Researchers at Northwestern University’s Institute for Cell Engineering are concentrating on progress with Bone Morphogenetic Proteins as a means of making a major breakthrough in recovery for victims of spinal cord injuries. As Northwestern’s research experts continue to learn about these complex proteins, they are discovering more and more ways in which they are beneficial in repairing spinal cords after traumatic accidents and injuries.

Betaferon® approved in China for treatment of Multiple Sclerosis

Bayer Schering Pharma AG announced that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon® (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS). Bayer plans to launch Betaferon in China by mid 2010.

Betaferon is available in more than 100 countries around the world. "This approval is good news for MS patients in China, allowing them access to Betaferon, that has been demonstrated to modify the course of MS," said Habib Dable, Global Head, Neurology/Ophthalmology of Bayer Schering Pharma AG. "The approval of Betaferon in China underscores Bayer's ongoing commitment to address the unmet medical needs of people around the world.

A study led by a Scripps Research Institute scientist describes a new, highly pragmatic approach to the identification of molecules that prevent a specific type of immune cells from attacking their host. The findings add a powerful new tool to the ongoing search for potential treatments for autoimmune diseases, such as multiple sclerosis (MS), as well as blood cancers, such as myeloid leukemia.

The study by Thomas Kodadek, a professor in the Chemistry and Cancer Biology Departments at Scripps Florida, and colleagues was published in the journal Chemistry & Biology. In the new study, Kodadek and his colleagues used samples from an animal model of multiple sclerosis to screen for T cells -- a type of white blood cell that plays a central role in the immune system -- with a heightened presence in the disease. The screen also identified molecules that interfere with these T cells' "autoreactivity," in other words, their attack on the body itself rather than a foreign invader such as virus or bacteria.

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"Our technique simultaneously uncovers and isolates autoreactive T cells as well as inhibitors to them," Kodadek said. "It's a double whammy. At the heart of this is a comparative screening process of normal T cells versus disease-causing T cells. While the process is technically complicated and difficult, the thinking behind it is not. We wanted to simplify the process of identifying compounds that could inhibit autoreactive T cells with exceptional specificity, and we succeeded."

The scientists used a model of MS, an autoimmune inflammatory disease affecting the brain and spinal cord, for the study. In MS, the immune system attacks the myelin sheath covering and protecting nerve cells, leading to a variety of symptoms depending on which part of the nervous system is affected. Common symptoms of the condition include fatigue; numbness; walking, balance, and coordination problems; bladder and bowel dysfunction; vision problems; dizziness and vertigo; sexual dysfunction; pain; cognitive problems; emotional changes; and spasticity.

Simplifying the Process

In setting up the new method to shed light on such autoimmune diseases and other disorders, Kodadek and his colleagues created a large collection of peptoids -- molecules related to, but more stable than, the peptides that make up proteins. By arranging thousands of peptoids on a microscope slide, the pattern of binding antibodies (a type of immune molecule) and peptoids can be visualized. By looking at samples from animal models of a known disease like MS, peptoids that bind to antibodies closely associated with that disease can be easily recognized. Better still, peptoids that bind to autoreactive T cells can be identified without knowledge of the specific antigen (molecule triggering the immune attack), providing an unbiased method with which to search for potentially useful compounds.

Most autoimmune research has focused on finding the disease-causing antigens first, Kodadek said, a Quixote-like quest that has lasted more than four decades with little success to show for it. "With our process, it doesn't really matter what the antigen is," said Kodadek, a 2006 recipient of the National Institutes of Health Director's Pioneer Award, which is designed to support individual scientists of exceptional creativity. "That was really the breakthrough. We're setting up a system that recognizes T cell receptors that are very abundant in a sick animal and at low levels in a healthy animal. Why the abundance? Because that's what making them sick."

Potential for Therapeutic Discovery

The new process creates new potential for therapeutic discovery. Molecules that target autoreactive T cells directly, while ignoring those T cells that recognize foreign antigens, could serve as the foundation for a novel drug development program aimed at eradicating autoreactive cells without affecting the normal function of the immune system. "Almost without exception, drugs currently used to treat autoimmune conditions either inhibit something downstream of the autoimmune response itself, like inflammation, or they moderate the immune system non-selectively and that results in significant side effects," Kodadek said.

However, the new study isn't the final answer, according to Kodadek. He noted that the recent study used a model of MS triggered by a single antigen. In humans, there could be two -- or two dozen -- antigens triggering an autoimmune disease such as MS. This calls for further research. The method may be more easily applied to blood cancers, though, since the disease-causing T cells have been fully characterized and there are very few of them.

Source: ScienceDaily © 1995-2009 ScienceDaily LLC (01/12/09)

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While most people turn to their Nintendo Wii for family fun or a game of Super Mario Galaxy, more and more physical therapists are turning to the popular gaming console for its rehabilitative purposes. In particular, therapists are using the Wii Fit program to help victims of brain injury recover with a more fun routine and to help end the monotony of traditional rehabilitation programs.

Increasingly known as “Wii-hab,” the incorporation of the Nintendo Wii into brain injury rehabilitation has taken advantage of the basic functions of the interactive joystick, as well as the body’s basic motions. As was intended by the creation of the Wii Fit program, the regular Wii user receives quite the workout from the program’s software and special interactive equipment. However, for rehabilitative purposes, a person recovering from brain or spinal injuries using the equipment can find considerably more benefit among the game’s simplicities.

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For instance, just using the joystick’s buttons assists with the recovery of a patient’s basic motor skills. Making a routine of pressing buttons and flicking the wrist is not only fun for the person in recovery, but it also assists with recovery of regular motion and action in the fingers, hands, and lower arms. In other Wii sports games – such as bowling, tennis, baseball, golf, etc. – the motion of the joystick can help restore ranges of motion in the arms and legs. For the more advanced rehabilitation, newer games like Wii Fit Plus adds elements of balance, strength conditioning, stretching, aerobics, and yoga, as well as the traditional games and workouts.

Wii-hab – or Waggle Therapy as it is also known – continues to grow as a popular source for brain and spinal injury rehabilitation, and it is currently being utilized for its positive encouragement and therapeutic purposes in cases of stroke, motor vehicle accident, combat wounds, and even Parkinson’s disease.

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Auto accident TBI treatment licensed to BHR Pharma

BHR Pharma LLC, a subsidiary of the Belgian company Besins Healthcare SA, has been named the sole licensee of a new treatment that could very well be a monumental cure for traumatic brain injuries caused by serious debilitating blows to the head. The two-year old company is using a new treatment that involves the female hormone progesterone in eliminating and solving the effects of TBI.

In cooperation with Emory University, which granted the license to BHR Pharma’s President Tom MacAllister, the company plans to begin clinical trials in the beginning of 2010, recruiting recent victims of motor vehicle accidents with serious brain injuries from emergency rooms throughout the U.S. In all, BHR Pharma will begin clinical trials with 1,200 victims from 120 emergency rooms, while Emory University will conduct its own trials with 1,140 victims in 17 medical centers across the country. Both sets of clinical trials are purely cooperative and not competitive.

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The progesterone treatment was invented in the 1980s, and was developed further by Emory’s Don Stein. BHR Pharma’s team will be able to use its own clinical trial results as well as the Emory trial results in manufacturing a complete treatment for federal approval. Researchers and medical professionals agree that this treatment is revolutionary, in that it is the first of its kind in suppressing and reversing secondary cell damage in the brain after serious trauma induced by an automobile accident.

Once approval is gained by BHR Pharma, the company intends to use the final treatment for victims within eight hours of their automobile accidents. For five days, the progesterone solution will be filtered into the victim’s system, as the hormone will reduce all inflammation in the brain and reverse the body’s natural inclination toward the spread of secondary cell damage.

Currently, there are no U.S. Food and Drug Administration-approved drugs or treatments for traumatic brain injuries, meaning that if BHR Pharma is successful the company will have pulled off a coup in modern medical science. With more than one million cases of TBI reported in U.S. emergency rooms each year, doctors and medical experts have only been able to use emergency surgery to treat these brain injuries.

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Multiple Sclerosis progress slowed by giving birth, Belgian doctors say

Giving birth seems to slow the progression of multiple sclerosis (MS), Belgian and Dutch researchers say. The researchers tracked 330 women with MS for 18 years and found that among those who had children, severe disability took longer to develop.

Writing in the Journal of Neurology, Neurosurgery and Psychiatry, they say previous studies have suggested a worsening of MS just after birth. But the MS Society said the study was flawed and further research was needed. MS is a long-term inflammatory condition of the central nervous system. It affects the transfer of messages from the nervous system to the rest of the body. Women are twice as likely to develop MS as men and many of the new cases will be among women of childbearing age.

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The researchers from Belgium and the Netherlands said all the women had been referred to one specialist centre and had had their first symptoms from the ages of 22 to almost 38. Nearly a quarter of the women (24%) were childless; 170 had given birth before their symptoms developed (52%); 61 had their children after their symptoms developed (18%); and 19 had had children both before and afterwards (6%).

'Speed of progression'

The researchers used the Kurtzke Expanded Disability Status Scale (EDSS) which runs from one to 10, where 10 is death from MS and six is when an individual needs a cane, a crutch or a brace to walk 100m. After an average of 18 years living with MS, over half the women (55%) were categorised as EDSS six. They found that both the likelihood and speed of progression were affected by childbirth.

Women who had given birth to one or more children at any point before or after the start of MS symptoms were 34% less likely to progress to EDSS six than childless women. Women whose children had been born after their MS began were 39% less likely to progress to EDSS six than women who had not had children. They said this held true even after taking account of the age at which symptoms began. Women who had no children after their MS symptoms started progressed to EDSS six within 13 to 15 years on average. But women who did have children took an average of 22 to 23 years to reach this stage.

'Beneficial effect'

Dr Maria D'hooghe, from the National MS Centre in Melsbroek, Belgium, which co-ordinated the study, said it had shown for the first time the long-term effects of having a baby if you have MS. She said: "It's possible that the hormones released in pregnancy are having a beneficial effect on the immune system.

"Certainly, animal studies show that pregnancy can lead to less damage in their brains. "The other possibility is that it is lifestyle changes caused by having a baby that are delaying the effects of MS perhaps through increased activity or changes in the way we deal with stress."

But Dr Susan Kohlhaas, research communications officer for the MS Society, said it was a small study and they had not taken account of the fact that women with more severe MS may choose not to get pregnant because they are worried about a relapse or about taking care of a baby during a relapse. She said: "It is difficult to form any meaningful conclusions from this research given the small size of the study and its flaws, but further studies will hopefully clarify the effects of pregnancy in women with MS."

Source: BBC News © British Broadcasting Corporation 2009 (24/11/09)

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Vitamin D - the missing link for multiple sclerosis sufferers

Scientists have uncovered increasing evidence of the significance of Vitamin D in the development of multiple sclerosis. Now, Australian researchers have found that Vitamin D may actually reduce its symptoms.

Professor Bruce Taylor, a principal research fellow at the Menzies Institute in Hobart, studied 145 patients in southern Tasmania and tracked their seasonal susceptibility to the disease. He looked at how Vitamin D levels influenced their risk of having an attack of MS. 'We found that the higher your Vitamin D level, the lower your chance of relapse, and for each ten nanomole [a standard measure of concentration of Vitamin D in the blood] increase in Vitamin D, you can reduce your risk of having an attack of MS by about ten per cent. Doubling your Vitamin D will reduce your risk by up to 50 per cent - a major result.'

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Helen Yates, the Multiple Sclerosis Resource Centre's chief executive, says: 'It has long been believed that Vitamin D has a role to play in the risk of developing MS but this new research opens up the strong possibility that this vitamin could impact on relapse rates.' The MS Society's research communications officer, Dr Susan Kohlhaas, says: 'These results are very early-stage and need to be reviewed and validated before we draw any firm conclusions.'

It has been known for many years that the further you live from the Equator, the more likely you are to develop MS. For example, Malaysia has hardly any sufferers but in Scotland and Scandinavia MS is relatively common. It is believed this is due to a shortage of Vitamin D; countries far from the Equator, such as those in Northern Europe, enjoy less sunshine, the main source of Vitamin D.

Research has shown that babies born in May - who developed in the womb during the Vitamin D-scarce winter months - are the most likely to get MS in later life, while those born in November are at much lower risk. Another study this year found evidence that Vitamin D deficiency during pregnancy and infancy could increase a child's risk of developing MS in later life.

The researchers concluded that taking Vitamin D supplements during these times could reduce the risk, although this has yet to be proven.

Source The Mail Online © 2009 Associated Newspapers Ltd (22/11/09)

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Fifty percent of MS patients avoid treatment over injectable delivery fears

Around half of all multiple sclerosis (MS) patients that are eligible for treatment do not receive it and one in five of those patients that do begin therapy, delay doing so because of fear and anxiety over the treatment process, and not fear and anxiety about the disease.

These observations are according to Patricia Kennedy, a nurse practitioner and consultant at Can Do Multiple Sclerosis, formerly The Heuga Center for MS, US, who presented at the 2nd Vetter Drug Management Leadership Conference in Germany. If the injectable therapies that we have available today are good for MS, good for patients, and good for the future, why aren't patients taking them? questioned Kennedy. It is important for industry to be aware of MS patients' reasons for avoiding treatment and what they go through when facing the disease, she added. She then urged delivery-device manufacturers to consider patient behaviour and feelings when developing new devices in order to increase a patient's chances of initiating therapy and complying with long-term treatment.

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According to Kennedy, healthcare professionals face a number of challenges when dealing with MS patients, with those who are eligible for therapy opting out of treatment for a number of reasons, including: lack of belief that it is needed; fear of needles; the constant reminder of the disease each time they need to inject; lack of family support; and the financial burden of treatment.

Even in those patients that do begin treatment, it's another challenge to keep them on it, admitted Kennedy. She also advised of the problems that US healthcare systems currently face with disposal of syringes and sharp objects; this is a particular problem in more populated regions in the US. Education of patients and their support networks is incredibly important to help with patient compliance and disease management. However, Kennedy also provided advice to industry on how new device development might help MS patients to manage and control their disease since injection-related issues are still a primary cause for patient's fear of starting therapy and is the main reason for lack of compliance.

What can industry do?

The easier we can make it for a patient to administer treatment, the more likely it is that the medication is going to be used, explained Kennedy. In most cases, the smaller the needle, the better. Although a 29-gauge needle might be easier to use than a 30-gauge needle, and although both are small, the patient will opt for the slimmer 30-gauge every time. Psychologically, that's what they want, she added.

According to Kennedy, patients want titrated, prefilled syringes that are marked clearly. Not only does this avoid any issues of efficient mixing and incorrect dosing, but MS patients often have vision problems. Kennedy also emphasized the importance of travel devices, such as pens. Patients want devices that are easy to travel with because we live in a mobile society, and if we provide the option of transporting less bulky injections devices whilst they're away from home, patients are more likely to comply with their medication, she advised.

In general, Kennedy also believes that injection devices could help patients immensely. Most patients like injectors; even if the needle is a 30-gauge needle, patient's don't want to see it. So if you can hide the injector, then that's good. It's psychological, she said. Injection devices not only help overcome the psychological barrier to injections, but they are also easier to use than syringes, which is especially beneficial for those patients that suffer from tremors. In addition, they help patients to obtain a consistent depth of injection and thus reduce the number of injection-related side effects.

I also believe that needless devices would help improve patient compliance with drug therapy, added Kenney. The bottom-line for patients, according to Kennedy, is to provide them with delivery devices that are easy to use, offer choice and flexibility, with increased comfort. What patients really want, first of all, is control over their MS; easily-injectable systems can help with that. They want to be self-effective, they want a medication that's easy to use because then they're not reminded about their MS, and if they're reminded less often then life goes on and they're able to pursue other things.

So in the future, I would urge industry to continue to make injectable devices that are more patient-friendly. We need to work together to decrease the number of non-users; let's raise that 50% to 75%, she insisted. I doubt we'll ever make 100%, but we can lessen the impact of MS on a person's life by giving them maximum control and letting them get on with their life. If we treat people early with the medications, we already have available to us today, and treatment is consistent and easy to administer, it gives them hope for the future, she concluded.

Source: Pharmatech.com © 2009 Advanstar Communications, Inc (20/11/09)

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Drug studied as possible treatment for spinal injuries might also treat Multiple Sclerosis

Researchers have shown how an experimental drug might restore the function of nerves damaged in spinal cord injuries by preventing short circuits caused when tiny "potassium channels" in the fibers are exposed. The chemical compound also might be developed as a treatment for multiple sclerosis.

Because nerves usually are not severed in a common type of spinal cord trauma, called "compression" injuries, the drug offers hope as a possible treatment, said Riyi Shi, a professor in Purdue University's Department of Basic Medical Sciences, School of Veterinary Medicine, Center for Paralysis Research and Weldon School of Biomedical Engineering.

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"Compression is responsible for most spinal cord injuries, including many resulting in paralysis," Shi said. "Since the nerves are not severed, this type of drug represents a potential golden opportunity to treat spinal cord injuries." The experimental compound, 4-aminopyridine-3-methyl hydroxide, has been shown to restore function to damaged axons, slender fibers that extend from nerve cells and transmit electrical impulses in the spinal cord.

Findings, based on experiments with guinea pig spinal cord tissue, appeared online in the Journal of Neurophysiology. The work was led by Department of Basic Medical Sciences doctoral student Wenjing Sun. Shi said the findings were made possible by the interdisciplinary nature of the work, which also involves researchers Richard Borgens, director of Purdue's Center for Paralysis Research and the Mari Hulman George Professor of Neurology in the School of Veterinary Medicine; Stephen Byrn, the Charles B. Jordan Professor of Medicinal Chemistry, and Daniel Smith, a research assistant professor, both in the Department of Industrial and Physical Pharmacy; and Ji-Xin Cheng, an associate professor in the Weldon School of Biomedical Engineering and Department of Chemistry.

Researchers have shown how an experimental drug might restore the function of nerves damaged in spinal cord injuries by preventing short circuits caused when tiny "potassium channels" in the fibers are exposed by trauma. The compound also might be developed as a treatment for multiple sclerosis. This diagram illustrates how the drug functions as a "channel blocker," meaning it permits the conduction of signals even though the protective myelin insulation has been damaged.

The researchers subjected spinal cord tissue to stresses that mimic what happens in a compression injury, which stretches nerves. Then they treated the damaged axons with 4-aminopyridine-3-methyl hydroxide. The compound is a derivative of the drug 4-aminopyridine, used primarily as a research tool and also to manage symptoms of multiple sclerosis. The axons of each nerve are sheathed in a thick insulating lipid layer, called myelin, which enables the transmission of signals without short circuiting, much like the insulation surrounding electrical wires.

Spinal cord trauma damages the myelin sheath, exposing "fast potassium channels" that are embedded in the axons and are critical for transmitting nerve impulses. The researchers confirmed previous circumstantial evidence suggesting injury causes the myelin insulation to recede, exposing the channels and impairing signal transmission. Laboratory and imaging techniques revealed the exposed channels in damaged axons. The researchers also discovered that 4-aminopyridine-3-methyl hydroxide is a "potassium channel blocker," using a sophistic laboratory technique called "patch clamp" to measure signal conduction.

Findings confirmed that the compound prevents the exposed channels from leaking electrical current and enhances nerve conduction in segments of the damaged spinal cord. The compound could make it possible to sidestep spinal cord damage by enabling axons to transmit signals as though they were still sheathed in myelin, Shi said. Nerves transmit signals through a series of rapid electrical pulses, or "action potentials." For proper nerve function, the time gap between pulses must be as brief as possible. However, 4-aminopyridine has been shown to lengthen the gap, or "refractory period," between pulses.

The researchers found that 4-aminopyridine-3-methyl hydroxide restores function without affecting the refractory period. As a result, the damaged nerves perform more like healthy nerves than those treated with other drugs, he said. Another key advantage of the new compound is that it's about 10 times more potent than 4-aminopyridine, meaning lower doses can be used to reduce the likelihood of serious side effects.

Because myelin also is damaged in multiple sclerosis, the same drug might be used to restore nerve function in people stricken with the disease, Shi said. Since the newer drug can be used in lower doses, it might be more effective than 4-aminopyridine in treating multiple sclerosis, which affects more than 350,000 people in the United States and 2.5 million worldwide, he said.

Source: Science Codex (20/11/09)

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Breakthrough spine treatment could prevent nerve damage

In a study that appears in the medical journal Nature Nanomedicine, Purdue University researcher Ji-Xin Cheng has released a study that profiles a new treatment that could stop the secondary nerve damage caused by spinal injuries, as well as help restore movement in injury victims. By injecting tiny spheres known as copolymer micelles, rats that had suffered new spinal injuries immediately showed signs of recovery with no additional nerve damage.

The experimental surgery involves the injection of the tiny spheres, which then fuse to the initial injured nerves. This combination eliminates the possibility of inflammation and swelling in the surrounding nerves and tissues, thus decreasing the ultimate damage of the injury. Long used in surgeries and research as drug-carrying agents, the copolymer micelles are now used as a repair mechanism, something that is entirely new for these infinitesimally small spheres.

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Because of the micelles’ makeup, the tiny bodies are perfectly suited to travel through the bloodstream and not face any decomposition or rejection from the body’s immune system, nor are they affected by bodily fluids, as they thrive in fluids. By using dyed micelles, the researchers were able to prove that the spheres traveled directly to the injured area and immediately fused to the membranes to being a reparation process.

So far, in the cases of testing rats, the toxicity tests show that this process is ultimately safe. Rats that were treated immediately after their injuries showed recovery signs in all four limbs. Some of the test subjects, however, did not fare as well. The next step for this Purdue team is to test the micelles on rats that have suffered a spine injury three hours before treatment. The research team believes that if they can make progress on animals that were not treated immediately after injury, then they might be able to use this treatment process in emergency rooms for humans after accidents that led to spinal injuries.

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