tysabri

Medimmune Teams with NIH on Vaccines and Biogen’s TYSABRI(R) ...
Financial News USA (press release) - La Puente,CA,USA
... Idec (NASDAQ: BIIB) and Elan Corporation, plc recently announced that they received approval from the European Commission to market TYSABRI® (natalizumab) as ...

EU approves Biogen's Tysabri to be sold for severe MS cases
Boston Globe - United States
... and Elan Corp.'s recalled multiple sclerosis drug Tysabri won approval by European regulators for patients with the severest cases of the disease. ...
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Mortgage interest rates rise
San Diego Union Tribune - United States
... Biogen Idec and Elan Corp. received European Commission approval to market their multiple sclerosis treatment Tysabri throughout the 25-nation bloc. ...

EU approves sale of MS drug Tysabri AP via Yahoo! News Thu, 29 Jun 2006 3:57 AM PDT The U.S. and Irish makers of Tysabri, a highly touted drug used to suppress the effects of multiple sclerosis, said Thursday that European Union authorities have cleared the way for the drug's sale throughout the 25-nation bloc.

Man plans to row for wife's health
Provo Daily Herald Thu, 29 Jun 2006 0:19 AM PDT
Instead of feeling helpless, Bob Dietch of Provo will row. Over the past year, multiple sclerosis has forced Dietch's wife, Bettina, to walk with a walker, and rendered her dominant right hand so shaky as to require her to switch to the left. The disease causes the immune system to attack the nervous system, creating a domino effect of neurological and motor skills problems..

Multiple Sclerosis Drug Back On Market

Tom Durante - tdurante@longislandpress.com 06/29/2006 12:29 pm

Pamela Mastrota of the National Multiple Sclerosis Society says Tysabri needs to be monitored. After more than a year of uncertainty and doubt, patients are relieved at the possible re-emergence of a treatment to relieve the symptoms of multiple sclerosis, an incurable neurological disease affecting more than 300,000 Americans. After the deaths of two MS patients taking Tysabri, Biogen Idec Inc. and its partner, Elan, had taken the drug off pharmacy shelves in February 2005. Its removal was met with frustration from MS patients, including those on LI, where there are 7,000 confirmed cases. "There was a lot of disappointment when it came off the market," says Pamela Mastrota, president and CEO of the Long Island chapter of the National Multiple Sclerosis Society. Tysabri (pronounced Tie-SAH-bree) reduced the number of flare-ups of MS in patients with relapsing forms of the disease, which can cause blurry vision and slurred speech, tremors, numbness, paralysis and blindness. The drug, taken by intravenous injection every four weeks, keeps inflammatory cells from entering the brain. In two separate clinical trials at Stony Brook University Hospital in 2003, about 15 to 20 patients were treated with the drug. Researchers were encouraged by the results. "The drug was very well-tolerated," says Stony Brook neurologist Dr. Patricia K. Coyle. "And the patients did very well." Then in November 2004, the U.S. Food and Drug Administration (FDA) initially approved the drug for clinical trials in patients with MS, Crohn's disease and rheumatoid arthritis. But three patients out of the 3,000 participants nationwide developed progressive multifocal leukoencephalopathy (PML), a rare brain infection. PML is commonly associated with diseases such as cancer and AIDS. Two of the patients with PML died. The manufacturer withdrew Tysabri in February 2005, the same month the FDA put trials of the drug on hold. A year later, the FDA approved resumption of a clinical trial of the drug, and in March, dozens of MS patients testified at an FDA hearing on Tysabri. The drug will be back on the market in July, but with a mandatory registration and monitoring program for patients and their doctors. Tysabri will also carry a "black box" warning describing the types of risks associated with the drug. "It can be effective, but it needs to be monitored properly," says Mastrota. "We need to be aware of both the benefits and the potential risks." According to Biogen's website, patients are instructed to take Tysabri only after finding limited success with other MS treatments. One patient, 48-year-old James Blog of Huntington, was in the process of receiving the drug when it was pulled off shelves in February 2004. Blog, a New York City accountant, has had a mild case of MS for 15 years. Blog began taking Tysabri in October 2003 as dual therapy with Avonex, another MS drug. He was a part of the clinical trial at Stony Brook Hospital and felt the treatment was effective. "I was feeling good," he says. While Blog's diagnosis may not be as serious, he sometimes experiences relapses which cause disorientation, stiff legs and a lack of coordination. During his last episode, which happened six months after discontinuing Tysabri and Avonex, he needed steroids to help him bounce back. The decision to take or switch to Tysabri hinges on the opinion of the patient's neurologist. In July, Blog will be meeting with his neurologist at Stony Brook to determine if his future will include Tysabri. Speaking from experience, he hopes he's a candidate. "It works great," Blog says. "But in three weeks, I'll know if I can get back on it. I would trust my doctor."

08:41 Thursday June 29th 2006
Irish pharmaceutical company Elan is receiving the go-ahead to put its Multiple Sclerosis drug Tysabri back on the market.

The European Commission gave the company permission to release the drug following a recommendation from the European Medicines Agency.

The breakthrough medicine was taken off the market last year following the deaths of two patients, involved in trials of the drug, from a rare brain condition.

US officials cleared Tysabri for use in America earlier this month.

http://www.unison.ie/breakingnews/index.php3?ca=35&si=94106&printer=1

Multiple Sclerosis drug Tysabri will be back on shelves

Unison.ie - Bray,Ireland
Irish pharmaceutical company Elan is receiving the go-ahead to put its Multiple Sclerosis drug Tysabri back on the market. The European ...
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Biogen Idec (BIIB) and Elan (ELN) Said TYSABRI Receives Approval ...
StreetInsider.com (subscription) - Birmingham,MI,USA
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) said they have received approval from the European Commission to market TYSABRI as a treatment ...

Tysabri Triumphs
LongIslandPress.com - NY,USA
After the deaths of two MS patients taking Tysabri, Biogen Idec Inc. and its partner, Elan, had taken the drug off pharmacy shelves in February 2005. ...
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Elan's recovery continues as EU approves Tysabri
MarketWatch - USA
... PLC's (ELN) multiple sclerosis drug Tysabri Thursday received long-awaited approval from the European Commission as a therapy for highly active relapsing ...
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Elan's Tysabri EU Ruling Good News - Davy
newratings.com - USA
0748 GMT [Dow Jones] The EU approval of Elan's (ELN) Tysabri is "very good news, with the drug on track as per guidance," says Davy Stockbrokers. ...

By Stephanie Regina June 28, 2006

LI Chapter Hopeful, Cautious
The multiple sclerosis drug Tysabri, which has for the most part been a successful treatment for individuals who suffer from the disease, is expected to be made available next month despite the fact that it was pulled from the market last year after causing two fatalities. With some 7,000 people on Long Island who live with MS, President of the Long Island Chapter of the National Multiple Sclerosis Society Pamela Mastrota believes the return of Tysabri is good news.

“The Multiple Sclerosis Society is dedicated to providing choices,” she said, “and we’re pleased to give people another option to consider.” Locally, Stony Brook University Hospital participated in part of the study of the drug Tysabri.

Currently there are five drugs available for the treatment of MS, but Tysabri may be an option for individuals who do not find other drugs to be particularly effective. Because MS is not curable, individuals with the disease can receive treatments only to help control their symptoms. Symptoms vary from person to person and change over time, so that no particular treatment is considered most effective.

The FDA approved the drug after two clinical trials, which showed that in most individuals Tysabri delays the accumulation of physical disability and reduces the frequency of relapses in those with relapsing MS, according to documents from the National MS Society. During the trials, however, three patients out of 3,000 developed progressive multifocal leukoencephalopathy, or PML, which is caused by a virus and killed two of the three people who developed it while on Tysabri.

As one of the conditions for reintroducing Tysabri to the public, the drug will carry a “black box” warning on the label making users aware of the serious risks involved, according to the National MS Society. The drug will also include detailed protocol and be heavily restricted. Treatments will only be administered in clinics that have registered infusion centers where patients can receive the drug intravenously once a month. Those using the drug will be monitored closely and will not be permitted to use it in conjunction with any other MS drug.

Mastrota strongly suggests that those who consider using Tysabri discuss it extensively with their doctors before beginning the treatment. “That black box warning is a serious warning, which is why we strongly encourage patients to speak with their neurologists before making choices,” Mastrota said. “Everyone is different and it’s up to the individual to read patient materials and make careful decisions.”

James Blog of Huntington, who has had MS for 15 years, was part of the third phase of clinical trials. He received Tysabri treatments once a month for 18 months at Stony Brook University Hospital in combination with another MS drug called Avonex. He said he was virtually symptom-free while using Tysabri and believes people will benefit from its return. However, he’s not sure whether or not he’ll go back to using Tysabri himself.

“It’ll be a monotherapy, so I’ll have to talk to my neurologist before deciding,” he said. “The MS hasn’t disabled me much, so I have a choice whether or not to take the risk. But if I couldn’t walk very well, this would probably be a great thing.”

“We’re really thrilled that there’s another option,” Mastrota said, “but we can’t emphasize enough that people need to get educated, talk to their neurologist, and then make a decision.”

When the list of registered infusion centers for Tysabri becomes official, it will be available, along with other information about Tysabri, at the Long Island Chapter of the MS Society’s website at www.nationalmssociety.org.

http://www.zwire.com/site/news.cfm?newsid=16857237&BRD=1776&PAG=461&dept_id=6365&rfi=6

©Suffolk Life Newspapers 2006

Multiple Sclerosis Association Of America Receives The Berlex Award For The Best Poster In Patient And Family Education
Medical News Today Wed, 28 Jun 2006 0:05 AM PDT
Honored for the posterpresentation, "A Needs Assessment Survey of MS Patients and Care Partners,"the Multiple Sclerosis Association of America (MSAA) received the BerlexAward for the Best Poster in Patient and Family Education in MultipleSclerosis, at the 20th Annual Meeting of the Consortium of MultipleSclerosis Centers (CMSC) in Scottsdale, Arizona, June 1st - 3rd. [click link for full article]

http://www.biogenidec.com/site/TYSABRI-PI-MedGuide.pdf

Tysabri to cost well over $2,000 a vial

Athlone Advertiser - Athlone,Co. Westmeath,Ireland
Elan said this week that it anticipated its controversial MS wonder drug Tysabri would be available to patients in July following the the decision by the US ...

MS Drug Tysabri Approved By FDA
Suffolk Life Newspapers - Riverhead,NY,USA
The multiple sclerosis drug Tysabri, which has for the most part been a successful treatment for individuals who suffer from the disease, is expected to be ...

Susman, Ed

Ed Susman is a health and science journalist who contributes to WebMD, United Press International and other medical wire services.

<>Clay Walker took the pick in his right hand and started to strum his guitar as he warmed up backstage for his concert. The pick fell to the floor. He retrieved it and tried to play. Again it fell out of his hand. I'd drop the pick every time I went to strum, he recalls. I couldn't hold it with my two fingers, because I could not feel it.

Confused and concerned, Walker nevertheless took the stage that night to entertain thousands of fans - strumming the guitar with his fingers rather than a pick and trying not to fall as he had several times earlier in a basketball game with his band. I'm very active on stage, moving around a lot, dancing, having a good time, he says. But that night in the Seattle Dome, I could only stand still. I was afraid if I took a step, I'd fall over.

Just 26 years old then, Walker was on top of the world as well as the country charts. He had a 3-month-old daughter. He had a loving wife. He had a rising career as a singing sensation. He had it all.

He also had numbness, double vision, weakness on the right side of his body - and worsening symptoms. I got home and the facial spasms started from the top of my head to the bottom of my chin, and it lasted for eight weeks, 24-7, he recalls. I rubbed my eyes so much I developed blisters on them. I couldn't see out of my right eye as the blisters grew. My wife finally called a neurosurgeon and made an appointment. I said, 'Why?' She said, 'Because there's something wrong with you. This spasm is going on in the middle of the night, and I'm concerned you may have a tumor.'

It wasn't a tumor - it was multiple sclerosis (MS). I didn't know what MS was, he says. I thought it was worse than it was. Hearing the words, 'You have MS,' is like someone telling you, 'You have cancer.'

And worse: The neurosurgeon, who was neither a neurologist nor an MS specialist, told him he'd be dead within eight years.

Ten years after that death sentence, Clay Walker is still going strong as one of country music's top headliners.

He's had 11 platinum records. He's had 11 Number One singles. He's been churning out a hit CD per year since 1993, selling more than eight million albums. And he performs his dynamic stage show 200 nights each year, playing to sellout crowds that exceed 60,000 and placing among the Top Ten country acts in box office gross.

For all his accomplishments, though, his music career was hardly a concern that day he was diagnosed.

My only negative reaction when I found out I had multiple sclerosis was that I might not be able to walk my daughter down the aisle, says Walker, who now has two young daughters to inspire him. Being able to do that is very important to me. I think of that quite often, and that is my goal.

Warming up for yet another concert a decade later, this time at the American Academy of Neurology Foundation's 2005 Gala, Walker eagerly discusses the disease that's always just offstage in his life. I appreciate every show more than I used to, he says, because I know it could all be taken from me.

Preparing to take the stage in Miami, he smiles easily from beneath his black cowboy hat because it's been fully five years and a thousand concerts since his last MS attack. He still has weakness in his right leg, but it's noticeable only to neurologists and only after extreme exercise and fatigue.

<>His stressful career - songwriting, recording, touring, performing - would appear to raise the risk for frequent MS attacks. And indeed his stress level was never higher than when he was diagnosed with relapsing-remitting MS, the disease form with unpredictable relapses during which new symptoms appear or existing symptoms worsen. That was the most stressful week of my life, he says. There were tragedies in my family. My brother-in-law was killed in a violent motorcycle accident. There were a lot of things going on, a lot of career demands. I was not sleeping properly or eating properly and my body was like a piece of shoe leather. I was just worn out. At 26 years old, I felt like 50. Looking back, I'm sure the stress brought out the multiple sclerosis.

Now at 36, he works hard at managing stress to help manage his MS. I don't sweat the small stuff anymore, he says. It takes a lot to rock my world, and I can shut down if I feel like I'm getting really stressed out. It's self-discipline you learn from having this. Once you know you have your life, then nothing else really matters. Now I ask myself, 'Is this a life-or-death situation?' And if it's not, then I can get through it. MS has slowed me down, but my career is skyrocketing. It slowed me down to take things in.

Chief among those, of course, are his wife, Lori, and their two daughters. His family inspires him to treat the disease with medication, a healthy diet and an active lifestyle that ranges from horseback riding to running on the beach with his daughters. He considers that a responsibility, because it would be hurting your loved ones to know you're not doing everything you can. So not only does the needle-phobic star take a daily glatiramer acetate (Copaxone) injection, but his wife and his daughters actually give him the shot.

Turning his private struggle into a public fight against the disease three years ago, Walker formed a foundation called Band Against MS. Its mission is raising awareness about MS and raising money for research and programs. MS has been the biggest blessing of my life, he says. It's given me a true purpose - a chance to give people hope.

The same kind of hope and help he needed upon his 1996 diagnosis. Someone brought me literature on MS and the description was terrible, he recalls. After reading all these debilitating symptoms and what I had to look forward to with this chronic disease, I thought, 'Oh my gosh.' That's why it's so important to get a neurologist who's an MS specialist.

Since his diagnosis, he's had just one other MS attack. That was the one five years ago, when he felt more weakness in his right leg than usual and a subsequent magnetic resonance imaging (MRI) scan revealed bright spots indicating brain lesions associated with MS progression. And it has not kept him from continuing to lead his life and career without missing a beat.

My right hand that could not hold a guitar pick, or a fishing rod and reel, got stronger than my left hand - and I'm left-handed! he says, smiling. I smiled a long time after that. They say you can't regain strength, and yet I did.

Walker feels blessed to continue to be so healthy. And sometimes he'll actually feel guilty because I know not everyone diagnosed with MS is that lucky.

The people I admire the most are those who are debilitated the most from this disease and who continue to be wishful and hopeful we can find a cure, he says. It takes a lot to conquer this disease. I don't think conquering it means curing it - I think it means not letting it break your spirits. The spirit is what keeps us going, and I think the spirit is what we need to find a cure for this.

Sounds like the inspiration for another Clay Walker lyric.

For more information about MS, see RESOURCE CENTRAL on page 46.

http://www.neurologynow.com/pt/re/neuronow/fulltext.01222928-200602010-00008.htm;jsessionid=GjnGTyvYbL9gcSpHCbNhmxFFz25tlp2TxDnMsL3ppgmghq5jph8p!-1243080020!-949856145!8091!-1?&fullimage=true

I had a call in the afternoon from the doctor’s assistant/nurse and she said it will probably be a few more months until they approve tysabri in Canada and then they need more time to set it up and for the trillium provincial insurance program which pays for it to approve it. It may take another 9 months, who knows.

'You've got to find what you love,' Jobs says This is the text of the Commencement address by Steve Jobs, CEO of Apple Computer and of Pixar Animation Studios, delivered on June 12, 2005.
I am honored to be with you today at your commencement from one of the finest universities in the world. I never graduated from college. Truth be told, this is the closest I've ever gotten to a college graduation.

Today I want to tell you three stories from my life. That's it. No big deal. Just three stories.

The first story is about connecting the dots. I dropped out of Reed College after the first 6 months, but then stayed around as a drop-in for another 18 months or so before I really quit. So why did I drop out? It started before I was born. My biological mother was a young, unwed college graduate student, and she decided to put me up for adoption. She felt very strongly that I should be adopted by college graduates, so everything was all set for me to be adopted at birth by a lawyer and his wife. Except that when I popped out they decided at the last minute that they really wanted a girl. So my parents, who were on a waiting list, got a call in the middle of the night asking: "We have an unexpected baby boy; do you want him?" They said: "Of course." My biological mother later found out that my mother had never graduated from college and that my father had never graduated from high school. She refused to sign the final adoption papers. She only relented a few months later when my parents promised that I would someday go to college.

And 17 years later I did go to college. But I naively chose a college that was almost as expensive as Stanford, and all of my working-class parents' savings were being spent on my college tuition. After six months, I couldn't see the value in it. I had no idea what I wanted to do with my life and no idea how college was going to help me figure it out. And here I was spending all of the money my parents had saved their entire life. So I decided to drop out and trust that it would all work out OK. It was pretty scary at the time, but looking back it was one of the best decisions I ever made. The minute I dropped out I could stop taking the required classes that didn't interest me, and begin dropping in on the ones that looked interesting. It wasn't all romantic. I didn't have a dorm room, so I slept on the floor in friends' rooms, I returned coke bottles for the 5¢ deposits to buy food with, and I would walk the 7 miles across town every Sunday night to get one good meal a week at the Hare Krishna temple. I loved it. And much of what I stumbled into by following my curiosity and intuition turned out to be priceless later on.

Let me give you one example: Reed College at that time offered perhaps the best calligraphy instruction in the country. Throughout the campus every poster, every label on every drawer, was beautifully hand calligraphed. Because I had dropped out and didn't have to take the normal classes, I decided to take a calligraphy class to learn how to do this. I learned about serif and san serif typefaces, about varying the amount of space between different letter combinations, about what makes great typography great. It was beautiful, historical, artistically subtle in a way that science can't capture, and I found it fascinating. None of this had even a hope of any practical application in my life. But ten years later, when we were designing the first Macintosh computer, it all came back to me. And we designed it all into the Mac. It was the first computer with beautiful typography. If I had never dropped in on that single course in college, the Mac would have never had multiple typefaces or proportionally spaced fonts. And since Windows just copied the Mac, its likely that no personal computer would have them.

If I had never dropped out, I would have never dropped in on this calligraphy class, and personal computers might not have the wonderful typography that they do. Of course it was impossible to connect the dots looking forward when I was in college. But it was very, very clear looking backwards ten years later. Again, you can't connect the dots looking forward; you can only connect them looking backwards. So you have to trust that the dots will somehow connect in your future. You have to trust in something - your gut, destiny, life, karma, whatever. This approach has never let me down, and it has made all the difference in my life.

My second story is about love and loss. I was lucky – I found what I loved to do early in life. Woz and I started Apple in my parents garage when I was 20. We worked hard, and in 10 years Apple had grown from just the two of us in a garage into a $2 billion company with over 4000 employees. We had just released our finest creation - the Macintosh - a year earlier, and I had just turned 30. And then I got fired. How can you get fired from a company you started? Well, as Apple grew we hired someone who I thought was very talented to run the company with me, and for the first year or so things went well. But then our visions of the future began to diverge and eventually we had a falling out. When we did, our Board of Directors sided with him. So at 30 I was out. And very publicly out. What had been the focus of my entire adult life was gone, and it was devastating.

I really didn't know what to do for a few months. I felt that I had let the previous generation of entrepreneurs down - that I had dropped the baton as it was being passed to me. I met with David Packard and Bob Noyce and tried to apologize for screwing up so badly. I was a very public failure, and I even thought about running away from the valley. But something slowly began to dawn on me – I still loved what I did. The turn of events at Apple had not changed that one bit. I had been rejected, but I was still in love. And so I decided to start over.

I didn't see it then, but it turned out that getting fired from Apple was the best thing that could have ever happened to me. The heaviness of being successful was replaced by the lightness of being a beginner again, less sure about everything. It freed me to enter one of the most creative periods of my life.

During the next five years, I started a company named NeXT, another company named Pixar, and fell in love with an amazing woman who would become my wife. Pixar went on to create the worlds first computer animated feature film, Toy Story, and is now the most successful animation studio in the world. In a remarkable turn of events, Apple bought NeXT, I retuned to Apple, and the technology we developed at NeXT is at the heart of Apple's current renaissance. And Laurene and I have a wonderful family together. I'm pretty sure none of this would have happened if I hadn't been fired from Apple. It was awful tasting medicine, but I guess the patient needed it. Sometimes life hits you in the head with a brick. Don't lose faith. I'm convinced that the only thing that kept me going was that I loved what I did.

You've got to find what you love. And that is as true for your work as it is for your lovers. Your work is going to fill a large part of your life, and the only way to be truly satisfied is to do what you believe is great work. And the only way to do great work is to love what you do. If you haven't found it yet, keep looking. Don't settle. As with all matters of the heart, you'll know when you find it. And, like any great relationship, it just gets better and better as the years roll on. So keep looking until you find it. Don't settle.

My third story is about death. When I was 17, I read a quote that went something like: "If you live each day as if it was your last, someday you'll most certainly be right." It made an impression on me, and since then, for the past 33 years, I have looked in the mirror every morning and asked myself: "If today were the last day of my life, would I want to do what I am about to do today?" And whenever the answer has been "No" for too many days in a row, I know I need to change something.

Remembering that I'll be dead soon is the most important tool I've ever encountered to help me make the big choices in life. Because almost everything – all external expectations, all pride, all fear of embarrassment or failure - these things just fall away in the face of death, leaving only what is truly important. Remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose. You are already naked. There is no reason not to follow your heart.

About a year ago I was diagnosed with cancer. I had a scan at 7:30 in the morning, and it clearly showed a tumor on my pancreas. I didn't even know what a pancreas was. The doctors told me this was almost certainly a type of cancer that is incurable, and that I should expect to live no longer than three to six months. My doctor advised me to go home and get my affairs in order, which is doctor's code for prepare to die.

It means to try to tell your kids everything you thought you'd have the next 10 years to tell them in just a few months. It means to make sure everything is buttoned up so that it will be as easy as possible for your family. It means to say your goodbyes. I lived with that diagnosis all day. Later that evening I had a biopsy, where they stuck an endoscope down my throat, through my stomach and into my intestines, put a needle into my pancreas and got a few cells from the tumor.

I was sedated, but my wife, who was there, told me that when they viewed the cells under a microscope the doctors started crying because it turned out to be a very rare form of pancreatic cancer that is curable with surgery. I had the surgery and I'm fine now. This was the closest I've been to facing death, and I hope its the closest I get for a few more decades. Having lived through it, I can now say this to you with a bit more certainty than when death was a useful but purely intellectual concept: No one wants to die. Even people who want to go to heaven don't want to die to get there. And yet death is the destination we all share. No one has ever escaped it. And that is as it should be, because Death is very likely the single best invention of Life. It is Life's change agent. It clears out the old to make way for the new. Right now the new is you, but someday not too long from now, you will gradually become the old and be cleared away.

Sorry to be so dramatic, but it is quite true. Your time is limited, so don't waste it living someone else's life. Don't be trapped by dogma - which is living with the results of other people's thinking. Don't let the noise of other's opinions drown out your own inner voice. And most important, have the courage to follow your heart and intuition. They somehow already know what you truly want to become. Everything else is secondary.

When I was young, there was an amazing publication called The Whole Earth Catalog, which was one of the bibles of my generation. It was created by a fellow named Stewart Brand not far from here in Menlo Park, and he brought it to life with his poetic touch.

This was in the late 1960's, before personal computers and desktop publishing, so it was all made with typewriters, scissors, and polaroid cameras. It was sort of like Google in paperback form, 35 years before Google came along: it was idealistic, and overflowing with neat tools and great notions. Stewart and his team put out several issues of The Whole Earth Catalog, and then when it had run its course, they put out a final issue. It was the mid-1970s, and I was your age.

On the back cover of their final issue was a photograph of an early morning country road, the kind you might find yourself hitchhiking on if you were so adventurous. Beneath it were the words: "Stay Hungry. Stay Foolish." It was their farewell message as they signed off. Stay Hungry. Stay Foolish. And I have always wished that for myself. And now, as you graduate to begin anew, I wish that for you. Stay Hungry. Stay Foolish. Thank you all very much.

Medical Research News
Published: Monday, 26-Jun-2006

http://www.news-medical.net/?id=18553

In a dramatic display of stem cells' potential for healing, a team of Johns Hopkins scientists reports that they've engineered new, completed, fully-working motor neuron circuits - neurons stretching from spinal cord to target muscles - in paralyzed adult animals.

The research, in which mouse embryonic stem (ES) cells were injected into rats whose virus-damaged spinal cords model nerve disease, shows that such cells can be made to re-trace complex pathways of nerve development long shut off in adult mammals, the researchers say.

"This is proof of the principle that we can recapture what happens in early stages of motor neuron development and use that to repair damaged nervous systems," says Douglas Kerr, M.D., Ph.D., a neurologist who led the Hopkins team.

"It's a remarkable advance that can help us understand how stem cells can begin to fulfill their great promise," says Elias A. Zerhouni, director of the National Institutes of Health."Demonstrating restoration of function is an important step forward, though we still have a great distance to go."

The researchers created what amounts to a cookbook recipe to restore lost nerve function, Kerr explains. The approach could one day repair damage from such diseases as ALS (Lou Gehrig's disease), multiple sclerosis or transverse myelitis or from traumatic spinal cord injury, the researchers say. "With small adjustments keyed to differences in nervous system targets," Kerr says, "the approach may also apply to patients with Parkinson's or Huntington's disease."

In a report on the study, to be released online June 26 in the Annals of Neurology, the Hopkins team says 11 of the 15 treated rats gained significant, though partial, recovery from paralysis after losing motor neurons to an aggressive infection with Sindbis virus -- one that, in rodents, specifically targets motor neurons and kills them. The animals recovered enough muscle strength to bear weight and step with the previously paralyzed hind leg.

Kerr likens the approach to electrical repair. "Paralysis is like turning on a light switch and the light doesn't go on. The connectivity is messed up but you don't know where. We've asked stem cells to go where needed to fix the circuit."

For a brief period after a nerve dies, it leaves behind what's essentially an empty shell, with some scaffolding and non-nerve substances remaining. But with ES injections at the right time and place, and by adding the right cues, we've learned to restore the biological 'memory' for growing neurons, which is clearly still in place," he added.

The motor circuit engineering combines recent discoveries on stem cell differentiation, a growing understanding of early development of the nervous system, and insights into behavior of the nervous system in traumatic injury, Kerr notes.

"As adults, our cells no longer respond to early developmental cues because those cues are usually gone," says Kerr. "That's why we don't recover well from severe injuries. But that's what we believe we have changed. We asked what was there when motor neurons were born, and specifically what let motor neurons extend outward. Then we tried to bring that environment back, in the presence of adaptable, receptive stem cells."

In the study, Kerr's team first pre-treated cultures of mouse embryonic stem cells with growth factors that both increase survival and prompt specialization into motor neurons. Adding retinoic acid and sonic hedgehog protein -- agents that direct cells in the first weeks of life to assume the proper places in the spinal cord -- readied the conditioned ES cells for the motor neuron circuit that starts in the spinal cord. Then, stem cells were fed into the paralyzed rats' spinal cords.

Extending new motor neurons in an adult nervous system, however, meant overcoming hurdles. One involved myelin, the fatty material that insulates mature motor neurons. Like the coating on electrical wire, myelin prevents weakening of the traveling electrical impulse and lets it continue long distances. In humans, the myelinated sciatic nerve, for example, exits the spinal cord and extends to the leg muscles it activates, carrying impulses several feet.

Once laid down, however, myelin inhibits further nerve growth -- nature's way to discourage excessive wiring in the nervous system. "We had to overcome inhibition from myelin lingering in the dead nerve pathways," Kerr explains. Two recently-developed agents, rolipram and dbcAMP enabled that.

The assorted treatments let the new motor neurons survive, grow through the spinal cord and extend slightly into the outlying nervous system. A second hurdle remained in getting the neurons to skeletal muscle targets.

As suggested by earlier work by team member Ahmet Hoke on repair in the outlying, peripheral nervous system, the researchers applied GDNF, a powerful stimulator of neuron growth, to the remains of the newly-dead sciatic nerve at a point near its former leg muscle contacts. GDNF attracted the extending motor neurons, "luring" them to the muscles. To ensure a continuous supply of GDNF, the researchers relied on injected fetal mouse neural stem cells, a known source of the molecule.

Of some 4,100 new motor neurons created in the spinal cord, roughly 200 exited the cord and 120 reached skeletal muscle, forming typical nerve-muscle junctions, with appropriate, typical chemical markers. Microscopically, the neurons and their muscle associations appear identical to natural ones in healthy animals.

Fifty of the new neurons were found to carry electrical impulses. (Because such testing is time and labor intensive, only a small area of leg muscle was assayed. The improved ability of treated rats, however, suggests more functional neurons are likely.) The rats gained weight, were more mobile in their cages and measures of muscle strength increased. Animals treated without even one component of the "cocktail" experienced no such recovery. Novel ways of tracing the neurons back to their source assured the scientists that they indeed had come from the injected stem cells, not from lingering host neurons.

Research begins this summer to see how well the technique applies to human nerve recovery, using federally-approved human ES cells in larger mammals like pigs, Kerr says. Each of six academic institutions in a new collaboration will tackle a different major question of safety and effectiveness. Questions of tumor-formation, often a concern with ES cells, of the safety of surgery and of the ES cells' ability to form healthy motor circuits are major questions to answer. Several years of testing and thorough data evaluation would occur before applying to the FDA to approve human clinical trials. The study was supported by Families of SMA, Andrew's Buddies/Fight SMA, the ALS Association and The Robert Packard Center for ALS Research at Johns Hopkins, the Muscular Dystrophy Association, Wings Over Wall Street, and a grant from the NIH.

Kerr is a grantee of The Packard Center for ALS Research at Johns Hopkins. He also directs Project RESTORE, a Hopkins-based undertaking to advance therapies for transverse myelitis and multiple sclerosis.

Others on the research team from the Department of Neurology at the Johns Hopkins University School of Medicine include Jeffrey Rothstein, M.D., Ph.D.; Ahmet Hoke, M.D., Ph.D.; Nicholas Maragakis, M.D.; Yun Sook Kim, Ph.D.; Sonny Dike, M.D.; Deepa Deshpande, M.S.; Chitra Krishnan, M.S., and Jennifer Drummond. Researchers from the Department of Molecular Microbiology and Immunology at the Johns Hopkins University Bloomberg School of Public Health include Jessica Carmen, Tara Martinez and Irina Shats. Jeremy Shefner, M.D., Ph.D., of the Department of Neurology at the State University of New York Upstate Medical University, Syracuse, N.Y., also contributed to the study.

http://www.jhmi.edu

Article:
She is her father's daughter. Rain Pryor came to Connecticut to talk about growing up with the late comedian Richard Pryor. She did it to raise awareness about multiple sclerosis.

by News Channel 8's Jocelyn Maminta
His humor was raw and real, but Richard Pryor's fight against Multiple Sclerosis took him away from the spotlight.

"My mission really is to raise awareness about living with someone who had Multiple Sclerosis," Rain said.

Rain is the middle child of the comic's seven children. Richard Pryor died last December, but she draws strength in knowing there's a sense of purpose.

"I asked him, I said do you want me to still go out there and talk, and he said yes. My dad was always about truth."

And the truth rain says is her father was a loving and generous man.

"You see, like, oh, the drugs, the alcohol and the comedy, the women, because there were lots of them (laughs), but what you don't see is there's a real person underneath that. There was a loving father. He wasn't a great dad, but he was the only dad we had. We love him anyway regardless of his flaws."

Now she's crisscrossing the country to raise money for research and a cure for MS.

"If we can't find a cure right now at least create some sort of medication and treatment for people who have progressive forms of MS like my father."

Rain Pryor is herself an accomplished performer. She was in New Haven Friday as the keynote speaker at a national Multiple Sclerosis Society luncheon.

She is writing a book about her father. Look for that sometime in the fall.
Source: http://www.wtnh.com/Global/story.asp?S=5072019&nav=3YeX

Research
http://www.msanswers.ca/QuestionView.aspx?L=2&QID=8

Dr. Antel

Clinical neurologist, Montreal Neurological Institute, QC View BIO

Q :
Is there any stem cell research taking place in multiple sclerosis?
A :
“Stem cells” can be broadly defined as cells which retain the potential to develop into mature cell types. These can be classified into two major categories:
Ø cells that retain the capacity to develop into any cell type (“pleuripotential stem cells”)
Ø cells that can only develop into nervous system cells (“neural progenitor cells”).

The rationale for research into the role of “stem cells” in the process of remyelination in multiple sclerosis (MS) includes:

• examination of MS tissues and magnetic resonance based studies of MS patients indicate that some remyelination does occur.

• Studies in rodents demonstrate that the extensive remyelination that can follow demyelination induced by viruses, toxins, or immune mediated mechanisms is mediated by “stem cells” rather than by oligodendrocytes that produced the initial myelin and were then damaged.

• Analyses of adult human brain tissues indicate that “neural progenitor cells” exist in the normal adult brain and around MS lesions.

Current “stem cell” research focuses either on inducing such cells present in the nervous system (endogenous cells) to become myelinating cells or providing new sources of such cells (exogenous cells). As regards endogenous cells, challenges faced include providing necessary signals that will induce “stem ‘cells” to become myelin forming cells. Studies of development of oligodendrocytes in immature animals and of “stem cells” maintained in tissue culture are helping identify factors (molecules) that are critical to direct the process. An active question is whether “stem cells” in the mature nervous system, will respond to such signals. Remyelination in MS may also be limited by molecules that inhibit entry of “stem cells” into lesions and their subsequent differentiation into myelinating cells.

As regards provision of exogenous “stem cells”, challenges being faced include what is to be the source of such cells. The prototype pleuripotential cell capable of becoming any cell type is the embryonic stem cell derived from the newly fertilized ovum.

“Stem cells” found in the blood or bone marrow can readily be expanded into large numbers and used clinically to re-constitute populate the immune system. Some of these cells can migrate to the nervous system following transfusion into the blood but have only a limited if any capacity to become nervous system cells.

Experimental studies in animals show that neural progenitor cells isolated from the nervous system, can successfully mediate myelination when transplanted into the nervous system of animals who lack myelin due to genetic defects or whose myelin has been damaged by disease. When such cells are administered into the blood, some access the nervous system but relatively few become actively myelinating cells. They may however provide molecules or signals that support the function of progenitor cells already resident in the nervous system. Whether “neural progenitor cells” can be isolated and expanded from non nervous system sources (eg skin) remains under study; if derived from the individual for whom they would be used, the problem of immune rejection, faced if another individual provides the cells, would be by-passed.

http://www.msanswers.ca/?L=2

http://tinyurl.com/z4cye

http://www.prweb.com/releases/2005/11/prweb307888.htm

Olszowka was diagnosed with lung cancer on New Year's Eve, 2002. The prognosis was very grim: her disease had advanced to Stage four and was inoperable. Though Olszowka was told she had months to live, she decided she was going to fight the disease, and ultimately found her way to cancer specialist, Keith Block, MD, where she received chronotherapy as part of her treatment plan. Today, she is doing very well and enjoying her two children and six grandchildren.

EVANSTON, IL (PRWEB) November 8, 2005 -- Margaret Olszowka was diagnosed with lung cancer on New Year's Eve, 2002. The prognosis was very grim: her disease had advanced to Stage 4 and was inoperable. Doctors at a very well known university hospital told her there was nothing they could do for her. They didn't even offer chemotherapy as an option; she was told she had months to live. However, instead of giving up, she decided she was going to fight the disease, and ultimately found her way to cancer specialist, Keith Block, MD, where she received chronotherapy as part of her treatment plan. Today, she is doing very well and enjoying her two children and six grandchildren. She wants the world to know about the role chronotherapy played in her survival in the hopes of helping other cancer patients.

What is chronotherapy? Chronotherapy takes into account how our body's natural rhythms' impact our ability to process medications. Patterns like sleeping, menstrual cycles, even our physical response to the changing seasons, are different for everyone. In the old days we called these biorhythms. Today, doctors are finding that understanding a patient’s biorhythms, and coordinating the timing of their medical treatments to these biorhythms, can profoundly affect the outcome of their treatments. This is called "chronotherapy."

“Every drug has an optimal time when it is least toxic and most effective," says Keith Block, MD, editor-in-chief of the peer-reviewed journal Integrative Cancer Therapies, and Clinical Professor, Department of Medical Education, at the University of Illinois College of Medicine at Chicago (UIC), and at the Department of Pharmacology. For cancer treatment, this is determined by several factors, including the biological uniqueness of the particular drug being given, the time when the specific type of cancer cells divide the most, when the normal healthy cells of the patient generally divide the least, the patient’s circadian clock and individual rest-activity cycles, and even the time zone the person resides in."

According to Dr. Michael Smolensky, co-author of the book The Body Clock Guide to Better Health, "When cancer medications are given in a chronobiological manner, patients may be able to tolerate higher, more potent doses than would be possible otherwise."

“This method of administering chemotherapy is revolutionary and has demonstrated in large randomized trials its potential to improve survival,” states Dr. Block. ”We have found that often patients receiving chronotherapy reduce what would have been recurring side effects of nausea, vomiting, diarrhea, and fatigue. This is important because the debilitation caused by chemo can cause patients to reduce or even stop treatments that could otherwise help them win their battle with cancer.”

Chronotherapy is being widely researched around the world: There are over 62,000 references in PubMed (the National Institute of Health’s archive of biomedical and life sciences journal articles) about chronobiology (how biology is affected by timing) and over 500 scientific articles specifically about chronotherapy. The National Cancer Institute's Office of Cancer Complementary and Alternative Medicine (OCCAM) devoted an entire web cast for doctors on chronotherapy.

So why isn’t chronotherapy used more widely? One of the main problems has been logistics – figuring out how to deliver chemotherapy in exactly timed doses. “Portable infusion pumps may hold the answer,” explains Gerald Sokol, MD, an oncologist with the division of oncology in FDA's Center for Drug Evaluation and Research.

Dr. Block has brought technology to the U.S. that administers chemotherapy via a pump designed to precisely time up to four channels of infusion simultaneously to the individual needs of a patient. Highly portable and small enough to fit in a fanny pack, patients are able to maintain full mobility, play sports, and enjoy a full night's sleep – while receiving their specifically timed cancer therapy.


About the Block Center for Integrative Cancer Care and Optimal Health:

The Block Center for Integrative Cancer Care and Optimal Health, located in Evanston, Illinois, was founded in 1980 by Penny and Keith Block, M.D. with a focus on treating the patient as a whole person, not treating just the diagnosis or symptoms. The Center's research-based treatment integrates an innovative approach to the best of conventional medicine with scientifically sound complementary therapies -- therapeutic nutrition, botanical and phytonutrient supplementation, prescriptive exercise, and systematic mind-body strategies -- to enhance the recovery process. Block has pioneered this "middle ground" approach to cancer care and optimal health – designing a total treatment plan that is tailored to the precise needs of each patient, using a unique set of clinical and laboratory assessments. The Block Center is breaking new ground with the creation and development of Cancer Rehab as an innovative treatment modality, and is currently the only private North American medical center using chronomodulated chemotherapy. Dr .Block was recently appointed to the US National Institutes of Health’s PDQ Cancer Complementary and Alternative Medicine (CAM) Editorial Board in Bethesda, MD. While the Block Center is a full treatment clinic, it is involved in collaborative research with university facilities in the United States and Israel (www.blockmd.com).

Tysabri: What the New FDA Approval Means to You Broadcast on: June 22, 2006 Listen to the replay! Tysabri has been approved by the FDA for re-release for use in patients with relapsing-remitting MS. What does this mean for you? Experts will be discussing the recall and the re-approval, the benefits and safety of the drug, the risk management plan to be put into place at re-launch, and other information you need to know about this medication. One man’s Tysabri experience This HealthTalk program is sponsored through an educational grant from MS ActiveSource. Howard Rossman, D.O., F.A.C.N. Karen Blitz-Shabbir, M.D. Trevis Gleason, HealthTalk host http://www.healthtalk.com/multiplesclerosis/programs/10_542/index.cfm

San Diego, California - April 6, 2006 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that in Phase III multiple sclerosis (MS) studies TYSABRI® (natalizumab) showed significant effects on pre-specified health-related quality of life (QoL) measures, in addition to those previously reported on disability progression, relapse rate and MRI. Data presented this week at the annual meeting of the American Academy of Neurology in San Diego, CA also showed a significant impact on additional pre-specified measures of disability progression, including visual and cognitive function.

"MS is a debilitating disease that significantly reduces the quality of patients' lives by causing symptoms like fatigue, pain, and diminished emotional well-being. We have never before observed positive findings on our quality of life measures in a Phase III MS study. The TYSABRI study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, who presented the QoL findings at the AAN meeting.

TYSABRI Shows Improvement in Quality of Life Assessments

In the two Phase III TYSABRI clinical trials, AFFIRM and SENTINEL, QoL was assessed using three different measures, the Multiple Sclerosis Quality of Life Inventory (MSQLI), the Short Form-36 Health Survey (SF-36), which is a component of the MSQLI, and a Visual Analogue Scale (VAS). The MSQLI is an MS-specific battery of 10 scales that measure disease impact on QoL including, fatigue, pain, sexual function, bowel and bladder function, visual impairment, mental health and need for social support. SF-36 is comprised of 36 questions designed to assess patients' physical and mental well-being. General well-being was also measured using the VAS.

In the AFFIRM monotherapy study, patients in the TYSABRI-treated group realized a significant improvement in physical measures of the SF-36 compared with a decline in the placebo-treated group (p=0.003). A significant improvement was also seen in the mental component of the SF-36 in patients treated with TYSABRI compared with a decline in the placebo-group (p=0.011). Significant benefits were also seen using the VAS (p=0.007). Improvements on quality of life measures were also observed in the SENTINEL study, in which TYSABRI was added to AVONEX® (Interferon beta-1a).

TYSABRI Impacts Measures of Visual Function

In another analysis of the AFFIRM and SENTINEL data, patients treated with TYSABRI had a reduction in the risk of visual decline as measured by contrast testing compared to control. Loss of visual function is one of the most common causes of disability and lower QoL in MS patients. Low contrast letter acuity was a pre-specified endpoint in both studies. Recent studies have demonstrated that low contrast letter acuity (perception of light gray letters of progressively smaller size on a white background) is a more sensitive measure of visual dysfunction in MS than traditional measures.

TYSABRI Impacts Measures of Disability Progression

The primary efficacy endpoint of AFFIRM and SENTINEL at two years was the rate of disability progression sustained for three months as measured by the Expanded Disability Status Scale (EDSS). Additional measures of disability included the Multiple Sclerosis Functional Composite (MSFC), which consists of three tests that evaluate ambulation, upper extremity dexterity and cognitive function.

In AFFIRM, treatment with TYSABRI led to a 42% reduction in the risk of disability progression compared to placebo (p=0.0002). TYSABRI was also associated with significant delay in progressing to EDSS of 4.0 (ambulatory with moderate disability) and 6.0 (requiring a cane, crutch or brace). TYSABRI treatment also had a significant impact on all subscales of the MSFC, including the Paced Auditory Serial Addition Test (PASAT), a measure of cognitive function (p=0.005).

TYSABRI Phase III Safety

Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system has been reported in patients receiving TYSABRI. PML occurred in two MS patients who had received TYSABRI with AVONEX and in one Crohn's disease patient who had recently received an immunosuppressant. In placebo-controlled trials of TYSABRI in MS, the incidence and rate of other serious infections were balanced between TYSABRI-treated patients and controls. Serious infections reported in TYSABRI-treated patients included pneumonia, urinary tract infection and appendicitis. The overall incidence and rate of common infections were also balanced between treatment groups. Commonly reported infections included upper respiratory tract infections, influenza, urinary tract infections, and gastroenteritis. Herpes infections were slightly more common in patients treated with TYSABRI. The incidence and rate of other serious and common adverse events in clinical trials were similarly balanced between treatment groups. Serious events that occurred in TYSABRI-treated patients included hypersensitivity reactions, including systemic reactions, depression, and cholelithiasis. Common adverse events reported include infusion reactions, headache, fatigue, and arthralgia.

Biogen Idec and Elan had previously voluntarily suspended TYSABRI from the U.S. market and dosing in all ongoing clinical trials based on reports of PML. Biogen Idec and Elan completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.

On March 8, 2006, the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously to recommend reintroduction of TYSABRI as a treatment for relapsing forms of MS. The companies anticipate action by the Agency regarding the reintroduction for TYSABRI in the U.S. on or before June 28, 2006. The companies' application for approval of TYSABRI as a treatment for MS is also under review with the European Medicines Agency.

On March 29, 2006, the companies announced they have enrolled and dosed the first patients in the TYSABRI monotherapy safety extension study program in MS. Patients who previously participated in the Phase III MS trials and subsequent safety evaluation are eligible to be screened for entry in this open label multi-center study. Sites throughout Europe, the United States, Canada, Australia, New Zealand and Israel are expected to enroll patients.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding the potential and regulatory path forward of TYSABRI. The commercial potential and regulatory path forward of TYSABRI are subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may unable to adequately address concerns or questions raised by FDA or European regulatory authorities during the regulatory review process, that concerns may arise from additional data or analysis, or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to resume marketing and sales of TYSABRI. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information contact:

MEDIA CONTACTS:

Biogen Idec
Amy Brockelman
Ph: 617 914 6524

Elan
Davia B. Temin
Ph: 212 407 5740

Elizabeth Headon
353-1-498-0300

INVESTOR CONTACTS:

Biogen Idec
Oscar Velastegui
Ph: 617 679 2812

Elan
Emer Reynolds
Ph: 353 1 709 4000

Chris Burns
800 252 3526

http://www.biogenidec.com/site/019_0.html?pr_id=../news/BiogenIDECPR_123.htm

Celera Genomics saw its share price take a small hike yesterday after inking a deal with Schering AG - soon to be merged with Bayer - for its cathepsin S inhibitor programme in autoimmune disease. It comes with potential milestones worth up to $360 million and double-digit royalties, on top of a $5 million upfront payment, half of which will be paid now and the remainder after the rights are transferred, which is forecast to be in the next four months.

Multiple sclerosis is likely to be the first indication. Schering already markets the top-selling MS drug Betaferon/Betaseron (interferon beta-1b), which saw sales jump 23% during the first quarter of the year to 232 million euros, but has been looking to strengthen its portfolio in this area.

Celera's cathepsin S inhibitor - code-named CRA-028129 - entered the clinic in September 2005 and is currently being investigated in a Phase I study in New Zealand. It will join Schering's ongoing study of high-dose interferon beta-1b treatment and the leukaemia therapy Campath (alemtuzumab), which is currently in Phase II development in MS.

Last year, the company was forced to halt dosing in a Phase II study of Campath in MS after a patient died of a serious bleeding disorder. But Schering also reported that Campath had shown excellent efficacy, cutting the relapse rate in patients with MS by 75% compared to the comparator drug, Serono's blockbuster Rebif (interferon beta-1a). Campath is given just once a year, while Rebif is given three times a week.
http://www.pharmatimes.com/news/9099-Celera-Schering-AG.aspx?src=PharmaTimes&fr=1

Wednesday, June 21, 2006
By John Tunison
The Grand Rapids Press

ALLEGAN -- A truck driver's debilitating multiple sclerosis could prevent him from serving any jail time for causing a fiery crash that killed a 22-year-old Saugatuck woman, a judge said.

David Gale -- described as disoriented and essentially bedridden -- was found incompetent to be sentenced Tuesday.

Allegan County prosecutors said the ruling, based on a psychologist's opinion from the state's Center for Forensic Psychiatry, could end a case that began two years ago when Gale's tractor-trailer slammed into an Allegan County sheriff deputy's cruiser and a car the deputy pulled over for speeding.

Emily Van Dyke's father, James, this morning said he was upset the prosecution of Gale took so long, robbing the family of emotional relief that a sentencing might provide.

"He'll get what he deserves in the long run, but there still will not be any closure until he is sentenced for the crime he committed," he said.

VanDyke said it is difficult to understand how Gale could be competent to plead no contest, but not for sentencing.

Assistant Prosecutor Margaret Bakker acknowledged the family was unhappy with the resolution.

"It's been a horrific case for them," she said.

The case dragged on because of difficulties obtaining medical records and because of legal complications in his home state of Ohio and a parole violation in Wisconsin.

Emily Van Dyke, an Alma College graduate ready to start teaching at a North Carolina elementary school, died in the June 23, 2004, crash on Int. 196 near Saugatuck. Gale admitted falling asleep at the wheel.

Gale, 44, who suffers from progressive multiple sclerosis that made him prone to sudden bouts of fatigue and blackouts, pleaded no contest in January to vehicular manslaughter. The Ohio Bureau of Motor Vehicles later determined he lied about his condition and should not have received a commercial driver's license.

Gale came down with pneumonia in the Allegan County Jail while awaiting sentencing in February and was hospitalized in a coma.

He never sufficiently recovered forsentencing, a hearing that requires the same level of competency as someone going to trial. He now is at a Kalamazoo medical center.

Allegan County Circuit Judge George Corsiglia released Gale on a personal recognizance bond Tuesday so he could be transferred to a medical facility near his home in Ada, Ohio. The release removes any county liability for his long-term care. His Medicare coverage is to lapse July 8.

"I have absolutely no evidence to lead me to conclude that he is going to recover," Corsiglia said. "Everything this court has personally observed is that he has deteriorated progressively from the first time I saw him to the last time."

If Gale shows signs of recovery, state law allows for him to be sentenced up to one year after his plea.

Psychologist Dr. Jeffrey Wendt recently examined Gale and, in a June 9 report, described him as having an early condition of possible dementia and the onset of encephalopathy, a brain disease that causes an altered mental state.

Wendt wrote that Gale suffers from progressive memory loss, lethargy, loss of consciousness and confusion that impair his ability to understand others.

Gale's attorney, Mike McEwen, said Gale is bedridden and required a feeding tube at one point. He has only rudimentary communication skills.

"When I last spoke with him, he had no recollection as to who I was," he said.

Send e-mail to the author: jtunison@grpress.com



©2006 Grand Rapids Press
© 2006 Michigan Live. All Rights Reserved.

http://www.mlive.com/news/grpress/index.ssf?/base/news-30/1150895712228540.xml&coll=6

By JUDY HOBSON, Daily Mail 08:17am 20th June 2006

The umblical cord contains potentially lifesaving blood cells

Blood cells from your baby's umbilical cord can be stored to fight deadly diseases such as leukaemia and sickle cell. So why is it so hard to find a hospital that will do it? JUDY HOBSON investigates:

Claudia Harrison is expecting her second child this week. She has multiple sclerosis, and would like the stem cells from her newborn's umbilical cord so they can be used in the for treatment against any serious illnesses.

But there is little chance of that happening on the NHS, and she had to battle to persuade the authorities to allow her to do it privately.

Case study
• I feared taking cord blood from my son was wrong

Stem cells are the building blocks of life — they can turn into different types of tissue in the body and are used to treat conditions that would otherwise need bone marrow transplants.

Such cells taken from umbilical cord blood — in a five to ten-minute procedure immediately after the baby is born — can be used to treat diseases such as leukaemia, anaemia, sickle cell and thalassaemia. Some experts even say they could eventually be used to help Parkinson's, Alzheimer's and MS.

Last week, it was announced that the Department of Health is to invest £4.2million in a 'bank' of cord blood stem cells, providing hope for families with genetic diseases. But it has since emerged that this £4.2million is not extra money, but simply the normal funding for the scheme for the next two years. And for couples such as the Harrisons, the scheme offers little or no hope.

This is because the NHS collects cord stem cells just for families with a high risk of a genetic disorder, such as sickle cell disease — and only then if their doctor considers it appropriate.

So far, 200 at-risk families have stored blood samples on the NHS. Of these, only 13 have been used to help treat a family member.

The NHS cord blood bank also takes altruistic donations — similar to when people give blood — but this is possible only at three hospitals in the London area: Northwick Park, Barnet General and Luton & Dunstable NHS Trusts.

Treating life-threatening diseases

The NHS cord blood bank has around 10,000 donations — most of the cord blood from the 600,000-plus births each year is disposed of, despite the fact new research has shown its value in treating life-threatening diseases.

Professor Colin McGuckin, professor of regenerative medicine at Newcastle University, is working on using umbilical cord stem cells to repair heart tissue.

"Our research shows that cord blood has amazing capacity to develop into a wide range of human tissues, including blood, blood vessels, liver and nerves," he says.

"It could not only have a huge impact on treating human disease, but also provide human tissue for drug development and testing, removing the uncertainty of whether new medications will have side-effects."

His team is the first in the world to produce embryonic-like cells from cord blood, and is developing a range of treatments for liver complaints that could be in use in five years.

Professor McGuckin believes prospective parents should be encouraged to bank their baby's cord blood, ideally for the general good through a public bank. But there are not the facilities nationally to make this possible.

He sees nothing wrong if parents use a private bank "as long as it is properly run and accredited".

Some experts say the likelihood of a child needing their own stem cells is one in 20,000, but a Dutch study shows that over the course of a lifetime, the chances of a person requiring a transplant from their own cells is one in 400.

As for the question of whether these cells can be stored and remain useful, a study by the Indiana University School of Medicine found cord blood stem cells could be retrieved after at least 15 years.

An estimated 11,000 parents in Britain have paid to have stem cells taken from their baby's cord blood and frozen for possible future use — the ballerina Darcey Bussell and footballer Thierry Henry reportedly among them— even though, in many cases, there is no known risk of disease to their children. Globally, the figure is around a million.

Private cord stem cell banking is not cheap. Future Health Technologies in Nottingham — the only private bank in Britain accredited by the regulatory body, the Human Tissue Authority — charges £1,250 for processing plus £300 to store cells for 20 years.

But even if parents can afford to bank stem cells, they can face difficulty arranging to have it done.

Claudia Harrison, 33, a former financial consultant, first heard about cord blood stem cells when doing her own research into multiple sclerosis.

She asked her MS consultant about having her baby's cells removed and stored, but was told this would be considered only if she had leukaemia. Then the head of midwifery and the clinical director at her maternity hospital, the Princess of Wales, Bridgend, told her it was not hospital policy.

Her MP Madeleine Moon raised the issue in the Commons in March, and a few weeks ago Mrs Harrison received an e-mail from the deputy head of midwifery at the Princess of Wales to say she could pay to have her own private nurse extract and collect the blood.

"There doesn't seem to have been a change in hospital policy — I think it's only because I've been noisy," says Mrs Harrison.

So, when she goes into hospital to have her baby, her husband Neil will have to contact an agency nurse to come to the delivery room to extract the cord blood immediately after the birth.

Neil will also have to arrange for a courier to collect the sample and transport it to the private bank. Mrs Harrison's case is not unusual. The Royal College of Obstetricians & Gynaecologists has recently warned of the 'considerable logistical burden' on 'already over-stretched staff ', with collection of the blood being carried out during a particularly risky time for mother and baby.

George Macridis, the managing director of Future Health Technologies, estimates that fewer than one in three hospitals are allowing new parents to bank cord blood stem cells privately.

'An insurance policy'

However, in the public sector, the situation is slowly improving. The NHS cord blood bank — set up in 1996 and run by the National Blood Service — is considering establishing other hospitals as collection sites.

"As these treatments increase, the NHS will become more involved and the service enabling the banking of such cells will be expanded," says Rakesh Vasishtha, the bank's communications manager.

"We want to have a broader spectrum of tissue types on our register so we can provide an equal chance of treatment to everyone who needs it."

Such aims are laudable, but critics claim this is not enough. "Storage and processing is expensive, so it is understandable the NHS's public banking service is limited," says Mr Macridis.

"But many US states not only inform but encourage parents to consider banking. Here, the vast majority of parents get little or no advice from healthcare professionals and have no idea how useful the blood could be."

As Claudia Harrison says: "It is an insurance policy for me and my children. Every woman should have the right to that."

http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article_id=391545&in_page_id=1774&in_a_source=&ito=1490

The approach could one day repair damage from such diseases as ALS (Lou Gehrig’s disease), multiple sclerosis or transverse myelitis or from traumatic spinal cord injury, the researchers say. "With small adjustments keyed to differences in nervous system targets," Kerr says, "the approach may also apply to patients with Parkinson’s or Huntington’s disease."
http://www.webwire.com/ViewPressRel.asp?aId=15475

By LAURAN NEERGAARD AP Medical Writer

WASHINGTON Jun 20, 2006 (AP)— Scientists have used stem cells and a soup of nerve-friendly chemicals to not just bridge a damaged spinal cord but actually regrow the circuitry needed to move a muscle, helping partially paralyzed rats walk.

Years of additional research is needed before such an experiment could be attempted in people.

But the work marks a tantalizing new step in stem cell research that promises to one day help repair damage from nerve-destroying illnesses such as Lou Gehrig's disease, or from spinal cord injuries.

"This is an important first step, but it really is a first step, a proof of principle that … you can rewire part of the nervous system," said Dr. Douglas Kerr, a neurologist at Johns Hopkins University who led the work being published Monday in the journal Annals of Neurology.

Perhaps most importantly, the experiment illustrates that if stem cells eventually live up to their promise, treatment won't be simple they can't just be injected into a diseased body and repair it on their own.

Instead, the new research details a complex recipe of growth factors and other chemicals that entice the delicate cells to form correctly and make the right connections. Miss a single ingredient, and the cells wander aimlessly, unable to reach the muscle and make it move.

The study may bring "the appropriate tempering of expectations of stem cells," said Kerr, considered a leader in the field. "Some of my patients say, 'Oh, I'm going to pull into the stem-cell station and get my infusion of stem cells,' and it's never going to be that."

Stem cells are building blocks that turn into different types of tissue. Embryonic stem cells in particular have made headlines, as scientists attempt to harness them to regenerate damaged organs or other body parts. They're essentially a blank slate, able to turn into any tissue given the right biochemical instructions. But human embryonic stem cell research is politically controversial, because culling the cells destroys embryos.

The Hopkins experiment isn't the first to use stem cells to help paralyzed rodents move. But previous work bridged damage inside the spinal cord that blocked nerve cells from delivering their "move" messages to muscles, sort of like fixing the circuit that brings electricity to a fan.

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The new work essentially installs new wiring: replacing motor neurons specialized nerve cells for movement that have died to make a new circuit that grows neuronal connections out of the spinal cord and down to a leg muscle.

"They did something that people have been trying to do for at least 30 years and literally hit a brick wall until now," said Dr. Naomi Keitman of the National Institutes of Health's neurology division, which partly funded the work along with patient advocacy groups.

First, Kerr mixed embryonic stem cells from mice with chemicals that caused them to turn into motor neurons. He transplanted them into the spinal cords of partially paralyzed rats.

Some rats received neurons treated with substances to boost their survival chances.

Even if the fledgling motor neurons lived, insulation called myelin on surrounding nerve cells would inhibit their growth. So some rats also received injections of chemicals, including an antidepressant called rolipram, thought to neutralize myelin's antigrowth effect.

Still others were injected with a growth factor called GDNF near the leg muscle, as a signpost to direct the new neurons to form connections there.

Only the group of rats that got every extra ingredient improved, Kerr found. The paralysis wasn't completely gone, but six months after treatment, 11 of the 15 animals could bear weight, take steps and push away with the affected leg.

Of the roughly 4,000 new motor neurons generated in the rats' spinal cords, about 120 reached the muscle, and 50 were electrically active, further testing showed.

The next step, to start this summer: Redoing the experiment in pigs, to see if new neurons can be enticed to grow connections over the longer distances needed to reach from a pig's spinal cord to its leg.

On the Net:

NIH stem cell info: http://stemcells.nih.gov/index.asp
http://abcnews.go.com/Technology/wireStory?id=2099763