Guest guest Posted April 17, 2004 Report Share Posted April 17, 2004 Could someone summarize, in English, for those of us not familiar with medial terms? At 11:20 PM 4/16/2004, you wrote: >New study out..If someone wishes to read the whole article, pl. send >me a personal mail. > >J Neurol. 2004 Apr;251(4):407-13. Related Articles, Links > > >Effect of natalizumab on conversion of gadolinium enhancing lesions >to T1 hypointense lesions in relapsing multiple sclerosis. > >Dalton CM, Miszkiel KA, Barker GJ, MacManus DG, Pepple TI, Panzara >M, Yang M, Hulme A, O'Connor P, DH. > >Institute of Neurology, London, UK. > >BACKGROUND: Natalizumab, a humanized monoclonal anti-adhesion >molecule antibody, reduces the frequency of new gadolinium (Gd) >enhancing lesions and relapses in multiple sclerosis (MS). Its >effect on evolution of new Gd enhancing lesions to T1 hypointense >lesions is unknown. METHODS: 213 patients were randomized to receive >3 mg/kg or 6 mg/kg natalizumab or placebo monthly for 6 months and >then followed for a further 6 months. A subset of patients who had >one or more new gadolinium enhancing lesions from Month 0 to Month 6 >and available electronic data were analysed. Each new Gd enhancing >lesion that developed during treatment (months 1-6) was investigated >for conversion to a new T1 hypointense lesion at month 12. Lesions >were classified as large or small if their cross-sectional area was >greater or less than 20mm(2). Because of the similarity of both >doses of natalizumab on the frequency of new Gd enhancing lesions, >the two natalizumab arms were combined in all analyses. RESULTS: >Compared with the placebo group, the natalizumab group exhibited >significant decreases in: (i) the proportion of patients with new Gd >enhancing lesions that evolved to T1-hypointense lesions (10/38 [26 >%] versus 27/40 [68 %]; p < 0.01); (ii) the proportion of patients >who developed large T1 hypointense lesions (2/38 [5 %] versus 16/40 >[40 %]; p < 0.01); (iii) the proportion of new Gd enhancing lesions >that became T1 hypointense (11/75 [15 %] versus 118/466 [25 %]; p = >0.045); (iv) the mean proportion per patient of new Gd enhancing >lesions that converted to T1-hypointense lesions (0.15 versus 0.28; >p = 0.005), and (v) the odds ratio (OR) of converting from Gd >enhancing to T1-hypointense lesions (OR = 0.48; 95% CI = 0.24, 0.94, >p = 0.031)). CONCLUSION: Natalizumab significantly suppresses the >evolution of new Gd enhancing to T1-hypointense lesions. This may >reflect several mechanisms including reduced cell migration across >the blood brain barrier, reduced T cell activation within lesions, >an inhibitory effect on subsequent axonal damage within the new >central nervous system lesion, and a reduced likelihood of recurrent >lesion inflammation. > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 26, 2004 Report Share Posted April 26, 2004 So far so good. The company has already tried to fast-track the drug in the US, and is also seeking approval in Europe. Yash 3/23/2004 2:30:00 AM Biogen Idec and Elan Announce Intention to Submit Antegren for Approval for Multiple Sclerosis in Europe CAMBRIDGE, Mass., SAN DIEGO, Calif., & DUBLIN, Ireland--(BUSINESS WIRE)--March 23, 2004--Biogen Idec and Elan Corporation, plc today announced that they intend to submit to the European Agency for the Evaluation of Medicinal Products (EMEA) an application for approval of ANTEGREN® (natalizumab) as a treatment for multiple sclerosis (MS). The companies expect to submit the filing in the summer of 2004. The decision to file was made after discussion with European regulatory officials, based on one-year data from the ongoing Phase III trials in MS. The companies are committed to completing these two-year trials. To protect the integrity of these trials, the companies are not disclosing the one-year data at this time. Biogen Idec and Elan are collaborating equally on the development of natalizumab in MS, Crohn's disease, and rheumatoid arthritis. In February, the two companies announced they expect to submit a Biologics License Application (BLA) for natalizumab in MS with the U.S. Food and Drug Administration (FDA) mid-year 2004. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 30, 2004 Report Share Posted April 30, 2004 I've seen it widely quoted that they may be able to release Antegren in 2005. Here is one mention: http://www.irishexaminer.com/breaking/2004/04/14/story142851.html > I have seen some hope raised about Ategren being released in Jan. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 19, 2004 Report Share Posted June 19, 2004 Aegis understands that Antegren will be available sometime next January. Since the drug is not yet available, there is no experience as to how it will act with LDN. Theoretically speaking, Antegren blocks certain T-cells from entering the brain. So it should not affect the action of LDN. Aegis > Went to seemy neuro Tuesday and we discussed my going on Antegren as soon as > it is approved. I have been on LDN for 30 days now. Anyone have any idea if > LDN might be OK w/Antegren? Any of you planning on trying it? Quote Link to comment Share on other sites More sharing options...
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