients treated with the active comparator Rebif. These data closely mirror the three-year findings reported in the NEJM manuscript. Further, the annualized relapse rate and disability risk measured from year three to four remained at the same low level observed in prior years of the study.
Genzyme also announced that its CARE-MS II Phase 3 trial, one of two pivotal trials of alemtuzumab in the treatment of multiple sclerosis, has completed enrollment. CARE-MS I Phase 3 trial, a randomized trial comparing alemtuzumab to Rebif, completed enrollment earlier this year. CARE-MS I is studying early, active RRMS patients who have received no prior therapy. CARE-MS II, which also compares alemtuzumab to Rebif, is studying RRMS patients who relapsed while on other multiple sclerosis therapies.

Patients who enrolled at the start of both trials in 2007 will soon complete the protocol-specified two years of follow-up and begin to move into an extension trial which allows patients previously treated with Rebif to receive alemtuzumab. Patients previously treated with alemtuzumab will be allowed to take another treatment cycle as needed, said Genzyme.

Makes me happy!!!
I am going into month 5, and feel better than I have in about 20 years...

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It'd be good to hear from some of the members here who received their Campath infusions several years ago, like Ian or Robin, to hear some individual accounts. It's probably a good bet that they would reflect this data.

Scorpion / Patient X,

Here is the Genzyme press release which gives the titles of the papers presented at ECTRIMS about Campath (Alemtuzumab).

http://www.genzyme.com/corp/investors/G ... 091109.asp

In November it will be three years since my first infusion and two years since my second infusion. In that time I have had no relapses / good recovery of deficitis and no clinical / MRI signs of any disease activity (Dr Coles recently wrote to my GP telling him this). I last saw Dr Coles in July for a check-up and asked whether my experience was similar to others and he indicated that it was. So there's a chance of long term remission (no disease activity). Some in the early pilot trials are 7+ years without any sign of disease activity. But re-treatment is an option should the disease re-activate. I now have a yearly MRI (first in December) to check for signs of any activity.

The people I meet at Cambridge (fellow Campath patients) seem to have very similar experience to mine.

David's story shows long term good results.

http://www.davidscampathstory.org/

Another Campath patient has recently won a gold senior tour.

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Campath seems to have a good effect at putting this disease into remission. The associated risks (known to date) can be monitored and managed. What's nice is that the data from the trials seems to confirm my experience. The hope surrounding too many treatments in the past has been based on a couple of anecdotal stories. At least Campath has long term data to support to back up the claims

Ian

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Awwww Bob you big wimp!!!

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Thanks, Ian. It's good to hear from you.

I have to admit, hearing that both Campath studies have now completed enrollment was a little disappointing. I had felt like I always had that in my back pocket, to try to get into the CARE-II trial. But I guess it's a double-edged sword; maybe now the treatment will be available sooner.

I finished my second year of infusions in August. I had a slight hiccup during the second round but everything worked out. Things are going well at this time. Thanks again to Ian and Robin for the excellent information they have shared with me regarding their campath experience. I hope everyone is doing well.

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Lyon wrote:I just find it ironic that several times on the CCSVI forum the "failure" of Campath and Revimmune has been touted as a hint that MS is a disease owed to venous restriction, yet everything so far points to the success of Campath and Revimmune and things are only quiet on the Campath and Revimmune fronts because researchers are allowing the data to compile.

I just wanted to mention that I don't think that the success of Campath and the promise of CCSVI are in any way incompatible with each other. This has also been discussed in the CCSVI forum. There may be difference in opinion in some as to the origin of the disease, i.e. whether it is venous or auto-immune. This doesn't mean that only one treatment approach could work in the sense of stabilizing disease. I think it is very important to realize this.

radeck wrote:

Lyon wrote:I just find it ironic that several times on the CCSVI forum the "failure" of Campath and Revimmune has been touted as a hint that MS is a disease owed to venous restriction, yet everything so far points to the success of Campath and Revimmune and things are only quiet on the Campath and Revimmune fronts because researchers are allowing the data to compile.

I just wanted to mention that I don't think that the success of Campath and the promise of CCSVI are in any way incompatible with each other. This has also been discussed in the CCSVI forum. There may be difference in opinion in some as to the origin of the disease, i.e. whether it is venous or auto-immune. This doesn't mean that only one treatment approach could work in the sense of stabilizing disease. I think it is very important to realize this.

If I understand correctly, the agreement of CCSVI and the re-booting treatments is that with these treatments, the inflammation or disease process is shut down for some period of time. But the venous issues are still there, and the disease process can potentially start up again.

What doesn't quite add up to me, is that many of those receiving Campath are doing well many years out. In Ian's case, it's been 3 years since his first infusion, and for Robin it's been even longer. But in the report on their treatment using ballooning, Zamboni, et al stated that some proportion of their patients went into relpase very shortly after the veins occluded again. It just seems odd that the relapses happened so quickly after the venous issue re-appeared.

patientx wrote:

radeck wrote:

Lyon wrote:I just find it ironic that several times on the CCSVI forum the "failure" of Campath and Revimmune has been touted as a hint that MS is a disease owed to venous restriction, yet everything so far points to the success of Campath and Revimmune and things are only quiet on the Campath and Revimmune fronts because researchers are allowing the data to compile.

I just wanted to mention that I don't think that the success of Campath and the promise of CCSVI are in any way incompatible with each other. This has also been discussed in the CCSVI forum. There may be difference in opinion in some as to the origin of the disease, i.e. whether it is venous or auto-immune. This doesn't mean that only one treatment approach could work in the sense of stabilizing disease. I think it is very important to realize this.

If I understand correctly, the agreement of CCSVI and the re-booting treatments is that with these treatments, the inflammation or disease process is shut down for some period of time. But the venous issues are still there, and the disease process can potentially start up again.

What doesn't quite add up to me, is that many of those receiving Campath are doing well many years out. In Ian's case, it's been 3 years since his first infusion, and for Robin it's been even longer. But in the report on their treatment using ballooning, Zamboni, et al stated that some proportion of their patients went into relpase very shortly after the veins occluded again. It just seems odd that the relapses happened so quickly after the venous issue re-appeared.

That's a very good point in my opinion and I asked the same question on one of the CCSVI threads and gave myself the sort of hand-wavy answer that maybe if immune attacks are stopped for a long enough time the endothelium (blood vessel lining) in the brain can heal enough so that you're basically reset many ears in the disease process, i.e. before MS started. If, as some think, the stenoses seen exclusively in MS patients are mostly congenital, it does take 30 or so years for this to lead to bleeding in the brain/spine.

I think anybody would agree that having a stenosed jugular vein is a bad thing, i.e. it cuts blood circulation and leads to reflux, which has been shown in other organs to disrupt the endothelium. Also it's AFAIK the only explanation we have for MS lesions exclusively towards veins. If the immune system would simply decide to act up at some point we'd expect the lesions to be more scattered as in EAE, wouldn't we? However as you say, ballooning comes currently has the practical problem that stenoses re-ocurr and patients relapse relatively quickly after that (to be precise we don't know how many of the relapse-free patients of Zamboni have had re-stenoses). A possible explanation for this is that the areas of lesions are still frail, and if the stenosis suddenly kicks in again this leads to renewed disruption. Additionally it could be that the immune system has continuously eroded the areas of endothelium disruption/microbleeds/lesions, making it harder for these disruptions to heal. This picture then seems to call for a double treatment where in conjunction with the treatment of the stenosis one uses an efficient T&B cell depleter like Campath to allow old wounds to heal, and prevent new ones from kicking in.

Quick question: are there reliable data on after how many months/years the T&B cell populations fully recover post Campath infusion?

radeck wrote:Also it's AFAIK the only explanation we have for MS lesions exclusively towards veins. If the immune system would simply decide to act up at some point we'd expect the lesions to be more scattered as in EAE, wouldn't we?

I don't know, but, no matter what the cause of MS, no one questions that immune cells are migrating from blood vessels into the brain tissue. So, it wouldn't be too much to assume that most of the damage will take place near the site of the migration, i.e. the blood vessels.

However as you say, ballooning comes currently has the practical problem that stenoses re-ocurr and patients relapse relatively quickly after that (to be precise we don't know how many of the relapse-free patients of Zamboni have had re-stenoses). A possible explanation for this is that the areas of lesions are still frail, and if the stenosis suddenly kicks in again this leads to renewed disruption. Additionally it could be that the immune system has continuously eroded the areas of endothelium disruption/microbleeds/lesions, making it harder for these disruptions to heal.

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I guess that's one possible explanation. But when people receive IV steroids to quicken the recovery from an attack, after the attack resolves, they don't immediately have another one.

Quick question: are there reliable data on after how many months/years the T&B cell populations fully recover post Campath infusion?

I'm not sure. Maybe someone here who had received Campath could answer. I know as part of the trial, monthly blood draws are done to check platelet counts, but I'm not sure about WBC counts.