FRONT PAGE AMPYRA AUBAGIO AVONEX BETASERON COPAXONE EXTAVIA
Stan's Angels MS News Channel on YouTube GILENYA NOVANTRONE REBIF RITUXAN TECFIDERA TYSABRI
 Daily News for Neuros, Nurses & Savvy MSers: 208,152 Viewers, 8,368 Stories & Studies
Click Here For My Videos, Advice, Tips, Studies and Trials.
Timothy L. Vollmer, MD
Department of Neurology
University of Colorado Health Sciences Center Professor

Co-Director of the RMMSC at Anschutz Medical Center

Medical Director-Rocky Mountain MS Center
Click here to read my columns
Brian R. Apatoff, MD, PhD
Multiple Sclerosis Institute
Center for Neurological Disorders

Associate Professor Neurology and Neuroscience,

Weill Medical College of Cornell University

Clinical Attending in Neurology,
New York-Presbyterian Hospital
CLICK ON THE RED BUTTON BELOW
You'll get FREE Breaking News Alerts on new MS treatments as they are approved
MS NEWS ARCHIVES: by week

HERE'S A FEW OF OUR 6000+ Facebook & MySpace FRIENDS
Timothy L. Vollmer M.D.
Department of Neurology
University of Colorado Health Sciences Center
Co-Director of the RMMSC at Anschutz Medical Center
and
Medical Director-Rocky Mountain MS Center


Click to view 1280 MS Walk photos!

"MS Can Not
Rob You of Joy"
"I'm an M.D....my Mom has MS and we have a message for everyone."
- Jennifer Hartmark-Hill MD
Beverly Dean

"I've had MS for 2 years...this is the most important advice you'll ever hear."
"This is how I give myself a painless injection."
Heather Johnson

"A helpful tip for newly diagnosed MS patients."
"Important advice on choosing MS medication "
Joyce Moore


This page is powered by Blogger. Isn't yours?

Wednesday

 

Judge: Ill Franklin man charged with growing marijuana can't tell jury about medical use


SOMERSET COUNTY — John Ray Wilson was diagnosed with multiple sclerosis in 2002, had no health insurance and was unable to afford drugs to treat the disease, according to his attorney.

So Wilson, now 36, sought natural alleviation from the pain with a therapy involving the use of substances including bee venom and marijuana, the attorney said.

Wilson started growing his own marijuana, according to court documents, but his plan fell apart.

On Aug. 18, 2008, a helicopter pilot spotted his marijuana patch on Skillmans Lane in Franklin behind his rented home and township detectives arrested him, authorities said.

The 17 marijuana plants they confiscated, some 6 feet tall, brought Wilson a charge of operating a drug manufacturing facility, an offense that can bring up to a 20-year prison sentence if there's a conviction.

Under a judge's ruling in Superior Court, Somerville, on Monday, a jury won't hear Wilson's account of why he grew the marijuana.

Judge Robert Reed ruled that Wilson cannot use his medical condition as a defense or mention it to a jury. The reason follows the argument that led to the rejection of Wilson's motion for the dismissal of the indictment.

Since there is no legislatively permitted exemption for personal use in operating a drug manufacturing facility it cannot be used as a legitimate defense, state Deputy Attorney General Russell Curley argued and Reed agreed.

Mentioning multiple sclerosis would amount to an emotional appeal to the jury, Curley argued.
Reed wrote in his opinion that medical marijuana is a matter for lawmakers.

"If medical marijuana use is to be recognized to an exemption from our criminal law, the legislative process must produce that result," Reed wrote. "Defendant's assertion of a personal use defense is not permitted under our present law."

Allowing medical marijuana use for certain patients is being weighed by the state Legislature.

The most recent version of a bill permitting it, which cleared an Assembly committee in June, recognizes multiple sclerosis as a qualifying disease, but would not allow patients to grow their own. ... full story in My Central Jersey

 

Does Eating Animal Brains Cause Multiple Sclerosis?

A case-control study to investigate possible risk factors for MS in Brazilian people found that individuals who had consumed animal brains were 3.4 times more likely to have MS than people who had never eaten animal brains.

Honestly, I do not know what is going on here, but it is an interesting question to ponder. Interestingly, a Mexican study did not find an association between eating cow or pig brains and MS risk. ... full story and comments in About.com: Multiple Sclerosis

 

Cooking for your health Good nutrition tastes better than you think


We all know we should eat healthy — lower our intake of fat and salt, avoid junk food and empty calories. A healthy diet adds years to our lives, increases mental sharpness, lowers cholesterol, creates energy, gives us glowing skin and hair, and helps us maintain a healthy weight.

Good nutrition is about giving your body what it needs and if you have a health problem, nutrition is an essential element in how your feel from day to day.

Changing your eating habits is not a simple thing. It takes commitment to stick to a plan and say no to foods you love. But you don't have to give up everything and don't feel guilty if you slip now and then. As your habits change and you see how much better you feel, you will be more motivated to stick with it. ... full story in kdhnews.com Killeen Daily News

 

11th Tysabri Patient Develops PML

An 11th patient taking Biogen Idec's multiple sclerosis (MS) drug Tysabri has developed a potentially deadly brain infection.

In the latest confirmed case of progressive multifocal leukoencephalopathy, or PML, the patient took Tysabri for 29 doses, continuing the trend of the last six reported cases of the infection, where each patient had therapy for two years or longer.

The latest patient was located in the USA, the third American to have developed the infection. Of the 11 reported cases, one patient has died.

The PML incidence rate remains below the long-projected risk rate of one in 1,000 patients for those patients receiving the therapy for 12 months or 18 months.

The drug was temporarily withdrawn in 2005 after it was linked with PML, but was then brought back in 2006 with stricter safety warnings.

Tysabri continues to receive strong support from patients and doctors, however, because of the drug's perceived effectiveness. That support has remained steady because patients are made well-aware of the PML risk before they start taking Tysabri for MS.

This is the last case of PML that the company plans to announce on its website. In future any new cases will be reported by word of mouth to medical professional and patient groups. .... full report in Medical News Today

Labels: , ,


 

Diabetes Drug Shows MS Potential

A small trial testing the benefits in multiple sclerosis (MS) of a drug used to treat type II diabetes, in combination with beta-interferon-1a, has been shown to potentially prevent brain cell loss.

The results of the trial in 21 people investigating the effects of pioglitazone (also known as Actos) were published last month in the Journal of Neuroimmunology.

Although the results of the trial showed some evidence of less damage in the brains of people with MS, there were too few people in the study to determine whether this effect was real.

Dr. Susan Kohlhaas, Research Communications Officer at the MS Society said, "These results suggest that pioglitazone may have some benefit in combination with beta-interferon for people with relapsing remitting MS, but this trial is not large enough to determine exactly what that benefit will be.

She added, "A larger clinical trial is needed to decide whether or not pioglitazone will be of benefit to people with MS." .... frull report in Medical News Today

 

Experimental MS Drug Withdrawn From Trial

An experimental treatment for multiple sclerosis (MS) has been withdrawn from clinical trials after it failed to delay progression of the condition in a late-stage trial.

Dirucotide, manufactured by Eli Lilly and Co and BioMS Medical Corp, had earlier failed to meet a main goal in a mid-stage study, which tested whether the drug prevented symptoms returning among patients with relapsing remitting MS.

The drugmakers, which have been collaborating since late 2008 on dirucotide, said the latest negative results were seen in a study of the drug that involved 612 patients with secondary progressive (MS).

Patients in the study were divided into groups that received either dirucotide or a placebo intravenously every six months for two years.

In addition to failing its primary goal of delaying the time it took for the condition to worsen in patients, the drug also failed a number of secondary goals.

"We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data," BioMS Medical Chief Executive Kevin Giese said in a statement. report in Medical News Today

 

Mercury In Dental Fillings Not Harmful But Still Subject To Control, FDA Rules

The US Food and Drug Administration (FDA) issued a final regulation today, Wednesday, saying that at the levels dentists use for tooth cavity filling, elemental mercury in dental amalgam does not harm patients, although adverse health effects are known to occur at higher exposures.

Dental amalgam is made by combining mercury with other metals such as silver, copper and tin.

Under the new regulation, dental amalgam is classified as Class II, denoting moderate risk. Devices in Class II can be made subject to special FDA safety and effectiveness controls (in addition to the manufacturing standards required of all medical devices regardless of their risk level).

The announcement has received a mixed response. While the American Dental Association said they agreed with the FDA decision, a consumer group that is against using mercury in dental fillings said it showed contempt for children and the unborn. ... full report in Medical News Today

 

Neurologic Complications Seen with Swine Flu

LITTLE FALLS, N.J., July 23 -- Clinicians encountering children with flu-like symptoms accompanied by neurologic symptoms should consider infection with the pandemic H1N1 (swine flu) virus in the differential diagnosis, researchers said.

Since April, the Dallas County health department has detected four cases of neurological complications in children with confirmed H1N1 infection, Jane Siegel, MD, of the University of Texas Southwestern Medical Center in Dallas, and colleagues reported in the July 24 issue of Morbidity and Mortality Weekly Report.

When encountering children with flu-like symptoms and unexplained seizures or mental status changes, clinicians should begin antiviral treatment immediately -- especially in hospitalized patients -- and send specimens for viral testing, the researchers said.

Neurological complications, including seizures, encephalitis, encephalopathy, and Reye syndrome, had previously been associated with seasonal influenza viruses but had not yet been described in connection to the new pandemic strain. ... full report in MedPage Today

 

Improved Way to Identify 'Benign' MS Suggested

WHEELING, W.Va., July 29 -- Regular neurocognitive screening and MRI scans may be able to spot patients with so-called benign multiple sclerosis who will soon develop significant disabilities, researchers said.

Among 63 patients diagnosed with benign MS at baseline, 29% developed disabling symptoms during mean follow-up of five years, reported Maria Pia Amato, MD, of the University of Florence, Italy, and colleagues online in Neurology.

They found that T1-weighted brain lesion volume detected on MRI scans, the number of neurocognitive tests failed at baseline, and male gender, were each significantly predictive of disease progression.

A model combining all three predictors distinguished those who progressed with an accuracy of 82%, the researchers reported. ... full report in MedPage Today

 

What's new for "Multiple Sclerosis" in PubMed

Optical coherence tomography helps differentiate neuromyelitis optica and MS optic neuropathies. - Optical coherence tomography (OCT) shows more severe retinal damage after optic neuritis (ON) episodes in neuromyelitis optica (NMO) than in relapsing-remitting multiple sclerosis. Identification of substantial retinal nerve fiber layer loss (>15 mum) after ON in a non-multiple sclerosis patient should prompt consideration of an NMO spectrum condition. OCT may be a useful tool for the evaluation of patients with NMO. - Neurology. 2009 Jul 28;73(4):302-8. in PubMed

A population-based case-control study on viral infections and vaccinations and subsequent multiple sclerosis risk. -The aim of the present study was to clarify whether these infections or vaccinations, and two other infections, varicella and infectious mononucleosis, influence MS risk. We performed a population-based case-control study in Gothenburg that included 509 MS cases and 2,067 controls, born 1959-1986. - Eur J Epidemiol. 2009 Jul 26. [Epub ahead of print] in PubMed

MRI characteristics of patients with antiphospholipid syndrome and multiple sclerosis. - Therefore, the aim of this study was to investigate the differences in MRI measures among patients with PAPLS, MS and normal control (NC) subjects. We also explored non-conventional MRI measures in APLA+ and APLA- MS patients. - J Neurol. 2009 Jul 26. [Epub ahead of print] in PubMed

B-type natriuretic peptide as a marker of subclinical heart injury during mitoxantrone therapy in MS patients-Preliminary study. - The aim of this study was to evaluate the plasma level changes of B-type natriuretic peptide (BNP), biochemical marker of heart failure, and echocardiographic parameters during mitoxantrone treatment in 22 multiple sclerosis (MS) patients (8 males, 14 females, mean age 37.1+/-6.6). - Clin Neurol Neurosurg. 2009 Jul 24. [Epub ahead of print] in PubMed

Complementary and alternative medicines and dietary interventions in multiple sclerosis: what is being used in South Australia and why? - This study reports frequent use of CAM/dietary intervention amongst SA people with MS. The majority of users did so in conjunction with conventional treatments. - Complement ther Med. 2009 Aug;17(4):216-23. Epub 2009 Apr 21. in PubMed

Potential of a unique antibody gene signature to predict conversion to clinically definite multiple sclerosis. - If confirmed, signature prevalence would be a novel genetic diagnostic tool candidate for patients with early demyelinating disease of the central nervous system. - J Neuroimmunol. 2009 Jul 22. [Epub ahead of print] in PubMed

Matrix metalloproteinase-9 genotypes and haplotypes are associated with multiple sclerosis and with the degree of disability of the disease. - J Neuroimmunol. 2009 Jul 22. [Epub ahead of print] in PubMed

Breaking bad news: Communication around parental multiple sclerosis with children. - This study investigates the relation of communication around parental multiple sclerosis (MS) to family dysfunction and mental health problems of the children in Greek families. - Fam Syst Health. 2009 Mar;27(1):64-76. in PubMed

Killer immunoglobulin-like receptor ligand HLA-Bw4 protects against multiple sclerosis. -Carriage of the ligand of the inhibitory KIR3DL1 receptor, HLA-Bw4, was found to protect against MS in an HLA-DRB1 independent manner. - Ann Neurol. 2009 Mar 18;65(6):658-666. [Epub ahead of print] in PubMed

Activities of the enzymes that hydrolyze adenine nucleotides in platelets from multiple sclerosis patients. - Our results suggest that the alterations in NTPDase, E-NPP, 5'-nucleotidase and ADA may have contributed to the alterations in platelet function in MS by altering the levels of nucleotides and nucleosides in the circulation. -J Neurol. 2009 Jul 24. [Epub ahead of print] in PubMed

Parent-of-origin of HLA-DRB1*1501 and age of onset of multiple sclerosis. - J Hum Genet. 2009 Jul 24. [Epub ahead of print] in PubMed

PARP-1 deficiency increases the severity of disease in a mouse model of multiple sclerosis. - Together, our results indicate that PARP-1 plays an important role in regulating the physiological immune composition and in immune modulation during EAE, and our finding identifies a new aspect of immune regulation by PARPs in autoimmune CNS pathology. - J Biol Chem. 2009 Jul 23. [Epub ahead of print] in PubMed

Sunday

 

Facts and Myths about Generic Drugs


Today, 7 in 10 prescriptions filled in the United States are for generic drugs. This fact sheet explains how generic drugs are made and approved and debunks some common myths about these products. .... F.D.A. - U.S. Department of Health and Human Services

 

Biogen Reports New PML Case In Final Weekly Tysabri Update

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) reported another case of a rare brain infection in users of the multiple sclerosis drug Tysabri in the company's final weekly update Friday.

The latest patient represents the 11th case of progressive multifocal leukoencephalopathy, or PML, since the drug's relaunch in July 2006 and the fourth announced over the past seven updates. Tysabri - sold with Ireland's Elan Corp. (ELN) - was pulled from the U.S. market in 2005 because of PML concerns.

The total amount of cases remains below the risk rate on Tysabri's label, Biogen has said. However, the recent increase raises questions as to whether now is the time to stop the updates and adds to concerns that patients may stop taking Tysabri for a time to avoid developing the infection.

Duration of therapy is believed to play a role in Tysabri's PML risk, but such breaks - referred to as "drug holidays" - are opposed by Biogen and could hurt sales of a key growth driver for the company.

In the latest confirmed case, the patient took Tysabri for 29 doses, continuing a trend as those in the last six reported cases have each had therapy for two years or longer.

The latest patient was located in the U.S. This is notable because it's only the third such U.S. patient. Eight of the previous 10 cases have occurred overseas, and it's unknown why that has been the case.

The PML incidence remains below the long-projected risk of one in 1,000 patients developing the infection. After the previous case, a Jefferies & Co. research note last month put the revised PML incidence at one in 2,490 after 12-month Tysabri therapy; one in 1,400 after 18-month therapy; and one in 680 after 24-month therapy.

Tysabri receives strong support from patients and doctors because of the drug's perceived effectiveness. That support has remained steady because patients are well-aware of the PML risk before they start taking Tysabri for the otherwise debilitating disease of MS.

Nonetheless, the number of PML cases has frustrated Biogen's aim of making Tysabri into a blockbuster drug. The company has invested in treatments for PML and ways to mitigate the infection - once thought to be almost always fatal - and in persuading doctors that PML's risk in Tysabri patients is less severe and less likely. Of the 11 confirmed cases since the relaunch, one has died.

Biogen began issuing weekly updates in January after receiving criticism for its previous policy of disclosing new cases through 8-K filings with the Securities and Exchange Commission. From the start, Biogen had determined July 24 would be the final date because it was around the third anniversary of Tysabri's relaunch, by which time the company expected the risk/benefit profile to be clearer.

Tysabri was pulled from the U.S. market in 2005 after three initial cases, including two deaths.

The Food and Drug Administration allowed Tysabri to be reintroduced in 2006 because of the drug's effectiveness in fighting the degenerative disease, and under monitoring rules and a prohibition on using it in combination with other MS drugs. The system was aimed at reducing PML incidence.

Wall Street Journal

Labels: , ,


 

Dangerous Devic's Disease, Attacks Nervous System and Spinal Cord - Is there any Cure?

Devic’s Syndrome is a disease that is related to multiple sclerosis and lupus, but is unique in that it presents itself before MS and lupus and it progresses much more rapidly. Devic’s Disease targets and affects the optic nerves, the sheath of the spinal cord, and causes in continence. .. more info in My Channel News

 

Merck KGaA Submits Application For Cladribine Tablets As Multiple Sclerosis Therapy In Europe

Merck KGaA announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Cladribine Tablets, Merck's proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis (MS). Cladribine Tablets could become the first orally administered disease-modifying therapy available for patients with MS, as all disease-modifying therapies currently approved for the treatment of MS are injectable."

The submission of Cladribine Tablets to the EMEA brings us closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis and underscores our commitment to provide new options for the management of relapsing-remitting multiple sclerosis," said Roberto Gradnik, Executive Vice President Commercial Europe of the division Merck Serono. "We look forward to working with the EMEA and the European member states' authorities." The MAA submission is supported by results from the CLARITYa study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in patients with relapsing-remitting MS. The CLARITY data were presented at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009 and at the 19th Meeting of the European Neurological Society (ENS) in June 2009.

Merck is currently submitting new drug applications for Cladribine Tablets in several other countries, including the United States in the current quarter. ... full report in Medical News Today

 

Advances In Lab-Grown Motor Nerves Can Lead To Cures For Diabetic Neuropathy And Help Further Understand Multiple Sclerosis And Related Conditions

In the July issue of Biomaterials, published by Elsevier, researchers from the University of Central Florida (UCF) report on the first lab-grown motor nerves that are insulated and organized just like they are in the human body. The model system will drastically improve understanding of the causes of myelin-related conditions, such as diabetic neuropathy and later, possibly multiple sclerosis (MS). In addition, the model system will enable the discovery and testing of new drug therapies for these conditions.

MS, diabetic neuropathy, and many conditions that are caused by a loss of myelin, which forms protective insulation around our nerves, can be debilitating and even deadly. Adequate treatments do not yet exist. Researchers at the UCF have identified this to be a result of a deficiency in model research systems. ...full story in Medical News Today

 

Functional Gene Mutation Associated with RLS Identified


WHEELING, W.Va., July 24 -- Sequencing of two genes associated with restless legs syndrome (RLS) revealed a functional mutation in some patients with the condition -- the first ever found, researchers said.

The mutation was found in the MEIS1 gene, a member of the homeobox gene family thought to play a critical role in development, reported Carles Vilariño-Güell, PhD, of the Mayo Clinic in Jacksonville, Fla., and colleagues in the July issue of Neurology.

Although the mutation appears to be rare, even among RLS patients, it was found in all affected members of one family, suggesting a causative role. ...full report in MedPage Today

 

'Stigmatizing' Illness Is No Bar to Patient Cooperation in Research

WHEELING, W.Va., July 24 -- Patients with diseases that may expose them to discrimination were surprisingly willing to allow their personal and health information to be used for research purposes, researchers said.

Writing in the online journal BMC Medical Ethics, Dr. Willison and colleagues said fewer than 5% of such patients would refuse participation altogether and about 20% would demand specific permission for each use in studies like this.

On the other hand, patients were more likely to balk when the research was sponsored by for-profit companies or was intended for marketing purposes.

"Individual attitudes -- and concern about disclosure in particular -- were more predictive of consent choice than was one's health condition," the researchers wrote. .....full report in MedPage Today

 

What's new for "Multiple Sclerosis" in PubMed

Prediction of acute multiple sclerosis relapses by transcription levels of peripheral blood cells. - We conclude that gene expression analysis is a valuable tool that can be used in clinical practice to predict future MS disease activity. Similar approach can be also useful for dealing with other autoimmune diseases that characterized by relapsing-remitting nature. - BMC Med Genomics. 2009 Jul 22;2(1):46. [Epub ahead of print] in PubMed

Suspected multiple sclerosis - what to do? Evaluation of a patient information leaflet. - Taken together, our findings demonstrate that early information about possible MS is warranted by patients and does not show negative side effects. Further studies on evidence-based patient information in early MS seem necessary. - Mult Scler. 2009 Jul 22. [Epub ahead of print] in PubMed

Multiple sclerosis risk: interaction between human leukocyte antigen and the environment in Sardinian population. - In the Sardinian population, an environment more prone and propitious to autoimmunity may contribute toward the rising incidence of MS or anticipate overt manifestation of the disease in genetically predisposed subjects. - Mult Scler. 2009 Jul 22. [Epub ahead of print] in PubMed

Foreign accent syndrome as a first sign of multiple sclerosis. - FAS may be the first symptom of MS. It could result from extensive disturbances of brain function involving the right hemisphere. - Mult Scler. 2009 Jul 22. [Epub ahead of print] in PubMed

Follow-up examination of linkage and association to chromosome 1q43 in multiple sclerosis. - We found preliminary evidence to suggest that common variation within the RGS7 locus may be involved in disease susceptibility. - Genes Immun. 2009 Jul 23. [Epub ahead of print] in PubMed

PARP-1 deficiency increases the severity of disease in a mouse model of multiple sclerosis. - Together, our results indicate that PARP-1 plays an important role in regulating the physiological immune composition and in immune modulation during EAE, and our finding identifies a new aspect of immune regulation by PARPs in autoimmune CNS pathology. - J Biol Chem. 2009 Jul 23. [Epub ahead of print] in PubMed

Parent-of-origin of HLA-DRB1*1501 and age of onset of multiple sclerosis. - J Hum Genet. 2009 Jul 24. [Epub ahead of print] in PubMed

Activities of the enzymes that hydrolyze adenine nucleotides in platelets from multiple sclerosis patients. - Our results suggest that the alterations in NTPDase, E-NPP, 5'-nucleotidase and ADA may have contributed to the alterations in platelet function in MS by altering the levels of nucleotides and nucleosides in the circulation. - J Neurol. 2009 Jul 24. [Epub ahead of print] in PubMed

Killer immunoglobulin-like receptor ligand HLA-Bw4 protects against multiple sclerosis. - Carriage of the ligand of the inhibitory KIR3DL1 receptor, HLA-Bw4, was found to protect against MS in an HLA-DRB1 independent manner. - Ann Neurol. 2009 Mar 18;65(6):658-666. [Epub ahead of print] in PubMed

Thursday

 

The Right Messenger For A Healthy Immune Response

ScienceDaily (July 20, 2009) — Researchers from the Molecular Immunology group at the Helmholtz Centre for Infection Research (HZI) in Braunschweig, Germany have now shown that Beta-Interferon also plays a crucial role during an immune response: without Beta-Interferon immune cells are unable to show "wanted posters" of pathogens to other cells. As a consequence, these cells will not recognize the pathogen and the immune response does not start properly. ...read the full story in Science Daily

 

First Model Motor Nerve System That's Insulated And Organized Like Human Body

ScienceDaily (July 22, 2009) — Researchers from the University of Central Florida (UCF) report on the first lab-grown motor nerves that are insulated and organized just like they are in the human body. The model system will drastically improve understanding of the causes of myelin-related conditions, such as diabetic neuropathy and later, possibly multiple sclerosis (MS). In addition, the model system will enable the discovery and testing of new drug therapies for these conditions. ...read the full story in Science Daily

 

‘Biosimilars’ Are ‘Biodifferent’

'Biosimilar drugs are too dis-similar for fast-tracking'

WASHINGTON -- Hidden in the congressional fireworks bursting over health-care overhaul and cap-and-trade is another highly contentious consumer issue centered on a unique class of drug used to alleviate pain associated with the worst kinds of diseases, including multiple sclerosis and cancer.

The class of drugs at the center of the argument is biologics -- biologically produced drugs – and the legislative issue centers on how quickly biologics should be approved and moved to market. Congress faces a balancing act between maintaining product safety that comes from rigorous testing on one side, and on the other, fast-track approval to get generic copies of biologics to patients quickly.

The New York Times is the latest to explore the issue, July 22, 2009 in this article:
http://www.nytimes.com/2009/07/22/business/22biogenerics.html?hpw

Following commentary argues that biologics are too complex to be given quick passage through the FDA’s testing process.

By Dr. Richard Dolinar

“Biologics,” or biologically produced drugs, constitute a huge and growing segment of the medical marketplace. They include insulin and many vaccines.

In 2008, more than 600 new biotechnology medicines, for more than 100 diseases, were in development in the United States. More than 300 other biologics already had been approved for use by the federal Food and Drug Administration.

Because biologics are used to treat a wide range of diseases, including cancer, multiple sclerosis, and rheumatoid arthritis, legislators and medical professionals are interested in bringing less-costly “generic” versions to the marketplace. A bill proposed by Rep. Henry Waxman (D-CA), the Promoting Innovation and Access to Life-Saving Medicine Act (HR 1427), would allow for the manufacture and distribution of “biosimilars,” or generic biologic drugs, following standards similar to those governing generic chemical drugs.

In 1984, the Drug Price Competition and Patent Term Restoration Act, sponsored by Waxman and then-Rep. Orrin Hatch (R-UT), created an abbreviated approval process for generic chemical drugs.

Because the active ingredients in chemical generics are identical to those in the “innovator drugs,” or original name-brand medicines, it was possible to establish an approval process allowing generic manufacturers to piggyback on the research studies provided by the innovator companies. The ability to manufacture drugs that already had been extensively tested hastened the generic drugs’ entry into the marketplace, saving both time and money.

When chemical reactions are performed, the result is always the same. For instance: combining two hydrogen molecules with one of oxygen always produces water.

But that’s not the case with biologics, which are “grown” (biologically engineered), not created by a simple chemical reaction (e.g. Lipitor and Prozac). No two biologics created using different cell lines or different manufacturing processes ever turn out exactly the same.

That’s the problem with HR 1427. In mirroring the guidelines for generic chemical drugs, Waxman’s new bill assumes the copies of biologics made by follow-on manufacturers—though admittedly not identical—will be close enough to the originals to make extensive product testing before release unnecessary.

What is close enough for government work is not necessarily close enough for the treatment of patients. Small differences in drugs can have very profound effects on the body. Because biologics are huge, complex entities, predicting how small changes in them will affect safety, efficacy, and immunogenicity is not possible.

Perhaps follow-on biologics should be called “biodifferent” rather than “biosimilar.” It is the differences that are of concern, not the similarities. These differences, no matter how minute, can have major implications for patients.

Physicians and patients need to be confident that any biosimilar approved by the FDA has been subjected to the same rigorous clinical testing as the innovator drug. Waxman’s bill would not provide that security.

Dr. Richard Dolinar (drdolinar@dolinar.org ) is a practicing endocrinologist, has consulted for pharmaceutical companies, and is a senior fellow for health care policy at The Heartland Institute.

Read in The Heartland Institute

 

Advances In Lab-Grown Motor Nerves Can Lead To Cures For Diabetic Neuropathy And Help Further Understand Multiple Sclerosis And Related Conditions

In the July issue of Biomaterials, published by Elsevier, researchers from the University of Central Florida (UCF) report on the first lab-grown motor nerves that are insulated and organized just like they are in the human body. The model system will drastically improve understanding of the causes of myelin-related conditions, such as diabetic neuropathy and later, possibly multiple sclerosis (MS). In addition, the model system will enable the discovery and testing of new drug therapies for these conditions.

MS, diabetic neuropathy, and many conditions that are caused by a loss of myelin, which forms protective insulation around our nerves, can be debilitating and even deadly. Adequate treatments do not yet exist. Researchers at the UCF have identified this to be a result of a deficiency in model research systems. ....full report in Medical News Today

 

NIH Deepens Investment In Combination Study Of MS Drugs

The first large-scale "CombiRX" clinical trial testing the combined use of FDA-approved interferon beta-1a (Avonex®) and glatiramer acetate (Copaxone®) to treat relapsing-remitting MS has just received a $19-million renewal grant from the National Institutes of Health. This is the largest MS trial ever supported by the NIH, with a cumulative investment of more than $44 million. The long-term trial is led by principal investigator Fred Lublin, MD, (Corinne Goldsmith Dickinson Multiple Sclerosis Center at Mount Sinai School of Medicine, New York, NY).

The study is now fully enrolled, with more than 1,000 participants at 67 medical centers across the United States and Canada. Dr. Lublin is a member of the National Board of Directors of the National MS Society and the Society's National Clinical Advisory Board and the New York City Chapter Clinical Advisory Committee. ....full report in Medical News Today

Labels: ,


 

What's new for "Multiple Sclerosis" in PubMed

Diffusion tensor imaging of the cervical spinal cord of patients with relapsing-remising multiple sclerosis: a study of 41 cases. - We observed reduced fractional anisotropy in the demyelinating plaques and in the NASC of MS patients, corroborating the hypothesis that the histological extension of the MS lesions is more severe than the abnormalities seen in the conventional MRI sequences. - Arq Neuropsiquiatr. 2009 Jun;67(2B):391-5. in PubMed

Executive function and memory in patients with relapsing-remitting multiple sclerosis. - In contrast to the well known sensitive/motor deficits, the cognitive dysfunction has only been analyzed in the last few decades. - Psicothema. 2009 Aug;21(3):416-20. in PubMed

[Energy-saving strategies in the treatment of fatigue in patients with multiple sclerosis. A pilot study.] - Rev Neurol. 2009 Aug 16-31;49(4):181-5. in PubMed

The impact of regular physical activity on fatigue, depression and quality of life in persons with multiple sclerosis. - The participation in regular physical activity may positively influence fatigue, depression and quality of life scores in persons with MS. - Health Qual Life Outcomes. 2009 Jul 20;7(1):68. [Epub ahead of print] in PubMed

Injection anxiety remains a long-term barrier to medication adherence in multiple sclerosis. - Sustained adherence to DMT remains a challenge for a subset of individuals with MS well beyond the initial period of acclimation. Injection anxiety is an important and promising target of psychological intervention during all periods of medication use. - Rehabil Psychol. 2009 Feb;54(1):116-21. in PubMed

Tuesday

 

Elan revenues up 14% in Q2

Pharmaceutical firm Elan has announced that its revenues rose by 14% ($66m) to $526m in the second quarter of the year.

The company attributed the increase to a 30% rise in income from Tysabri, which is used to treat multiple sclerosis and Crohn's disease, and a 10% increase in revenues from Elan Drug Technologies.

Commentinng on the results, Elan executive vice-president and chief financial officer Shane Cooke said that there had been a 55% increase in the net number of patients using Tysabri since the first quarter. ..full story in RTE Business

Labels:


 

What's new for 'Multiple Sclerosis' in PubMed

Differential micro RNA expression in PBMC from multiple sclerosis patients. - This work highlights the importance of miRNA expression in the molecular mechanisms implicated in the disease. Moreover, the proposed involvement of these small molecules in multiple sclerosis opens up a new therapeutic approach to explore and highlight some candidate biomarker targets in MS. - PLoS One. 2009 Jul 20;4(7):e6309. in PubMed

What multiple sclerosis could bring to cognitive neuroscience? - The early disseminated nature of brain lesions, their dynamic and unstable nature, the prevalence of white-matter lesions, and the alteration of non-modular aspects of cognition: all these arguments have discouraged neuropsychologists for a long time. Today, these very same specific properties of multiple sclerosis offer an extremely relevant model to explore cognitive dimensions of brain plasticity, to revivify the concept of disconnection in neuropsychology, and to evaluate some neuroscientific models of consciousness. - Rev Neurol (Paris). 2009 Jul 17. [Epub ahead of print] in PubMed

Inhibition of CXCR2 signaling promotes recovery in models of Multiple Sclerosis. - Our findings demonstrate the importance of antagonizing CXCR2 in enhancing myelin repair by reducing lesion load and functionality in models of multiple sclerosis and thus provide a therapeutic target for demyelinating diseases. - Exp Neurol. 2009 Jul 16. [Epub ahead of print] in PubMed

Does the DRB11501 allele confer more severe and faster progression in primary progressive multiple sclerosis patients? HLA in primary progressive multiple sclerosis. - This exploratory study raises new hypotheses for future research and emphasizes the need to investigate possible candidate genes other than HLA that may contribute towards heterogeneity in the course of the disease. - J Neuroimmunol. 2009 Jul 16. [Epub ahead of print] in PubMed

Effect of geranylgeranylacetone on optic neuritis in experimental autoimmune encephalomyelitis. - Neurosci Lett. 2009 Jul 15. [Epub ahead of print] in PubMed

Post-marketing of disease modifying drugs in multiple sclerosis: An exploratory analysis of gender effect in interferon beta treatment. - The results of this exploratory analysis seem to suggest that male patients do not respond to IFNbeta treatment in the same way of females. - J Neurol Sci. 2009 Jul 15. [Epub ahead of print] in PubMed

Capturing the costs of end-of-life care: comparisons of multiple sclerosis, Parkinson's disease, and dementia. - Studies of multiple sclerosis, Parkinson's disease, and dementia that have used this questionnaire are described in this article. What is clear is that the costs of providing end-of-life care can be high and that informal care from family members and friends accounts for a substantial amount of the overall costs. - J Pain Symptom Manage. 2009 Jul;38(1):62-7 in PubMed

Efficacy of natalizumab in second line therapy of relapsing-remitting multiple sclerosis: results from a multi-center study in German speaking countries. - Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity. - Eur J Neurol. 2009 Jul 9. [Epub ahead of print] in PubMed

Pregnancy, prolactin and white matter regeneration. - Here I discuss work that demonstrates that hormonal changes during pregnancy promote increased OPC proliferation and oligodendrocyte production in the maternal CNS. - J Neurol Sci. 2009 Jul 14. [Epub ahead of print] in PubMed

Monday

 

Restrictions don't halt illegal use of drugs

I am concerned about Republican gubernatorial candidate Chris Christie's stance on New Jersey's medical marijuana bill, as stated on his Web site. I have had multiple sclerosis for the past 12 years and the New Jersey Compassionate Use Medical Marijuana bill would greatly benefit me if it is enacted into law.

After stating his concern for my suffering, he goes on to say that he cannot support this bill unless it is changed to enable it to do what New Jersey's total efforts against drug abuse have failed to accomplish. "I would only consider a bill which had sufficient safeguards in it to prevent the widespread use of this drug by people who do not really need it," he said.

We already have what he considers widespread use of marijuana in New Jersey, even though medical marijuana is not legal. The people he worries about getting legal medical marijuana — even though they were not qualified patients — are probably smoking pot as I write this. Legitimate patients should not suffer because Christie places unachievable goals on this bill.

There is diversion of virtually all opiate-based prescriptions, even with all of the restrictions placed on them. I'm glad Christie had no say in those restrictions or I would have no medicine at all. Medical marijuana is an integral part of my therapy for multiple sclerosis. ...story and comments on APP.com From the Jersey Shore to You

Sunday

 

I suffer with Multiple Sclerosis. Can I get a prescription for Sativex?


Sarah Martin is a British Multiple Sclerosis sufferer who has found success in aleviating the symptoms of her condition by using cannabis. And whilst the government tries to enforce their way on the British population, by maintaining the illegal status of cannabis, in other global regions where cannabis use is permitted with a doctors note, the medical profession are lifting the curtain higher and higher, and in doing so they're making British patients feel like second class citizens.

Whilst American and Canadian MS sufferers may grow their own cannabis, here in the UK, seriously ill people are risking court cases and jail-terms in a bid to find some pain relief.

Make no bones about it, cannabis treatment is available in the UK right now, by way of a drug called Sativex. But it turns out you can only have it, if you can afford to pay for it. So some users are turning to growing their own medicine to fill the void.

http://pr.cannazine.co.uk/ : The political and financial wranglings surrounding the most emotive of pharmaceutical treatments has been turned into something of a soap-opera, as the UK government attempts on the one hand, to deny cannabis has any medicinal benefits to offer humanity, whilst on the other hand keeping cannabis out of the hands of those that need it most, using the police and the judicial system as their 'enforcers'. ..full story in PR.CannaZine

Labels:


 

Drug deal, R&D hike hit Biogen profit

Biogen Idec's profit for the second quarter was down significantly from the same period last year, due in part to the acquisition of a new experimental treatment for multiple sclerosis. The company included the acquisition as part of a 60-percent increase in year-on-year research and development costs.

The Cambridge, Mass.-based biopharmaceutical company reported net income of $144.9 million for the three months ending June 30, 2009, down from $208.1 million for the second quarter last year.

Revenue for the company was up for the second quarter, to $1.1 billion from $993 million during the second quarter of 2008. The increase was led by sales of the company’s two marketed treatments for Multiple Sclerosis, Avonex , which booked revenues of $591.2 million, up from $527.2 million and Tysabri, with sales of $187.6 million, up from $147.2 million. The increase in sales of Tysabri beat investors’ expectations.

Biogen paid $110 million to Accordia Therapeutics Inc. to licence the drug candidate Ampyra (Fampridine-SR).

Biogen’s (Nasdaq: BIIB) stock rose slightly on the news, during mid day trading on Thursday, to $47.06 from $46.67 at the previous close. .. story in the Boston Business Journal

Labels: , ,


 

Biogen Idec 2Q profit falls on charge for MS drug

CAMBRIDGE, Mass. -- Biotechnology company Biogen Idec Inc. said Thursday its second-quarter profit fell on charges for a drug development deal with Acorda Therapeutics Inc., but sales of its multiple sclerosis drugs gained ground.

The company earned $142.8 million, or 49 cents per share, compared with profit of $206.6 million, or 70 cents per share, during the same period a year prior. Revenue rose 10 percent to $1.09 billion from $993.4 million. ... full story in Forbes.com

 

ICAD: DASH Diet May Slow Cognitive Decline

VIENNA, July 15 -- A diet rich in fruits and vegetables and low in salt, sweets, and red meats -- the Dietary Approaches to Stop Hypertension (DASH) model -- appears to slow cognitive decline, researchers said here at the International Conference on Alzheimer's Disease. ...full story in MedPage Today

 

Online Brain Game For People With Multiple Sclerosis Launched By Technology Collaborative

The MS Technology Collaborative has created a new way for people living with multiple sclerosis (MS) to exercise their brain power. The Collaborative, an alliance of Bayer HealthCare Pharmaceuticals, Microsoft, and the National Multiple Sclerosis Society, today announced the launch of MyBrainGames, a free suite of online games filled with cognitive challenges for the MS community.

Approximately 50 percent of people living with MS develop cognitive challenges, often in the areas of processing speed, working memory and complex attention. These challenges can involve difficulty in learning and remembering information; focusing, maintaining and shifting attention; and organizing, planning and problem-solving.

MyBrainGames, available for free at MyMSMyWay.com, are the first online games designed specifically for people with MS under the direction of a team of leading healthcare professionals specializing in MS and cognition, as well as members of the MS community. The games provide a series of fun and interactive cognitive challenges for the MS community. .... full report in Medical News Today

 

Gene Regulates Immune Cells' Ability To Harm The Body

A recently identified gene allows immune cells to start the self-destructive processes thought to underlie autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis, researchers at Washington University School of Medicine in St. Louis have found.

Researchers showed that mice without the Batf gene lacked a type of inflammatory immune cell and were resistant to a procedure that normally induces an autoimmune condition similar to human MS. They plan to look for other genes and proteins influenced by Batf that could be targets for new treatments for autoimmune diseases. ..full report in Medical News Today

 

MS Society Pleased With Government Recognition Of Crisis In Social Care

The government's Green Paper 'Shaping the Future of Care Together' has been welcomed by the MS Society as the radical step necessary to address the crisis in social care.

Announced on Tuesday, the bold proposals set out a vision for a care system as important as the NHS, billed as the 'National Care Service', which could potentially bring an end to the postcode lottery in care and improve its quality.

The Green Paper presents proposals for the long term funding of better care for the growing number of older people, and people with long-term conditions such as multiple sclerosis (MS). ...full report in Medical News Today

 

What's new for 'Multiple Sclerosis' in PubMed

Impact of Immunomodulatory Treatment on Leukocyte Cytokine Production in Multiple Sclerosis Patients and Healthy Donors. -Treatment with interferon(IFN) beta, glatiramer acetate (GLAT) and intravenous immunoglobulins (IVIG) alters the cytokine production in multiple sclerosis (MS) patients. To date, it is not clear whether the effect on cytokines varies among these drugs. - Neuroimmunomodulation. - in PubMed

Is multiple sclerosis a mitochondrial disease? - In this article, we discuss the latest developments on MS research, including etiology, pathology, genetic association, EAE animal models, mechanisms of neuronal injury and axonal transport and therapeutics. In this article, we also focus on the mechanisms of mitochondrial dysfunction that are involved in MS, including mitochondrial DNA defects, and mitochondrial structural/functional changes. - Biochim Biophys Acta. Jul 13. [Epub ahead of print] in PubMed

Getting the balance right: A randomised controlled trial of physiotherapy and exercise interventions for ambulatory people with multiple sclerosis. -Data analysis will analyse change in each group, and the differences between groups. Sub group analysis may be performed if sufficient numbers are recruited. - BMC Neurol.. 2009 Jul 16;9(1):34. [Epub ahead of print] in PubMed

Cladribine: not just another purine analogue? - This review highlights pharmacological, toxicological and clinical data for the use of cladribine. It also discusses existing and new mechanisms that may contribute to its unique clinical activity. - Expert Opin Investig Drugs. 2009 Aug;18(8):1169-81. in PubMed

User Interface of a Teleradiology System for the MR Assessment of Multiple Sclerosis. - The aim of this study was to assess the image display of a web-based teleradiology system that uses a common web browser and has no need of proprietary applets, plug-ins, or dedicated software for DICOM display. - J Digit Imaging. 2009 Jul 15. [Epub ahead of print] in PubMed

Genetic polymorphisms, their allele combinations and IFN-beta treatment response in Irish multiple sclerosis patients. - The genetic mechanism of response to IFN-beta is complex and as yet poorly understood. Data mining algorithms may help in uncovering hidden allele combinations involved in drug response versus nonresponse. - Pharmacogenomics. 2009 Jul;10(7):1177-86. in PubMed

Monday

 

Smoking May Speed Multiple Sclerosis Symptoms

Patients who smoke appear to progress to severe disease more rapidly, study finds.

MONDAY, July 13 (HealthDay News) -- In addition to the well-known hazards of smoking, research now suggests that the dangerous habit causes a more rapid progression of multiple sclerosis.

The new findings are from a study that included 1,465 multiple sclerosis (MS) patients, average age 42, who had had MS for an average of 9.4 years. There were 257 current smokers, 428 past smokers and 780 participants who had never smoked.

At the start of the study, current smokers had significantly more severe disease and were also more likely to have primary progressive MS (a steady decline in health status), rather than relapsing-remitting MS (alternating periods with and without symptoms).

The Boston researchers tracked a group of 891 patients for an average of three years to identify how many changed from relapsing-remitting MS to secondary progressive MS, which is a steady decline that develops after a period of relapsing-remitting MS. During the follow-up, this change was seen in 20 of 154 smokers, 20 of 237 ex-smokers and 32 of 500 never-smokers.

"The conversion from relapsing-remitting MS to secondary progressive MS occurred faster in current smokers compared with never-smokers, but was similar in ex-smokers and never-smokers," according to Brian C. Healy of Brigham and Women's Hospital, Harvard Medical School and Massachusetts General Hospital, and colleagues.

The study was reported in the July issue of Archives of Neurology .

The findings "support the hypothesis that cigarette smoking has an adverse effect on progression of MS as measured by clinical and MRI outcomes," the study authors concluded.

"Although causality remains to be proved, these findings suggest that patients with MS who quit smoking may not only reduce their risk of smoking-related diseases but also delay the progression of MS."

More information: The U.S. National Institute of Neurological Disorders and Stroke has more about MS. SOURCE: JAMA/Archives journals, news release, July 13, 2009

Story found in HONnews

 

GTC Agreement Takes Aim At MS

Framingham-based GTC Biotherapeutics Inc. now has the rights to develop and commercialize a protein that could be used to treat multiple sclerosis and other autoimmune diseases.

The protein is recombinant human alpha-fetoprotein (rhAFP) and it has been in development by Cambridge-based Merrimack Pharmaceuticals in the milk of genetically modified goats at GTC's facilities. Under the new agreement, GTC will receive enough rhAFP from Merrimack for use in clinical studies and will assume control of the goats.

Financial terms of the deal were not disclosed.

Human AFP is a blood protein produced in very high levels in women during pregnancy. It plays a role in strengthening women's immune systems in order to protect gestating fetuses. Apart from pregnancy, AFP is produced in very low levels.

GTC plans to study whether human AFP produced by genetically modified goats can treat autoimmune diseases multiple sclerosis and myasthenia gravis.
Story found in Worcester Business Journal Online

 

Biogen Idec Receives Fast Track Designation From FDA For PEGylated Interferon Beta-1a For Relapsing Multiple Sclerosis

Biogen Idec (NASDAQ: BIIB) announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.

"Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis," said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology at Biogen Idec. "We look forward to working closely with the FDA to expedite the compound's development and review process." ...full report in Medical News Today

 

MS Society Appoints New Director

The MS Society has appointed Sue Farrington to its newly created role of Director of Information and Education. Sue was formerly Director of Corporate Affairs at CSV.

In her new role, which starts this month, Sue is responsible for the management of the MS Society's information for people affected by MS - through its website, annual conference programme and publications team. Sue will also be overseeing a drive to improve the Society's professional education programme. ...full report in Medical News Today

 

Kineta Acquires Novel Drug Candidates From Airmid For Potential Treatment Of Multiple Sclerosis, Type 1 Diabetes And Other Autoimmune Diseases

Kineta, Inc. of Seattle and Airmid Incorporated of Redwood City, CA jointly announce an agreement in which a Kineta subsidiary has acquired exclusive commercial rights to a portfolio of novel therapeutic compounds from Airmid. The array of compounds holds extraordinary potential for the treatment of multiple sclerosis, type 1 diabetes mellitus and numerous other autoimmune diseases.

"This transaction is a significant milestone for Airmid. It places our peptidic Kv1.3 blockers into the very capable hands of Kineta's drug development team, sets Airmid on a path to provide substantial return-on-investment for our shareholders, and provides funding to enhance the value of Airmid's retained assets," said George Miljanich, Ph.D., CEO of Airmid. Under the terms of the deal, Airmid will receive upfront payments, development, regulatory and commercial milestones as well as sales royalties.

Airmid founder, K. George Chandy, MD, Ph.D., also applauded the announcement: "Kineta possesses both the scientific capacity and the track record of success necessary to advance these promising therapeutics toward the goal of conquering multiple devastating autoimmune diseases." ...full report in Medical News Today

 

MS Society-funded Study Unlocks Part Of The Mystery Of Remyelination In MS

Researchers working in Cambridge and San Francisco have discovered clues about how stem cells promote myelin repair. The study, published earlier this week in the journal Genes and Development, was partly funded by the MS Society and took place at the MS Society Cambridge Centre for Myelin Repair.

Researchers looked at what factors are important for remyelination (the process by which damaged myelin is repaired by brain cells) in MS and discovered that a cell signalling pathway called the Wnt pathway is involved in remyelination.

Cell signalling pathways are complex processes in cells that, when turned on or off, can change the role of that particular cell in the body. The Wnt pathway is an important pathway for all stages of development, including development in the womb, and for this reason researchers have been studying it for years.

In this case, researchers have shown for the first time that the Wnt pathway is involved in remyelination - and that when it is not working properly cells cannot remyelinate properly. The study looked specifically at the Wnt pathway in oligodendrocytes (specialised brain cells that are responsible for making and repairing myelin). They found that if the Wnt pathway is over-active then remyelination is impaired, suggesting that the Wnt pathway is not functioning as it should in MS lesions. This is potentially a good therapeutic target to help promote myelin repair in people with MS. ....full report in Medical News Today

 

Drug Manufacturer Receives Fast Track Designation From FDA

Pharmaceutical firm Biogen Idec announced that the American drug watchdog the Food and Drug Administration (FDA) has granted Fast Track designation for its multiple sclerosis (MS) drug PEGylated interferon beta-1a (BIIB017).

The company is currently enrolling patients in a global Phase III study evaluating the effectiveness and safety of either bi-weekly or once-monthly injections of the therapy in people with relapsing remitting MS.

If the trial reports promising results it means that people could inject their medication less often without sacrificing effectiveness. ....full report in Medical News Today

 

MS Society-Funded Study Investigates Experiences Of Partners Of People With MS

An MS Society-funded study has highlighted the impact that MS has on partners' lives and demonstrates the need for support and services for partners of people with MS.

A study recently published in the journal Multiple Sclerosis has concluded that partners of people in the early stages of MS report feeling isolated and helpless. The study involved conducting telephone interviews with 15 people whose partners were recently diagnosed with MS and asking them a series of broad open-ended questions such as "Can you start by telling me all about what you thought and felt when your partner was first diagnosed with MS?" The interviews covered aspects of participants' lives that ranged from feelings when their partner was first diagnosed to the impact of MS on various aspects of their lives and also with how they cope with these challenges. ....full report in Medical News Today

 

Smoking Speeds MS Progression

WHEELING, W.Va., July 13 -- Multiple sclerosis shifts from the relapsing-remitting form to steadily progressive disease more quickly in patients who smoke, researchers said.

The adjusted hazard ratio for advancing to secondary progressive MS was 2.50 for smokers relative to patients who had never used cigarettes (95% CI 1.42 to 4.41) over a median of 3.3 years of follow-up, reported Alberto Ascherio, MD, of Harvard School of Public Health, and colleagues in the July issue of Archives of Neurology.

Among 1,465 patients referred to the Partners MS Center in Boston, smokers were also significantly more likely to have primary progressive MS and to have worse disease compared with patients who never smoked, the researchers also found.

"Our data suggest that cigarette smoke has an adverse influence on the progression of MS and accelerates conversion from a relapsing-remitting to a progressive course," they wrote.

The findings conflict with a Dutch study published in 2007 that found no relationship between smoking and MS progression, but support earlier research suggesting such a link. (See: Tobacco Smoke Dispelled as Factor in MS Progression) ..... Full report in MedPage Today

 

What's new for 'Multiple Sclerosis' in PubMed

Enhanced number and activity of mitochondria in multiple sclerosis lesions. - Our data indicate the occurrence of severe mitochondrial alterations in MS lesions, which coincides with enhanced mitochondrial oxidative stress. Together, these findings support a mechanism whereby enhanced density of mitochondria in MS lesions might contribute to the formation of free radicals and subsequent tissue damage. Copyright (c) 2009 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd. - J Pathol. 2009 May 26. [Epub ahead of print] in PubMed

Sensory complaints of the upper extremities in multiple sclerosis: relative efficacy of nortriptyline and transcutaneous electrical nerve stimulation. - This study demonstrates that both nortriptyline and TENS can be effective in reducing the intensity of pain and/or sensory complaints in the upper extremities of people with MS. However given the side-effect profile of nortriptyline, TENS may have some benefits over nortriptyline. This modest reduction in the intensity of pain and/or sensory complaints suggests that physicians should carefully weigh the risk and benefits of nortriptyline and TENS in people with MS with pain and/or sensory complaints. - Clin J Pain. 2009 May;25(4):281-5. in PubMed

Headaches in the different phases of relapsing-remitting multiple sclerosis: a tendency for stabbing headaches during relapses. - The high frequency of PSHs in relapse was notable, and, to the best of our knowledge, PSH was not reported in relapsing-remitting multiple sclerosis before. Further studies with larger samples are recommended. - Neurologist. 2009 Jul;15(4):212-6. in PubMed

Interferon-beta(1b) Treatment in Neuromyelitis Optica. - In NMO patients, IFN-beta(1b) treatment was not effective in reducing the relapse number and the disability progression. - Eur Neurol. 2009 Jul 7;62(3):167-170. [Epub ahead of print] in PubMed

Adherence of adolescents to multiple sclerosis disease-modifying therapy. - In conclusion, adolescents in this cohort had difficulty adhering to disease-modifying therapies, and peers played an important role in mediating their adjustment to multiple sclerosis. Specific strategies are required to improve adolescents' adherence to treatment, including less intrusive options and enhancing peer support. - Pediatr Neurol. 2009 Aug;41(2):119-23. in PubMed

Immunotoxicity profile of natalizumab. - Overall, natalizumab was well tolerated in monkeys, demonstrated the expected pharmacologic effect on cell trafficking, and showed no adverse effect on immune cell function. - J Immunotoxicol. 2009 Jun;6(2):115-29. in PubMed

Treatment of seizures in multiple sclerosis. - Well-designed randomised controlled trials are needed to guide clinical practice. Such trials should preferably contain a head-to-head comparison of antiepileptic drugs in patients with MS. - Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007150. in PubMed

Oral versus Intravenous Steroids for Treatment of Relapses in Multiple Sclerosis. - The trials reviewed support the hypothesis that no significant differences in clinical, radiological or pharmacological outcomes oral and intravenous steroids for MS relapses exist. However, with the small number of patients and methodological limitations, conclusions of equivalence are premature. - Cochran Database Syst Rev. 2009 Jul 8;(3):CD006921 in PubMed

Sustained release oral fampridine in the treatment of multiple sclerosis. - Fampridine-SR 10 mg twice a day has been shown to be safe and effective in improving the ambulation of patients with walking disability due to MS. It will probably find clinical application beyond this specific indication in a significant proportion of patients. - Expert Opin Pharmacother. 2009 Jul 8. [Epub ahead of print] in PubMed

Brazilian experience with two conditioning regimens in patients with multiple sclerosis: BEAM/horse ATG and CY/rabbit ATG - Studies have shown that autologous hematopoietic SCT (HSCT) can be used as an intensive immunosuppressive therapy to treat refractory patients and to prevent the progression of multiple sclerosis (MS). This is a prospective multicentric Brazilian MS trial comparing two conditioning regimens: BEAM/horse ATG and CY/rabbit ATG. Most (80.4%) of the 41 subjects in the study had the secondary progressive MS subtype and the mean age was 42 years. The baseline EDSS score in 58.5% of the subjects was 6.5 and 78% had a score of 6.0 or higher, respectively. The complication rate during the intra-transplantation period was 56% for all patients: 71.4% of the patients in the BEAM/hATG group and 40% in the CY/rATG group (P=0.04). Three subjects (7.5%) died of cardiac toxicity, sepsis and alveolar hemorrhage, all of them in the BEAM/ATG group. EFS was 58.54% for all patients: 47% in the BEAM/hATG group and 70% in the CY/rATG group (P=0.288). In conclusion, the CY/rATG regimen seems to be associated with similar outcome results, but presented less toxicity when compared with the BEAM/hATG regimen. Long-term follow-up would be required to fully assess the differences in therapeutic effectiveness between the two regimens. Bone Marrow Transplantation advance online publication, 6 July 2009; doi:10.1038/bmt.2009.127. - Bone Marrow Transplant. 2009 Jul 6. [Epub ahead of print] in PubMed

Saturday

 

Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement to Develop and Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.

CAMBRIDGE, Ma. & HAWTHORNE, N.Y.--(BUSINESS WIRE)--Jul 1, 2009 - Biogen Idec (NASDAQ:BIIB) and Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that they have entered into an exclusive collaboration and license agreement to develop and commercializeFampridine-SR, a multiple sclerosis (MS) therapy, in markets outside the United States. Fampridine-SR is a novel, oral sustained-release compound being developed to improve walking ability in people with MS. The parties have also entered into a related supply agreement. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan Pharma International Limited, a subsidiary of Elan Corporation plc (NYSE:ELN). ...full story in PharmaLive

 

UCB And Biogen Idec Discontinue Phase II Clinical Trial Of CDP323 - Analysis Showed No Clinically Relevant Benefit For Patients

UCB and Biogen Idec announced today the discontinuation of the Phase II clinical trial of CDP323 for the treatment of relapsing multiple sclerosis (MS). Preliminary interim efficacy analysis showed that patients enrolled in this clinical trial did not benefit as expected from CDP323 compared to placebo after a six month treatment period. No cases of PML (progressive multifocal leukoencephalopathy) were noted.

CDP323 is an oral small molecule alpha4 integrin inhibitor that was being developed by UCB and Biogen Idec for relapsing forms of multiple sclerosis.

For UCB, results of this interim analysis trigger a re-valuation of the intangible asset "CDP323". UCB expects a non-cash, non-recurring impairment of a high double-digit million pre-tax euro amount. This will be more than compensated by cash, non-recurring capital gains, which resulted from the divestitures UCB made earlier this year. More information on the financial impacts of both the impairment and the capital gains will be included in the Half Year Report 2009 of UCB, due July 31, 2009. ...full report in Medical News Today

Labels: ,


 

Hard To Treat Diseases (HTDS) Clinical Trial Update On Therapeutic Effects Of Combined Treatment With Ribavirin And Tiazofurin

Hard To Treat Diseases (HTDS) Chief Scientist with its Slavica BioChem subsidiary, Dr. Sanja Pekovic provided updates on recent clinical trials with animal subjects in regards to the use of Ribavirin And Tiazofurin for the potential treatment of Multiple Sclerosis (MS).

Dr. Pekovic reported; "It is now well accepted that axonal injury begins at an early stage in MS, and likely accounts for clinical progression seen later in the disease course, suggesting that early, aggressive treatment is critical in order to suppress long-term disability progression. Researchers from IBISS group (a related research group) tested the effect of combined treatment with ribavirin (R) and tiazofurin (T) administrated during the effecter phase of disease.

Dr. Pekovic added: "We are hopeful, that with additional funding, we will be able to continue along this promising path, and continue researching the potential applications of a combination of ribavirin and tiazofurin in the treatment of MS." ...full report in Medical News Today

 

Insight Into How Brain Stem Cells Develop Into Cells Which Repair Damaged Tissue

The joint research, funded by the National Multiple Sclerosis Society and the UK MS Society as well as the National Institutes of Health and Howard Hughes Medical Institute, was conducted by scientists at the University of California San Francisco (UCSF) and University of Cambridge and was published in the journal Genes and Development. ...full report in Medical News Today

 

Mri Data Showing Tysabri® Promoted Remyelination Presented At The 61st Annual Meeting Of The American Academy Of Neurology

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced results of a study demonstrating that TYSABRI® (natalizumab) promoted regeneration and stabilization of damage done to the myelin sheath, as measured by advanced MRI technology. Damage to the myelin sheath causes the symptoms of multiple sclerosis (MS). Additional posters will also be presented during the Congress highlighting the ability of TYSABRI, in some patients, to improve physical function and patient reported outcomes on cognition, quality of life, and fatigue. TYSABRI is the first approved MS therapy with reported data suggesting that some of the signs of disease progression can be stopped. The strong efficacy profile demonstrated in clinical trials is enhanced further from these data and may help redefine success in MS. ...full report in Medical News Today

Labels:


 

First Ten-Year Follow-Up Shows That Treatment With AVONEX® Leads To Long-Term Benefits In Early Multiple Sclerosis Patients

Biogen Idec (NASDAQ: BIIB) announced data results from the CHAMPIONS (Controlled High-Risk AVONEX (interferon beta-1a) Multiple Sclerosis (MS) Prevention Study In Ongoing Neurologic Surveillance) study, an open label follow-up to CHAMPS (Controlled High Risk Subjects AVONEX MS Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. The CHAMPIONS ten-year follow up showed that patients treated immediately after their first episode had significantly less chance of experiencing a second attack versus those patients with delayed treatment. These results at ten years also indicate that 80 percent of patients taking AVONEX were below an expanded disability status scale (EDSS) score of three. These data were presented as a poster at the Annual American Academy of Neurology (AAN) meeting. ...full report in Medical News Today

Labels:


 

What's new for "Multiple Sclerosis" in PubMed

[Alterations in early auditory evoked potentials in multiple sclerosis patients.] -these findings stress the importance of looking at EAEP in cases where there is suspicion of demyelinating disease and in patients with a defined diagnosis for MS. - Braz J Otorhinolargol. 2009 Apr;75(2):177-181. in PubMed

Cognitive reserve moderates the negative effect of brain atrophy on cognitive efficiency in multiple sclerosis. - J Int Neuropsychol. 2009 Jul;15(4):606-612. in PubMed

Relationship between Psychosocial Factors and Onset of Multiple Sclerosis. - The psychosocial factors are closely associated with MS onset and may play important roles in the development of the disease. - Eur Neurol. 2009 Jul 1;62(3):130-136. [Epub ahead of print] in PubMed

Dose-dependent melanonychia by mitoxantrone. - Mult Scler. 2009 Jul 1. [Epub ahead of print] in PubMed

Gadolinium-enhancing or active T2 magnetic resonance imaging lesions in multiple sclerosis clinical trials? - Mult Scler. 2009 Jul 1. [Epub ahead of print] in PubMed

Autonomic dysreflexia in a man with multiple sclerosis. - This report emphasizes that AD can occur in MS. Somatic symptoms warrant thorough investigation before attributing them to psychosomatic causes. - J Spinal Cord Med. 2009;32(2):198-203. in PubMed

Using prior knowledge and genome-wide association to identify pathways involved in multiple sclerosis. - This and other pathway-based approaches are likely to continue to emerge in the GWAS literature, as they provide a powerful strategy to detect important modest single-locus effects and gene-gene interaction effects. - Genome Med. 2009 Jun 29;1(6):65. [Epub ahead of print] in PubMed

HHV-6 infection in multiple sclerosis. A clinical and laboratory analysis. - Human herpesvirus-6 infection may be an associated agent in some MS cases. Viral studies are needed to identify a possible viral etiology and give specific therapy. - Eur J Neurol. 2009 Jun 29. [Epub ahead of print] in PubMed

An exploration of anger phenomenology in multiple sclerosis. - The presence of an altered pattern of anger, unrelated to the clinical severity of MS, suggests that anger is not an emotional reaction to disease stress. An alteration of anger mechanisms might be a direct consequence of the demyelination of the connections among the amygdale, the basal ganglia and the medial prefrontal cortex. - Eur J Neurol. 2009 Jun 29. [Epub ahead of print] in PubMed

The role of natalizumab in hematopoietic stem cell mobilization. - The use of natalizumab alone or in combination with either cytotoxic drugs or other antibodies might be a new modality for stem cell mobilization and a therapeutic option for patients with hematologic malignancies. - Expert Opin Biol Ther. 2009 Jul 1. [Epub ahead of print] in PubMed


Go to Newer News Go to Older News