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Tuesday

 

Biogen Idec shares rise on drug sales outlook

NEW YORK - Biogen Idec Inc. shares rose Monday, bucking a declining market as analysts continued to maintain a positive outlook for sales of the biotechnology company's multiple sclerosis drugs.
Shares rose $1.27, or 2.6 percent, to $51.04 in afternoon trading. Meanwhile, the Dow Jones Industrial average and other indexes plummeted as the House failed to pass a $700 billion financial bailout package for the financial sector.
Wall Street has remained positive on the outlook for Biogen's multiple sclerosis drug Tysabri, despite potential safety issues. Tysabri was pulled from the market in 2005 after being linked to a rare brain disease called progressive multifocal leukoencephalopathy, or PML. The drug was reintroduced in mid-2006 under restricted sales conditions. About 32,000 patients are on Tysabri worldwide, with 17,800 in the U.S., and the company hopes to eventually get 100,000 patients worldwide.
In July, the company reported two new cases of PML. Still, analysts have been pointing to sales estimates from pharmaceutical data company IMS Health (nyse: RX - news - people ) showing gains for both Tysabri and the multiple sclerosis drug Avonex.
"We do concede that IMS sales tracking for Tysabri is highly variable, but are encouraged by the August trends," Citi analyst Dr. Yaron Werber said in a note to investors.
He said a projected sales of about $115 million for the quarter for Tysabri are consistent with his $114 million estimate. Based on discussions with physicians, he said, the vast majority are not planning on changing usage of Tysabri.
Meanwhile, sales of Avonex seem to tracking at about $316 million, compared with his estimate of $332 million, but an average estimate of $308 million.
Werber reaffirmed a "Hold" rating on the Cambridge, Mass.-based company.
Associated Press
Forbes.com
CLICK HERE FOR FULL STORY & RELATED ARTICLES

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Oral drug teriflunomide study recruiting

This study will assess the safety and effectiveness of an investigational study medication versus placebo (an inactive substance which contains no active medication) in people ages 18-55 years old with RRMS.

The investigational medication used in this study is called teriflunomide. You can find out more about participating here.

MSNews

accelereatedcure.org

CLICK HERE FOR MORE INFORMATION


 

Medicare no longer requires you to reuse catheters

People using intermittent catheters no longer need to re-use their catheters due to a new Medicare policy effective April 1, 2008. The change affects nearly 1 million individuals living with spinal cord injury, multiple sclerosis and spina bifida, as well as those who have other permanent conditions requiring bladder management or experience urinary incontinence or retention.

MSNews - News for the MS Community
acceleratedcure.org
CLICK HERE TO FOR MORE INFORMATION

Saturday

 

Neural Cells Derived From Human Embryonic Stem Cells Reduce Symptoms in EAE

I've corrected the headline from this report to reflect the mouse-vs-human results, but either way they are promising.

While the title claims it is reducing symptoms, if you look at Figure 2 from the paper it appears to have mostly halted the progression after administration rather than caused a big improvement (although there was some).

Let's inject some of these cells into humans and see if they do the same thing.

MS News
Accelerated Cure Project

CLICK HERE FOR FULL STUDY INFORMATION & LINKS

 

Study supports stress-relapse link

Stressful life events have been associated with MS relapses in past research studies, but the findings haven't been unanimous. A new study adds to the evidence that there is a connection between stress and relapses, at least in women.

In this study, researchers followed 26 women with relapsing-remitting MS for a little over a year on average. The women recorded stressful life events (SLEs) in diaries, classifying them as having a long term impact (at least 10-14 days) or not. They also determined how severe each SLE was. When this information was combined with relapse records, the researchers found that having three or more SLEs in four weeks resulted in a 5-fold increase in relapse rate, and having one long-term SLE increased the risk of relapse during the following month by three times. Relapse risk was not affected by severity or type of stressful event.

So if you have MS and are able to reduce the number of stressful events in your life, you may experience fewer relapses (while also reducing the other harmful effects of stress).

MS News
Accelerated Cure Project
CLICK HERE FOR FULL STUDY AND RELATED INFO

 

Cognitive impairment and structural brain damage in benign multiple sclerosis

Objective: Although in benign multiple sclerosis (BMS) locomotor disability is absent or only minimal, subclinical cognitive impairment seems to occur in many cases. Diffusion tensor (DT) MRI enables us to quantify the extent of "actual" tissue damage, which goes undetected when using conventional MRI. Against this background, we investigated the extent of structural brain damage underlying cognitive dysfunction in BMS, with the ultimate aim to move a first step toward a more reliable definition of this disease phenotype.

Conclusions: In benign multiple sclerosis (BMS), cognitive dysfunction is associated with severe structural brain damage, which resembles that of patients with a much more disabling disease course. A reliable definition of BMS should, therefore, include the preservation of cognitive functioning as an additional requisite.

Published online before print September 24, 2008
(Neurology 2008, doi:10.1212/01.wnl.0000319694.14251.95)
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

Review: reflexology improved urinary symptoms in multiple sclerosis but was not effective for other outcomes in various conditions

QUESTION: What is the efficacy and safety of reflexology in patients with any condition?

REVIEW SCOPE: Studies selected compared reflexology with control or other interventions in patients with any condition; reported outcomes of symptom relief, psychological wellbeing, quality of life, or perception of reflexology; and had quality assessment ratings of fair or above according to US Preventive Services Task Force criteria. Excluded studies evaluated combination therapies of reflexology with other interventions, a young age group {ie, <18 y},* <10 participants/group, or provided insufficient information about the principal measures of effect. Outcomes were urinary symptoms, paraesthesia, muscle strength, spasticity, lung function, menopausal symptoms, anxiety, depression, quality of life, improvement of symptoms of irritable bowel syndrome, leg circumference, and adverse events.

Evidence-Based Nursing 2008;11:112; doi:10.1136/ebn.11.4.112
CLICK HERE FOR THE LINK TO THE FULL TEXT REVIEW ARTICLE

 

Concomitant radiochemotherapy in a patient with multiple sclerosis and glioblastoma.

Department of Neurology, LBI-Neurooncology, Kaiser Franz Josef Hospital, Vienna, Austria.

The coincidence of multiple sclerosis (MS) and glioblastoma has been reported in several anecdotal reports. Little is known concerning the effects of radio- and/or chemotherapy on demyelinating brain lesions in MS patients.

This report demonstrates that concomitant radiochemotherapy according to the STUPP protocol, was safe in our patient with respect to the radiological as well as the clinical course of multiple sclerosis.

Publication Type: Journal article PMID: 18808066
HighWires Press Stanford University
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

Analysis of cerebrospinal fluid and cerebrospinal fluid cells from patients with multiple sclerosis for detection of JC virus DNA.

Department of Clinical Neuroscience, Neuroimmunology Unit, Karolinska Institute at Karolinska University Hospital, Stockholm, Sweden;

Objective: 1) To determine whether JC virus (JCV) DNA was present in the cerebrospinal fluid (CSF) and blood from patients with multiple sclerosis (MS) in comparison with controls and 2) to find out if our clinical material, based on presence of JCV DNA, included any patient at risk for progressive multifocal leukoencephalopathy (PML).

Conclusion: A low copy number of JCV DNA may occasionally be observed both in MS and other diseases and may occur as part of the normal biology of JC virus in humans. This study does not support the hypothesis that patients with MS would be at increased risk to develop PML, and consequently screening of CSF as a measurable risk for PML is not useful.

PMID: 18805840
HighWire Press Stanford University
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

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Interferon-{beta} bioactivity measurement in multiple sclerosis: feasibility for routine clinical practice.

Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands.

Background: Neutralising antibodies (NAb) to interferon beta (IFNbeta) are associated with a reduced bioactivity and efficacy of IFNbeta in multiple sclerosis (MS). Unclear is how to apply IFNbeta bioactivity measurements (quantification of Myxovirus resistance protein A (MxA) mRNA) in clinical practice.

Objectives: To evaluate value and feasibility of IFNbeta bioactivity measurement with a single MxA mRNA measurement for screening and a second measurement before and after IFNbeta administration for definite confirmation of IFNbeta bioactivity status.

PMID: 18805837
HighWire Press Stanford University
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

'Restricting choices and limiting independence': social and economic impact of multiple sclerosis upon households by level of disability.

Department of Health and Human Sciences, University of Essex, UK

OBJECTIVE: To examine the relationship between the social and economic impact of multiple sclerosis (MS) and levels of MS-related disability upon households in the following domains: household composition, housing modification, employment, standard of living, children, intimate and close relationships, and social life.

DISCUSSION: MS restricts social and economic opportunities for pwMS and those who they live with. These findings extend the literature to households to illustrate the impact of MS not only on pwMS but also on their partners, children and other family members.

Publication Type: Journal article PMID: 18796505
HighWire Press Stanford University
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

Cognitive impairment in multiple sclerosis.

Department of Neurology, University of Catania, Catania, Italy.

Background: Cognitive impairment is increasingly being recognized as a common and disabling symptom of multiple sclerosis (MS) that contributes to poor quality of life in affected patients.

Conclusions: It is only through further studies that it will be possible to identify patients with, or at risk of, cognitive impairment and to provide appropriate therapy to limit the effects of this potentially devastating symptom.

PMID: 18805842
HighWire Press Stanford University
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

Differential diagnosis of suspected multiple sclerosis: a consensus approach.

Department of Inflammation, Institute of Neurology, NMR Research Unit, University College London, UK.

Background and objectives: Diagnosis of multiple sclerosis (MS) requires exclusion of diseases that could better explain the clinical and paraclinical findings. A systematic process for exclusion of alternative diagnoses has not been defined. An International Panel of MS experts developed consensus perspectives on MS differential diagnosis.

Conclusions: Differential diagnosis leading to MS or alternatives is complex and a strong evidence base is lacking. Consensus-determined guidelines provide a practical path for diagnosis and will be useful for the non-MS specialist neurologist. Recommendations are made for future research to validate and support these guidelines. Guidance on the differential diagnosis process when MS is under consideration will enhance diagnostic accuracy and precision.

PMID: 18805839
HighWire Press Stanford University
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Autoimmune disease and the female patient.

Department of Oral and Maxillofacial Surgery, New York University College of Dentistry, 345 East 24th Street, New York, NY 10010, USA.

This article focuses on the pathogenesis of the gender gap of autoimmune disease. Specifically, the discussion characterizes the role of sex hormones in the immune response and a female predilection for the common diseases seen in daily practice (ie, lupus erythematosus, myasthenia gravis, and other autoimmune diseases). A comparison between the sexes, with respect to autoimmune disease mechanisms, is presented to give oral and maxillofacial surgeons a better insight as to the role of sex and successful surgical treatment outcomes in this population of patients.

PMID: 18088874 [PubMed - indexed for MEDLINE]
Oral Maxillofac Surg Clin North Am. 2007 May;19(2):153-62, v.
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

Cellular remyelinating therapy in multiple sclerosis.

Department of Neurology, Thomas Jefferson University, 900 Walnut Street, Room 300, Philadelphia, Pennsylvania 19107, United States.

Demyelination is a pathological hallmark of multiple sclerosis (MS), a chronic autoimmune disorder of the central nervous system (CNS) that affects mainly young people in western countries. Recent studies have shown that remyelination can be accomplished by supplying demyelinated regions with myelinogenic cells or neural stem cells via transplantation.....

....Here we present a brief view focusing on myelin-forming cell types that can be used for cell transplantation and draw on a variety of recent experimental findings to speculate on the likely future evolution of remyelinating therapies.

PMID: 18814888 [PubMed - as supplied by publisher]
J Neurol Sci. 2008 Sep 23. [Epub ahead of print]
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

The efficacy of reflexology: systematic review.

Graduate Institute of Medical Science, College of Medicine, Taipei Medical University, Taiwan.

AIM: This paper is a report of a systematic review to evaluate the efficacy of reflexology in any condition.

BACKGROUND: Anecdotal evidence has shown potential benefits of reflexology in a variety of health conditions. However, the efficacy of reflexology has yet to be determined.

CONCLUSION: There is no evidence for any specific effect of reflexology in any conditions, with the exception of urinary symptoms associated with multiple sclerosis. Routine provision of reflexology is therefore not recommended.

PMID: 18489444 [PubMed - indexed for MEDLINE]
J Adv Nurs. 2008 Jun;62(5):512-20.
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

Cognitive impairment and structural brain damage in benign multiple sclerosis.

From the Neuroimaging Research Unit (M.R., G.R., M. Filippi) and Department of Neurology (M.R., E.J., F.P., M. Falautano, V.M., G.C., M. Filippi), Scientific Institute and University Ospedale San Raffaele, Milan; Department of Neurology (D.C.), Scientific Institute Don Gnocchi, Milan; Multiple Sclerosis Center (A.G.), Ospedale di Gallarate, Gallarate; Multiple Sclerosis Center (A.B.), Ospedale di Orbassano, Orbassano; and Multiple Sclerosis Center (R.C., F.M.), Spedali Civili, Brescia, Italy.

OBJECTIVE: Although in benign multiple sclerosis (BMS) locomotor disability is absent or only minimal, subclinical cognitive impairment seems to occur in many cases. Diffusion tensor (DT) MRI enables us to quantify the extent of "actual" tissue damage, which goes undetected when using conventional MRI. Against this background, we investigated the extent of structural brain damage underlying cognitive dysfunction in BMS, with the ultimate aim to move a first step toward a more reliable definition of this disease phenotype.

CONCLUSIONS: In benign multiple sclerosis (BMS), cognitive dysfunction is associated with severe structural brain damage, which resembles that of patients with a much more disabling disease course. A reliable definition of BMS should, therefore, include the preservation of cognitive functioning as an additional requisite.

PMID: 18815387 [PubMed - as supplied by publisher]
Neurology. 2008 Sep 24. [Epub ahead of print]
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

Wednesday

 

RxTrials Institute Drug Pipeline Alert

Primary Endpoint Met in Merck Serono’s MS Trial

Merck Serono received promising findings from its Phase IIIb study using a new formulation of Rebif in patients with relapsing-remitting multiple sclerosis (MS).

The two-arm, randomized, double-blind, controlled, multicenter, international study evaluated the efficacy, safety and tolerability of the drug in 180 patients.

The primary efficacy analysis showed that, at week 16, the number of combined unique active brain lesions was lower in patients treated with the drug than in patients who received a placebo. The mean number of combined unique active brain lesions per patient was reduced by 69 percent in patients treated with the drug, Merck said.

FDA News

CLICK HERE FOR THE REPORT & RELATED ARTICLES


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Monday

 

Laquinimod Demonstrated Significant and Sustained Impact on Multiple Sclerosis Disease Activity

Jerusalem, Israel & Lund, Sweden September 18, 2008

New data from the extension phase of oral laquinimod in relapsing-remitting multiple sclerosis (RRMS) demonstrated a significant reduction in the mean number of gadolinium-enhancing (GdE) lesions in both patients who switched from placebo to laquinimod and patients who continued with their initial laquinimod dose.

In RRMS patients who switched from placebo to laquinimod, 52 percent reduction in the mean number of GdE lesions was observed (p<0.0007). The reduction was significant for both patients switching to high-dose (p<0.009) and low-dose laquinimod (p<0.03). In addition, the proportion of patients who switched to active treatment from placebo, and remained enhancing lesion-free, increased from 31 percent to 47 percent (p<0.012), further reinforcing the efficacy of laquinimod on magnetic resonance imaging (MRI) measured disease activity.

Patients initially treated with 0.6mg/day and 0.3mg/day during the double-blind trial remained on the same dose during the 36-week extension phase. An additional significant reduction in the mean number of GdE lesions was also observed in these patients (n=94, p=0.0062 and n=80, p=0.0013, respectively), a high proportion of which remained completely free of GdE lesions, demonstrating the sustained effect of laquinimod on MRI disease activity.

“These latest data show the rapid onset and sustainability of laquinimod efficacy in MS patients,” said Giancarlo Comi, M.D., University Vita-Salute San Raffaele, Scientific Institute San Raffaele, Milan, Italy, principal investigator of the study. “Just as exciting is the fact that, with increased number of patients exposed to laquinimod, we found no new risks or safety issues. This reinforces earlier results demonstrating the laquinimod safety profile. The MS community looks forward to future data as we continue enrolling patients in the laquinimod Phase III clinical program.”

These new data from the extension study build upon the initial 36-week, Phase IIb study results published in The Lancet*, which demonstrated that once-daily, oral 0.6mg laquinimod significantly reduced MRI disease activity by a median of 60 percent, compared to placebo, and was well tolerated.

Teva is currently enrolling patients for Allegro and Bravo, two pivotal Phase III clinical trials of laquinimod. For more information please visit www.TevaClinicalTrials.com.

Pipeline Review.com
CLICK HERE FOR FULL STORY & RELATED INFORMATION

 

Assessment: the use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review):

report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.

University of California at San Francisco, USA.

The clinical and radiologic impact of natalizumab (Tysabri) as therapy for multiple sclerosis (MS) is assessed. On the basis of Class I evidence, natalizumab has been demonstrated to reduce measures of disease activity and to improve measures of disease severity in patients with relapsing-remitting (RR) MS (Level A). The relative efficacy of natalizumab compared to current disease-modifying therapies cannot be defined accurately (Level U). Similarly, the value of natalizumab in the treatment of secondary progressive (SP) MS is unknown (Level U).

PMID: 18765653 [PubMed - in process]
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

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The vitamin D deficiency pandemic and consequences for nonskeletal health: Mechanisms of action.Holick MF.

Department of Medicine, Section of Endocrinology, Nutrition, and Diabetes, Vitamin D, Skin and Bone Research Laboratory, Boston University Medical Center, Boston, MA, United States.

Vitamin D, the sunshine vitamin, is important for childhood bone health. Over the past two decades, it is now recognized that vitamin D not only is important for calcium metabolism and maintenance of bone health throughout life, but also plays an important role in reducing risk of many chronic diseases including type I diabetes, multiple sclerosis, rheumatoid arthritis, deadly cancers, heart disease and infectious diseases.

PMID: 18801384 [PubMed - as supplied by publisher]
CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

[Acute disseminated encephalomyelitis: study of factors involved in a possible development towards multiple sclerosis.]

Acute disseminated encephalomyelitis (ADEM) is an uncommon disease characterized by inflammation and demyelination of the central nervous system (CNS). It typically occurs after a viral infection or vaccination and is more frequent in children. Its immediate and longterm prognosis is expected to be good (20% of cases with sequelae).........

...Our work supports that also observed in recent publications: that both conversion to MS or presence of sequelae after an episode of ADEM are more frequent than traditionally considered.

Neurologia. 2008 Sep 18. [Epub ahead of print]
PMID: 18802800 [PubMed - as supplied by publisher]
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Adherence to Mediterranean Diet Reduces Risk of Major Chronic Diseases

September 15, 2008 — Sticking with any diet is difficult, but the incentives of adhering to the traditional Mediterranean diet are particularly beneficial, a new meta-analysis has shown [1]. Strictly following the Mediterranean diet reduced the risk of dying from cancer and cardiovascular disease as well as the risk of developing Parkinson's and Alzheimer's disease, and investigators say that greater adherence can be a relatively simple tool to reduce the risk of premature death in the general population.

"The practical implication is that we are able to talk to our patients and show them that sticking to this diet, the specific characteristics of the diet, improves their overall health and quality of life," lead investigator Dr Francesco Sofi (University of Florence, Italy) told heartwire. "This is good information to give, especially if we're able to tell them something as simple as eating more fruits and vegetables."

Individuals who stuck strictly to a Mediterranean diet—defined as a two-point increase in the adherence score—had significant improvements in their overall health, including a 9% reduction in all-cause mortality, a 9% reduction in mortality from cardiovascular disease, and 6% reduction in cancer mortality. Although only three trials examined the association between adhering to the diet and the risk of Parkinson's and Alzheimer's disease, there was a reduced risk of these diseases when individuals closely followed the Mediterranean diet.

"The results overall showed that increasing two points on the adherence score results in a significant protective effect in terms of chronic diseases," said Sofi. "The study supports the current guidelines and recommendations of all the current scientific organizations that encourage the Mediterranean diet. It does say more, however, in terms of adherence, meaning it is important to actually stick with the diet."

In terms of applying the findings to the real world, Sofi said creating an adherence score based on "a theoretically defined Mediterranean diet" could be used as preventive tool for reducing the risk of mortality and morbidity in the general population. However, he added, it is important to define the diet properly.

"The problem with the literature is that a lot of papers suggest eating in a Mediterranean way, but what is the Mediterranean way? That's the problem. If you ask two subjects, you're going to get two different answers. We need to attempt to develop the characteristics of the Mediterranean diet and create the adherence score based on that."

Medscape Today
CLICK HERE FOR FULL STORY & RELATED INFORMATION

 

COPAXONE® INJECTION HELP LINE...PLUS "injection tips that can help over the long term"


The following story was posted today on our MS News Channel MySpace Blog.

It is one of 4,613 stories on our MySpace Blog! Our 3,300 MySpace Friends have made 29,896 Comments & 42,234 Kudos on the 4,613 stories!

CLICK HERE TO GO TO THE NEWS CHANNEL MYSPACE BLOG & LEAVE A COMMENT

CLICK HERE TO GO TO THE COPAXONE'S INJECTION ASSISTANCE SITE

I copied and pasted the following from Copaxone's Injection Assistance Page:

COPAXONE® injection tips that can help over the long term

It may be more comfortable to inject your COPAXONE® if it's at room temperature, so make sure to take your COPAXONE® out of the refrigerator at least 20 minutes before you are ready to inject.

Try applying a warm compress to the injection site for 5 minutes before injecting. Be sure to heat the compress (according to the manufacturer's instructions), and then place a cloth barrier between the heated pack and your skin. Remember not to use a heat pack in any area where sensation of temperature is impaired

Everybody is different: Changes in body size or weight may affect proper autoject® 2 for glass syringe settings. Learn more about setting your autoject2 for glass syringe.

Help keep your skin healthy! Rotating your COPAXONE® injection sites each day reduces the potential for injection site reactions such as swelling, pain, itching, redness, lumps and skin indentations, which can happen with any injectable therapy including COPAXONE®

COPAXONE® can be stored at room temperature (between 59°F and 86°F) for up to one month, offering more flexibility when refrigeration isn't available.

-- As a general rule, we recommend that you keep your COPAXONE® in the refrigerator as part of your regular routine. But, what this new extended storage time offers you is added flexibility during travel or special circumstances. It's just one more way COPAXONE® can fit your lifestyle. Think of your COPAXONE® injections as your daily dose of empowerment helping you to fight your multiple sclerosis! Remember to take advantage of our online videos for injection techniques, as well as our online COPAXONE® injection guide.

And for more about the resources available from Shared Solutions®, click here or call 1-800-887-8100.

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Bayer Joins Other Multiple Sclerosis Drugmakers in Showing Early Treatment is Beneficial (Update 2)


Researchers with Bayer AG state that findings from a study with multiple sclerosis (MS) patients has shown that giving their drug Betaferon (Betaseron in the U.S.) on the first signs of the disease is more effective by between 37 and 45 percent than if given later. Further details.

In a five year study involving 468 patients, Bayer´s multiple sclerosis (MS) treatment Betaferon/Betaseron was shown to be more effective when given on the first sign of the disease than if treatment is delayed, researchers said in a presentation at the World Congress on

Treatment and Research in Multiple Sclerosis, being held in Montreal, Canada.
Compared to initial placebo treatment, early use of Betaferon/Betaseron delayed the onset of definite MS by 37 percent or 45 percent over a five-year period, depending which of two commonly used definitions of MS was used, the five-year study showed.

In the trial, one group was given the drug on the first symptoms pointing to MS, while the other group received a placebo at first and was switched to Betaferon as soon as a second attack occurred or after two years at the latest.

The study suggested that no time should be wasted after the first MS attack because some of the early nerve damage resisted repair by later therapy, stated Mark Freedman, professor of neurology and lead investigator of the study.

Further analysis showed that patients treated earlier had less severe disabilities and impairment of cognitive functions as the disease progressed than those in the control group.

Bayer bought Betaferon/Betaseron as part of its acquisition of German competitor Schering AG in 2006, in a $ 22 billion-dollar deal. The Betaferon/Betaseron injection earned Bayer and partner Schering Pharma $ 855 million dollars in the first half of 2008.

Last week, Germany´s Merck KGaA announced the launching of a new late-stage Phase III clinical trial of its experimental MS pill cladribine, also to explore the benefit of using the drug on the first signs of MS.

Merck is racing other drugmakers, including Novartis, to develop the world´s first MS drug that can be given by mouth, to take market share from the prevailing injections (such as Bayer´s Betaferon/Betaseron).

Cladribine tablets have already been granted a fast track designation by the U.S. Food and Drug Administration (FDA).

Merck has its own MS injection treatment, Rebif, with sales of over $ 1 billion dollars in the first six months of the year. The other strong competitors are Teva´s Copaxone, with earnings of $ 1.1 billion dollars in the first half of 2008, and Biogen´s Avonex, $ 1.06 billion dollars for the same period.




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Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple Sclerosis

GENEVA, Switzerland, September 22 /PRNewswire/ --

- Study Meets Primary Endpoint by Demonstrating Significant Effect of new Formulation of Rebif(R) on Disease Activity as Measured by MRI After 16 Weeks of Treatment

- Data Presented at Late-Breaking Session of the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the ongoing IMPROVE (Investigating MRI Parameters with Rebif imprOVEd formulation) study met its primary endpoint. The primary objective of the study was to evaluate the efficacy of the new formulation of Rebif(R), compared to placebo, in patients with relapsing-remitting multiple sclerosis (RRMS) and active disease by means of magnetic resonance imaging (MRI) at the end of 16 weeks of treatment. The 16-week study results show that the mean number of combined unique active brain MRI lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif(R) compared with those receiving placebo, a statistically significant result (p"Patients who received Rebif(R) experienced far fewer new active brain MRI lesions than the placebo group after 16 weeks of treatment," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa, Director of the MS Research Clinic at the Ottawa Hospital, and an investigator of the IMPROVE trial. "These data demonstrate a significant effect of the new formulation of Rebif(R) on disease activity and provide further evidence of its benefit in treating patients with relapsing-remitting multiple sclerosis."

The IMPROVE study is a two-arm, randomized, double-blind, controlled, multicenter, international Phase IIIb study to evaluate the efficacy, safety and tolerability of the new formulation of Rebif(R) in patients with RRMS according to the revised McDonald criteria and evidence of active disease. A total of 180 patients were randomized in a 2:1 ratio to receive either the new formulation of Rebif(R) 44 micrograms three times a week subcutaneously, or placebo for an initial period of 16 weeks. At the end of this initial 16-week treatment period, patients from the placebo group have been switched in a single-blinded fashion to treatment with the new formulation of Rebif(R) 44 micrograms three times a week subcutaneously for a period of 24 weeks (the physician assessing treatment response and side effects is blinded). Patients who were initially assigned to the new formulation of Rebif(R) group continue to receive active treatment for an additional period of 24 weeks. The duration of the whole treatment period is 40 weeks.

The primary endpoint of the study is the difference between the number of combined unique active MRI lesions at week 16 in the group treated with the new formulation of Rebif(R) versus the placebo group. Combined unique active MRI lesions are defined as an active lesion on T1 sequence with gadolinium or T2 sequence, or both, avoiding double counting. The primary endpoint mainly reflects inflammatory activity (gadolinium-enhancing T1 lesions), but also reflects disease progression (T2 lesions).

The primary efficacy analysis showed that, at week 16, the number of combined unique active brain lesions was significantly lower in patients treated with the new formulation of Rebif(R) than in patients who received a placebo (pResults for the secondary and tertiary endpoints of the IMPROVE study will be available at the end of the 40-week treatment period.

The safety profile of the new formulation of Rebif(R) reported in this study is consistent with the known safety profile of Rebif(R). No unexpected safety concerns were identified in this study.

The new formulation of Rebif(R) was approved in the European Union in August 2007 and in Canada in September 2007. It is now marketed in all EU countries and in Canada. The new formulation of Rebif(R) is not available in the United States.

About Rebif(R):
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif(R) in chronic progressive MS has not been established. Interferons are thought to help modulate the body's immune system and reduce inflammation. The exact mechanism is unknown.Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif(R) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area.* Rebif(R) is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms).Rebif(R) should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif(R) with their doctors. For more information about Rebif(R), please visit http://www.mslifelines.com/ for prescribing information.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

About Merck Serono and multiple sclerosis:
Merck Serono is a leader in multiple sclerosis (MS) with Rebif(R) (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. Full prescribing information for Rebif(R) can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

About multiple sclerosis:
Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, disabling, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono:
Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.Merck Serono has leading brands serving patients with cancer (Erbitux(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)), endocrine and cardiometabolic disorders (Glucophage(R), Concor(R), Euthyrox(R), Saizen(R), Serostim(R)), as well as psoriasis (Raptiva(R)). With an annual R&D expenditure of around EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck:
Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since. For more information, please visit http://www.merckserono.net/ or http://www.merck.de/Merck Serono : 9 Chemin des Mines, 1202 Geneva, Switzerland

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BioMS Medical announces receipt of milestone payment from Eli Lilly and Company


- US$10 million received based on the positive review of interim analysis for international pivotal multiple sclerosis trial -

EDMONTON , Sept. 22 - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that it has received the US$10 million milestone payment from its partner, Eli Lilly and Company.

The milestone payment is based on the previously announced positive review of the scheduled interim analysis of the Company's pivotal phase II/III Canadian and European trial (MAESTRO-01) of dirucotide (MBP8298) in patients with secondary progressive MS. The independent Data Safety Monitoring Board (DSMB) for the MAESTRO-01 trial recommended that the trial proceed to completion based on the interim analysis which included efficacy and safety data from the first 200 patients to complete the trial.

To date, BioMS has received a total of US$97 million in payments from Eli Lilly and Company, based on the licensing and development agreement for dirucotide (MBP8298). An additional $400 million in milestone payments are possible under the terms of the licensing agreement, in addition to escalating royalties on sales.

"We are pleased that our partner has recognized the outcome of the interim analysis as a significant positive event," said Kevin Giese, President and CEO of BioMS Medical. "We look forward to completing the MAESTRO-01 trial and reviewing the complete data set in the second half of 2009."

About BioMS Medical Corp.

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, dirucotide (MBP8298), is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide (MBP8298) in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com/.

Sunday

 

Biogen Idec Testing Regenerative Medicine Drug to Reverse the Path of Multiple Sclerosis


Biogen Idec has made a lot of its money on Avonex and Tysabri, drugs that slow down the rate of flare-ups for people with multiple sclerosis. Now the Cambridge, MA-based biotech company (NASDAQ: BIIB) is pursuing a loftier goal. It is working on the first experimental drug that may reverse the symptoms of the neurodegenerative disease.

The drug, being tested in animals and prepped for its first human trial, is designed to block a protein called Lingo-1 that interferes with body’s production of myelin, the fatty protective coating around nerve fibers. People with multiple sclerosis have an overactive immune system that eats away at the myelin layer, and they have no ability to regenerate myelin in the brain or spinal cord, says Sha Mi, a Biogen researcher. That means nerve impulses that control speech, vision, and movement get short-circuited, sort of like when an electrical wire is stripped of its insulation. Biogen thinks it now has engineered a drug that can stop Lingo-1 from doing its dirty work, allowing the body to regenerate myelin coating around nerves. That could restore normal functions, like walking.

“People around the company are very excited about this,” says Kenneth Rhodes, Biogen’s vice president of discovery neurobiology. “It’s potentially a transformational therapy.” Sha Mi, the Biogen scientist who discovered the molecular switch that paved the way for the program, put it this way, “As a scientist, I came all the way from China. If we can create a new medicine to affect patients, that is my dream.”

The drug hasn’t even entered clinical trials yet, and it’s already been an eight-year odyssey. Sha Mi (who goes by the name Misha) joined the company in 2000 from Wyeth’s Genetics Institute unit in Cambridge, MA. Not long after joining Biogen, she found the Lingo-1 protein in a database and learned it was expressed solely in the central nervous system and, then, only in neurons. Later experiments showed that when scientists delete the gene that makes Lingo-1 in mice, those altered mice would recover from a disease in which the immune system eats away at myelin, called autoimmune encephalomyelitis. The same recovery was seen in mice when they were given an antibody drug designed to block the Lingo-1 protein. There were no side effects or dangers seen from producing too much myelin, because the body will only produce the amount needed to cover nerves, Sha Mi says. The combination of experiments, conducted by Biogen scientists and collaborators in China, made the cover of Nature Medicine last October.

Other researchers are working on myelin repair, such as a group led by Bruce Trapp at the Cleveland Clinic, says Rhodes, the Biogen vice president. Madison, NJ-based Wyeth (NYSE: WYE) has attempted to develop conventional small molecule drugs against Lingo, but hasn’t been successful, he says.

Biogen is developing a genetically engineered antibody against Lingo because that approach should do a better job of binding with the Lingo protein target on the surface of cells, Rhodes says. The first version, however, wasn’t quite “optimal,” and a newer one is being engineered with better properties, he says. The latest version is made with fully human DNA, instead of partial mouse DNA, because researchers want to be confident that the drug won’t spark the immune system to reject it, especially if it needs to be given chronically. The company is planning to ask the FDA for permission to start its first human clinical trials, although he wouldn’t say when.

No details are available yet on how the trials will be crafted, but Rhodes made clear that the company’s vision is for Lingo to be used in combination with Avonex or Tysabri. The idea is that those drugs can reduce the immune system’s assault on neurons, quieting the storm. That would give an opportunity for the anti-Lingo-1 drug to step in and regenerate myelin around the nerves.

Since 400,000 people in the U.S. suffer from MS, and there’s nothing else quite like this program poised for clinical trials, it seems unlikely that Biogen will have much trouble recruiting patients in the first study. If they show they can regenerate myelin in even a few people, Biogen will be a few steps closer to fulfilling Sha Mi’s dream.


Xconomy

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Saturday

 

[Open use of natalizumab. Neutralising antibodies and clinical data]

St.-Josef-Hospital, Neurologische Klinik der Ruhr-Universität, Gudrunstrasse 56, Bochum, Germany. Aiden.

BACKGROUND: Since June 2006 natalizumab has been available for use as monotherapy in relapsing-remitting MS with high disease activity. The AFFIRM study showed the occurrence of persisting and neutralising antinatalizumab antibodies (nAb) in 6% of the patients. We present data revealing the number of nAb-positive patients assessed in our independent laboratory. Additionally we provide retrospective clinical data on the efficacy of natalizumab as escalating immunotherapy.

CONCLUSION: During natalizumab therapy, testing for nAb should be strongly considered for further therapy decisions and in cases of suspected allergic reaction. Basically the obtained data compare with those of the AFFIRM study. Natalizumab is applied as escalating therapy in MS according to the recommendations of the MSTKG, and it seems to match the expectations in open-label use.

PMID: 18437340 [PubMed - indexed for MEDLINE]
PubMed - Nervenarzt. 2008 Jun;79(6):716-9.
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Impact of methylprednisolone treatment on the expression of macrophage inflammatory protein 3alpha and B lymphocyte chemoattractant in serum of multip

Neuroimmunological Unit, Medical Research Center, Polish Academy of Sciences, Przybyszewskiego 49, PL 60-355 Poznań, Poland.

In order to extend our studies designed to elucidate the mechanism of action of intravenous methylprednisolone (ivMP) in symptomatic therapy of relapses in multiple sclerosis (MS) victims, we have evaluated the expression of chemokines: macrophage inflammatory protein 3alpha (MIP-3alpha) and B-lymphocyte chemoattractant (CXCL13) before and after treatment.

The observed difference in CXCL13 expression between responder and non-responder group of patients should be regarded as a step towards elucidation of the therapeutic effect of ivMP in MS relapses.

PMID: 18799824 [PubMed - in process]
PubMed - Pharmacol Rep. 2008 Jul-Aug;60(4):549-54.
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Leg power asymmetry and postural control in women with multiple sclerosis.

Department of Kinesiology, University of Massachusetts, Amherst, MA 01003, USA.

The extent of and the interactions between muscle strength, walking speed, postural control, and symptomatic fatigue in multiple sclerosis (MS) are not known, nor are the effects of bilateral strength asymmetries on these variables.

PURPOSE: To quantify the magnitude of and the associations between bilateral strength and limb-loading asymmetries, postural control, and symptomatic fatigue in women with MS.

CONCLUSIONS: These data provide new evidence of a potential role for KE strength asymmetries in the symptomatic fatigue and physical dysfunction of persons with MS, possibly through an effect on postural stability.

PMID: 18799980 [PubMed - in process]
PubMed
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

In Vitro and In Vivo Pharmacological Models to Assess Demyelination and Remyelination.

1CNS Division, Neurology Section, Sanofi-Aventis, Bridgewater, NJ, USA.

In making a selection of cellular tools and animal models for generating screening assays in the search for new drugs, one needs to take into consideration the practicality of their use in the drug discovery process.

Neuropsychopharmacology advance online publication, 17 September 2008; doi:10.1038/npp.2008.145.
PMID: 18800062 [PubMed - as supplied by publisher]
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Differential diagnosis of suspected multiple sclerosis: a consensus approach

Background and objectives: Diagnosis of multiple sclerosis (MS) requires exclusion of diseases that could better explain the clinical and paraclinical findings. A systematic process for exclusion of alternative diagnoses has not been defined. An International Panel of MS experts developed consensus perspectives on MS differential diagnosis.

Conclusions: Differential diagnosis leading to MS or alternatives is complex and a strong evidence base is lacking. Consensus-determined guidelines provide a practical path for diagnosis and will be useful for the non-MS specialist neurologist. Recommendations are made for future research to validate and support these guidelines. Guidance on the differential diagnosis process when MS is under consideration will enhance diagnostic accuracy and precision.

Sage Journals Online
Multiple Sclerosis 2008, doi:10.1177/1352458508096878
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Cognitive impairment in multiple sclerosis

Department of Neurology, University of Catania, Catania, Italy

Background: Cognitive impairment is increasingly being recognized as a common and disabling symptom of multiple sclerosis (MS) that contributes to poor quality of life in affected patients. Despite the high prevalence of cognitive impairment in MS, cognitive function is not assessed routinely in clinical practice or in clinical trials. The perception that cognitive assessments are costly, time-consuming, complicated, and difficult to administer and interpret has contributed, at least in part, to the failure to incorporate cognitive testing into standard clinical evaluation of patients with MS. Detailed studies of cognitive impairment in MS are rare and guidelines for the assessment of cognitive function in MS are lacking.

Conclusions: It is only through further studies that it will be possible to identify patients with, or at risk of, cognitive impairment and to provide appropriate therapy to limit the effects of this potentially devastating symptom.

Sage Journals Online
Multiple Sclerosis 2008, doi:10.1177/1352458508096684
CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Analysis of cerebrospinal fluid and cerebrospinal fluid cells from patients with multiple sclerosis for detection of JC virus DNA

Objective: 1) To determine whether JC virus (JCV) DNA was present in the cerebrospinal fluid (CSF) and blood from patients with multiple sclerosis (MS) in comparison with controls and 2) to find out if our clinical material, based on presence of JCV DNA, included any patient at risk for progressive multifocal leukoencephalopathy (PML).

Conclusion: A low copy number of JCV DNA may occasionally be observed both in MS and other diseases and may occur as part of the normal biology of JC virus in humans. This study does not support the hypothesis that patients with MS would be at increased risk to develop PML, and consequently screening of CSF as a measurable risk for PML is not useful.

Sage Journals Online
Multiple Sclerosis 2008, doi:10.1177/1352458508096870

CLICK HERE FOR FULL ABSTRACT & RELATED INFO

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Smoking is a risk factor for early conversion to clinically definite multiple sclerosis

Background: Cigarette smoking increases the risk for development of multiple sclerosis and modifies the clinical course of the disease. In this study, we determined whether smoking is a risk factor for early conversion to clinically definite multiple sclerosis after a clinically isolated syndrome.

Conclusions: Smoking is associated with an increased risk for early conversion to clinically definite multiple sclerosis after a clinically isolated syndrome, and our results suggest that smoking is an independent but modifiable risk factor for disease progression of multiple sclerosis. Therefore, it should be considered in the counseling of patients with a clinically isolated syndrome.

Sage Journals Online
This version was published on September 1, 2008Multiple Sclerosis, Vol. 14, No. 8, 1026-1030 (2008)

CLICK HERE FOR FULL ABSTRACT & RELATED INFO

 

Smoking worsens the prognosis in multiple sclerosis

Department of Neurology, Umeå University Hospital, Umeå, Sweden
L Nyström; Department of Public Health and Clinical Medicine, Epidemiology and Public Health Sciences, Umeå University, Umeå, Sweden

Objective: To estimate the effect of smoking on the risk for progression in multiple sclerosis (MS).

Conclusion: Past smoking is associated with a worsened prognosis in MS. The negative effect from smoking is most obvious in ever smokers with early smoking debut, which also affects MS phenotype significantly.



Sage Journals Online
CLICK HERE TO READ FULL ABSTRACT & RELATED INFO

Friday

 

"At least one analyst questioned the significance of the finding".....TYSABRI BREAKING NEWS:

The following story was posted today on our MS News Channel MySpace Blog</ span>.

It is one of 4,613 stories on our MySpace Blog</ span>! Our 3,300 MySpace Friends have made 29,896 Comments & 42,234 Kudos on the 4,613 stories!
CLICK HERE TO VIEW THE MS NEWS CHANNEL MYSPACE BLOG & LEAVE A COMMENT
Biogen shares rise following MS drug reports
Biogen Idec shares gain ground following positive studies on MS drugs Avonex, Tysabri
NEW YORK (Associated Press) - Shares of Biogen Idec Inc. gained ground Friday after separate studies showed the positive long-term effects of the multiple sclerosis drug Avonex and allayed some side-effect fears over the MS treatment Tysabri.

Shares rose $1.01, or 2.1 percent, to $48.15 in afternoon trading. The stock has traded between $45.37 and $84.75 over the last 52 weeks.

On Thursday, the company said a study of Tysabri showed the drug did not increase the risk of a virus called JCV, which is the underlying cause of a rare viral infection called progressive multifocal leukoencephalopathy, or PML. Tysabri was pulled from the market in 2005 after being linked to the rare brain disease but was reintroduced under restricted sales conditions in mid-2006.

Recently, the company and its partner Elan Corp. reported two new cases of the condition in European patients, sending shares into a tailspin. Shares are down about 30 percent since the announcement was made July 31.

Multiple sclerosis is an autoimmune disorder that results in physical and neurological damage. There are about 32,000 patients on Tysabri worldwide, with 17,800 in the U.S. The company hopes to eventually get 100,000 patients on Tysabri worldwide.

Sales of the drug nearly tripled to $200 million during the second quarter and Wall Street has been concerned that the new PML cases could impact future sales.

In the recent study results, there was no difference between the prevalence of JCV in patients' urine before or after treatment with Tysabri.
At least one analyst questioned the significance of the finding.


"Even though the concern continues to be that pre-existing, dormant JC virus can spread to the brain in patients taking Tysabri, detection of JC virus in serum or urine are not diagnostic or predictive of PML," Citi analyst Dr. Yaron Werber said in a note to investors.

He reaffirmed a "Hold" rating with a $59 price target.

Meanwhile, the company also said patients taking Avonex over a 15-year period had significantly lower disability progression compared with patients who aren't taking the therapy.

This story originally appeared on CNN Money.com

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Thursday

 

Genzyme Reaching For a Slice From Biogen’s Breadbasket, Multiple Sclerosis Drugs

If Genzyme gets its way, it will be eating Biogen Idec’s lunch in a few more years. The two Cambridge, MA-based companies, the largest independent biotechs in the state, could be duking it out with competing multiple sclerosis treatments, in a market worth an estimated $8 billion to $9 billion annually by 2011. It would also be the first time the companies have faced off in a direct competition for patients with the same disease.

Genzyme (NASDAQ: GENZ) is recruiting patients in two final-stage clinical trials of Campath, currently approved as a leukemia drug, for patients with multiple sclerosis. Biogen (NASDAQ: BIIB) is already entrenched as the world’s largest maker of drugs for multiple sclerosis, offering both the current market-leader, Avonex, and Tysabri, a newer and more effective drug co-marketed with Ireland-based Elan.

It’s hard for Wall Street to see this far ahead, but Genzyme envisions Campath as a key to driving its future growth, beyond the financial forecasts the company has given analysts through 2011. The company says Campath, which works by knocking out overactive B cells and T cells of the immune system, may be the most effective agent yet against multiple sclerosis, a disease in which immune cells attack the insulating coating on nerve fibers. About 400,000 Americans suffer from the condition, which can rob patients’ of their ability to walk, see, or speak.

In a mid-stage clinical trial, Campath was able to cut the risk of MS flare-ups by 73 percent over a three-year period, while lowering the risk of progressive disability about 70 percent when compared with a standard treatment. “We’ve actually seen improvement in disability in patients, and that may be unprecedented,” says Terry Murdock, Genzyme’s senior vice president for Campath, from his offices in San Antonio, in a telephone interview. Genzyme will finish enrollment in one of the current Phase III trials in the first half of 2009 and aims to have data ready to send to the FDA for approval in 2011, Murdock says.

“The numbers would have been impressive when compared with placebo and thus are even more impressive when compared with a currently approved disease-modifying agent,” said John Richert, executive vice president of research and clinical programs for the National MS Society, in an e-mail. “The Phase III data will be very important.”

Genzyme’s current trials are monitoring patients’ blood samples, and performing regular phone calls to keep close watch on any dangerous side effects, Murdock said. The monitoring takes some extra effort, because patients don’t have to come see the doctor regularly to get treatment with the drug. Campath is designed to be given as an intravenous infusion daily for five days, then patients can take a year off, and get annual boosts, Murdock said.

For its part, Biogen has a lot riding on getting the most mileage possible out of Tysabri. The company has forecasted it will have 100,000 patients taking the drug by the end of 2010, which would generate $2.8 billion annually at current prices. (Avonex, currently Biogen’s biggest-selling product, had $1.87 billion in sales in 2007, almost 60 percent of the company’s total revenue.) But Tysabri still hasn’t entirely stepped out from under the shadow of PML, the rare, fatal brain infection that has been associated with the drug and led it to be pulled from the market in 2005. Biogen brought the drug back to the market in July 2006 under a stringent monitoring program. No new cases of PML have been reported since, the company has said.

Each passing day without a new PML case makes Tysabri stronger, yet Biogen certainly can hear footsteps from its neighborhood rival. Campath’s efficacy numbers appear so far to be better than Tysabri’s, which is shown to reduce the risk of MS flare-ups by two-thirds. Campath and another experimental drug from Basel, Switzerland-based Novartis, FTY-720, “may offer patients greater efficacy, but there is greater risk than first-generation therapies,” said Biogen spokeswoman Shannon Altimari in an e-mail. “The risk-benefit of these therapies will have to be taken into consideration.”

To date, MS patients on Campath haven’t had any reported cases of PML. If that holds, and if the current studies of the drug are as successful as the earlier ones, Genzyme could end up taking a large bite out of Biogen’s biggest moneymaker.

Xconomy

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Market Report -- In Play (BIIB)

Biogen Idec features data on Avonex and Tysabri and showcases the co's multiple sclerosis development pipeline at the World Congress On Treatment and Research in Multiple Sclerosis Co announces it will present new data on its leading multiple sclerosis franchise at the World Congress on Treatment and Research in Multiple Sclerosis.

MSN Money

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Biogen Idec to present data about lead Multiple Sclerosis drugs in Montreal - Update

RTTNews) - Biogen Idec (BIIB: News ) said Thursday it would present data on the company's leading multiple sclerosis or MS products-Tysabri, Avonex, as well as its pipeline of products, at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.

The company said the data would provide physicians with new information about the benefits of Tysabri and Avonex, and also update the MS community on the company's progress in its investigational compounds - daclizumab, Rituxan and BG-12, the company's novel oral compound that is in Phase III trials.

In addition, Biogen announced that the U.S. FDA had granted Fast Track Designation to BG-12. BG-12 is an oral formulation of dimethyl fumarate in development for MS. The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

RTTNews

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CTLA4Ig treatment in patients with multiple sclerosis: An open-label, phase 1 clinical trial.

Center for Neurologic Diseases, Brigham and Women's Hospital, 77 Avenue Louis Pasteur, HIM 712, Boston, MA 02115 skhoury@rics.bwh.harvard.edu.

BACKGROUND: The modulation of costimulatory pathways represents an original therapeutic approach to regulate T cell-mediated autoimmune diseases by preventing or reducing autoantigen-driven T-cell activation in humans. Autoreactive CD4(+) T cells play a critical role in initiating the immune response leading to the chronic inflammation and demyelination characteristic of multiple sclerosis (MS).

CONCLUSIONS: Inhibiting costimulatory molecule interactions by using CTLA4Ig seems safe in multiple sclerosis (MS), and the immunologic effects suggest that it may be a promising approach to regulate the inflammatory process associated with MS.

PMID: 18794494 [PubMed - in process]
Neurology. 2008 Sep 16;71(12):917-24.

CLICK HERE FOR FULL ABSTRACT & RELATED INFORMATION

 

IL17 and IFNgamma production by peripheral blood mononuclear cells from clinically isolated syndrome to secondary progressive multiple sclerosis.

Institute of Neurology, Department of Neuroscience, Catholic University, Largo Agostino Gemelli, 8, 00168 Rome, Italy.

Our data suggest that IL17 might play a crucial role mainly in the early phase of MS, while IFNgamma seems to be involved both in the early phase and in the following relapses of the disease.

PMID: 18793860 [PubMed - as supplied by publisher]
Cytokine. 2008 Sep 13. [Epub ahead of print]

CLICK HERE FOR FULL ABSTRACT & RELATED INFO


 

Multiple Sclerosis in the UK: Service Use, Costs, Quality of Life and Disability.

Institute of Psychiatry, King's College London, London, UK.

BACKGROUND: Multiple sclerosis (MS) is a chronic condition that affects quality of life (QOL), leads to disability and requires ongoing care inputs. Few studies have examined the impact of QOL, disability and demographic characteristics on treatment costs.

CONCLUSIONS: This study showed that MS participants had high levels of service use, and that QOL was low in comparison with other conditions. There were significant associations between costs, QOL and disability.

PMID: 18793032 [PubMed - in process]
Pharmacoeconomics. 2008;26(10):847-60.

CLICK HERE FOR FULL ABSTRACT & RELATED INFO



 

The Role of Neurotrophic Factors in the Pathology and Treatment of Multiple Sclerosis.

2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.

It has been found that inflammatory cells crucial for MS pathogenesis are able to release neurotrophic factors (NFs). Thus the concept of neuroprotective effect of inflammation has arisen.

PMID: 18792835 [PubMed - as supplied by publisher]
Immunopharmacol Immunotoxicol. 2008 Sep 15:1-14. [Epub ahead of print]

CLICK HERE FOR FULL ABSTRACT & RELATED INFO


 

Congress Passes Bill With Protections for Disabled

WASHINGTON — Congress gave final approval on Wednesday to a major civil rights bill, expanding protections for people with disabilities and overturning several recent Supreme Court decisions.

The voice vote in the House, following Senate passage by unanimous consent last week, clears the bill for President Bush.

The White House said Mr. Bush would sign the bill, just as his father signed the original Americans With Disabilities Act in 1990.

The bill expands the definition of disability and makes it easier for workers to prove discrimination. It explicitly rejects the strict standards used by the Supreme Court to determine who is disabled.

The bill declares that the court went wrong by “eliminating protection for many individuals whom Congress intended to protect” under the 1990 law.

“The Supreme Court misconstrued our intent,” said Representative Steny H. Hoyer of Maryland, the House Democratic leader. “Our intent was to be inclusive.”

In an effort to clarify the intent of Congress, the bill says, “The definition of disability in this act shall be construed in favor of broad coverage.”

Representative F. James Sensenbrenner Jr. of Wisconsin, the principal Republican sponsor in the House, said, “Courts have focused too heavily on whether individuals are covered by the law, rather than on whether discrimination occurred.”

Bills passed with overwhelming support are often insignificant or noncontroversial, but that was not true for this bill. “This is one of the most important pieces of civil rights legislation of our time,” said Representative Jim Langevin, Democrat of Rhode Island, who uses a wheelchair.

Disagreements over the bill were worked out in two years of intense behind-the-scenes negotiations that included members of both parties and people with disabilities, as well as the National Association of Manufacturers and the United States Chamber of Commerce.

LeAnne Wilson, chief operating officer of the association, said the bill would help “meet the work force needs” of employers.

Lawrence Z. Lorber, a labor law specialist who represents employers, said the bill would change the outcome of “a slew of cases that were thrown out of court in the past.” Now, he said, “employees who have cancer or diabetes or learning disabilities will get their day in court and are more likely to get accommodations from employers.”

Lawmakers said that people with epilepsy, diabetes, cancer, multiple sclerosis and other ailments had been improperly denied protection because their conditions could be controlled by medications or other measures. In a Texas case, for example, a federal judge said a worker with epilepsy was not disabled because he was taking medications that reduced his seizures.

In deciding whether a person is disabled, the bill says, courts should not consider the effects of “mitigating measures” like prescription drugs, hearing aids and artificial limbs. Moreover, it says, “an impairment that is episodic or in remission is a disability if it would substantially limit a major life activity when active.”

Senator Tom Harkin, Democrat of Iowa, the chief sponsor of the bill, said: “The Supreme Court decisions have led to a supreme absurdity, a Catch-22 situation. The more successful a person is at coping with a disability, the more likely it is the court will find that they are no longer disabled and therefore no longer covered under the A.D.A.”

Senator Orrin G. Hatch, Republican of Utah, said the bill, by establishing more generous coverage and protection, “will make a real difference in the lives of real people.”

The New York Times

CLICK HERE FOR FULL ARTICLE & RELATED NEWS


Tuesday

 

A DNA vaccine for multiple sclerosis.

Stanford University, Department of Neurology and Neurological Sciences, Stanford, CA, USA.

RESULTS/CONCLUSION: Phase I and II trials of BHT-3009, a DNA vaccine encoding myelin basic protein, demonstrated that it was safe, well-tolerated, and caused antigen-specific immune tolerance. BHT-3009 showed efficacy in reducing brain lesion activity as well as clinical relapses in patients that were immunologically active at baseline. BHT-3009 is a promising therapy in development for MS, and may prove to be one of the first antigen-specific treatments for this disease.

PMID: 18774921 [PubMed - in process]
Expert Opin Biol Ther. 2008 Oct;8(10):1539-50.

CLICK HERE FOR FULL ABSTRACT & RELATED INFO


 

Role of Optic Neuritis Diagnosis in the Early Identification and Treatment of MS.

Department of Neurology,AHEPA Hospital, Aristotle University of Thessaloniki 1,Stilp. Kyriakidis Str 54636, Thessaloniki, Greece Phone +30 23 1099 4681/3 Fax +30 23 1099 4689

Optic neuritis is an inflammation of one optic nerve, usually resulting in temporary loss of vision. It is frequently an early clinical manifestation of multiple sclerosis (MS), meaning ophthalmologists are often the first healthcare professionals to detect MS. Numerous studies have shown a significant correlation between Optic neuritis and MS. A 30-year follow-up showed that patients with Optic neuritis had a 40% risk of developing MS within 15 years, and a retrospective review found that 18% of MS patients first presented with Optic neuritis. Corticosteroids can provide rapid visual recovery, but provide no long-term impact on MS. Immunomodulatory agents, such as interferon betas, have been shown to delay MS significantly, and identifying patients who might benefit from such treatment is important. It is, therefore, essential that ophthalmologists refer Optic neuritis patients for detailed MS assessment and early treatment to help expedite visual recovery. Additionally there are some data suggesting that treatment may slow MS disease progression.

PMID: 18782503 [PubMed - in process]
Int MS J. 2008 Jun;15(2):69-79.

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Spotlight on teriflunomide.

Division of Clinical Neurology, University of Nottingham, UK.

Currently, licensed disease-modifying agents for multiple sclerosis (MS) all share the need for parenteral administration. Oral therapies would carry the advantage of convenience and greater acceptability. Teriflunomide is one of several oral agents currently undergoing Phase III investigation. This article describes the mode of action of teriflunomide which largely depends on inhibition of pyrimidine synthesis. We review the evidence so far on the efficacy of teriflunomide in animal models and Phase II human studies. In view of teriflunomides favourable safety profile it appears to be a promising oral alternative to interferon beta and glatiramer acetate. The ongoing Phase III investigations of teriflunomide as mono- and combination therapy are discussed.

PMID: 18782502 [PubMed - in process]
Int MS J. 2008 Jun;15(2):62-8.

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'Restricting choices and limiting independence': social and economic impact of multiple sclerosis upon households by level of disability

Department of Health and Human Sciences, University of Essex, UK

Objective: To examine the relationship between the social and economic impact of multiple sclerosis (MS) and levels of MS-related disability upon households in the following domains: household composition, housing modification, employment, standard of living, children, intimate and close relationships, and social life.

Discussion: MS restricts social and economic opportunities for pwMS and those who they live with. These findings extend the literature to households to illustrate the impact of MS not only on pwMS but also on their partners, children and other family members.

Sage Journals On Line

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Estimating time-to-event from longitudinal ordinal data using random-effects Markov models: application to multiple sclerosis progression

Department of Statistics, The Hebrew University of Jerusalem, Mount Scopus, Jerusalem, Israel; Department of Biostatistics, Harvard School of Public Health, 665 Huntington Avenue, Boston, MA, USA

Longitudinal ordinal data are common in many scientific studies, including those of multiple sclerosis (MS), and are frequently modeled using Markov dependency.

In this paper, we go one step further and study prediction based on random-effects Markov models.

Biostatistics Oxford Journals

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CTLA4Ig treatment in patients with multiple sclerosis

An open-label, phase 1 clinical trial


From the Center for Neurologic Diseases (V.V., G.J.B., B.H., H.L.W., D.A.H., S.J.K.), Brigham and Women’s Hospital and Harvard Medical School, Boston, MA; ITN (Immune Tolerance Network) (K.B.), Bethesda, MD; Center for Neurological Imaging (S.E., C.R.G.G.), Brigham and Women’s Hospital, Boston, MA; and Repligen Corporation (J.R.R.), Waltham, MA.

Conclusions: Inhibiting costimulatory molecule interactions by using CTLA4Ig seems safe in multiple sclerosis (MS), and the immunologic effects suggest that it may be a promising approach to regulate the inflammatory process associated with MS.

NEUROLOGY 2008;71:917-924

CLICK HERE TO VIEW FULL ABSTRACT & RELATED INFO


Monday

 

BREAKING NEWS: "MUSCLE STEM CELL IDENTITY CONFIRMED BY STANFORD RESEARCHERS"

The following story was posted today on our MS News Channel MySpace Blog.

It is one of 4,613 stories on our MySpace Blog! Our 3,300 MySpace Friends have made 29,896 Comments & 42,234 Kudos on the 4,613 stories!

CLICK HERE TO GO TO THE MYSPACE NEWS CHANNEL BLOG AND LEAVE A COMMENT

MUSCLE STEM CELL IDENTITY CONFIRMED BY STANFORD RESEARCHERS

Date: September 15, 2008 10:28:37 AM GMT-07:00

EMBARGOED FOR RELEASE UNTIL: Wednesday, Sept. 17, 2008, at 10 a.m. Pacific time to coincide with online publication in Nature:

We will post the entire news release for you on Wednesday.

 

Breaking News: Betaseron(R) to Offer the Thinnest Needle in Multiple Sclerosis

The following story was posted today on our MS News Channel MySpace Blog.

It is one of 4,613 stories on our MySpace Blog! Our 3,300 MySpace Friends have made 29,896 Comments & 42,234 Kudos on the 4,613 stories!


I just received the following press release

(Click here to go to Betaseron's web page that explains more about thisnew needle)

CLICK HERE TO VIEW THE MYSPACE BLOG AND LEAVE A COMMENT


Betaseron(R) to Offer the Thinnest Needle in Multiple Sclerosis

Bayer HealthCare Pharmaceuticals Inc. today announced that Betaseron(R)* (interferon beta-1b), its treatment for relapsing forms of multiple sclerosis (MS), will soon be available with a new 30-gauge needle, which will be the thinnest needle of any injectable disease-modifying therapy for people with MS. The new needle is as thin as the needle commonly used for insulin and pediatric injections.

"One of the barriers that many people with multiple sclerosis face in starting an MS treatment is injection anxiety," said Ludger Heeck, Vice President and General Manager, Specialty Medicine, Bayer HealthCare Pharmaceuticals Inc. "Betaseron is a safe and effective treatment for people with relapsing forms of MS, as well as those with the earliest signs of the disease. By introducing the thinnest needle of any injectable disease-modifying medication for MS, we are taking another important step in our commitment to continuously improve Betaseron and its use to help people start and stay on Betaseron long term, particularly those who may have resisted because of anxiety and concerns about injections."

According to a recent North American survey of people with MS, "Injection Anxiety and Barriers to MS Treatment Commitment," the majority of people with MS have, at some point, felt anxiety, nervousness, and fear associated with their injections. Also in the survey, which interviewed 220 people in the United States and Canada who have been diagnosed with MS in the past five years, the majority (56%) of respondents named at least one thing about injections that made them uncomfortable, most often the length (33%) and thickness (31%) of a needle. This was followed by "the thought of a needle" (28%) and "the sight of a needle" (21%).(1)

Additionally, two-thirds (67%) of participants in the survey agree they would be more comfortable injecting themselves if they knew they were using the thinnest needle possible, and about half of the patients surveyed who are not currently on therapy stated they would consider/reconsider taking an injectable MS drug if a thinner needle was shown to be less painful. Benefits cited by participants to using a thinner needle include less pain during injection (55%), less bruising (42%), less pain after injection (40%), and less anxiety immediately before injection (34%).(1)"

Discomfort and anxiety around injections affect many people with MS. Injection anxiety actually can be so high that it keeps people with MS from taking their medication consistently, which is essential to help slow disease progression," stated Dr. Mark Cascione, Neurologist, Tampa Neurology Associates and Medical Director, South Tampa Multiple Sclerosis Center. "

The new Betaseron 30-gauge needle is a welcome advancement for people with MS, and particularly for those with anxiety about their injections."

Issues around injections, such as injection anxiety, injection fatigue and injection site pain, are among the top reasons patients cite for not starting or continuing an injectable medication.(1) Betaseron therapy requires half as many injections as Copaxone(R)* (glatiramer acetate) with a needle that is 25 percent thinner.(2),(3) Additionally, in a study, significantly more Betaseron than Rebif(R)* patients were pain-free at all time points measured (immediately after injection, and 30 and 60 minutes after injection) over the course of 15 injections.(4) Also in that same study, Betaseron patients using the new 30-gauge needle reported more than 50 percent of their injections were pain-free immediately after injection.+ ++ (4)

The new thinnest, 30-gauge needle will be introduced with an optional new autoinjector called BETAJECT(R) Lite.*Section In a survey of patients who used the new 30-gauge needle along with the new autoinjector, 98 percent were "satisfied" or "very satisfied" with the new thinner needle and autoinjector after their first injection,(5) and nearly all of the patients who tried the BETAJECT LiteSection said the new autoinjector was easy to use.(5)

There have been no changes to the formulation or the mixing process of Betaseron -- it is still the same effective medication that patients and doctors have relied on for more than 15 years. People who are currently taking Betaseron can log onto www.betaseron.com/thinner for more information about the new needle and to request the optional BETAJECT Lite autoinjector.

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