Campath interim results

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

Campath interim results

Postby dignan » Thu Sep 14, 2006 9:18 am

This is interesting.

"Analysis of the first co-primary endpoint showed that patients taking alemtuzumab at high and low doses experienced at least a 75 percent reduction in the risk for relapse after at least two years of follow up when compared to patients treated with interferon beta-1a."

That's pretty amazing because they're not saying a 75% overall reduction, they're seeing a 75% reduction compared to Rebif! And the Campath patients have only had 2 infusions and haven't had an infusion for the last year as the trial is suspended, while the Rebif patients have continued taking Rebif!

I really hope they figure out how to minimize the side effects because Campath looks to be in a league of its own for RRMS.




Genzyme Reports Interim Results from Trial of Campath(R) for Multiple Sclerosis

Sept. 14 - PRNewswire-FirstCall - Genzyme Corporation today announced two-year interim results from a Phase 2 trial comparing Campath(R) (alemtuzumab) with Rebif(R) (interferon beta-1a) for the treatment of multiple sclerosis. The results derive from a pre-specified analysis conducted after two years of treatment for 334 patients in the planned three-year trial. This review was conducted in conjunction with an independent data and safety monitoring board.

As previously announced, dosing of alemtuzumab in this study was
suspended in September 2005 after three patients developed immune
thrombocytopenic purpura (ITP), a treatable condition in which patients
experience a low platelet count as a result of an immune response directed against the platelets. At that time, most patients had received two cycles of therapy with alemtuzumab. Treatment with Rebif in the control arm has continued without interruption. The trial remains on clinical hold in the United States, and Genzyme is working closely with clinical investigators and regulatory agencies to complete the study and ensure that the risk of ITP is well understood and managed. The company discourages physicians and patients from using alemtuzumab for MS outside of a clinical trial setting in which procedures are in place for managing ITP risk.

Analysis of the first co-primary endpoint showed that patients taking
alemtuzumab at high and low doses experienced at least a 75 percent
reduction in the risk for relapse after at least two years of follow up
when compared to patients treated with interferon beta-1a. This difference
was statistically significant in favor of the alemtuzumab patients at both
high and low doses, with a p-value less than the pre-specified value
(p=0.00328) assigned for the two-year interim analysis.

Analysis of the other co-primary endpoint showed that patients taking
alemtuzumab at high and low doses experienced at least a 65 percent
reduction in the risk for progression of clinically significant disability
when compared to patients treated with interferon beta-1a. This difference
was statistically significant in favor of the alemtuzumab patients at both
high and low doses, with a p-value less than the pre-specified value
(p=0.01194) assigned for the two-year interim analysis.

Results of additional secondary and tertiary efficacy endpoints,
including MRI data, functional assessments, and quality of life measures,
support the findings seen in the co-primary endpoints.

"These results continue to demonstrate that alemtuzumab has great
potential to make a meaningful impact on the treatment of multiple
sclerosis," said Richard A. Moscicki, MD, chief medical officer for
Genzyme. "We will work with regulatory agencies in the United States and
Europe, as well as our clinical investigators, to successfully complete
this important trial and to prepare for the initiation of a Phase 3 trial
in the first half of 2007."

Genzyme has requested a meeting with the U.S. Food and Drug
Administration to present these data and to address the next steps in the
development of alemtuzumab. The company has already received scientific advice from the European Medicines Agency for moving forward with a Phase 3 study.

Dosing of alemtuzumab in this study was suspended in the United States
in September 2005 after three patients were diagnosed with ITP. The first
patient to present with ITP died from the disease. Genzyme immediately
implemented enhanced monitoring for ITP and has since created a
comprehensive risk management plan to help physicians and patients
participating in the trial detect ITP early and minimize the risk of
complications. These efforts have been effective and have enabled the
identification of all five additional patients with ITP symptoms. All
patients requiring medical treatment for ITP have responded well. To date, a total of six patients have been diagnosed with ITP in this trial.

Other than ITP, serious adverse events related to treatment occurred
among four patients treated with the low dose of alemtuzumab and four
treated with the high dose. Two patients treated with interferon beta-1a
experienced serious adverse events related to treatment. Common non-serious adverse events included infusion reactions in the alemtuzumab patients and flu-like symptoms in patients using interferon beta-1a. The incidence of all thyroid adverse events, including Graves' disease, was less than expected compared to reports in the literature on the use of Campath in MS.

Safety information from the study related both to ITP and thyroid disorders will be presented in two weeks at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis.

The phase 2 trial randomized 334 patients with active relapsing-remitting multiple sclerosis at 49 medical centers in Europe and the United States. Patients in the trial were treated with alemtuzumab at one of two doses (12 or 24/mg per day for five days at initial treatment, and three days of re-treatment), or interferon beta-1a (44 mcg administered three times per week, as indicated in its product label). The alemtuzumab regimen was administered once per year by intravenous infusion, while the interferon beta-1a regimen was administered three times per week by subcutaneous injection. The randomized trial compares the safety and efficacy of alemtuzumab with interferon beta-1a using two primary endpoints: the rate of relapse of MS symptoms, and the time to progression of clinically significant disability (time to Sustained Accumulated Disability over six months as measured by Expanded Disability Status Scale [EDSS]). Although treating physicians are aware of which treatment patients received, independent (blinded) neurologists assessed the disability
efficacy endpoint.

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Postby bromley » Thu Sep 14, 2006 10:18 am

Dignan,

You beat me to it - just!

On the efficacy rates, I posted a presentation this week by Professor Compston who is working with Dr Coles at Cambridge on Campath - he mentioned a 95% reduction.

Dr Coles is one of my neuros and is lead investigator on the Campath trial. Attached is a presentation he gave earlier this year. The interesting page is on disability changes following Campath. For those with SP MS there was stabilisation at first but then disability progression. For those with RR there were improvements in disability - pretty impressive improvements. Raven on this site has posted his experience after having Campath.


http://www.mssociety.org.uk/search_clic ... eid=332294


Ian
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Postby bromley » Fri Sep 15, 2006 7:22 am

Here is the UK MS Society's view on the Campath results - also some links to earlier articles on Campath.

Ian

http://www.mssociety.org.uk/news_events ... ults2.html
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Postby Teri » Fri Sep 15, 2006 7:32 am

Hello all - I was so pleased to read the interim results of the Campath study. October 2006 will mark my 3 year anniversary as a patient in this study. I consider myself to be very lucky.

I have had ZERO relapses since enrollment in the trial. I do some leftover symptoms from prior attacks (weakness in left leg, facial numbness, mild spasticity in right arm) and I still have problems with fatigue but I have had nothing new whatsoever. I am anxiously awaiting the results of an MRI scheduled at the end of this month. Even though I feel fine, I really want to know if any new lesion activity will be detected.

I had two Campath infusions and the third was cancelled due to the trial being suspended. I developed an underactive thyroid condition about halfway through the study. The endocrinologist could not say conclusively if this was related to the Campath. His opinion was that the condition was idiopathic and the condition does run in my family. All I have to do is take a pill every day so I don't have any problems with it.

I truly hope that the FDA will release the suspension and allow Phase III of the trial to begin. It scares me to think about what my health would be like now if I hadn't participated in the study. Would I still be able to walk? Would I still be able to see? The possibility of blindness scared me the most - I had two episodes of Optic Neuritis before I was treated with Campath. My vision is normal now, thank goodness.

I wish I could personally thank the scientists and doctors who began this study. Wherever you are ... Thank You!
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Postby bromley » Fri Sep 15, 2006 9:32 am

Teri,

Good to meet you and to hear that you have seen good results with this drug. Another poster on the site - Raven - has also seen good results. Dr Coles, one of my neurologists, is overseeing the Campath trials. If all goes to plan, I start on a Campath study in late November. To stop the disease progressing is my main hope and any retrieval of deficits would be a big bonus. Keep us posted on how you do. Do you know anyone else on the trial and how they are doing?

Ian

PS I'll thank Dr Coles for you when I next see him.
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Postby raven » Fri Sep 15, 2006 11:17 am

Hi Teri

Good to meet another Campath lab rat (so to speak). I'm happy that you're also doing well, good stuff isn't it?

Ian, don't worry I've already thanked Dr Coles and all those at the research facility, they really are nice people... :)

Robin
Do not go gentle into that good night. Rage, rage against the dying of the light.
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Postby sh8un » Fri Sep 15, 2006 5:36 pm

Hi Raven...really nice to see. Wow...what a great day. I am so happy for you Raven and Teri. This is such good news. Ian...I knew I sensed some hope in you :wink: . I am so happy for you...you guys...I have tears in my eyes as I write this. I am just so very happy for all of you. Thank you for being brave enough to participate in the trials. You feel that you want to thank the researchers that come up with the drugs but I want to thank you for particiapting. You are all, in your own way, contributing to a better life for all of us. Thank you also for taking the time to tell us about what you have experienced.

ps didn't you guys read my dream in the Daily life section? If this drug works I will be saying "I told you so."
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