Five year results

[bromley]

April 14, 2011 12:00 PM Eastern Daylight Time 

Five-year Alemtuzumab Phase 2 Data Shows Large Percentage of MS Patients Remain Free of Clinically-Active Disease

Data Presented at 63rd Annual Meeting of the American Academy Of Neurology

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corp., a subsidiary of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), today reported additional five-year patient data from its completed Phase 2 multiple sclerosis (MS) trial showing that nearly two-thirds of alemtuzumab treated patients remained free of clinically-active disease as much as four years after most patients received their last course of the investigational drug. The data were presented at the American Academy of Neurology's 63rd Annual Meeting.

The CAMMS223 Phase 2 trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to the approved MS therapy Rebif® (high dose interferon beta-1a) in early, active, relapsing-remitting multiple sclerosis (RRMS) patients who had received no prior therapy. 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 study included an extended phase for collection of long-term efficacy and safety data.

“The improvements seen with alemtuzumab treatment as compared with interferon beta are encouraging.”

Results of the five-year review showed:

an estimated 65 percent of alemtuzumab-treated patients were free of clinically-active disease, compared to 27 percent of patients taking Rebif (p<0.0001). To be free of clinically-active disease, MS patients in the trial were both relapse-free and without a sustained increase in disability as measured by the Expanded Disability Status Scale (EDSS) through five years;

an estimated 72 percent of alemtuzumab-treated patients were relapse-free compared to 41 percent of patients taking Rebif; and

an estimated 87 percent of alemtuzumab-treated patients were free of sustained accumulation of disability compared to 62 percent of patients taking Rebif (previously reported).

“These data suggest that alemtuzumab may have great potential for MS patients,” said abstract author Cary Twyman, MD, principal Investigator, Associates in Neurology, Lexington, KY.

Two pivotal Phase 3 studies investigating alemtuzumab, CARE-MS I and II, are currently ongoing. Top-line results from these trials are expected to be available respectively early in the third quarter of 2011 and in the fourth quarter of 2011. The company expects to file for U.S. and E.U. approval in early 2012, and has been granted fast track status by the FDA for this submission.

[leetz]

As for me didn't do a thing....in all fairness though the 2 "other's" that were in the study with me did well......

[LR1234]

Great news:) I hear you are doing ok on Campath Brom:)

Shame it did not work for you Leetz. Did they say why they think it did not work?:(

I hope you are both keeping well x

[leetz]

No they didn't say why...just one of those work's for some and not other's type deal i suppose...

[Lyon]

..

[freiguy]

Hey guys - I haven't posted much here lately. The information looks encouraging. I hope everyone is doing well.

[patientx]

Hey Freiguy,

How have you been doing - in terms of MS and otherwise?

[freiguy]

This are going well for me on all fronts. There's not much to report which is a positive thing. I will be going for my three year mri soon and I am curious to see what it shows.

[k6ristin]

I'm headed in for round 3, part of phaseII CareMS study. it's been 2 years since my last infusion, they're (genzyme) letting me get another dose as part of the extension study.

The news coming out from genzyme is very promising. I want to know the total # of people they are using to get these percentages from.

I also wanted to point out how they continuously talk about MRI's being disease free. But they are only imaging the brain. Yes, my brain MRI is stable. But when I asked for an MRI of my spine (thank goodness I have insurance); it showed 1 active, new lesion. And that doesn't get put into their statistics. I think that's very misleading.

[LR1234]

Its very cheeky kristen! I think the drug companies trial results should be honest and reflect what MSers are actually experiencing.

So glad we have TIMS to do that:)

Sorry to hear about your lesion on your spine. How are you feeling in general? x

[k6ristin]

as for how I'm feeling, it's the usual MS story, some days good, some days bad. I can still walk, but not very far. I'm sure that if it were not for both Campath and 2 stents, I wouldn't be walking at all. The neuropathy that disappeared for about a year has returned. But it's summertime in Florida, and the heat is bad.
I thought post stent, that heat sensitivity was gone, but this summer, it is shutting me down bad.
Overall, I think the Campath stopped the downward spiral, the CCSVI stenting helped to correct some of the side effects of MS (spasticity, numbness, neuropathy, fatigue)
But I started feeling all those things again once it got hot, so I need something, and consider myself lucky to be a part of the study, and have some good doctors nearby who listen to me. (I'm "Sugarmomma's" campath partner/friend, who just posted a different thread as to whether or not she should take this 3rd infusion. She did not get the CCSVI tx)

Diet is the last frontier, the hardest thing for me, and possibly the missing piece to my MS mystery....
so I'll take the Campath for now, given none of the other drugs available are any good, in my experience
Thanks for being here, TIMS!!!