Monthly Archives: May 2016

FDA OKs Monthly Multiple Sclerosis Drug: Zinbryta

There’s now a once-a-month injection for treating relapsing multiple sclerosis.

The drug is called Zinbryta (daclizumab) and it was just approved by the Food and Drug Administration.  Zinbryta is self-administered subcutaneously, which means using Printneedles that are shorter than the ones that are used for drugs, such as Avonex, which are administered into the muscle.

Clinical data, reported by Zinbryta’s manufacturer, Biogen, shows Zinbryta significantly reduced relapses and brain lesions for up to three years compared to Avonx. (interferon beta-1a).

Zinbryta research

The FDA approval of Zinbryta is primarily based on results from two clinical trials, including DECIDE, the largest and longest head-to-head Phase 3 clinical trial ever conducted in MS. The Phase 2b SELECT and Phase 3 DECIDE studies were global, randomized, double-blind, controlled studies that involved approximately 2,400 people living with RMS. Some patients in DECIDE were treated for up to three years. In DECIDE and SELECT Zinbryta significantly reduced the annualized relapse rate by 45 percent compared to AVONEX and by 54 percent compared to a placebo.

Zinbryta risks

There are risks involved with Zinbryta.  Because of that, the manufacturer’s news release says the drug “should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis.”

The Zinbryta label includes a warning for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders. Because of these risks patients using the drug will be closely monitored and will undergo monthly liver function tests.

Zinbryta is being marketed in the U.S. by Biogen and AbbVie.

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I Won’t Stop Running on World Multiple Sclerosis Day

I’ve been remiss in not noting World Multiple Sclerosis Day today until the day is almost over.  But I hope that sharing this music video, by the band A Great Big World, will encourage you to take the name of the song to heart and that you Won’t Stop Running.

 

 

Band member Chad King was diagnosed with MS in 2007.   His first symptoms were vertigo and a weakness in her legs.

“The first doctor I saw said I had MS. I didn’t believe her, I didn’t know what it was,” King told New York City radio station 1010 WINS. Doctors told King he’d likely be paralyzed in seven years without medication but, he says, the meds gave him severe side effects.  Instead, King began an alternative, holistic approach.  And he says he’s been symptom-free for years.

“I Wont Stop Running” was released today.

“This song in particular was my response to that doctor who said I would be paralyzed,” King told WINS.

 

 

Good Test Results for Primary-Progressive MS Drug Ocrelizumab

My neurologist tells me “the buzz is good” about ocrelizumab.

The investing web site Motley Fool calls it “the revolutionary Multiple Sclerosis drug you’ve never heard of.”

Ocrelizumab, which Genentech hopes to market under the name Ocrevus, is special because it’s designed to treat primary-progressive, as well as relapsing-remitting, MS.

How does it work?

I’m not a scientist, but after reading a lot of scientific writing here’s my best attempt to ‘splain it in “people-speak.”  (I’ve linked to some of these reports in case you want to wade through yourself).

B-cells are white blood cells that create infection-fighting antibodies. In MS patients some of these B-cells carry abnormal antibodies. Scientists believe these “rogue” B-cells play a role in the way the immune system attacks the brain and spinal cord tissues in MS patients.Ocrelizumab diagram crop

Ocrelizumab binds to a molecule called CD20 on the surface of B cells and depletes those cells from the circulation. The result appears to be a reduction in MS activity while still leaving the immune system capable of fighting off infections such as PML, a very dangerous potential side effect of the current group of powerful MS drugs.

Ocrelizumab is similar to rituximab, marketed as Rituxam, in the way it works. But rituximab is a CD20 antibody that is derived from mice and humans.  Ocrelizumab is derived from humans.

Encouraging test results

Genentech recently announced encouraging results from a Phase 3 study of 732 primary-progressive MS patients.  Ocrelizumab was administered intravenously; two infusions given two weeks apart every six months. The results showed that the drug reduced the risk of disease progression, as measured by the Expanded Disability Status Scale (EDSS), by 24-25 percent compared to a placebo.  MRIs also showed a large 17 percent reducti0n in the rate of brain volume loss.

Data from two related Phase 3 studies, testing the efficacy of ocrelizumab in 1,656 patients with relapsing forms of MS, found that it was superior to interferon beta-1a, reducing the annualized relapse rate by nearly 50 percent over two-years of treatment.

What’s next?

This past February the Food and Drug Administration designated ocrelizumab a Breakthrough Therapy for use as a possible primary-progressive MS treatment.  That designation allows quicker drug development and FDA review.

Roche says ocrelizumab is the first investigational medicine to show very positive results with both primary-progressive and relapsing-remitting MS patients. The company says it plans to submit data from all three studies to the FDA this year.  If so, it’s possible there could be FDA action on the drug by the end of the year.

 

Are wearable robotics in the future for MS gimps?

You have MS but you have some mobility.  You need help to walk because your legs are weak or stiff, and your balance is off, but canes don’t give enough help and braces are too cumbersome or limiting.  How great would it be to have something that’s relatively lightweight that you could wear and would help your legs move? That’s what a group of roboticists, mechanical and biomechanical engineers, software engineers, physical therapists and even apparel designers (!) is trying to create.exosuit

It’s called exosuit technology; form-fitting, fabric-based designs that are lightweight and non-restrictive. They use flexible sensors on the knees, hips and ankles, and compact, powerful motors, packaged in a belt, to help a patient walk with greater ease and stability.

The Wyss Institute for Biologically Inspired Engineering at Harvard University has just teamed with ReWalk Robotics Ltd to accelerate development of the Institute’s exosuit technologies.  “There is a great need in the health care system for lightweight, lower-cost wearable exoskeleton designs to support stroke patients, individuals diagnosed with multiple sclerosis and senior citizens who require mechanical mobility assistance,” says ReWalk CEO Larry Jasinski. “This collaboration will help create the next generation of exoskeleton systems.” Continue reading

Trip to Ground Zero

I grew up in Lower Manhattan.

Though I’ve lived in Maryland since 1973, once a New Yorker…always a New Yorker.  So, I’ve always felt the closeness of a New Yorker to the events of September 11, 2001.  Earlier this month I finally had the opportunity to visit the 9/11 Memorial and Museum to pay my respects to those who died there and also to see the magnificent 1 World Trade Center, which soars above the memorial, just to its North.

9-11 museum wall edit

The museum and the memorial are fully accessible.  But you may have to detour around a bit to avoid some steps at the memorial and to skirt some construction that blocks some nearby sidewalks.

The 9/11 Museum

The museum (the yellow square on the map) is on the Greenwich Street side of the plaza, between the North and South memorials.  Trying to ride my scooter along Greenwich Street, on one side of the plaza, and West Street, on the other, required zig-zagging from one side of the street to the other to dodge construction blocking the sidewalk, but it wasn’t a big deal.9-11 memorial map

At the museum you need a ticket.  You can buy one at the museum ($24 a person with discounts for seniors, students, teens and the military), but if you go that route you can pretty much plan on waiting in line at the ticket booth.  It’s much easier and faster to buy a ticket on the museum’s web site.  Since the tickets are issued for specific entry-times, buying on-line also avoids a possible wait between purchase time and entry time. When I visited there was also a line of ticket-holders waiting to actually enter.  However, when a museum volunteer spotted my scooter I was ushered right in via the entrance that’s reserved for staff, museum contributors and relatives of 9/11 victims.

9-11 museum steelInside everything is accessible, either via ramp or elevator, and there are plenty of volunteers stationed all over if help is needed.  If you’re not using a scooter or a chair be warned, there’s lots of walking.  But wheelchairs and walkers are available at the information desk at no charge, first-come first-served. You might want to take advantage of that.  There are accessible rest rooms on several levels of the museum.

Guided tours are available, at an extra charge. I was on my scooter but, since my wife is a slow walker, rather than feel rushed by the pace of a group we decided to download the museum’s app to our iPhones.  It contains an audio tour which allowed us to go at our own pace. Continue reading

Belly to Brain…Maybe There’s an Inflammation Connection

“You are what you eat,” some say, and that may be even truer when it comes to your MS.

Researchers at Brigham and Women’s Hospital in Boston report that bacteria living in your stomach may influence cells that help control inflammation and degeneration in your brain.

Astrocyte cells

“For the first time, we’ve been able to identify that food has some sort of remote control over central nervous system inflammation,” says Francisco Quintana, PhD, one of the authors of a new study.  “What we eat influences the ability of bacteria in our gut to produce small molecules, some of which are capable of traveling all the way to the brain. This opens up an area that’s largely been unknown until now: how the gut controls brain inflammation.” Continue reading

New Cancer Risk May be Linked to Mitoxantrone

Patients who use mitoxantrone appear to be at increased risk of colon cancer, according to a new study, and as well as acute myeloid leukemia (AML).

Mitoxantrone is used to treat aggressive relapsing-remitting, and also progressive, MS when the patient doesn’t respond to other drugs.  It suppresses the immune system and was first developed as a treatment for some cancers.  Its use is limited because past studies have shown that it may increase a patients risk of leukemia and heart damage.Mitoxantrone

This new study, published in the journal Neurology, checked the records of 676 MS patients who were treated with mitoxantrone at a German hospital’s MS center between 1994 and 2007.  Thirty-seven of those patients, or 5.5 percent, developed some form of cancer.

When they were compared to the general population of Germany the study found that the mitoxantrone patients were at 10 times greater risk of developing AML and 3 times greater risk of developing colorectal cancer.  Though there had been an association made between mitoxantrone and AML in an earlier study this was the first time a possible link had been identified with colon cancer. Continue reading