Press Releases

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Multiple Sclerosis: new MRI contrast medium enables early diagnosis in animal model

In an animal model of multiple sclerosis (MS), neuroradiologists and neurologists of the University hospitals of Heidelberg and Würzburg have been able to visualize inflammatory tissue damage, most of which had remained unrecognized up to now, with the aid of a new contrast medium, Gadofluorine M, in magnetic resonance imaging. The scientists have published their results in the online edition of the renowned medical journal Brain.

In particular at the early stage of the disease, drug treatment is effective. Up to now, how-ever, an early diagnosis is frequently not established with certainty, especially if no (or very few) inflammatory lesions are present on MRI. "With this new contrast medium, we were able to visualize five to ten times more foci of inflammation in comparison to conventional MRI images and contrast media", reports Professor Dr. Martin Bendszus, Medical Director of the Department of Neuroradiology at the University hospital of Heidelberg.

Previously unrecognized patches of demyelination visible in MRI

MS is a chronic inflammatory disease of the central nervous system of unknown cause. It usually begins in young adults, and women are affected more frequently. In Germany, ap-proximately 120,000 patients are afflicted. MS is characterized by multiple inflammatory le-sions in which nerve fibers lose their myelin sheath. These patches of demyelination cause neurological malfunctions that may regress upon remyelination. At later stages, MS may re-sult in a loss of nerve fibers, leading to irreversible damage and persistent neurological symptoms. MRI plays a crucial role in the early diagnosis of MS and monitoring of the dis-ease.

The scientists from Heidelberg and Würzburg examined brains and spinal cords of animals at different stages of the disease with the new contrast medium and found significantly more inflammatory lesions than with conventional contrast media. Examinations of tissue sections from these lesions showed that these were actually foci of inflammation. The application of this new contrast medium was clearly superior to conventional contrast media, especially for the spinal cord or optical nerve, nerve regions that are particularly difficult to examine on MRI.

New contrast medium accumulates better in MS lesions

The results of the study could help dramatically improve the diagnostic work-up in MS with a potential impact on early treatment. "MS is the most frequent cause of occupational disability and handicap in young adults", explains Professor Bendszus. "New therapies have a positive influence on the course of the disease, but are often not initiated at early stages since the diagnosis of MS is not yet established. "

The new contrast medium gadofluorine M supposedly visualizes MS lesions better because it binds especially well to certain components of the extracellular matrix of inflammatory foci. Because of this, it accumulates in these lesions in higher concentrations.

Now, the next objective of the interdisciplinary working group is to further develop the new MRI contrast medium for application in clinical practice. As of now, the contrast medium is not yet approved. Additional preclinical tests are necessary for the planned clinical application.

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New Zealand has become the first country in the world to fully research the incidence of multiple sclerosis (MS) over an entire country.

A jointly funded report by the Multiple Sclerosis Society and the Health Research Council, released today, says that close to 3000 people have been clinically identified as having MS (or 71.9 per 100,000 people), with a further 1200 potentially with the condition.

The $500,000 report, which took nearly two years to compile, shows that the prevalence of MS is significantly related to regions of the country -- increasing from 50.8 people per 100,000 in Northland to 134.6 people per 100,000 in Southland.

Worldwide, MS becomes more common the further away from the equator you are.

MS is an auto-immune disease where the body produces a misdirected immune system attack on the central nervous system. There is no known cure.

The symptoms of MS usually appear and disappear unpredictably and they vary from person to person. Common symptoms include: weak or uncoordinated limbs, impaired balance, urinary dysfunction and vision problems as well as fatigue.

MS affects women at a rate three times that of men and is most often diagnosed in the late 20s to early 30s.

MSNZ national director Graham Billings said New Zealand's geographic spread, small population and consistent health services meant the study was possible.

It would become the ground work for a number of other studies into MS and trying to understand the disease, he said.

The cause of MS is still not known. However, researchers are closer to finding the answer and think that both the genetic and environmental factors are important.

"The real problem is there doesn't appear to be a single silver bullet. It's clearly possible that geographic location has something to do with it, and possibly a link to exposure to sunlight and vitamin D. And clearly there is some element of genetic background. Scotland has the highest incidence in the world," Mr Billings said.

Aspects of the results will be presented to the International MS Federation conference in Canada later this year.

Regional data of people with MS (followed by per 100,000):
Northland 82 (50.8)
Auckland 732 (59)
Waikato 177 (46.4)
Bay of Plenty 132 (50)
Gisborne 20 (46.7)
Hawkes Bay 82 (54.3)
Taranaki 72 (66.8)
Manawatu-Wanganui 120 (54)
Wellington 383 (86.2)
Nelson-Tasman 75 (77.7)
Marlborough 42 (86.8)
Canterbury 557 (103)
West Coast 40 (119.2)
Otago 234 (119.3)
Southland 148 (134.6).

People in NZ with MS:
male 720 or 24.86 percent, female 2176 or 75.14 percent.

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Montel Williams MS Foundation announces recipients of 2008 research grants
Organization distributing $325,000 to forward research on early detection, myelin restoration and new treatments for multiple sclerosis
NEW YORK, Sept. 3, 2008 ─ Continuing its commitment to furthering the scientific study of Multiple Sclerosis, The Montel Williams MS Foundation announces the recipients of its 2008 research grants. The funds, which total $325,000, are drawn solely from grassroots public donations and fundraisers.

The research grants were awarded to institutions studying new treatments for MS, methods for restoring MS-depleted myelin throughout the nervous system, and methods for early detection, which has been shown to slow or halt the progression of the disease.

"It gives me great pleasure to say that every dollar that our foundation raises from individuals throughout the year goes to research dedicated toward a cure for MS," said Montel Williams, founder, Emmy award-winning daytime talk show host and MS survivor. "We're confident that this year's grant recipients will make great strides toward our end goals."

Widely believed to be an autoimmune disease, multiple sclerosis affects more than one million people in the United States and probably more than 2 million people worldwide. The first signs of the disease usually appear between the ages of 20 and 50, and include a broad array of motor and sensory disabilities.

In order to be considered for Montel Williams MS Foundation research grants, applicants must submit applications for review by the Foundation's Scientific Advisory Board (SAB), a multidisciplinary group of leading neurologists and MS physician-scientists.

"The projects being conducted by this year's grant recipients show great promise in advancing knowledge that will lead to more effective diagnosis and treatment of MS," said Dr. Adam Kaplin, chairman of The Montel Williams MS Foundation SAB. "Early diagnosis and treatment can help arrest the suffering and loss of function brought on by MS, and understanding the causes of the disease will get us closer to a cure."

Dr. Kaplin is the Chief Psychiatric Consultant to the Multiple Sclerosis (MS) and Transverse Myelitis (TM) Centers at the Johns Hopkins University School of Medicine.

The 2008 recipients of the Montel Williams MS Foundation grants are as follows:

Stony Brook University Medical Center, Stony Brook, NY
Project Title: Biomarkers in the early detection of MS
Principal Investigator: Lauren B. Krupp, M.D.
Additional Information: www.pediatricmscenter.org

Johns Hopkins University School of Medicine, Baltimore, MD
Project Title: The Impact of Vitamin D Replacement on Immunologic Markers in MS
Principal Investigator: Benjamin Greenberg, M.D., M.H.S.
Additional Information: www.hopkinsneuro.org

University of Virginia, Charlottesville, VA
Project Title: Development of a New Treatment Regimen for Copaxone® in Relapsing/Remitting EAE
Principal Investigator: Jonathan Kipnis
Additional Information: www.virginia.edu

University of Medicine and Dentistry of New Jersey (UMDNJ), Newark, NJ
Project Title: Treg-Th17 Axis in Multiple Sclerosis
Principal Investigator: Dr. Christine Rohowsky-Kochan
Additional Information: http://njms.umdnj.edu

EpiVax Inc., Providence, RI
Project Title: Development of a Novel "Natural" Regulatory T-cell Therapy for MS
Principal Investigator: Anne Searls DeGroot, M.D.
Additional Information: www.epivax.com

Karolinska Institute, Stockholm, Sweden
Project Title: Neural Stem Cells in Multiple Sclerosis
Principal Investigator: Lou Brundin
Additional Information: www.ki.se

Neuroimmunology Unit, Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden
Project Title: Pathogenesis and Genetics of Autoimmune Neuroinflammation
Principal Investigator: Tomas Olsson
Additional Information: www.ki.se

Accelerated Cure Project for Multiple Sclerosis, Waltham, MA
Project Title: MS Repository Program
Principal Investigator: Hollie Schmidt, Vice President, Scientific Operations
Additional Information: www.acceleratedcure.org[/size][/color]


For more information on The Montel Williams MS Foundation, please visit www.montelms.org. For information about submitting grant proposals, please go to www.montelms.org/grants.
Source: press release

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Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey

Nov. 15, 2008
Fatigue is a common disabling symptom of multiple sclerosis (MS) and has a significantly negative impact on quality of life. Persons with MS enrolled in the North American Research Committee on Multiple Sclerosis (NARCOMS) Patient Registry are invited to complete follow-up surveys every six months to update their original registration information.

One of these surveys was designed to focus on the severity and impact of fatigue, and its association with other clinical parameters of MS such as physical disability.

Methods: In addition to the usual data collected in Registry update surveys such as demographic characteristics, MS-related medical history, disability and handicap, immunomodulatory and symptomatic therapies taken, and healthcare services used, the survey for this study included two validated self-report fatigue scales, the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS) and questions about the use of symptomatic management for fatigue, both pharmacologic and non-pharmacologic treatments.

This Registry update survey was mailed to all NARCOMS registrants (n= 18,595) in November 2002. Information provided by registry participants was approved for research purposes by the Yale University Institutional Review Board.

Results: The response rate for the survey was 49.5% (9205/18,595).

Severe fatigue as measured with the FSS using the developer's recommended severity cutpoint of >=36 was reported by 6691 (74%) of evaluable respondents (n=9077). A higher prevalence of severe fatigue was observed in relapsing-worsening MS compared with relapsing-stable and primary progressive MS.

A distinct pattern of fatigue was observed across the disability levels of the Patient-Determined Disease Steps (PDDS). Although there were no differences in the severity or impact of fatigue by immunomodulatory agents (IMA), respondents who recalled therapy changes in the prior six months reported different patterns of change in fatigue with lower fatigue levels reported after changing from interferon-beta to glatiramer acetate than after changing from glatiramer acetate to interferon-beta.

Concomitant therapy for fatigue was used by 47.2% of the 5799 survey respondents receiving IMA.

Conclusions: Characterizing MS symptoms like fatigue can increase awareness about their impact on persons with MS and suggest recommendations for a care plan.
Author: Olympia Hadjimichael, Timothy Vollmer and MerriKay Oleen-Burkey

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$1 million funding boost for Multiple Sclerosis research

Press release issued 9 January 2009

Funding worth around US$1 million has been secured for Apitope, a Bristol University spinout company that is looking at a potential life-altering therapy for people with Multiple Sclerosis (MS), an autoimmune disorder that affects the central nervous system.

The company, founded by Professor David Wraith in the University’s Department of Cellular and Molecular Biology, has secured the first ever investment from Fast Forward, a non-profit organisation established by the US National MS Society. The investment aims to bridge the gap between research carried out at the University and Apitope by accelerating the testing of new treatments and funding the costly 'proof of principle' stage, which any new drug must undergo before full-scale clinical trials can begin.

Professor Wraith said: “It was a fellowship from the US National MS Society that was the catalyst to devoting my life to MS research. It is with great pride that I, together with Apitope, come back to a partnership with the Society for a potentially life altering therapy for people with MS.”

MS is a debilitating disorder in which the immune system incorrectly attacks healthy tissue. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision.

Apitope is developing novel therapeutic products to revolutionise the diagnosis and treatment of chronic autoimmune and allergic disorders, representing major advances in therapy. The company has developed patented technology based on scientific evidence showing that soluble, synthetic peptides can reinstate tolerance and selectively weaken autoimmune responses. The ApitopesTM (Antigen Processing Independent epiTOPES) inhibit the immune system's harmful attack on the body while preserving normal immune responses to harmful antigens, such as infections.

Dr Keith Martin, CEO of Apitope, said: "The National MS Society's support provides a strong independent validation of our approach to the treatment of MS. We are very grateful for this funding from a world leader in MS research."

Dr Timothy Coetzee, Fast Forward’s Executive Director, said: “We are pleased to partner with Apitope to accelerate the development of innovative therapies for MS.  We are concerned about the small number of therapies in development for MS relative to other diseases and the impact that the current economic climate will have on development of new treatments for people with MS.  Fast Forward is committed to reversing this trend by deploying its resources to spur development of innovative MS therapies and bring them to market as quickly as possible.”

 

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New Interferon Formulations Promise to Eliminate Injections in Multiple Sclerosis Treatment

Jan 12, 2009

Nerveda Inc. and Aegis Therapeutics LLC today announced preclinical results from their joint collaboration aimed at developing non-injectable formulations of the beta-interferons. The beta interferons, beta-1a (tradename Rebif(R)), and beta 1b (tradenames Betaseron(R) and Betaferon(R)) are closely related injectable protein drugs in the interferon family that are used to treat both the relapsing-remitting and secondary-progressive forms of multiple sclerosis (MS). The beta interferons are currently administered by subcutaneous injection and have been proven clinically to slow the advance of multiple sclerosis and reduce the frequency of attacks. Current worldwide combined annual sales of Rebif(R), Betaseron(R) and Betaferon(R) are approximately $4 Billion.

Because proteins are large and fragile molecules, they cannot be administered orally and are typically administered by injection. They are often subject to instability due to aggregation of the protein molecules -- particularly upon storage and handling at non-refrigerated temperatures. The resulting protein aggregates are more poorly absorbed into the blood stream upon injection due to their increased size, and induce development of circulating antibodies to interferon in patients that reduce the effectiveness of the drug over time.

Leading medical scientists at Johns Hopkins University, expert in the treatment of neurological diseases, in collaboration with Nerveda and Aegis have applied Aegis' Intravail(R) transmucosal absorption enhancement, and ProTek(R) protein stabilization technologies to address these problems and have demonstrated for the first time that the beta interferons can be administered intranasally to prevent nerve damage in preclinical animal models of multiple sclerosis. In addition, the new formulations were shown to reduce or eliminate the immunogenicity of Betaseron(R) and Rebif(R), administered either by injection or intranasally, while substantially increasing stability in a stress test involving constant agitation at elevated temperatures for extended periods of time.

Dr. Edward Maggio, Ph.D., CEO of Aegis Therapeutics, who participated in the research, said, "since interferons will continue to be the foundation of MS therapy, it is critical that non-invasive delivery options for patients be developed." Maggio also indicated, "the reduction in immunogenicity and the increase in stability also address a significant unmet need of the currently available beta-interferon therapies."

Nerveda plans to begin testing the new formulation in clinical trials in early 2009 in collaboration with clinicians and scientists at John Hopkins University Medical Center and other sites.

* Rebif(R) is a registered trademark of Pfizer, Inc.

* Betaseron(R) is a registered trademark of Bayer Healthcare Pharmaceuticals

* Betaferon(R) is a registered trademark of Bayer Schering Pharma AG

* Intravail(R) and ProTek(R) are registered trademarks of Aegis Therapeutics, LLC
About Nerveda Inc.

Nerveda is a privately funded specialty pharmaceutical and diagnostic company focused on improving the quality of life for patients suffering from neurodegenerative diseases and their caregivers. Nerveda supports the clinical development of products licensed from Johns Hopkins University, including neuroprotective compounds and stem cell therapeutics that show promise in treating auto-immune disorders.
About Aegis Therapeutics

Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented or proprietary drug delivery and drug formulation technologies through product-specific licenses. Our patented Intravail(R) drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide macromolecular therapeutics that can currently only be administered by injection. Aegis' Intravail(R) absorption enhancement agents provide exceptionally high and unmatched bioavailability performance, comparable in efficiency to subcutaneous injection, via the intranasal administration route. Intravail(R) has also been successfully applied to buccal, oral, and rectal administration of small molecule, peptide, and nucleotide-analog type drugs. Our patented ProTek(R) technology allows creation of proprietary, easily manufacturable, and stable aqueous or lyophilized dosage forms that maintain the integrity and physiological activity of many protein and peptide therapeutics. ProTek(R) technology is applicable to injectable, intranasal, and other dosage forms of peptide or protein therapeutics.

For more information about Aegis, please visit the Aegis website at: http://www.aegisthera.com.


SOURCE: Aegis Therapeutics LLC/ Press Release

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Stem cell transplant reverses early stage multiple sclerosis

Researchers from Northwestern University's Feinberg School of Medicine appear to have reversed the neurological dysfunction of early-stage multiple sclerosis patients by transplanting their own immune stem cells into their bodies and thereby "resetting" their immune systems.

"This is the first time we have turned the tide on this disease," said principal investigator Richard Burt, M.D. chief of immunotherapy for autoimmune diseases at the Feinberg School. The clinical trial was performed at Northwestern Memorial Hospital where Burt holds the same title.

The patients in the small phase I/II trial continued to improve for up to 24 months after the transplantation procedure and then stabilized. They experienced improvements in areas in which they had been affected by multiple sclerosis including walking, ataxia, limb strength, vision and incontinence. The study will be published online January 30 and in the March issue of The Lancet Neurology.

Multiple sclerosis (MS) is an autoimmune disease in which the immune system attacks the central nervous system. In its early stages, the disease is characterized by intermittent neurological symptoms, called relapsing-remitting MS. During this time, the person will either fully or partially recover from the symptoms experienced during the attacks. Common symptoms are visual problems, fatigue, sensory changes, weakness or paralysis of limbs, tremors, lack of coordination, poor balance, bladder or bowel changes and psychological changes.

Within 10 to 15 years after onset of the disease, most patients with this relapsing-remitting MS progress to a later stage called secondary progressive multiple sclerosis. In this stage, they experience a steady worsening of irreversible neurological damage.

The 21 patients in the trial, ages 20 to 53, had relapsing-remitting multiple sclerosis that had not responded to at least six months of treatment with interferon beta. The patients had had MS for an average of five years. After an average follow-up of three years after transplantation, 17 patients (81 percent) improved by at least one point on a disability scale. The disease also stabilized in all patients.

In the procedure, Burt and colleagues treated patients with chemotherapy to destroy their immune system. They then injected the patients with their own immune stem cells, obtained from the patients' blood before the chemotherapy, to create a new immune system. The procedure is called autologous non-myeloablative haematopoietic stem-cell transplantion.

"We focus on destroying only the immune component of the bone marrow and then regenerate the immune component, which makes the procedure much safer and less toxic than traditional chemotherapy for cancer," Burt said. After the transplantation, the patient's new lymphocytes or immune cells are self-tolerant and do not attack the immune system.

"In MS the immune system is attacking your brain," Burt said. "After the procedure, it doesn't do that anymore."

In previous studies, Burt had transplanted immune stem cells into late-stage MS patients. "It didn't help in the late stages, but when we treat them in the early stage, they get better and continue to get better," he said.

"What we did is promising and exiting, but we need to prove it in a randomized trial," Burt noted. He has launched a randomized national trial.

For more information visit : http://clinicaltrials.gov/ct2/show/NCT00273364

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Multiple Sclerosis - Bayer Offers New Betaferon(R) Titration Pack

Bayer will launch a titration pack for patients with multiple sclerosis (MS) that is specially designed to make it easier for them to start Betaferon® (interferon beta-1b) therapy. From now on, the titration pack will be available in Germany. More European countries will follow in 2009. The four-week pack facilitates a gradual increase in dose as recommended for patients new on Betaferon®.

Betaferon® is a well-established therapy for people starting their MS treatment as early as after the first signs of the condition. Findings from the recent landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) trial have shown that gradual dose titration of the medication contributes to a high acceptance of Betaferon® treatment from the start. Delivering Betaferon® in an easy-to-use titration pack for the first four weeks of therapy will simplify the titration process for physicians, MS-nurses and patients.

"The new pack will make it easier for people with MS to start therapy. The titration process helps the body to better adjust to the medication, resulting regularly in fewer side effects. This is important because greater patient comfort, especially during the start of the therapy, can improve patient compliance to therapy and, consequently, its effectiveness," said Habib Dable, Vice President and Global Head, Neurology/Ophthalmology of Bayer Schering Pharma`s Global Business Unit Specialty Medicine.

The launch of the new titration pack for Betaferon® underscores the ongoing commitment of Bayer to bridge the gap between treatment and care by addressing the day-to-day needs of people living with MS.

About Betaferon® / Betaseron®

Betaferon®, which is marketed in the U.S. and Canada under the trademark Betaseron®, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. In the U.S., Europe and Japan, Betaferon® has been approved for all relapsing forms of MS. Betaferon® (interferon beta-1b) has achieved one million patient years of experience in the treatment of multiple sclerosis (MS). The accomplishment, coupled with 16 years of follow-up clinical data, makes Betaferon® the MS therapy with the longest experience.

About Multiple Sclerosis

MS is a chronic, progressive disease of the central nervous system and the likelihood of disability increases the longer someone has MS. Symptoms of MS vary from person to person and can be unpredictable. They may include: Fatigue or tiredness, dimness of vision in one or both eyes, weakness in one or more extremities, numbness and tingling in the face, arms, legs and trunk of the body, spasticity (muscle stiffness), dizziness, double vision, slurred speech and loss of bladder control.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.
Source
Bayer HealthCare