Monday, December 18, 2006

Soy-Based Inhibitor Holds Promise as MS Treatment





Dec 15, 2006 - 1:23:59 PM

Natural substance reduced nervous system inflammation in animal study


FRIDAY, Dec. 15 (HealthDay News) -- A natural soy-based substance called Bowmann-Birk Inhibitor Concentrate (BBIC) improved the condition of animals with a disease similar to multiple sclerosis, a U.S. study says.

One group of animals with the MS-like disease called autoimmune encephalomyelitis (EAE) received BBIC, while another group of animals with the same disease received an inert substance.

"Animals that received BBIC were able to walk, while those that didn't get the drug were not," study leader Dr. A.M. Rostami, professor and chair of the department of neurology at Jefferson Medical College in Philadelphia, said in a prepared statement.

The animals that received BBIC weren't cured of their illness and did walk with some limp or weakness. However, the results are promising, the researchers said.

They also found that the central nervous systems of the animals that received BBIC had "significantly less inflammation and demyelination" than animals that didn't receive BBIC.

"It's the first time that BBIC has been used in an EAE model and has shown significant disease suppression, and we hope it can eventually be used in humans," Rostami said.

BBIC inhibits proteases, which are enzymes that play a major role in the inflammation and demyelination associated with multiple sclerosis, in which the myelin coating of nerve fibers become inflamed and scarred.

The study was published Dec. 12 in the journal Multiple Sclerosis.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.

-- Robert Preidt

SOURCE: Jefferson Medical College, news release, Dec. 12, 2006

Last Updated: Dec. 15, 2006

Copyright © 2006 ScoutNews, LLC. All rights reserved.

Institute seeks MS patients for drug trials





Bradenton Herald - Dec. 16, 2006

If you or someone you know has the relapsing/remitting form of multiple sclerosis, grab your scissors and clip this article or e-mail it to your friend or relative.

The Roskamp Institute in Sarasota is screening potential candidates for a research study on an experimental MS drug called fingolimod that has shown promise in earlier clinical trials. It was developed by Novartis.

What makes fingolimod so exciting is the fact that this is a once-a-day capsule, said Dr. Richard Mullan, Roskamp's director.

Currently the only treatment option available for this type of MS is a drug that must be given by injection, Mullan said.

The fingolimod study, which is part of the FDA approval process, is designed to determine the effectiveness and safety of the drug. fingolimod appears to help relapsing/remitting MS patients by causing white blood cells to move away from areas of inflammation and retreat to the lymph system, thereby lessening the symptoms.

The white cells known as T-cells are responsible for immune reactions that characterize MS, Mullan said.

And it's here - the trigger that causes the white cells to retreat - where one finds the connection that links one of the nation's leading research institutes in Alzheimer's disease with research on multiple sclerosis.

Roskamp scientists have found that patients with Alzheimer's disease and patients with MS have the same marker on their T-cells.

This marker appears to act as a switch, directing the T-cells' response, said Mullan.

In the case of Alzheimer's it triggers a decrease in T-cells. That leads to a build-up of a sticky substance, a protein called beta amyloid, in the brain. The build-up causes major damage to neurons, Mullan said.

In MS patients, the marker appears to cause the T-cells to aggressively attack the body.

It's this very research in how that marker works to influence the T-cell that has Roskamp scientists excited, said Dr. Andrew Keegan, an investigator in the clinical trials division participating in the fingolimod study.

Results so far in European clinical studies are promising.

Data recently presented at the 15th European Neurological Society in Vienna showed that fingolimod reduced the rate of clinical relapses by more than 50 percent and inflammatory disease activity as measured by magnetic resonance imaging by up to 80 percent over six months compared to a placebo, according to the Novartis' Web site.

Benefits were seen as soon as after two months of treatment and continued to increase over the six-month treatment period, Novartis said.

The drug appeared to be well-tolerated by trial participants, according to Novartis.

Roskamp's commitment to finding cures to neurodegenerative disorders has put the Sarasota institute in the forefront of the latest research.

The fingolimod study will have three groups of participants. One group will get a moderate dose of the experimental drug, the second group will get a lower dose and the third group will be given a placebo, Mullan said.

For more information, contact the Roskamp Institute at 256-8018 or visit the center's Web site at www.RoskampInstitute.com. For more information on Novartis and fingolimod, check out www.novartisclinicaltrials.com.

Donna Wright, health and social services reporter, can be reached at 745-7049 or at dwright@HeraldToday.com.

Fingolimod clinical trials

The Roskamp Institute of Sarasota is recruiting participants for clinical trials of fingolimod, a new oral medication developed by Novartis that may offer a new treatment option in the future.

Eligibility requirements:

18-55 years of age

Diagnosed relapsing-remitting multiple sclerosis

Ambulatory (some assisted devices allowed)

Medically stable

Have had one relapse in past year or two relapse over last two years

Not currently on medication

Be able to participate in local medical exams

About multiple sclerosis

MS is a chronic, progressive, potentially disabling disorder of the central nervous system affecting young people in the prime of their lives.

MS is the leading cause of neurological disability in young adults and is twice as common in women as it is in men.

MS is usually diagnosed between the ages of 20 and 40.

The relapsing-remitting course is the most common form of the disease.

About 50 percent of patients advance to the secondary progressive (SPMS) form of the disease within 10 years.

Source: Roskamp Institute and Novartis

Health Scan: Study shows treatment should begin with first MS attack





Dec. 16, 2006 21:03 | Updated Dec. 17, 2006 13:24

By JUDY SIEGEL-ITZKOVICH

Neurologists almost always wait until a second attack of symptoms before diagnosing multiple sclerosis - the potentially severe and incurable autoimmune disease in which the myelin coating of the nerves in the central nervous system is attacked by the body. Only then do they try to treat it with Copaxone or various types of interferon injections to slow the frequency of attacks and reduce their severity.

The fewer the attacks - which can involve a tingling of the extremities, muscle weakness or paralysis, blurred vision, tics, slurred speech, vertigo and swallowing problems, among others - the less the accumulated disability, thus delaying attacks and minimizing their long-term effects.

New research, however, indicates a need to take action with the first symptoms, says Prof. Mark Freedman, a senior neurologist at the University of Ottawa and head of the MS research division at the Ottawa Hospital General Campus.

Freedman, who was born in Toronto but speaks near-fluent Hebrew after studying at the Weizmann Institute as well as in London and Montreal, was in Israel recently to present this new research at a meeting of the Israel Society for Neuroimmunology.

The published clinical trial examined the results of treating patients with initial symptoms and whose MS was confirmed by magnetic resonance imaging. Some of the patients received interferon beta (Betaferon of Schering Pharmaceuticals) injections immediately, while others waited for subsequent attacks.

"Confirmed patients should be started on the drugs immediately; if you wait for the second attack, they don't work as well," Freedman told The Jerusalem Post. All patients are going to be studied for at least five years.

The two-year study showed that early intervention is effective in delaying attacks and reducing their severity. When the medication is injected every other day, patients were half as likely to develop the full-fledged disease.

"It is not a cure, but it could push disability far into the future," said Freedman, who urged neurologists to take a proactive approach.

"Using clinical criteria and MRI, we can know in 85% to 90% of patients when it is MS. It is not wise to wait for therapy, even though the drugs are expensive."

Early intervention, he said, would probably work for Teva's Copaxone and Biogen's Avonex or Serono's Rebif (both interferon beta 1-a), and not only for Schering's Betaferon (interferon beta 1-b). Preliminary studies have already been started abroad on interferon beta 1-a and Copaxone, he said.

Some researchers are giving MS patients two or more kinds of medications simultaneously, as this may have a synergistic effect, he said.

Freedman is quite hopeful there will eventually be a cure for MS.

"We in the field have made substantial progress in the past two decades, and new agents are being developed. Stem cells could someday be used to heal the myelin or cause regeneration."

Vanderbilt mixes alternative with conventional to heal





Monday, 12/18/06

Center's opening signals growth of integrative approach

By JOY BUCHANAN
Staff Writer

Glowing candlelight softly illuminates the doctor's exam room, where the only sound is the muted tick of a small clock.

Andrea Wheeler lies on a padded table with her eyes closed.

Dr. Dainia Baugh circles her hand over Wheeler's head without touching her. Then she forms circles over her chest and stomach before sweeping a hand from the top of Wheeler's head to her feet and flicking her fingers as if she's shaking off crumbs.

Baugh completes the Reiki treatment, used to move energy through the body.

Not a typical medical setting, not a typical visit to the doctor. Baugh, owner of Nima Holistic Wellness in Nashville, is one of a handful of local doctors who combine unconventional therapies with Western medicine, such as drugs and surgery, in an approach called integrative medicine.

The recent opening of the Center for Integrative Health at Vanderbilt University Medical Center may signal growing acceptance of the approach.

Internet-savvy patients and people desperate for relief that Western medicine hasn't provided are asking for different therapies than doctors typically offer — but they still want the expertise and credibility of an M.D.

Wheeler came to Baugh because she was dissatisfied with the typical doctor visit.

"It felt all physical. They never really asked how I was doing," she said. "They're going to give you a medicine and tell you what to do. I was looking for more."

Wheeler wasn't sick when she came to Baugh, but she said the Reiki treatment helps her feel more alert and energized. She's also lost 20 pounds.

While a traditional doctor may prescribe medication for high blood pressure, an integrative physician probably will ask about diet, exercise, stress and family life. Such doctors often perform lab tests and take a complete medical history to develop a medical plan.

For advocates of integrative medicine, neither conventional medicine nor complementary therapies are enough on their own.
"I think our approach to alternative medicine is a little different because it's more scientific," Baugh said.
Studied therapies used

Complementary and alternative medicine, also known as CAM, includes diverse medical practices and products not part of conventional medicine. Therapies used alone are often referred to as alternative. When used in tandem with conventional medicine, they're considered complementary.

But integrative medicine is different from complementary because a team of practitioners works with a patient and, typically, a doctor monitors the patient's progress. The other critical factor is evidence.

Advocates of integrative medicine mostly use therapies proved to be safe and effective by scientifically valid studies, though they also may use treatments that are being studied if the methods show benefits for patients.

Integrated medicine is the focus of the new Vanderbilt center, which employs an acupuncturist, two yoga instructors and four massage therapists, among others.

Dr. Roy Elam is the center's medical director and lone doctor, and he believes the integrated approach fills a gap in medicine when people are not helped by conventional means.

"The system works great if you sail through it and everything works and you feel great," he said.

"But if you're one of those patients who are struggling and the procedures and the medications are not helping, you get lost. There's no place for you to go."

More adopt approach

The approach is catching on nationally. The American Hospital Association reported that the number of hospitals offering these therapies has risen from 7.7 percent in 1998 to 18.3 percent in 2005.

The most popular therapies offered on an outpatient basis are massage, tai chi, qigong, relaxation training and yoga.

According to the Association of American Medical Colleges, 78 percent of schools require students to take a complementary medicine course compared with 21 percent in 2001. Vanderbilt offers such classes, but Meharry Medical College does not.

Yang Guo is a third-year med ical student at Meharry interested in integrative medicine. "I like the whole philosophy to be able to heal people with as many options as possible," she said.

She acknowledges that someone who's been in a car wreck or is having a heart attack needs surgery and drugs, not herbs, but integrative medicine is about prevention and maintenance, not life-and-death intervention.

"If we want people to accept this, we have to go out and make them see that this is not just some other type of medicine," Guo said. "It's a way of life."

Patients drive trend

While some doctors gravitate toward integrative health care, the trend is largely driven by patient demand.

About 87 percent of the nation's hospitals that offer complementary therapy do it because patients ask for it, according to the American Hospital Association.

Dr. Stephen Reisman owns Mind-Body Medical Center in Nashville. Patients come to him because they want to take fewer prescriptions or because years of medicine, surgery and testing haven't cured their illness or made them feel better.
Tabb Loveless, 39, of Columbia was a skeptic.

"I would have told you, 'Don't go see some goon who's going to give you some herbal tea to drink and, voila, you're better.' "
He came to Reisman in desperation. Nearly two years ago, he was diagnosed with multiple sclerosis, a debilitating disease of the nervous system.

The diagnosis shocked Loveless. He immediately began steroid therapy and special injections he'd have to continue for life, but his symptoms didn't improve.

"It got to where I could hardly walk," he said. "The last straw came when I went to the mailbox but got so tired that I sat down on the lawn for 20 minutes. I couldn't go back to the house."

His own research pointed to Lyme disease, but his doctors dismissed it. Finally, Loveless took a friend's suggestion to see Reisman. The doctor also suspected Lyme, and a lab test confirmed it.

Reisman prescribed antibiotics, a five-day fast and detox on little more than juice and supplements to rid his body of the steroids and injections. Loveless has improved dramatically, with just occasional tingling in his legs. More recent medical tests have ruled out MS.

"I'm convinced now that the mind-body connection is strong," he said.

Skeptics abound

Despite growing interest in integrative therapies, skeptics abound.

"I think skepticism is good in medicine," said Dr. Donna Seger, medical director of the Tennessee Poison Control Center.

"You don't want to dismiss therapies that may prove beneficial to patients, but you want a physician to be skeptical, too, so they don't adopt therapies that are unproven and may not be safe."

Seger said people should always check with their primary care doctor before using any supplement, procedure or therapy.
"We don't have surgeons doing surgeries without the proper certifications or surgery that isn't up to the standard of care," she said. "We shouldn't have physicians doing therapies that aren't scientifically sound either."

Baugh doesn't disagree. She said people may feel better using a method that isn't proved to work, and that's fine, so long as they don't quit a proven therapy.

Trust matters

Integrative-medicine doctors who are trusted by patients are often trusted by doctors, too. Most of Baugh's patients initially came from recommendations and word of mouth. In the past year, many of her patients are coming from other, more traditional doctors whom she has sent patients to for acute or advanced care.

Elam said most of the integrated health center's patients come from other Vanderbilt doctors.

"We don't see ourselves as providing services as an alternative to traditional medicine," he said. "When research documents that this works and the outcomes are positive, then this is the way medicine will go."

Vanderbilt mixes alternative with conventional to heal





Monday, 12/18/06

Center's opening signals growth of integrative approach

By JOY BUCHANAN
Staff Writer

Glowing candlelight softly illuminates the doctor's exam room, where the only sound is the muted tick of a small clock.

Andrea Wheeler lies on a padded table with her eyes closed.

Dr. Dainia Baugh circles her hand over Wheeler's head without touching her. Then she forms circles over her chest and stomach before sweeping a hand from the top of Wheeler's head to her feet and flicking her fingers as if she's shaking off crumbs.

Baugh completes the Reiki treatment, used to move energy through the body.

Not a typical medical setting, not a typical visit to the doctor. Baugh, owner of Nima Holistic Wellness in Nashville, is one of a handful of local doctors who combine unconventional therapies with Western medicine, such as drugs and surgery, in an approach called integrative medicine.

The recent opening of the Center for Integrative Health at Vanderbilt University Medical Center may signal growing acceptance of the approach.

Internet-savvy patients and people desperate for relief that Western medicine hasn't provided are asking for different therapies than doctors typically offer — but they still want the expertise and credibility of an M.D.

Wheeler came to Baugh because she was dissatisfied with the typical doctor visit.

"It felt all physical. They never really asked how I was doing," she said. "They're going to give you a medicine and tell you what to do. I was looking for more."

Wheeler wasn't sick when she came to Baugh, but she said the Reiki treatment helps her feel more alert and energized. She's also lost 20 pounds.

While a traditional doctor may prescribe medication for high blood pressure, an integrative physician probably will ask about diet, exercise, stress and family life. Such doctors often perform lab tests and take a complete medical history to develop a medical plan.

For advocates of integrative medicine, neither conventional medicine nor complementary therapies are enough on their own.
"I think our approach to alternative medicine is a little different because it's more scientific," Baugh said.
Studied therapies used

Complementary and alternative medicine, also known as CAM, includes diverse medical practices and products not part of conventional medicine. Therapies used alone are often referred to as alternative. When used in tandem with conventional medicine, they're considered complementary.

But integrative medicine is different from complementary because a team of practitioners works with a patient and, typically, a doctor monitors the patient's progress. The other critical factor is evidence.

Advocates of integrative medicine mostly use therapies proved to be safe and effective by scientifically valid studies, though they also may use treatments that are being studied if the methods show benefits for patients.

Integrated medicine is the focus of the new Vanderbilt center, which employs an acupuncturist, two yoga instructors and four massage therapists, among others.

Dr. Roy Elam is the center's medical director and lone doctor, and he believes the integrated approach fills a gap in medicine when people are not helped by conventional means.

"The system works great if you sail through it and everything works and you feel great," he said.

"But if you're one of those patients who are struggling and the procedures and the medications are not helping, you get lost. There's no place for you to go."

More adopt approach

The approach is catching on nationally. The American Hospital Association reported that the number of hospitals offering these therapies has risen from 7.7 percent in 1998 to 18.3 percent in 2005.

The most popular therapies offered on an outpatient basis are massage, tai chi, qigong, relaxation training and yoga.

According to the Association of American Medical Colleges, 78 percent of schools require students to take a complementary medicine course compared with 21 percent in 2001. Vanderbilt offers such classes, but Meharry Medical College does not.

Yang Guo is a third-year med ical student at Meharry interested in integrative medicine. "I like the whole philosophy to be able to heal people with as many options as possible," she said.

She acknowledges that someone who's been in a car wreck or is having a heart attack needs surgery and drugs, not herbs, but integrative medicine is about prevention and maintenance, not life-and-death intervention.

"If we want people to accept this, we have to go out and make them see that this is not just some other type of medicine," Guo said. "It's a way of life."

Patients drive trend

While some doctors gravitate toward integrative health care, the trend is largely driven by patient demand.

About 87 percent of the nation's hospitals that offer complementary therapy do it because patients ask for it, according to the American Hospital Association.

Dr. Stephen Reisman owns Mind-Body Medical Center in Nashville. Patients come to him because they want to take fewer prescriptions or because years of medicine, surgery and testing haven't cured their illness or made them feel better.
Tabb Loveless, 39, of Columbia was a skeptic.

"I would have told you, 'Don't go see some goon who's going to give you some herbal tea to drink and, voila, you're better.' "
He came to Reisman in desperation. Nearly two years ago, he was diagnosed with multiple sclerosis, a debilitating disease of the nervous system.

The diagnosis shocked Loveless. He immediately began steroid therapy and special injections he'd have to continue for life, but his symptoms didn't improve.

"It got to where I could hardly walk," he said. "The last straw came when I went to the mailbox but got so tired that I sat down on the lawn for 20 minutes. I couldn't go back to the house."

His own research pointed to Lyme disease, but his doctors dismissed it. Finally, Loveless took a friend's suggestion to see Reisman. The doctor also suspected Lyme, and a lab test confirmed it.

Reisman prescribed antibiotics, a five-day fast and detox on little more than juice and supplements to rid his body of the steroids and injections. Loveless has improved dramatically, with just occasional tingling in his legs. More recent medical tests have ruled out MS.

"I'm convinced now that the mind-body connection is strong," he said.

Skeptics abound

Despite growing interest in integrative therapies, skeptics abound.

"I think skepticism is good in medicine," said Dr. Donna Seger, medical director of the Tennessee Poison Control Center.

"You don't want to dismiss therapies that may prove beneficial to patients, but you want a physician to be skeptical, too, so they don't adopt therapies that are unproven and may not be safe."

Seger said people should always check with their primary care doctor before using any supplement, procedure or therapy.
"We don't have surgeons doing surgeries without the proper certifications or surgery that isn't up to the standard of care," she said. "We shouldn't have physicians doing therapies that aren't scientifically sound either."

Baugh doesn't disagree. She said people may feel better using a method that isn't proved to work, and that's fine, so long as they don't quit a proven therapy.

Trust matters

Integrative-medicine doctors who are trusted by patients are often trusted by doctors, too. Most of Baugh's patients initially came from recommendations and word of mouth. In the past year, many of her patients are coming from other, more traditional doctors whom she has sent patients to for acute or advanced care.

Elam said most of the integrated health center's patients come from other Vanderbilt doctors.

"We don't see ourselves as providing services as an alternative to traditional medicine," he said. "When research documents that this works and the outcomes are positive, then this is the way medicine will go."

Merck cleared to buy stake in Serono





The Associated Press December 18, 2006, 5:58AM EST

BRUSSELS, Belgium

EU regulators on Monday cleared Germany's Merck KGaA to buy Swiss biotechnology company Serono SA.

The European Commission cleared the deal automatically after identifying no antitrust problems and receiving no complaints from rivals within a deadline of 25 working days.

After losing a bid to acquire Schering AG earlier this year, Merck announced in September that it had bought a majority stake in Serono as part of a 16.6 billion Swiss franc (euro10.5 billion; US$13.31 billion) takeover, expanding its range of drugs and increasing its share of the global biotechnology market.

Merck bought the 64.5 percent stake held by the Bertarelli family and will make a public tender offer for the rest of the shares after its deal with the family has closed in January, Chief Financial Officer Michael Becker told reporters in October.

He also said that, as of Sept. 30, Merck had acquired Serono shares on the market, paying euro455 million (US$571.3 million), and planned to buy more.

The deal will give the Darmstadt-based pharmaceutical maker, whose products include the cardiovascular treatment Concor and cancer drug Erbitux, access to new markets thanks to Serono's partnership with Pfizer Inc. to market the multiple sclerosis drug Rebif.

Analysts said the deal is part of Merck's strategy to stay competitive. Many mid-sized drug companies have looked at combining their operations and research with others in an attempt to keep pace.

Merck's Pharma Ethicals division will be combined with Serono to create Merck-Serono Biopharmaceuticals. The headquarters of that business will be in Geneva, while its U.S. base of operations will be in Boston.

The new group is forecast to have pro forma sales of euro7.7 billion (US$10.1 billion), of which euro3.6 billion (US$4.7 billion) will be biopharmaceutical sales.

Merck, founded as a pharmacy in 1668, is the oldest pharmaceutical business in the world. It has been entirely separate from New Jersey-based Merck & Co. since the end of World War I and employs some 29,000 people.

------

On the Net:

http://www.merck.de

http://www.serono.com

Standard Life turns down 14% of CI claims





Standard Life paid out £9.8m over 184 critical illness claims in the first half of 2006, with only 14% of claims being declined. The insurer said that of the number declined 6% did not meet policy definitions and 8% were declined due to non-disclosure. The top five causes for claims were: cancer (60%), heart attack (11%), multiple sclerosis (8%), stroke (4%) and benign brain tumour (3%). The average claim value was £53,546, with the largest at £300,000. The majority of people (60%) were aged between 40 and 59. Only 32% of claimants were aged between 0 and 39 and 8% were over 60. Of the claimants 58% were female and 42% were male.

Friday, December 15, 2006

Stem cell therapy in patients with multiple sclerosis





Multiple Sclerosis 2006; 12: 677

Stem cell therapy in patients with multiple sclerosis

It is an unusual week that does not see some new headline in the lay press concerning stem cells and their exciting potential for curing this or that disease. Predictably, conditions that are currently considered incurable claim the most attention, and amongst these multiple sclerosis (MS) is hardly the least conspicuous. The challenging emergence of any number of profiteering outfits dedicated to pocketing enormous sums from the sale directly to patients of so-called stem cell therapies has added controversy to the already much excited lay media. Claims and counterclaims rebound, leaving not only patients and carers but also the clinical and scientific community bemused if not a little weary.

Media headlines apart, there is of course nothing unusual or inappropriate about clinical uncertainty regarding the efficacy or promise of an emerging therapy. But in relation to MS, the (not quite) simultaneous appearance of two very different species of stem cell therapy has complicated matters. Two significant position papers in this issue of Multiple Sclerosis offer valuable insights into the current status of one form of stem cell therapy

WE'RE SHATTERED BY SHUTDOWN OF 'MS CURE' CLINIC





Exclusive by Natalie Walker

A CONTROVERSIAL clinic which offered hopes of a miracle cure for multiple sclerosis has been shut down.

The PMC Clinic in Holland was closed after allegations were made that stem cells used in its treatments were not intended for human use.

Scots who had been pinning their hopes on the clinic have been left devastated.

MS sufferer Tom Forrester had been saving to pay for treatment at PMC.

He tried to kill himself when he found out it had closed.

Tom, 54, of Kirkcaldy, Fife, said: "I had had enough.

"I went to bed on a Saturday night and took 70 painkillers."

Tom was found by carers the following day and spent 10 days in hospital recovering.

The clinic is run by Advanced Cell Therapeutics (ACT).

The Dutch government closed the clinic after ACT were accused of buying stem cells intended for research and using them to treat people instead. It has also been claimed that some of the cells used came from animals.

Many MS patients paid thousands of pounds for stem cell treatment at the clinic after claims that their symptoms could dramatically improve or even disappear.

Such treatment is banned in Britain because doctors are not convinced about how safe or effective it is.

MS sufferer Amanda Bryson, 20, of Inverness, handed over £12,000 to the clinic in November last year.

After the treatment, she was able to walk again for the first time in a year.

But within months, her symptoms had returned and she was immobilised.

Despite Amanda's experience, many MS sufferers were counting on the clinic as their only hope of living a normal life.

Margaret Byrne had been on the clinic's waiting list for treatment. She has been wheelchair-bound since 2003. Margaret, 51, of Buckhaven, Fife, said: "I thought I would be walking at Christmas. Now I have nothing to look forward to. I'm devastated."

Between them, Margaret and Tom had raised £14,000 for treatment.

Margaret said: "When the money came in, I thought, great, I'm getting another chance at life.

"We were signing our lives over to the clinic, believing heir treatment was legitimate."

The Multiple Sclerosis Trust said there are no other clinics in Europe offering stem cell treatment.

Chief executive Chris Jones said: "We are excited by legitimate research into stem cell treatment. But there's an awful lot of work needed before we can talk about delivering stem cell treatment in a safe, licensed environment."

Storeman Phil Cuthbertson was due to have treatment at the clinic this month after Daily Record readers donated cash.

He has Lebers, a rare genetic condition which has left him blind.

He hoped stem cell therapy would restore his eyesight.

Now he has had to start the process again at another clinic in Holland and faces a three-month wait for treatment.

Phil, 24, of Paisley, said: "I'd been so looking forward to seeing my family opening presents at Christmas."

Phil hopes to have his sight back in time to be best man to his dad Ian, 53, in 10 weeks.

His own wedding is in August, when he will tie the knot with Yvette Bruce, 23.

Phil said: "I'm looking forward to enjoying two big weddings when, hopefully, I'll be able to see."

MultiCell Technologies Fulfills Upfront License Fee Payment Obligation to Amarin Neuroscience for MCT-125





SAN DIEGO--(BUSINESS WIRE)--Dec 15, 2006 - MultiCell Technologies, Inc. (OTCBB:MCET), developing first-in-class drugs based on advanced immune system modulation and other proprietary technologies, today announced that the Company has completed payment of all upfront license fees related to its acquisition of MCT-125, a breakthrough drug candidate being developed as a treatment for primary chronic fatigue associated with multiple sclerosis (MS).

The payment was completed pursuant to the terms of the amended license agreement with Amarin Neuroscience Ltd. MultiCell estimates MCT-125 could generate up to $3 billion in cumulative worldwide sales during the time MCT-125 is under patent protection. If such revenue forecasts are realized by MCT-125, under the terms of the agreement, Amarin could receive up to $275 million in milestone payments and cumulative royalty payments during the same period.


"MCT-125 is one of our leading therapeutic candidates because it promises to be among the first treatments for the debilitating effects of chronic fatigue caused by multiple sclerosis," said Dr. Stephen M. Chang, Chief Executive Officer of MultiCell Technologies.

MCT-125 targets fatigue associated with MS, an autoimmune disease in which immune cells attack and destroy the myelin sheath protecting neurons in the brain and spinal cord. About two million people worldwide are afflicted with MS, and approximately 70 percent of them report fatigue as the worst symptom of their disease.

In a 138 patient, multi-center, double-blind placebo controlled Phase II clinical trial conducted in the UK by Amarin, MCT-125 (then known as LAX-202) demonstrated efficacy in significantly reducing the levels of fatigue, with few if any side effects, in all MS patient populations enrolled in the study including relapse-remitting, secondary progressive and primary progressive.

About MultiCell Technologies, Inc.

MultiCell Technologies, Inc. is an integrated biopharmaceutical company committed to the development of breakthrough therapeutics based on a portfolio of therapeutic candidates and patented drug development technology. MultiCell's drug development program is focused on modulation of the immune system.

MultiCell's therapeutic pipeline includes drug candidates some of which are in various advanced stages of human clinical trials. These therapies include:

-- MCT-125 for the treatment of chronic fatigue in MS patients. MCT-125 completed a Phase II clinical trial and demonstrated significant efficacy in reducing chronic fatigue in MS patients. There is no drug specifically approved for the treatment of chronic fatigue in MS patients anywhere in the world.

-- MCT-175 for the treatment of relapsing-remitting MS. MCT-175, in preclinical development for the treatment of relapsing-remitting MS, targets disease specific autoaggressive T-cells that destroy the myelin sheath of nerve cells. MCT-175 successfully ameliorated the disease in animal models.

-- MCT-275 for the treatment of type-1 diabetes. MCT-275, in preclinical development, targets disease-specific autoaggressive T-cells that destroy insulin producing cells in the pancreas. MCT-275 completely reversed the type-1 diabetic phenotype and prolonged life in animal models.

-- MCT-465 in an adjuvant therapy for the treatment of virus infection and cancer. MCT-465 in preclinical studies successfully reduced pulmonary influenza virus levels 1,000-fold in animal models, and has demonstrated effectiveness in reducing virus levels of HIV and HCV in animal models. MCT-465 in preclinical studies successfully eliminated certain types of tumors in animal models.

The Company also holds unique cell-based technology for use in drug discovery screening applications, and is a leading producer of the cell lines needed by the biotechnology industry to develop new drugs and therapeutics.

For more information about MultiCell Technologies, please visit http://www.multicelltech.com. For investor information about MultiCell, please visit http://www.trilogy-capital.com/tcp/multicell.

Caution Regarding Forward-Looking Statements

Any statements in this press release about MultiCell's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). These statements are often, but not always, made through the use of words or phrases such as "believe," "will," "expect," "anticipate," "estimate," "intend," "plan," "forecast," "could," and "would." Examples of such forward looking statements include statements regarding the timing, design, scope, and anticipated results of our clinical development of MCT-125, and statements regarding expected milestone and royalty payments to Amarin and worldwide sales relating to MCT-125. MultiCell bases these forward-looking statements on current expectations about future events. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections in the forward-looking statement include, but are not limited to, the risk that we might not achieve our anticipated clinical development milestones, receive regulatory approval, or successfully commercialize MCT-125 as expected, the market for our products will not grow as expected, and the risk that our products will not achieve expectations. For additional information about risks and uncertainties MultiCell faces, see documents MultiCell files with the SEC, including MultiCell's report on Form 10-KSB for the fiscal year ended November 30, 2004, and all our quarterly and other periodic SEC filings. MultiCell claims the protection of the safe harbor for forward-looking statements under the Act and each assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

Contact

MultiCell Technologies, Inc.
Dr. Stephen Chang, CEO, 401-333-0610
MCETInvestor@MultiCelltech.com

Cannabis chocolate trio convicted





Cash receipts totalling £30,000 were seized by police

Three people have been found guilty of supplying thousands of cannabis-laced chocolate bars to multiple sclerosis sufferers for pain relief.

Mark Gibson and his wife Lezley, both 42, of Alston, Cumbria, were standing trial at Carlisle Crown Court with Marcus Davies, 36, of St Ives, Cambs.

They were convicted of two counts each of conspiring to supply cannabis throughout 2004 until February 2005.

All three were ordered to return to court on 26 January for sentencing.

The Cumbrian couple admitted running a cottage industry making and posting out more than 20,000 Canna-Biz bars containing about 3.5g of the drug, to victims of the disease around the world.


Bringing ill people to court and torturing them like this isn't what you do.
Lezley Gibson, after the hearing

But in their testimonies they both insisted this was a free service funded by voluntary donations, which was only available to MS sufferers who provided a medical note confirming their condition.

Davies admitted running a website and post office box, but had denied any involvement in making or posting the chocolate.

Cash receipts totalling £30,000 were seized by police, but the court heard Lezley Gibson told officers these referred to donations, which were ploughed "straight back in" to fund the Canna-Biz operation.

All three told the court they believed they had a defence of medical necessity in supplying the cannabis-laced bars, but this was rejected by the jury.

After the hearing Lezley Gibson said: "The maximum sentence for what we've been found guilty of is 14 years in jail. If you were a child pervert your maximum sentence is only 12.

"I think there's a mistake in the law, and I think they really, really really need to re-think the law on cannabis and medicinal use. Bringing ill people to court and torturing them like this isn't what you do.

"You look after ill people, and you try to make them better. You do not torture them and drag them back and forward to a court of law."

Elan and Biogen Idec Submit Supplemental Biologics License Application to the FDA for the Approval of Tysabri as a Treatment for Crohn's Disease





DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 15, 2006 - Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market TYSABRI(R) (natalizumab) in the U.S. as a treatment for patients with moderately to severely active Crohn's disease (CD).

The filing is based on the results of three randomized, double-blind, placebo-controlled, multi-center trials of TYSABRI assessing the safety and efficacy as both an induction and maintenance therapy - ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission), ENACT-1 (Efficacy of Natalizumab as Active Crohn's Therapy) and ENACT-2 (Evaluation of Natalizumab As Continuous Therapy). The filing also includes proposed labeling and a risk management plan, both of which are similar to those approved for the multiple sclerosis indication.


About TYSABRI

In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML. Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program.

In the European Union, TYSABRI is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS.

Serious adverse events that occurred in MS patients treated with TYSABRI included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. In MS trials, the rate of other serious and non-serious adverse events, including the overall rate of infections, was balanced between treatment groups. Herpes infections were slightly more common in MS patients treated with TYSABRI. The most common adverse reactions (incidence greater than or equal to 10%) in MS patients were headache, fatigue, arthralgia, urinary infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea, and rash.

Serious adverse events that occurred in CD patients receiving TYSABRI included intestinal obstruction, hypersensitivity reactions, abscesses, gastroenteritis, intestinal adhesions and gallstones. In CD trials, the rate of infections was slightly higher in patients treated with TYSABRI than those receiving placebo. However, the incidence of serious infections was comparable between groups. Serious opportunistic and other atypical infections have been uncommonly observed in patients treated with TYSABRI, more so in CD patients than those suffering from MS. Some of these patients were receiving concurrent immunosuppressants. One of the 3 previously reported cases of PML was seen in a CD patient. The most common adverse reactions (incidence greater than or equal to 10%) in CD patients were headache, upper respiratory tract infection, nausea, and fatigue.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

About Crohn's Disease

Crohn's disease is a serious autoimmune disease with no known medical or surgical cure. It is a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.

The disease usually causes diarrhea, crampy abdominal pain, fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), malnutrition and decreased growth rate in children.

Approximately one million people worldwide have Crohn's disease, can progress to be severely debilitating and have a significant impact on quality of life.

Source: Crohn's and Colitis Foundation (CCFA)

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.

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.

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is 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 be unable to adequately address concerns or questions raised by FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected hurdles. 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 and current 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.

Contact

Media:
Elan
Davia B. Temin, 212-407-5740
Elizabeth Headon, 353-1-498-0300
or
Biogen Idec
Amy Brockelman, 617-914-6524
or
Investor:
Elan
Emer Reynolds, 353-1-709-4000
Chris Burns, 800-252-3526
or
Biogen Idec
Eric Hoffman, 617-679-2812

Monday, December 11, 2006

ON THE ROAD

We will not be posting Tues Dec. 12 through Thurs. Dec. 14 - on the road again.

MS drug unlikely to gain OK for Crohn's





Biogen CEO: More development needed

By Jeffrey Krasner, Globe Staff | December 11, 2006

Biogen Idec's chief executive, James Mullen, says the Cambridge biotechnology company is unlikely to receive approval from European regulators to use its drug Tysabri to treat patients with Crohn's disease, a debilitating intestinal ailment.

Mullen said in a recent interview that results from drug trials included in an application to the European Medicines Agency are "interesting but need more development." Regulators are likely to require an additional clinical trial before approval, he said. That could take years and cost Biogen Idec millions of dollars.

"Almost irrespective of a regulatory response, it's going to need more clinical trials," Mullen said.

Biogen Idec and Elan Corp. of Ireland have partnered on development of Tysabri since 2001. After showing promising results in testing, the drug was introduced in the United States in November 2004 to treat patients with multiple sclerosis, but was abruptly withdrawn from the market after the companies found two patients in Tysabri trials had contracted a potentially fatal brain disease. Ultimately, three patients were found to have contracted the brain disease, progressive multifocal leukoencephalopathy, or PML, and two died from it.

After impassioned testimony from multiple sclerosis patients anxious for a chance to take Tysabri, the Food and Drug Administration last summer permitted sales to resume, but Biogen Idec was required to take additional safety precautions, including a mandatory registry of patients receiving the drug.

In recent public statements and discussions with stock analysts, officials from Biogen Idec and Elan said the firms planned to file an application to sell Tysabri to treat Crohn's with the FDA by Dec. 31. They also touted Tysabri's ability, demonstrated in clinical trials, to induce remission in Crohn's patients.

In their joint development of Tysabri, Biogen Idec has led trials and regulatory filings related to multiple sclerosis, and Elan has overseen its potential expansion as a treatment for Crohn's disease.

"The data suggest that Tysabri could be an alternative biologic choice for Crohn's disease patients," Elan said in a written response to questions regarding Mullen's comments. "As the data continue to unfold, [Elan and Biogen Idec] will explore additional indications, as appropriate, to unmet medical needs."

In a comprehensive safety review last year, the companies found two multiple sclerosis patients with PML who were also being treated with Biogen Idec's drug Avonex, another treatment for multiple sclerosis. One of those patients survived. Another patient in a Crohn's trial, who died from PML, had been treated with immunosuppressants.

That pattern suggested the risks of contracting PML while using Tysabri could increase if a patient is also being given a drug that affects the immune system. If so, that raises the risks of treating Crohn's patients with Tysabri, because many have weakened immune systems.

"Against the backdrop of PML, where you have a set of patients that already get bombarded with immunosuppressants over 20 to 30 years, [Crohn's] is not the first place we'd go to develop Tysabri," said Mullen. He said the drug looks more promising as a treatment for Lupus and certain cancers.

Biogen Idec and Elan share revenues from Tysabri, but failure to win approval to sell it as a treatment for Crohn's disease would not have much impact on Biogen Idec, stock analysts said.

"We stripped revenues from Crohn's out of our expectations when Tysabri was withdrawn from the market," said Jennifer Chao, biotechnology analyst with Deutsche Bank. "We have zero revenue expectations from Crohn's disease. My interpretation is that Jim Mullen is clearly trying to downplay any expectations for Tysabri around Crohn's disease."
But there could be an impact on Elan, a smaller company than Biogen Idec that is largely dependent on revenues from Tysabri.

William Tanner, an analyst with Leerink, Swann & Co., questioned the wisdom of trying to win approval to treat Crohn's patients with Tysabri. An unexpected side effect or death during Crohn's testing could endanger Tysabri's role in multiple sclerosis treatment , where it seems poised to become a blockbuster, he said.

"We predict $150 million in global Tysabri sales this year, growing to $474 million in 2007 and north of $1 billion in 2008," Tanner said. "There's not a lot of upside with revenues from Crohn's patients, so you have to wonder if the potential benefit is worth the risk."

Jeffrey Krasner can be reached at krasner@globe.com.
© Copyright 2006 Globe Newspaper Company.

Roche presents yet more promising data on MabThera


Roche presents yet more promising data on MabThera - 11/12/2006




Roche has unveiled long-term data showing that its antibody drug MabThera, when given as a first-line therapy, prolongs survival for patients suffering from advanced follicular non-Hodgkin's lymphoma.

The Phase III study of 321 patients, presented at the American Society of Hematology meeting in Orlando shows that MabThera (rituximab), in combination with cyclophosphamide, vincristine and prednisolone (CVP) increased overall survival at four years, with 81% patients treated with rituximab and chemotherapy still alive compared with only 71% on chemotherapy alone.

In addition, patients in the investigative arm saw a significantly extended time to disease progression or death of 34 months compared with 15 months for patients receiving CVP alone. This meant estimated disease-free survival at four years was 54% for patients given the four drug regimen, versus 17% for those on CVP, says the firm.

Lead investigator of the study, Dr Robert Marcus of Addenbrookes Hospital, Cambridge, said that the data demonstrating "a modest but definite improvement in overall survival are encouraging" and suggests the addition of rituximab to CVP confers long-term benefit.

MabThera, sold in North America and Mexico by Roche's partner Genentech as Rituxan, is an integral part of the firm's cancer portfolio, along with Herceptin (trastuzumab) and Avastin (bevacizumab). MabThera is one of the star's in Roche's pipeline and is helping to drive growth - having pulled in a whopping 2.3 billion swiss francs ($1.9 billion) during the first half of this year alone. And the Swiss firm clearly sees additional potential in the compound, which has shown promise in various other indications, notably rheumatoid arthritis and multiple sclerosis.

In Europe, MabThera is approved as maintenance therapy for patients with relapsed or refractory follicular Non-Hodgkin's lymphoma, as first-line treatment of both aggressive and indolent NHL (in combination with chemotherapy), as a second-line monotherapy for indolent NHL, and for rheumatoid arthritis.

Xeloda meets survival endpoint
Meantime Roche noted that its latest Phase III study of oncology drug
Xeloda (capecitabine) with 627 previously-reated patients with advanced
colorectal cancer met its primary endpoint of progression-free survival.

Study results showed that the chemotherapy combination Xelox - oral Xeloda plus oxaliplatin - was as effective in delaying disease progression as the chemotherapy combination Folfox-4 (infused 5-FU/leucovorin plus
oxaliplatin).

Deborah Kotz, "The ABCs of D"





A single nutrient that keeps bones strong, wards off diabetes, and protects against tuberculosis, cancer, colds, and the flu. Sound too good to be true? There's more: It's free. But you're almost certainly not getting enough.

Research on vitamin D has flooded out over the past few months, linking a growing array of health ills to low levels of the nutrient. Scientists now know that the vitamin, which is naturally produced in skin exposed to the sun's ultraviolet rays, binds to cell receptors throughout the body and that a lack can cause various systems to malfunction. Last week, for example, University of Pittsburgh researchers reported that a D deficiency doubles the risk of dangerous hypertension during pregnancy, since the nutrient helps control a hormone affecting blood pressure. In March, a study examining how the vitamin affects the pancreas's release of insulin found the risk of diabetes to be one-third lower in people with the highest levels than in those getting the least. "The vitamin D story is becoming clear. I think it's very exciting," says Robert Heaney, a professor of medicine at Creighton University in Nebraska who has researched the nutrient's effects on the bones and who, like many researchers, now thinks supplements are a good idea.

Prior to the industrial revolution, humans had no trouble getting an abundance of the sunshine vitamin; a mere 10 to 15 minutes outdoors at midday gives the average fair-skinned person 10,000 international units. That's far above the government's dietary recommendations of 200 IUs a day up to age 50, 400 IUs to age 70, and 600 IUs over 70. But most people nowadays spend little time outdoors, and food sources such as milk and salmon contain relatively modest amounts. What's more, the rash of new findings suggests to the experts that the guidelines are way too low. "There's no one working in the field who thinks these levels still make sense," says Walter Willett, a professor of epidemiology and nutrition at Harvard University whose recent studies have focused on the connection between vitamin D and cancer.

Many people run particularly short during the winter, says vitamin D researcher Michael Holick, a professor of medicine at Boston University School of Medicine. That's because anyone living north of Atlanta makes little, if any, from the sun when the UV rays fall at too low an angle to penetrate the atmosphere.

Beyond bones. Vitamin D is best known for promoting bone health. It was first added to the milk supply in the 1930s to prevent the bone-deforming disease rickets, and it defends against osteoporosis by triggering the absorption of calcium into bone cells. New evidence indicates that many people suffering symptoms of chronic fatigue syndrome and fibromyalgia actually have a painful softening of the bones that is caused by a D deficiency.

But having too little appears to cause the immune system to weaken as well. A landmark study published in the March issue of Science found that cells from African-Americans (whose dark skin doesn't efficiently absorb UV rays) churned out 63 percent less of a protein needed to fight off tuberculosis than expected. When added to the cells, vitamin D appeared to signal the cells to produce normal levels of the protein.

An immune system link might explain why the flu seems to strike only during the winter. A review of more than 100 studies on vitamin D and respiratory diseases, published in the current Epidemiology and Infection, found that low levels probably allow the viruses to penetrate the immune system. "It's the first comprehensive theory set forth to explain the seasonality of influenza," says vitamin D expert and lead author John Cannell, president of the Vitamin D Council and staff psychiatrist at Atascadero State Hospital in California. What's now needed, he says, is a trial to see if those exposed to flu viruses are less likely to come down with an infection if they take supplements.

The possibility intrigues researchers bracing for an outbreak of avian flu, which quickly kills by triggering an excessive immune response. Victims often suffocate when an onslaught of disease-fighting cells, known as a cytokine storm, results in a rapid buildup of fluid in the lungs. Experts think vitamin D might rev up the part of the immune system that prevents the germs from gaining entry to cells in the first place. "This puts a damper on the part of the immune system that releases the cytokine storm," says Michael Zasloff, an immunologist and vitamin D researcher at Georgetown University in Washington, D.C. Research shows that the mechanism also seems to protect against multiple sclerosis and rheumatoid arthritis, in which the immune system attacks the body's own healthy tissue.

With cancer, it's thought that vitamin D might prevent tumors from rapidly growing by controlling the expression of certain genes that regulate cell division. In a study of more than 46,000 men and 75,000 women reported in September, Harvard University researchers led by Walter Willett found that people who took in the highest amounts of vitamin D cut their risk of pancreatic cancer almost in half, compared with those with the lowest intakes. Earlier, they'd found a similar degree of protection against colon cancer in women. Other researchers are examining vitamin D in breast and prostate cancers. "The epidemiological evidence is very strong; we know there has to be something going on," says Anthony Norman, a professor of biochemistry at the University of California-Riverside who has extensively researched the vitamin D receptor. Is the evidence strong enough to recommend supplements for cancer prevention? "Unequivocally yes," he says.

How much to take? The government last year suggested that African-Americans and the elderly might want more than the guidelines suggest, but it has set 2,000 IUs as its ceiling for safety. Most experts think the limit is too conservative, noting that there's no evidence of toxicity at much higher doses and that 2,000 IUs is a worthy goal for everybody. Consuming 3 ounces of tuna, two glasses of milk, and a glass of fortified orange juice will get you to 500 IUs, and a supplement or two will get you the rest.

Xanthus Presents Preclinical Data Demonstrating Potent Symadex Activity in Leukemia Cells





CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 11, 2006 - Xanthus Pharmaceuticals, Inc., a privately-held oncology drug development company, today announced the presentation of data from preclinical studies in which Symadex(TM) (C-1311) demonstrated potent in vitro and in vivo activity against leukemia cells. The presentation was made in a poster session at the American Society of Hematology 48th Annual Meeting and Exposition in Orlando, Florida.

Researchers from Xanthus and the Medical University of South Carolina, Charleston, previously identified Symadex as a potent and selective inhibitor of the FLT3 receptor tyrosine kinase, in addition to its topoisomerase II activity. In the preclinical studies being discussed here, Symadex was examined in acute myeloid and lymphoid leukemia cell lines and was found to be active, especially in those expressing FLT3. This finding was further supported by data observed from in vivo studies. The data was presented on Sunday, December 10th in the Leukemias: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: AML session in a poster titled, "Imidazoacridinones are Bifunctional Targeting Agents Active in Leukemia Cells."


"These new data provide further support for our strategy to initiate a leukemia-focused clinical development program for Symadex," stated Robert L. Capizzi, M.D., Chief Medical Officer at Xanthus. "The dual function of Symadex may be the reason why we saw more potent activity in the FLT3 expressing cell lines, suggesting that Symadex or other novel imidazoacridinones in our portfolio may be useful for a variety of hematological malignancies and other tumor types."

About Symadex(TM)

Symadex (formerly C-1311) is the lead compound in clinical development from a new series of agents, the imidazoacridinones, and in vitro have shown it to be a potent and selective FLT3 receptor tyrosine kinase inhibitor. Symadex is currently in Phase 2 clinical trials in oncology. Xanthus is also exploring the use of Symadex for the treatment of a number of autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis, where early preclinical data has shown encouraging signs of activity. Xanthus licensed intellectual property related to Symadex from BTG International, Ltd.

About Xanthus Pharmaceuticals, Inc.

Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule oncology candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. The Company is applying its expertise both to advance its current pipeline and expand it into indications of unmet medical need beyond oncology.

Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at www.xanthus.com.

This press release contains forward-looking statements concerning Xanthus that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Xanthus' actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in early clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future clinical trials or warrant additional trials; whether products based on Xanthus' technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the company will have the cash resources to develop and commercialize its products; and whether the patent and patent applications owned or licensed by Xanthus will protect the Company's technology and prevent others from infringing it. Xanthus disclaims any intention or obligation to update any forward-looking statements.

Contact

MacDougall Biomedical Communications, Inc.
Kari Watson, 508-647-0209
kwatson@macbiocom.com
or
Xanthus Pharmaceuticals, Inc.
Lisa Terry, 617-225-0522, x 105
lisa.terry@xanthus.com

Friday, December 08, 2006

Fla. Court Rejects Disabled Man's Appeal





Friday December 8, 2006 12:01 AM

By MITCH STACY

Associated Press Writer

TAMPA, Fla. (AP) - A disabled man who said he needed vast amounts of prescription drugs to control pain is a drug trafficker in the eyes of the law and has to serve at least 25 years in prison, an appeals court has ruled.

The 2nd District Court of Appeal expressed sympathy for Richard Paey, whose story was featured on the ``60 Minutes'' TV program and in other national media earlier this year. His argument that he doesn't deserve the long sentence ``does not fall on deaf ears, but it falls on the wrong ears,'' court said.

In its 2-1 opinion handed down Wednesday, the court suggested that Paey ask Gov. Jeb Bush to commute it.

Paey's attorney, John Flannery, said Thursday he immediately wrote to Bush's office. Bush spokesman Anthony DeLuise said the office has received more than 100 letters on Paey's behalf but hadn't yet received any clemency request.

Paey, 48, severely injured his back in a 1985 car accident, has multiple sclerosis, and uses a wheelchair. The father of three was sentenced in 2004 on drug trafficking and other charges to a mandatory minimum sentence of 25 years.

Prosecutors said he was forging prescriptions and getting hundreds of pills that he had to be selling them, even though they had no evidence to support their claims. At one point, they said he got 800 Oxycodone pills in a month-and-a-half time.

In a dissenting opinion, Associate Judge James H. Seals said took issue with Paey's prosecution, saying ``the State decided to bring out the artillery designed to bring down the drug cartels.''

State Attorney Bernie McCabe said Thursday that he made multiple plea offers to Paey that didn't involve him going to prison. Paey's wife has said he had rejected offers because he didn't want to be branded a drug trafficker.

Acorda Therapeutics Provides Update on Clinical Development of Fampridine-SR





HAWTHORNE, N.Y.--(BUSINESS WIRE)--Dec. 8, 2006--Acorda Therapeutics, Inc.(R) (Nasdaq: ACOR) today confirmed that, based on feedback it received in a meeting with the U.S. Food and Drug Administration (FDA), it will design and conduct an additional Phase 3 trial of Fampridine-SR in people with MS. Consistent with that meeting, the company expects to discuss with the FDA a study of the same or shorter duration as its MS-F203 study with a single criterion for efficacy, a consistent response on the Timed 25 Foot Walk.

In September 2006, the Company announced the results of its recent Phase 3 study, MS-F203, which was based on a Special Protocol Assessment (SPA) from the FDA. The FDA indicated that, while this would require confirmation in a New Drug Application (NDA) filing, the criteria for the SPA appear to have been met. Typically, the FDA requires two adequate and well-controlled studies, each convincing on its own, to establish substantial evidence of effectiveness.

Based on the discussion, Acorda also plans to execute a QT study in accordance with the FDA's October 2005 guidance, "Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs". The Company will continue to consult with the FDA on protocol development for both of these studies and any additional requirements that might be needed.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. Acorda's lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.


CONTACT: Acorda Therapeutics
Tierney Saccavino, 914-347-4300 ext. 104
tsaccavino@acorda.com

SOURCE: Acorda Therapeutics, Inc.

Thursday, December 07, 2006

Researchers Find Extensive Repair of Myelin in Brains of





December 1, 2006

A study by an international team of collaborators funded in part by the National MS Society suggests that a substantial amount of natural repair can occur to the myelin coating that insulates and protects nerve fibers in the brain and which is damaged by immune forces in people with MS. While previous studies had shown that natural myelin repair occurs in people with MS, this study found evidence of myelin repair, or “remyelination,” in a proportion of patients’ tissues across most types and stages of multiple sclerosis.

The study, published early online in the journal Brain (doi: 10.1093/brain/awl217; slated for December 2006 publication), was conducted by Drs. Peter Patrikios and Hans Lassmann (Medical University of Vienna) and was financed by the National Institutes of Health and the European Union, with additional support from the National MS Society’s “MS Lesion Project” led by Dr. Claudia Lucchinetti (Mayo Clinic).

The investigators examined autopsied brain tissues from 51 people who’d had MS in their lifetimes, including individuals with relapsing-remitting MS, secondary-progressive MS, primary-progressive MS and some with an unknown clinical course. Regions showing past or current disease activity, or lesions, were analyzed for signs of myelin damage (“plaques”) and repair (“shadow plaques”) using a variety of microscopic, staining and labeling techniques.

In about 20 percent of patients’ brains studied, remyelination was extensive, not only in those with the more common relapsing course, but also in those with progressive disease. The investigators found that the amount of remyelination ranged from sparse to nearly complete repair. Longer disease duration and older age at death were associated with more extensive remyelination. No link was found between the extent of repair and the age at onset, gender or type of MS.

When myelin is damaged, messages being sent along the underlying nerve fibers can misfire or be lost. Remyelination of nerve fibers is thought to restore function and also protect them from damage. Further research is required to uncover factors that determine why some individuals show highly efficient myelin repair while others do not. The investigators emphasize that their findings of variable rates of remyelination should be factored into the design of future clinical trials aimed at stimulating myelin repair.

-- Research and Clinical Programs Department