Two fresh cases of brain infection linked to Biogen/Elan's Tysabri
Biogen Idec and Elan Corp have suffered a stock slide in after-hours trading after the firms revealed two new cases of progressive multifocal leukoencephalopathy, in MS patients being treated with Tysabri, the brain infection that led to the drug being withdrawn in 2005read more
Two fresh cases of brain infection linked to Biogen/Elan's Tysabri
01 August 2008
Biogen Idec and Elan Corp have suffered a stock slide in after-hours trading after the firms revealed two new cases of progressive multifocal leukoencephalopathy, in multiple sclerosis patients being treated with Tysabri, the brain infection that led to the drug being withdrawn in 2005.
In a filing to the US Securities and Exchange Commission, the two companies said they had notified the relevant regulatory agencies of two confirmed cases of PML in MS patients treated with Tysabri (natalizumab). The first case involves a treatment-naive patient who had been taking the drug as monotherapy for around 17 months, but “remains clinically stable and ambulatory at home”.
The second case involves a patient, who is currently hospitalised, who was taking Tysabri as monotherapy for 14 months but has a history of prior disease-modifying therapies including azathioprine and beta-interferons. These are the first cases to be recorded since the reintroduction of natalizumab in the USA and approval in Europe two years ago. Biogen and Elan had voluntarily withdrawn the drug a year earlier after three patients developed PML.
Since re-introduction, Tysabri has boomed and earlier this month the two companies noted that some 31,800 patients were being treated with the drug, which had second-quarter sales of $200 million. It has also recently been approved in the USA as a treatment for Crohn's disease.
Given the increase in patients on Tysabri, fresh cases of PML come as no surprise and the fact that the plight of the two patients, who are both in the European Union, has been identified so quickly is proof that Biogen and Elan’s stringent monitoring programme for the therapy is working. Nevertheless, as Morgan Stanley analyst Steven Harr has pointed out in a research note, doctors may be less keen to start patients on Tysabri as they are reminded of the long-term potential safety issues.
This is the second blow in as many days for Elan’s stock which lost one-third of its value on Wednesday over mixed data from a Phase II trial of the experimental Alzheimer's drug bapineuzumab which is being developing with Wyeth. The Irish firm and Biogen will host a conference call to discuss the cases at 1:30 this afternoon, UK time.
By Kevin Grogan
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Dr. Short
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View BIO
Q :
Is it possible for optic neuritis to cause a severe sensitivity to sunlight? I have a client who is experiencing this very symptom. As soon as she gets out in the sun, she feels like going to sleep almost immediately. Sunglasses have helped, but not entirely. She has seen an optometrist who has suggested it could be a residual effect of the optic neuritis which she has had under control for the last year.
A :
Optic Neuritis can be associated with pain but this usually occurs with eye movement. Having said this although less common light sensitivity could be associated with residual nerve damage from optic neuritis. If the optic neuritis was previously controlled (no symptoms) then it would be important to have this new symptom checked out by your MS neurologist to make sure that there is not new inflammation in the eye causing the new problem.
8/1/2008 6:16:59 AM
More answers from Dr. Christine Short
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Nerves of sponge?
Nerves of sponge?
Posted by Megan Scudellari
[Entry posted at 31st July 2008 05:00 PM GMT]
The unassuming cells of a sea sponge may hold a clue to the origin of the nervous system, according to a paper published next Tuesday, August 5th, in Current Biology. The detection of proneural pathways in the ancient organism suggests that genes for neurogenesis evolved earlier than previously believed.
Researchers have widely believed that nerve cells evolved after the divergence of sponges, which lack organs and nervous systems, from the rest of the animal kingdom (bilaterians). But Bernard Degnan of the University of Queensland in Australia and colleagues detected the expression of two key components of neuronal differentiation in bilaterians, Notch-Delta signaling and basis helix loop helix (bHLH) genes, in the surface cells of the sea sponge Amphimedon queenslandica.
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The team scanned the genome of Amphimedon, the first sponge to have its full genome sequenced, for gene homologs to bHLH and Notch signaling pathway genes. After identifying them in the genome, the team carried out in situ hybridizations to prove that the genes are expressed in the outer layer of cells of a late Amphimedon embryo.
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However, expression of AmqbHLH1 induced proneural activity in both species, mimicking the proneural gene of choice: neurogenin in Xenopus and atonal in Drosophila.
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Degnan and his team are currently working to determine if the cells have sensory function, and their data suggest the cells are involved in sensing the environment, Degnan noted.
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Two fresh cases of brain infection linked to Biogen/Elan's Tysabri
Biogen Idec and Elan Corp have suffered a stock slide in after-hours trading after the firms revealed two new cases of progressive multifocal leukoencephalopathy, in MS patients being treated with Tysabri, the brain infection that led to the drug being withdrawn in 2005read more
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posted by Bill at 6:05 AM
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