Archive: September, 2009

• RegeneRx’s Tβ4 Significantly Improves Functional Recovery in MS Animal Model

  BETHESDA, Md.–REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers at the Henry Ford Health System in Detroit, Michigan, demonstrated for the first time that Tβ4 treatment [...]

  • Caroline says: This is good stuff...we shouldn't get too excited because mouse MS (EAE) and human MS are very different...animals (pardon the pun). According to this study, in animals with EAE, RegeneRx improved neurological function, reduced inflammatory infiltrates in the brain, and increased oligodendrocyte progenitor cells (a type of stem cell) and mature oligodendrocytes in the brain. I don't know what some of that means, but it sounds groovy to me.
     
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  • Novartis says FTY720 reduces relapses

    ZURICH, Sept 30 (Reuters) – Swiss drugmaker Novartis AG said on Wednesday its FTY720 oral drug to treat multiple sclerosis reduced both relapses and disability progression. Initial [...]

    • Caroline says: Oral update: Novartis is addressing the safety concerns with FTY-720. According to execs, FDA review for FTY-720 will be in the next 6 months.
       
    
    

    • Merck Discontinues Ph 2 Trial of Atacicept in MS

      September 28, 2009 by Matthew Dennis Merck KGaA has decided to discontinue Phase II clinical trials of atacicept for the treatment of multiple sclerosis based on a recommendation [...]

      
      

      • Don’t Hold Your Breath For Generic Avonex

        September 16, 2009 — 11:47am ET | By George Miller Biogen Idec has succeeded in extending patent protection for its multiple sclerosis drug Avonex to 2026, some [...]

        • Caroline says: I think this is lame. Lame for patients who can't afford to spend $50/month on Avonex (that's what mine costs, anyway), and lame on the part of Biogen to get around patent expiration laws that are in effect for a reason. A lower cost, generic version of Avonex will not be available until 2026 -- that's a full 13 years beyond the original patent granted to Biogen. Shame on you, Biogen.
           
        
        

        • Biogen Reports 2 More Cases of PML with Tysabri

          By THOMAS GRYTA Two more cases of a rare brain infection have emerged in users of the multiple-sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan [...]

          • Caroline says: Two new PML cases have been reported since Biogen stopped reporting the incidences to investors in July 2009. At least one is in Europe, and all cases reported have been in people taking Tysabri for at least a year.
             
          
          

          • MS and Diet: What do You Think?

            Excerpt from Chapter 1: What is MS? A safe conclusion is that MS is one or, possibly, many diseases in which there is destruction of the myelin [...]

            • Caroline says: I have to be honest here and say that I have never given much credence to the idea that diet can improve or control my MS. This is partially because practically every "MS Miracle Cure Diet" theory has been debunked by experts and patients alike. BUT, yesterday I was in my neurologist's infusion suite getting Day 2 of IVIG and I spoke with a patient who has been religiously following the MS Recovery Diet since April and has noticed marked improvements in how she feels (also: she has had no medication changes since April)-- her MS has never been more controlled and her energy is improved (this woman is in grad school, a band, AND has a full time job). So, I have decided that diet and MS deserves some further study. To read more about the MS Recovery Diet, see my post.
               
            
            

            • Hot off the ECTRIMS Press…Alemtuzumab Shows Lasting Benefits in RRMS

              (RTTNews) -  Friday, biotechnology company Genzyme Corp. said that four-year follow-up data from its completed Phase 2 multiple sclerosis trial continued to show durable reductions in relapse rate [...]

              • Caroline says: The possibility of alemtuzumab (Campath) being FDA approved for MS should excite some of you b-cell MS'ers. Genzyme says that four-year follow-up data from its completed Phase 2 MStrial show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.
                 
              
              

              • Hot off the ECTRIMS Press…Sanofi Oral is Promising

                LONDON, Sept 11 (Reuters) – Patients given an experimental multiple sclerosis tablet from Sanofi-Aventis showed a significant improvement compared to those on placebo in a mid-stage test, [...]

                • Caroline says: In the 24-week study, patients receiving teriflunomide experienced a 56% and 81% reduction in cerebral inflammatory lesions compared with those on placebo, as measured by MRI scan. Patients were given two doses and teriflunomide was well tolerated.
                   
                
                

                • Hot off the ECTRIMS Press…Fewer Injection Site Reactions with Avonex

                  CAMBRIDGE, MA – Sept. 11, 2009 – Data from an observational phase IV study of 499 patients entitled The Swiss MS Skin Project show that multiple sclerosis [...]

                  • Caroline says: I think it is important to note that injection site reactions are different than side effects (see my side effect post here)...so, this study makes sense since Avonex is a once-weekly injection and the other injectables are administered more frequently -- and thus are more likely to cause site reactions.
                     
                  
                  

                  • Hot off the ECTRIMS Press…Cladribine Reduces Disease Activity in a Big Way

                    Darmstadt, Germany, September 11, 2009 – Merck KGaA announced today new data from a post-hoc analysis of the two-year (96-week) placebo-controlled CLARITY(1) Phase III trial using a [...]

                    • Caroline says: These data are significant! Two-year data were released at ECTRIMS showing that 44% of patients treated with cladribine had no disease activity compared with 16% on placebo. Merck submitted their EMEA approval application in July 2009 and will file it in other countries, including the US, in Q3...meaning the end of this month, I believe.
                       
                    
                    
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