Pharma

Major new step towards treating MS

Wed, 22 Oct 2008 21:40:46 -0400

This article discusses the study results released yesterday by doctors at Cambridge University of the drug, alemtuzumab.

In the 3-year trial, patients who were given the new drug were 74% less likely to relapse and had a 71% lower risk of being disabled within three years. But most remarkably, those on the new treatment showed fewer signs of disability at the end of the trial than they began with.

The drug is a synthetic antibody that was developed at Cambridge 30 years ago as a treatment (called Campath) for leukaemia. While it is now licensed as a treatment for chronic leukaemia, scientists suspected it might also benefit MS patients because it dampens down the immune system.

Also interesting findings showing that patients who take beta interferon have slowly shrinking brains while patients who have alemtuzumab have enlarging brains as the lost tissue is restored. Somehow the drug is promoting brain repair.

Merck Serono initiates Phase III Cladribine Trial

art — Mon, 22 Sep 2008 16:12:37 -0400

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.

More info on Tysabri PML cases

art — Mon, 22 Sep 2008 16:05:54 -0400

Past reports didn't have much information on the new PML cases, but this article has a bit more.

Tovaxin results in - news not good

art — Mon, 22 Sep 2008 16:04:33 -0400

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.

Laquinimod Demonstrated Impact on MS

art — Mon, 22 Sep 2008 16:00:56 -0400

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.

Patent for use of ALS drug in MS

art — Mon, 22 Sep 2008 15:15:35 -0400

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.

Oral drug teriflunomide study recruiting

art — Mon, 22 Sep 2008 10:03:25 -0400

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.

SPMSS Drug Gets FDA Fast-Track

art — Thu, 04 Sep 2008 09:57:31 -0400

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 Testing Regenerative Medicine Drug to Reverse the Path of MS

art — Wed, 03 Sep 2008 15:14:47 -0400

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.

Tysabri Label Update

art — Wed, 03 Sep 2008 15:06:28 -0400

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.