Archive: June, 2009

• Biogen Reports 13th Case of PML

  By KEITH J. WINSTEIN Biogen Idec Inc.’s disclosure of a debilitating brain infection in a patient taking its Tysabri multiple-sclerosis medicine sparked a selloff in shares of [...]

  • Caroline says: We seemed to have skipped cases 11 and 12 because I haven't seen reports on these anywhere...Biogen STILL says a "drug holiday" is unjustified after 2 years of Tysabri and 13 cases of PML?? GIVE ME A BREAK! Give me a break! I also am appalled that I read about these cases first and only from financial journals reporting about how much their stockholders have lost because of each new PML case...WTF? This information is NOT on Biogen's website, nor is it even on their Tysabri webpage.
     
  
  

  • Hot off the ENS Press…Rebif Autoinject Improves SC Delivery

    MILAN, Italy June 26, 2009 A new electronic, multidose, autoinjection device improves subcutaneous delivery of interferon beta (IFNB)-1a in patients with relapsing multiple sclerosis (MS), according to [...]

    • Caroline says: I've seen links to this in the last week but when I clicked on them, the link was dead...UNTIL NOW...mwah, mwah, mwah. I think it was embargoed until it was presented yesterday. Rebif is the one drug out of the CRABs (who was responsible for coming up with THAT acronym, anyway?) that I have not had the pleasure of being on. It's interferon-1a (like Avonex), only it is administered three-times weekly subcutaneously.
       
    
    

    • 10th PML Case Confirmed by Biogen

      Biogen Idec Inc. has reported a new case of a potentially lethal brain inflammation in a patient using its drug Tysabri, the tenth such case since the [...]

      • Caroline says: This is the 3rd case in the last couple of weeks, all are in people who have received around 30 infusions (Biogen says PML shows up on average after 24 months)...I think there is going to be a Tysabri-holiday mandated after 24 months because this seems like an awful lot of PML.
         
      
      

      • Teva completes enrollment in second Phase III trial

        Jun 26, 2009 (Datamonitor via COMTEX) — Teva Pharmaceutical Industries, an Israeli generic pharmaceutical company, and Active Biotech, a Swedish pharmaceutical company, have completed patient enrollment for [...]

        • Caroline says: Laquinimod is a pipeline oral MS drug. Teva and Active Biotech have completed pt enrollment for the 2nd pivotal Phase III clinical trial, Bravo, evaluating the oral once-daily immunomodulating compound, laquinimod, for the treatment of RRMS. Bravo is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod compared to placebo, and to provide risk-benefit data for laquinimod compared to a currently available injectable treatment, Avonex.
           
        
        

        • Hot off the ENS Press: Immunomodulatory Treatment Improves Cognitive Function in PWMS

          By Judith Moser, MD MILAN, Italy — June 26, 2009 — Patients with relapsing-remitting multiple sclerosis (RRMS) who receive glatiramer acetate (GA) or interferon (IFN) beta show [...]

          • Caroline says: 752 pts with RRMS were enrolled in 79 Italian centers and treated with either glatiramer acetate or interferon beta. After 2 years, a significant reduction in cognitive impairment was observed. At baseline, 40% of all patients showed mild cognitive impairment, and 16% showed severe cognitive impairment, which the researchers said was reduced to 30% and 11%, respectively, at 2 years.
             
          
          

          • Put on Your Thinking Cap: Learning Increases Myelin

            Researchers at Oxford have proven that, when people learn a new skill (juggling), brain imaging shows that the white matter in their brain increased. This increase in [...]

            • Caroline says: This article is from About.com's MS blog. Basically, if you have MS, learn as many new skills (juggling, knitting, trivial pursuit) as you can, because it's seriously upping your myelin AND making you smarter!
               
            
            

            • Riddler: Who Will Benefit Most From A New MS Therapy?

              In a recent phase II clinical trial, the drug alemtuzumab (Campath-1H) was found to be a highly effective treatment for individuals with early relapsing-remitting multiple sclerosis. However, [...]

              • Caroline says: Campath (alemtuzumab) has been in the MS drug pipeline for a long time, but it's a serious drug with serious side effects for your immune system. According to a recent phase II clinical trial, alemtuzumab was found to be a highly effective treatment for people with early RRMS. Unfortunately, 30% of those in the study who received alemtuzumab went on to develop another autoimmune disease (mostly of the thyroid nature). This 30% were subsequently determined to have higher levels of soluble factor IL-21 (IL-21 is essential for fighting infections) in their blood prior to alemtuzumab treatment (these levels are also genetically predetermined). The authors conclude that levels of IL-21 can be measured in the blood of MS patients prior to treatment, and thus might help to weed some of these people out so the autoimmunity side effect won't be an issue. Bottom line: alemtuzumab for RRMS is still in the Pipeline.
                 
              
              

              • Hot off the ENS Press: Cladribine Is Safe Overall in Patients With Multiple Sclerosis

                MILAN, Italy — June 24, 2009 — According to a safety analysis of a study presented here at the 19th Meeting of the European Neurological Society (ENS), [...]

                • Caroline says: This is good news for people who are excited about orals. Cladribine seems to be the safer option out of the ones that are coming out soon. Incidence of treatment-emergent AE's in the trial of 1326 RRMS patients were comparable between 2 doses of cladribine and placebo. As expected based on the MOA of cladribine, lymphopenia (low white blood cells) occurred with the highest incidence in patients receiving the higher dose of the drug.
                   
                
                

                • Tysabri Side Effects Linked to 9th PML Infection Case

                  A new case of a rare, often lethal, brain infection has been linked to the multiple sclerosis drug Tysabri, making it the ninth case of progressive multifocal [...]

                  • Caroline says: Yikes...This is the second Tysabri-induced PML infection I've read about in a week. This article is quick to point out that this particular patient lives outside of the US (so perhaps there are less stringent monitoring requirements when it is prescribed?) and developed PML after his 34th infusion.
                     
                  
                  

                  • Biogen enrolls patients in new MS trial

                    Biogen Idec has enrolled its first patient in a phase 3 trial for a potential multiple sclerosis treatment that, when compared with existing therapies, would reduce the [...]

                    • Caroline says: This is interesting...Biogen is launching a Phase III study using Avonex and PEGylation, which can potentially extend the amount of time a drug stays in your system (read: fewer injections). I have never had an issue with injections, especially when they're only once-weekly. That said, I know many people DO have serious side effects and nasty injection site reactions, so, this is good news.
                       
                    
                    
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