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To: Jibacoa who wrote (9515)	7/19/2005 12:44:15 PM
From: Galirayo	Read Replies (1) \| Respond to of 23958

[KOPN] I added it with a Stop at 5.45. stockcharts.com[w,a]dacayiay[da][pb50!c13!f][vc60][iut!Ua12,26,9!Uv25]&pref=G Thanks Bernard. Next one ?? :) Ray

To: Jibacoa who wrote (9515)	7/21/2005 8:19:58 AM
From: Esoteric1	Respond to of 23958

ELN From the advance copy of the New England Journal of Medicine to be published July 24, 2005 Biogen Idec offers strategy for resuming use of natalizumab Testing for JC viral infection could identify patients at risk of PML before it’s too late, researchers write as New England Journal of Medicine releases reports of three cases. Responding to three cases of progressive multifocal leukoencephalopathy (PML) in patients taking natalizumab (Tysabri—Biogen Idec; Elan) released today on the Web site of the New England Journal of Medicine, three Biogen Idec medical researchers propose testing of patients taking the drug for presence of the JC virus, a neurotropic polyomavirus associated with development of PML. If the strategy turns out to be an effective and efficient means of identifying those at risk of PML, the way could be paved for a resumption of use of the monoclonal antibody in patients with multiple sclerosis (MS). The companies had voluntarily suspended marketing and distribution of the drug on February 28 after reports of PML surfaced. Patients in the cases were a 23-year-old man and a 46-year-old woman with relapsing-remitting MS and a 60-year-old man receiving natalizumab for Crohn’s disease. The latter two patients died, and the younger man has been left with disabling ataxia, cognitive impairment, mild neglect, and mild left hemiparesis, the investigators report. FDA and the companies are reportedly investigating a fourth case of PML. In proposing the testing strategy, Burt Adelman, MD, and Biogen Idec colleagues write, “One [of these case reports] suggests that clinical PML may be preceded by JC viremia. Another demonstrates that PML is not uniformly fatal. It is possible that testing for the appearance of JC virus in plasma, along with a high degree of clinical suspicion, will permit early diagnosis and discontinuation of natalizumab therapy and allow patients to recover.” In a related editorial, Joseph R. Berger, MD, of the University of Kentucky, and Igor J. Koralnik, MD, of Harvard Medical School, are supportive of Biogen Idec’s proposed strategy, “The prospective measurement of the JC viral load in plasma and the preemptive reduction of doses or interruption of treatment if JC virus DNA appears in the blood might actually prevent the development of PML in this setting. By analogy, a similar strategy has been used successfully for the prevention of a nephropathy caused by the JC virus-related BK polyomavirus in kidney-transplant recipients. In addition, analysis of the JC virus regulatory region, which contains determinants of neurotropism and neurovirulence, may provide important insight into the mechanisms of JC virus reactivation in patients treated with novel immunomodulatory medications.” The cases, the above editorial plus related one by the NEJM editor, and the letter are available now as PDF files on the Journal’s Web site and scheduled for publication in its July 24 issue. pharmacist.com