BIOGEN IDEC, ELAN TO DELAY RELEASE OF PHASE III ANTEGREN DATA UNTIL RECEIPT OF APPROVAL FROM FDA
This is probably not a major development. They are still on course to get it approved at the end of the year in the US. The article does mention that there is speculation that this might be a sign that an antegren/avonex combination study is not yielding desired results.
http://www.pharmexec.com/pharmexec/arti ... ?id=115017
Biogen/Elan delay release of Phase III Antegren data
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ELMO
Antegren Study Patient
I'm a first time poster to this or any other MS related forum.
I'm writting on behalf of my younger 26 year old sister, diagnosted with having MS.
We are trying to get information on any published Antegren study results.
Here's her story.
Being a seemingly healthy person, with no prior medical conditions, she was diagnosed with MS in 2001. She was approached by her neurologist to participate in a Natalizumab study (Biogen Protocol Number C-1801) at St. Micheal's Hospital, in Toronto, Ontario. She was on the drug for over one year. One night she experienced what she thought was a relapse of MS. Several months ago, she called the doctor & hospital with hours of experience MS-like symptoms. They told her not to worry for at least 24 hours. That night she suffered a debilitating stroke.
After seeing the neuroligist, they opened her study files and confirmed that she was in fact part of the study group being receiving Natalizumab.
She was assured by the neurologist (who is the primary investigator for study) that this was not a result of the drug. However, she was immediately removed from the study. None of the doctors, specialists that were called in to investigate her case could provide an explaination as to why a 26 woman, with no blood, heart problems suffered this stroke. Based on the seemingly evasive requests for information and fact that other medical specialists involved in the study were aware of the fact this had occured to her, we question whether this was ever reported.
Is there anywhere we can go to see the results of these studies? Would this type of thing be reported anywhere that we could verify?
Thanks for any help
I'm writting on behalf of my younger 26 year old sister, diagnosted with having MS.
We are trying to get information on any published Antegren study results.
Here's her story.
Being a seemingly healthy person, with no prior medical conditions, she was diagnosed with MS in 2001. She was approached by her neurologist to participate in a Natalizumab study (Biogen Protocol Number C-1801) at St. Micheal's Hospital, in Toronto, Ontario. She was on the drug for over one year. One night she experienced what she thought was a relapse of MS. Several months ago, she called the doctor & hospital with hours of experience MS-like symptoms. They told her not to worry for at least 24 hours. That night she suffered a debilitating stroke.
After seeing the neuroligist, they opened her study files and confirmed that she was in fact part of the study group being receiving Natalizumab.
She was assured by the neurologist (who is the primary investigator for study) that this was not a result of the drug. However, she was immediately removed from the study. None of the doctors, specialists that were called in to investigate her case could provide an explaination as to why a 26 woman, with no blood, heart problems suffered this stroke. Based on the seemingly evasive requests for information and fact that other medical specialists involved in the study were aware of the fact this had occured to her, we question whether this was ever reported.
Is there anywhere we can go to see the results of these studies? Would this type of thing be reported anywhere that we could verify?
Thanks for any help
Hello all.......I'm new to this site. So far I like what I see. It just so happens that my wife and I met with her neurologist yesterday and discussed Tysabri. An informational letter from Biogen Eldec stated that the companies findings, in regards to the phase III study data, should be ready for release around May, 2005. BB