Pharma
The trial, called Oracle MS, will evaluate the safety and efficacy of two dosage regimens of cladribine tablets versus placebo in the treatment of patients who have experienced a first clinical event suggestive of multiple sclerosis (MS). Cladribine tablets are currently also being evaluated in a fully enrolled Phase III pivotal trial - the Clarity study - for treatment of relapsing forms of MS.
Info on current MS/Cladribine trials is here.
Past reports didn't have much information on the new PML cases, but this article has a bit more.
Opexa Therapeutics Inc. said its lead drug candidate aimed at treating multiple sclerosis failed to meet its main goal in a midstage study. Still, Opexa said the results for Tovaxin showed a "positive trend" in reducing the annual relapse rate for multiple sclerosis patients, compared with placebo.
"Positive trend" is what gets reported when the graph looks good, but the statistics say it is just a fluke.
New data from the extension phase of oral laquinimod in (RRMS) demonstrated a reduction in the mean number of gadolinium-enhancing lesions in both patients who switched from placebo to laquinimod and patients who continued with their initial laquinimod dose.
Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease-modifying treatment for RRMS. Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A Phase IIb study in 306 patients was recently published in The Lancet and demonstrated that an oral 0.6 mg dose of laquinimod, administered daily, reduced MRI disease activity by a median of 60 percent versus placebo in RRMS patients.
This patent suggests the use of riluzole, an ALS drug, for MS would be useful. In an attempt to find out who the inventor is, I found an MS researcher of the same name who looked at riluzole back in 2005.
It isn't clear if this is something someone is actively pursuing, or just one of those "my institute wants me to file some patents" things.
This study will assess the safety and effectiveness of an investigational study medication versus placebo (an inactive substance which contains no active medication) in people ages 18-55 years old with RRMS.
The investigational medication used in this study is called teriflunomide. You can find out more about participating here.
Fast-track designation could help development and speed the review process of dirucotide, for the treatment of secondary progressive MS, now being evaluated in a U.S. Phase 3 trial.
BioMS says about 510 patients have been recruited for the company's U.S. trial at 68 sites and will receive either dirucotide (MBP8298) or a placebo intravenously every six months for two years.
Biogen Idec is working on the first experimental drug that may reverse the symptoms of the neurodegenerative disease.
The drug, being tested in animals and prepped for its first human trial, is designed to block a protein called Lingo-1 that interferes with body’s production of myelin, the fatty protective coating around nerve fibers.
No name or code name given in the article, but we'll be watching the progress of this one.
Here's some more info on the FDA response to the two new cases of PML with Tysabri. Not sure what this does beyond all the warnings you get when enrolling in the TOUCH program, but hey, somebody needed to do something I guess. A PDF of the new prescribing info is here.
On the flip side, here's a study modeling the long-term risks and benefits of natalizumab in individuals with relapsing multiple sclerosis that concludes that a more than sevenfold increase in actual risk of progressive multifocal leukoencephalopathy was required to decrease natalizumab's health gain below that of interferon beta-1a.
