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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: IRWIN JAMES FRANKEL who wrote (9604)	3/2/2008 10:20:53 AM
From: fred hayes	Respond to of 10345

Thanks IJ. Hope all goes well for her and that even better stuff becomes available soon. fred

To: IRWIN JAMES FRANKEL who wrote (9604)	3/2/2008 10:36:56 AM
From: david nordic	Respond to of 10345

There is a method to test for anti-bodies to Tysabri. PML can be idetified thru a MRI. Patients who react to treatments and do not use antihistamines are discountinued. Antihistamines reduce swelling. ELN has still not identified the root cause. Trial and error. This is still great news to patients. At the same time the early PML case was 1/3000 patients. With 21000 patients, the tests above has identified more than 7 patients out of the 21000. No doubt ELN has made advancements. It was good it was removed from the market until further data, tests were developed. Expanding Tysabri for Crohn disease. Are these patients at risk for PML? Below, ELN also has a testing method for Chron's disease "The addition of Tysabri to the treatment options for sufferers of Crohn's disease is important, but one that carries serious risks," said Daniel Shames, deputy director of the Office for Drug Evaluation III and director of the Division of Gastroenterology Products for the Center for Drug Evaluation and Research. "Health care providers must carefully monitor patients for these risks. The CD-TOUCH Prescribing Program will aid FDA in monitoring this drug through its life cycle." Tysabri carries a boxed warning for progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection that affects the brain and can lead to death or severe disability. Other serious adverse events that have occurred in Tysabri-treated patients include hypersensitivity reactions, such as anaphylaxis and liver injury. Serious opportunistic and other atypical infections have been observed in patients receiving immunosuppressants while on Tysabri, and Tysabri should generally not be used in patients receiving immunosuppressants. Serious herpes infections have also been observed. Common side effects include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash. Because of these risks, patients, prescribers, pharmacies, and infusion centers must all be enrolled in CD-TOUCH and agree to comply with the company's strict monitoring guidelines. Additionally, they must participate in an extensive educational program designed to inform people about the risks of Tysabri treatment. Tysabri is administered intravenously by trained professionals at infusion centers. Under CD-TOUCH, health care providers evaluate Crohn's disease patients after three months of treatment to determine if they have improved on Tysabri. If not, patients should discontinue treatment. People who are taking steroids for Crohn's disease should begin tapering steroid doses while on Tysabri. Treatment should be discontinued if steroids cannot be fully tapered within six months

To: IRWIN JAMES FRANKEL who wrote (9604)	3/2/2008 12:37:23 PM
From: pgo-neil	Read Replies (1) \| Respond to of 10345

Hi Jim, Thank you for your field report. You are also a minor celebrity at InvestorVillage. One of the 2 or 3 top technical analysts reposted your note over there on the Elan board and it is in just a couple of hours among the top 100 most recommended posts of this week. [No mean feat considering the quantity and quality of the posts there in a weeks time]. www1.investorvillage.com A couple of comments on your points... >- the local infusion center is seeing about 15% of patients develop anti-bodies to T< Historically, the figure has been about 6% for neutralizing anti-bodies. But there has been enough anecdotes recently that I have been using 10% in my uptake models. Do you have a feel for how many patients your center has on Ty? I may have to further increase the dropout rate. >- they are excited about new treatments advancing that will change the management of MS < One of the few things we can count on besides death and taxes is continued progress as we better understand the underlying science... But patience is required. Hopefully Elan will have at least one entry in the new solution space. They are still working small molecule treatments for MS, which should remove the antibody issue. They should be able to use their nano materials to provide easy delivery and bio-availability. All the best to you and your wife, graham --

To: IRWIN JAMES FRANKEL who wrote (9604)	3/2/2008 1:28:36 PM
From: pgo-neil	Respond to of 10345

Another comment... AAN program details just released and Ty/Natalizumab is prominently featured. >- there are still no available assays for PML and thus the regular survey questions and MRI's when suspect< Your comment still stands, but there is more information... if somewhat murkier: [P02.154] Detection of JC/BK Virus in Patients with Multiple Sclerosis Treated with Natalizumab Lauren M. Puccio, Jacqueline Dinzey, Christina A. Poopatana, Kathleen V. Barrett, Saud A. Sadiq, New York, NY OBJECTIVE: To determine if JC or BK Virus DNA is detected in plasma or CSF after six months of treatment with Natalizumab. BACKGROUND: Natalizumab is a FDA-approved treatment for MS. However, there is a concern that patients may develop progressive multifocal leucoencephalopathy (PML). The risk of PML when natalizumab is used as a single agent is unknown. It is probable that viral DNA is detectable in cerebro-spinal fluid (CSF) prior to the development of PML. In such cases termination of therapy may abort the development of PML. DESIGN/METHODS: All patients at our center receiving natalizumab were included in the analysis (n=175). All patients had pre-treatment brain MRI and monthly neurological evaluations, as well as brain scans after six months of treatment. At our center in addition, we screened for JC/BK virus DNA in plasma and CSF prior to treatment with natalizumab and after six months of treatment under an IRB-approved protocol. Six monthly CSF and plasma screening will continue for two years. RESULTS: No patients developed clinical or brain MRI signs of PML after six months of treatment with natalizumab. Seven of the 175 patients had detectable JC/BK viral DNA after six months of treatment. All seven were negative for viral DNA at baseline. Five patients were positive for BK virus DNA in the CSF and the other two patients were positive for JC virus DNA (one in plasma and the other in CSF). Five of the 7 patients have converted to undetectable viral DNA values within 3 months of cessation of treatment. The other two have not developed overt signs of PML and repeat CSF testing is ongoing. CONCLUSIONS/RELEVANCE: CSF and plasma DNA testing for JC/BK virus may help prevent the development of overt PML. Ongoing 12 and 18 month data will enable more robust conclusions. Supported by: Advisory Board of MSRCNY. abstracts2view.com Perhaps more details in the middle of April after the paper and poster are generally available. Best, graham --

To: IRWIN JAMES FRANKEL who wrote (9604)	5/13/2008 2:35:29 PM
From: IRWIN JAMES FRANKEL	Read Replies (3) \| Respond to of 10345

Over the years I have followed Tysabri and ELN partly out of an investment interest and partly out of concern for my wife who has RRMS (over 25 years now). My wife suffers as many do with fatigue and generally not feeling well. That is every day life for her. My wife had been on Copaxone for many years and last July had a bad exacerbation, then another in November and one more in January. That pattern was different and alarming. Her doctor described it as a possible treatment failure and wanted to switch her to T. A little over 3 months ago my wife got her first T infusion. I was very hopeful that she would start to feel better. (I can't imagine what it is like to feel bad every day - hope I never do.) The first two infusions saw no change in her life. After the third infusion she had a couple of days where she felt better but soon days were back to "normal". We did not know what to think of that. Eight days ago she had her fourth infusion and has felt well ever since. No fatigue, feels well and can stand firmly/comfortably on one leg (something she has not been able to do for a long time). So we are hopeful that T is now working for her and that eventually she will feel well every day. BTW - I do not own any ELN so this is not someone talking his book. :-) ij