Phase 2 complete....results in NEJM

A board to discuss the soon-to-be released drug Campath as a treatment for Multiple Sclerosis

Phase 2 complete....results in NEJM

Postby cheerleader » Wed Oct 22, 2008 7:14 pm

improvements on disability scale in campath group, reduced lesions, better brain volume, no diff. between 12 or 24 mg doses....looks alot better than interferon-


Results Alemtuzumab significantly reduced the rate of sustained accumulation of disability, as compared with interferon beta-1a (9.0% vs. 26.2%; hazard ratio, 0.29; 95% confidence interval [CI], 0.16 to 0.54; P<0.001) and the annualized rate of relapse (0.10 vs. 0.36; hazard ratio, 0.26; 95% CI, 0.16 to 0.41; P<0.001). The mean disability score on a 10-point scale improved by 0.39 point in the alemtuzumab group and worsened by 0.38 point in the interferon beta-1a group (P<0.001). In the alemtuzumab group, the lesion burden (as seen on T2-weighted magnetic resonance imaging) was reduced, as compared with that in the interferon beta-1a group (P=0.005). From month 12 to month 36, brain volume (as seen on T1-weighted magnetic resonance imaging) increased in the alemtuzumab group but decreased in the interferon beta-1a group (P=0.02). Adverse events in the alemtuzumab group, as compared with the interferon beta-1a group, included autoimmunity (thyroid disorders [23% vs. 3%] and immune thrombocytopenic purpura [3% vs. 1%]) and infections (66% vs. 47%). There were no significant differences in outcomes between the 12-mg dose and the 24-mg dose of alemtuzumab.

http://content.nejm.org/cgi/content/short/359/17/1786
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Postby tzmisst » Wed Oct 22, 2008 9:44 pm

Probably should add Alemtuzumab to the name of this sub-forum as that seems to be the name for the drug as used in the MS trials.

Here is some more info:

GENZ Genzyme : Study results have shown that Multiple Sclerosis patients have significant and sustained reduction in disability and risk of relapse on Alemtuzumab versus active comparative drug (66.11 -2.21) -Update-

Co Genzyme Corporation (GENZ) and Bayer HealthCare Pharmaceuticals announced study results showing that patients with early relapsing-remitting multiple sclerosis (RRMS) taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 74% and the risk of sustained accumulation of disability by 71% compared to patients treated with the active comparator Rebif (high-dose interferon beta-1a). Importantly, the mean disability of patients on alemtuzumab improved from baseline, whereas the mean disability of those on Rebif worsened. The treatment benefits of alemtuzumab were sustained for at least three years, even though the majority of alemtuzumab-treated patients were last dosed two years earlier. These results come from the final three-year analysis of a Phase 2 clinical study (CAMMS223) reported in the Oct. 23 issue of the New England Journal of Medicine. The study involved 334 patients who had not previously been treated for their disease. "The alemtuzumab trial data continue to suggest a potentially new and exciting treatment for patients with early, active multiple sclerosis," says Alastair Compston, Professor of Neurology and the head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom, and the study's principal investigator. "This randomized study confirms findings from prior studies demonstrating that treatment with alemtuzumab can have a profound and durable impact on patients with relapsing-remitting multiple sclerosis, including restoring some lost function in many patients... The trial was larger and follow-up was longer than the typical Phase 2 trial in multiple sclerosis. It is important to note that we compared the investigative drug directly against a widely used therapy rather than against placebo. The trial did not show an increased risk of life-threatening or opportunistic infections, but a proportion of alemtuzumab patients experienced new autoimmune disease. We have been able to create a robust patient monitoring program that allows us to proceed into our two international Phase 3 trials with greater assurance on safety associated with patient management," says Dr. Richard Moscicki, chief medical officer for Genzyme.





. . . .


Doctors yesterday hailed a major success in the treatment of multiple sclerosis, after trials revealed that a drug had halted and reversed the debilitating effects of the disease for the first time.

The unprecedented results will boost the hopes of thousands of people in Britain in the early stages of the condition, which destroys the central nervous system.

Existing medications, such as beta interferon, at best slow the disease, which causes the immune system mistakenly to attack fatty coatings around nerves that are needed to make sure signals are passed down them properly.

Doctors at Cambridge University led a three-year trial of the drug, alemtuzumab, to compare its effectiveness against the market-leading beta interferon treatment. They recruited 334 patients with MS in their 20s and 30s, all of whom had experienced their first symptoms no more than three years ago.

Patients who were given the new drug were 74% less likely to relapse and had a 71% lower risk of being disabled within three years. But most remarkably, those on the new treatment showed fewer signs of disability at the end of the trial than they began with.

The drug is a synthetic antibody that was developed at Cambridge 30 years ago as a treatment for leukaemia. While it is now licensed as a treatment for chronic leukaemia, scientists suspected it might also benefit MS patients because it dampens down the immune system.

"For the first time we've shown definitely that treating people early on with this aggressive immunosuppression is a good thing and we can say people's disability improves. That's never been seen before and goes counter to everything we thought," said Alasdair Coles, a member of the Cambridge team, whose study appears in the New England Journal of Medicine.

"What is unprecedented and fascinating is that patients who take beta interferon have slowly shrinking brains as the disease attacks their brain tissue. We used MRI scans to show that patients who have alemtuzumab have enlarging brains as the lost tissue is restored. Somehow the drug is promoting brain repair," Coles added.

In the trial, patients were given either a beta interferon injection three times a week for a year, or five days of alemtuzumab infusions followed by a three-day follow-up treatment a year later. The drug is now in a phase three clinical trial, which will be used to work out the best dosages. If the trial is a success, it could be licensed as early as 2010. For the drug to be approved, licensing bodies will have to be convinced that it can be used safely, but two major side-effects have been identified.

When the drug is given, it appears to suppress the immune system by reducing white blood cells called lymphocytes, which are crucial for the body to fight infections. Although the patients in the trial did not suffer from a rise in infections, some did develop new immune disorders. The most common side-effect involved the immune system attacking the thyroid gland, which affected nearly 25% on the new drug. A few patients (2.8%) suffered an immune disorder which affected plate lets in their bloodstream. One patient in the trial died of the condition. "Both of these conditions can be monitored and treated providing diagnosis is made quickly enough," said Coles.

"I'm sure this is the most effective way to treat MS and it's the best we'll see in terms of efficacy," he added. The trial intentionally focused on patients who were in the early stages of the disease. Longer-term patients are not expected to respond as well to the treatment.

Despite the potential for serious side-effects, the trial was lauded as a major step towards treating the disease. In Britain about 100,000 people are affected by multiple sclerosis.

also see:

<WebMD: Guarded Optimism for Experimental MS Drug>

<Boston Herald: Leukemia Drug May Treat MS>

<Google Article>

<BBC UK>
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Postby Jamie » Thu Oct 23, 2008 5:33 pm

That's fantastic, it also gives me great hope for the HiCy results too.
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Postby Grumpster » Fri Oct 24, 2008 12:09 pm

I need to figure out how to get on a trial across the pond here in the states. There are some trials open, but prior treatment with Rebif / interfeuron is an exclusion criteria. I want to get on this now and not wait till it is too late for the major benefits!!

New neuro for off label use anyone?? I am tired of declining so rapidly.
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Postby cheerleader » Fri Oct 24, 2008 1:11 pm

Grump...
Have you seen this trial?
Didn't see anything about interferon exclusion. There's some locations in socal- USC, La Habra and Fountain Valley

http://clinicaltrials.gov/ct2/show/NCT00548405

Wishing you luck, Grumpster-
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Postby Grumpster » Fri Oct 24, 2008 1:50 pm

AC- thanks a lot. I did not see that one. I have emailed the study coordinator and hopefully can get onboard with the trial. Thanks again!!
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Postby Frank » Sat Oct 25, 2008 9:52 am

Statistics question:
---------------------

Has anyone seen the actual numbers behind the statistics of 71% and 74% benefit, has anyone access to the full study?
I'm concerened that they might sound better than they actually are.

If they somehow calculated with a low percent value for the INF group of about 15% and then take the relative improvement in percent, this would not be what the statistics presented suggest.

Example: Take 15% basic value for INF group, raise it by 71% (=10,65%) then the overall value for Campath group is 25,65%.
Still a good result, but not the kind you would expect when someone tells you about 71% improvement - and not to placebo but to a well established treatment.

While I dont the situation is as drastic as my example, I would really be interested to see the numbers behind it.
How do you feel about this?

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby Grumpster » Sun Oct 26, 2008 12:17 pm

You have a good point Frank. The clinicaltrials.gov site might have more details on the study results. the NEJM may have the full published study results, not just the abstract which is what everyone has been quoting. I am going to look for the full study summary because I am likely volunteering for the open study. I can not afford to wait any longer. I am too screwed up already. The known side effects are pretty spooky - attack to thyroid gland, and something else that 1 person has died from :(
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new campath results

Postby k6ristin » Sun Oct 26, 2008 4:54 pm

i would like to hear from the 16 percent that did not fare well. all i see is the 84% with a reduction statistic (plus or minus). Slowly, on the forum, a few are trickling in and saying they aren't any better off. that's not near the numbers of people talking about their experiences with LDN, ABX, etc.

i'm only 6 months in-1infusion, according to the new data/report that is filling up the MS news section on google, it's after 3 years they've seen the results. that's two more infusions. and 2 1/2 more years. a long time.

i'm way to early in the treatment to really talk about my results with any authority, i suppose.
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Postby CureOrBust » Sun Oct 26, 2008 7:48 pm

Frank wrote:Has anyone seen the actual numbers behind the statistics of 71% and 74% benefit, has anyone access to the full study?
I'm concerened that they might sound better than they actually are
Have yet to read it, but I found this PDF on another MS web site. It appears to be the full paper at first glance.<shortened url>
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Postby Frank » Mon Oct 27, 2008 5:39 am

Hey Cure, GREAT FIND!
Thanks :)
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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