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Wednesday, June 24, 2009

Stu's Views and MS News e-newsletter - June 24th edition

The June 24th - Stu's Views and MS News e-newsletter is now archived at:

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Continuous Disease-Modifying Treatment Without Interruptions Provides Better Long-Term Outcomes in Multiple Sclerosis

Docguide.com -
Presented at European Neurological Society (ENS).
By Judith Moser, MD

MILAN, Italy -- June 23, 2009 -- Patients with multiple sclerosis (MS) who adhere to their treatment with interferon (IFN) beta-1a without interruption have lower relapse and progression rates than patients who do not adhere to their medication as regularly, said researchers here at the 19th Meeting of the European Neurological Society (ENS).

In the Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study, IFN beta-1a 22 or 44 mcg administered subcutaneously 3 times weekly proved effective in reducing relapses and delaying disability progression in patients with relapsing-remitting multiple sclerosis (RRMS) compared with placebo.

After the initial 2-year double-blind phase, patients originally randomised to placebo were re-randomised to IFN beta-1a 22 or 44 mcg 3 times weekly for an additional 2 years.

On study completion, all patients were offered the choice of continuing to receive blinded or open-label treatment during years 5 to 6. Beyond year 6, patients could continue on any or no disease-modifying drug.

Data from the long-term follow-up (LTFU, up to 8 years) supported the efficacy of the treatment.

Continue to read from the 6th paragraph

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RebiSmart(TM), First Electronic Injection Device for Delivery of Multiple Sclerosis Treatment Rebif(R)

Merck Serono Launches RebiSmart(TM), First Electronic Injection Device for Delivery of Multiple Sclerosis Treatment Rebif(R)
- RebiSmart(TM) is Designed to Improve Ease of Handling and Usage and Introduces the Potential for Improved Treatment Adherence for Multiple Sclerosis Patients

Jun. 24, 2009

GENEVA, June 24 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the launch of the innovative individually adjustable electronic injection device RebiSmart(TM) for the self-administration of Rebif(R) (interferon beta-1a), the company's disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS). RebiSmart(TM) is the first device of its kind in this indication and was specifically designed for ease of handling and use. The unique features of RebiSmart(TM) also introduce the potential for improved treatment adherence, helping patients receive the full benefit from their treatment.

RebiSmart(TM) is used with Rebif(R) multidose cartridges, each of which contains one week's worth of medicine. Interactive, on-screen instructions and signals guide patients through the injection process, individually adjustable comfort settings give patients more flexibility with injection duration and depth, helping minimize discomfort and pain.

"Making injection more comfortable for the patient is important to ensure optimal treatment outcomes in multiple sclerosis," said Dr. Virginia Devonshire, Assistant Professor of Neurology at the University of British Columbia in Vancouver, Canada. "The first electronic injection device in MS is an innovative approach and could contribute to increasing patient adherence to therapy."

Continue reading from the 4th Paragraph


Tuesday, June 23, 2009

Coping strategy and anxiety evolution in multiple sclerosis patients initiating interferon-beta treatment

summary: Different coping strategies have been described in people dealing with stressful situations. Symptoms of anxiety and depression may occur in a high percentage of people recently diagnosed with MS, especially if they are about to start treatment. In this article the authors aimed to investigate whether the levels of anxiety and depression in people recently diagnosed with MS and who were due to start disease modifying drugs were different depending on the specific coping strategy they followed.

They found that most people in the study chose a coping strategy consisting of obtaining information about the stressful situation (diagnosis and treatment) and dealing directly with the stressor (task-oriented strategy). Those people that chose a task-oriented strategy exhibited lower levels of anxiety compared to people who chose an emotion-oriented strategy (controlling all emotional issues related to the stressor) or an avoidance-oriented strategy (avoiding all kinds of confrontation). The authors concluded that understanding coping strategies may help health professionals to customise support and, in this case, increase adherence to treatment.

authors: Moreau T, Schmidt N, Joyeux O, Bungener C, Souvignet V

source: Eur Neurol. 2009 Jun 12;62(2):79-85

To read more: click here

information source: msif.org

Fingolimod And Cladribine: Two New Oral Substances Show Promising Results In Current Clinical Trials For MS Therapy

June 23, 2009

The results of current clinical trials on new substances for MS therapy are among the new research findings that are being discussed with particular interest at the ENS meeting. Professor Comi is part of an international research team presenting the latest results of a study involving the orally administered drug fingolimod that is still in the clinical trial state and yet to be approved. An earlier study showed that oral fingolimod reduced the annualizied relapse rate in MS patients by more than 50 percent versus placebo.

The new data now being presented by Professor Comi and his colleagues document developments over a longer period of time. "After four years, patients continuously treated with the substance had a low relapse rate, and 63% to 70% of these patients remain relapse free," the expert reports. "The majority of those patients treated also remained free from inflammatory activity and disability progression."

Another trial being presented in Milan by an international study group investigated the efficacy of a cladribine tablet therapy ,.... click to continue
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Figuring Out Who Will Benefit Most From A New Therapy For Multiple Sclerosis

Medical News Today
June 23, 2009

In a recent phase II clinical trial, the drug alemtuzumab (Campath-1H) was found to be a highly effective treatment for individuals with early relapsing-remitting multiple sclerosis. However, a substantial proportion of the patients treated (30%) went on to develop another autoimmune disease, mostly thyroid autoimmunity. Now, Joanne Jones and colleagues, at the University of Cambridge, United Kingdom, have determined that individuals with higher levels of the soluble factor IL-21 in their blood prior to alemtuzumab treatment were those that went on to develop an autoimmune disease.

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Advanced nerve cell system could help cure diabetic neuropathy, related diseases

June 23rd, 2009

Multiple sclerosis, diabetic neuropathy, and other conditions caused by a loss of myelin insulation around nerves can be debilitating and even deadly, but adequate treatments do not yet exist. That's in large part because of deficiencies in model research systems. In an upcoming issue of the journal Biomaterials, a UCF team addresses this problem with a report on the first lab-grown motor nerves that are insulated and organized the same way they are in the body.

The group's model system, along with further advances now within reach, could dramatically improve understanding of the causes of myelin-related conditions, and enable discovery and testing of new drug therapies.

Nerve malfunctions, or neuropathies, involve a breakdown in the way the brain sends and receives electric signals along nerve cells. In mammals, these signals are able to travel long distances because of breaks in their myelin insulation called nodes of Ranvier, each of which chemically boosts the signal, allowing it to travel to the next node. "They're like power station relays," says James Hickman, a bioengineer at UCF who led the new research, which achieved the first successful nodes of Ranvier formation ever on motor nerves in a lab culture, among other advances.

Continue reading more

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MS Related: Smoking Linked To Brain Damage, New Study

Medical News Today
June 23, 2009

Research led by scientists in India suggests there is a direct link between smoking and brain damage whereby a compound in tobacco that turns into a cancer-causing chemical once it has been through the body's metabolism, triggers white blood cells in the brain's immune system to attack healthy brain cells.

Click to read more

Monday, June 22, 2009

Biogen Idec Announces First Patient Enrolled in the Global Phase III Study of PEGylated Interferon Beta-1a for Relapsing Multiple Sclerosis

June 22, 2009
  • Press Release
  • Source: Biogen Idec via Yahoo finance
–Less Frequent Injections would be a Significant Advancement for People Living with MS–

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec today announced enrollment of the first patient in a Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a (BIIB017) in patients with relapsing multiple sclerosis (RMS). The trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS.

“A major issue with patient adherence to injectable therapies for MS is the frequency of injections,” said Peter Calabresi, M.D., principal investigator of the ADVANCE trial and professor of neurology and director of The Johns Hopkins Multiple Sclerosis Center, Baltimore, MD. “Examined in Phase I studies, PEGylated interferon beta-1a was shown to be much longer acting than intramuscular interferon beta-1a and thus offers the possibility of every two or four week dosing without compromising efficacy. This could greatly increase the convenience of this first line class of therapy."

Interferon beta-1a has been successfully used to treat patients with relapsing-remitting multiple sclerosis for more than 10 years. PEGylation protects the interferon beta-1a molecule from being degraded, extending the amount of time the drug remains in a patient's system. The process has been used in other therapeutic areas, and Biogen Idec is studying this innovation in interferon therapy for MS. Administered via subcutaneous injection, PEGylated interferon beta-1a is being studied to evaluate its potential to reduce the frequency of treatment injections and provide patients with an effective and more convenient dosing option.

To Read More, Click Here

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Sunday, June 21, 2009

Redefining functionality and treatment efficacy in multiple sclerosis

summary: MS is a disease in which various symptoms can seriously affect the quality of life (QoL) of people affected. However, scales and measurements used in clinical practice are mostly focused on mobility and ambulatory issues. The authors of this article describe the different tools used so far to assess QoL and expose the tools' lack of sensitivity to detect many problems related to QoL. Finally they propose new definitions of functionality and efficacy and highlight the important need to assess people with MS in a more comprehensive way, looking important issues such as cognitive function, emotional status, visual acuity, fatigue and pain as well as physical disability.

authors: Foley JF, Brandes DW

source: Neurology. 2009 Jun 9;72(23 Suppl 5):S1-11

to read : click here

source : msif.org

Tysabri Update


Patients Treated with TYSABRI as of the end of March 2009:

Cumulatively, in the combined clinical trial and post-marketing settings, approximately
56,700 patients have been treated with TYSABRI. Of these, approximately 52,000
patients have been treated in the post-marketing setting.

In the post-marketing setting only and since the reintroduction of TYSABRI in July 2006,
• 24,900 patients have received at least one year of TYSABRI therapy,
• 14,400 patients have received at least 18 months of TYSABRI therapy,
• 6,800 patients have received at least 24 months of TYSABRI therapy.

As of the end of March 2009:
• Approximately 40,000 patients were on TYSABRI therapy worldwide; of these:
• In the U.S., approximately 20,800 patients were on TYSABRI therapy commercially;
• In the rest of world, approximately 18,500 patients were on TYSABRI therapy commercially; and
• In global clinical trials, approximately 600 patients were on TYSABRI therapy.

Progressive multifocal leukoencephalopathy (PML):
In the period between the reintroduction and approval of TYSABRI in July 2006 and
June 19, 2009, the following cases of PML have been confirmed:

>> Click here to review this listing


Biogen reports 9th case of PML in Tysabri patients

June 19, 2009

LOS ANGELES, June 19 (Reuters) - A ninth patient taking Biogen Idec Inc's multiple sclerosis drug Tysabri has developed a potentially deadly brain infection since the drug was reintroduced onto the market in July 2006.

The Cambridge, Massachusetts-based biotech company announced the news late on Friday on its website.

Biogen has said it does not plan to announce each new case of progressive multifocal leukoencephalopathy, or PML, except as a weekly update on its website.

Sales of Tysabri, Biogen's most important potential growth driver, have been curtailed by concerns over PML. The drug was temporarily withdrawn from the market in 2005 before being returned with stricter safety warnings.

Biogen has said physicians are becoming more comfortable with the risk of PML, but sales of Tysabri in the first quarter were $227 million, less than the $246 million analysts had expected.

Biogen sells Tysabri in partnership with Elan Corp Plc (ELN.I) of Ireland.

Biogen's shares, which fell 32 cents to close at $51.67 on Nasdaq, were slightly higher at $51.74 after hours. (Reporting by Deena Beasley; Editing by Gary Hill)


Understanding & coping with Multiple Sclerosis

By Kumudini Hettiarachchi

Many have heard the tongue-twister, Multiple Sclerosis (MS), but given it scant thought. Did you know that MS, a chronic neurological disease, affects young adults in the prime of their life, in their 20's and 30's, a majority of whom may be breadwinners?

Considered a "special disease" since 1868, when the first case of MS was diagnosed, the world has at last woken up to the gravity of this illness which leads to progressive loss of nerve function and 141 years later declared May 27 as 'World MS Day'.

Graphic courtesy nytimes.com

For pretty Dr. Hithaishi Weerakoon, it all started when she was just 24 years old. Pins and needles in her feet, sometimes her foot felt like plastic. There was numbness of face and feet; inability to pick up things or hold papers and difficulty in coordinating hand movements.

>> READ MORE beginning with fourth paragraph