Monday, October 30, 2006

The Immune Response Corporation to Present at the Rodman & Renshaw Eighth Annual Healthcare Conference 2006

CARLSBAD, Calif.--(BUSINESS WIRE)--The Immune Response Corporation (OTCBB: IMNR), an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases, announced that Dr. Joseph O'Neill, President and CEO, will present an overview of the Company’s immune-based therapies, currently in Phase II clinical trials, at the Rodman & Renshaw Eighth Annual Healthcare Conference in New York City.

The Company’s presentation to the investment community will take place on Tuesday, November 7, 2006, at 3:55 p.m. (EST).

A live webcast of this presentation will be available at http://www.wsw.com/webcast/rrshq10/imnr/. The online replay will be available for 90 days after the presentation.

Dr. ONeill will discuss a key strategic agreement, signed October 10, 2006, with Accelsiors CRO & Consultancy Services, a clinical research organization (CRO) with extensive experience in conducting multiple sclerosis (MS) trials, to oversee a 200-patient Phase IIb trial of NeuroVax, an investigational T-cell receptor (TCR) peptide vaccine for the treatment of multiple sclerosis (MS). He will review in detail the Companys drug development pipeline, and status of the Phase II clinical trials in progress for NeuroVax, and for IR103, for the treatment of human immunodeficiency virus (HIV). IR103 is based on the Companys patented whole-inactivated virus technology, co-invented by Dr. Jonas Salk.

By harnessing the bodys own defenses to control disease, NeuroVax and IR103 potentially offer important clinical advances for patients suffering from MS and HIV. said Dr. ONeill. We continue to make significant strides in the development of these immune based therapies and are optimistic that they may benefit the millions of patients in need of more effective and tolerable treatment options.

http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20061030005853&newsLang=en

Tysabri


Biogen Idec Upgraded On Tysabri Outlook
Forbes - NY,USA
... Stearns upgraded shares of Biogen Idec to "peer perform" from "underperform" on Monday and said the prospects for multiple sclerosis drug Tysabri look brighter ...

Options Update: Elan Wrestles With 15
Schaeffers Research - Cincinnati,Ohio,USA
... However, the company did note that it is encouraged by the initial results from the re-launch of its Tysabri. A quick refresher ...


NeuroVax™

The Immune Response Corporation to Present at the Rodman & Renshaw ...
Business Wire (press release) - San Francisco,CA,USA
... CRO) with extensive experience in conducting multiple sclerosis (MS) trials, to oversee a 200-patient Phase IIb trial of NeuroVax™, an investigational T-cell ...



The Body: Bulletproof

If you want to live forever, change your skin color, or just firm up those abs from the comfort of your own couch, you might be in luck: Gene therapy is on its way--and it's coming fast.

From: Issue 103 | March 2006 | Page 88 | By: Ramez Naam

You wouldn't think that creating old, pumped-up mice would pose much of an ethical dilemma. But University of Pennsylvania professor Lee Sweeney was invited to speak before the President's Council on Bioethics a few years ago because that's exactly what he does. The commission, created by George W. Bush to map out the moral and ethical consequences of advances in medicine and biotechnology, heard Sweeney describe his research into ways of turning back the rodents' biological clock, reversing the deterioration of muscle caused by aging and even degenerative diseases. The treatments, Sweeney explained, had all but halted, and in some cases reversed, the age-related decline in mouse muscle. Essentially, he'd given a 27-month-old mouse (age 80-plus in human years) the body of a 6-month-old.

But Sweeney is not building his buff little Mus musculus with a new drug or physical therapy. He's injecting them with genes, extra copies of the very gene that causes our own bodies to develop muscle mass. And his research points the way not only toward a possible slowing of diseases like Lou Gehrig's but to a way of giving perfectly healthy men and women bigger and stronger muscles--permanently, after just a single dose. As Sweeney puts it, one of these days you could "just take a few injections of the virus [that delivers the genes] and a month later, while you're watching television, your muscles have gotten bigger."

Designer muscles are just one potential feature of the Body 2.0, a new, customizable version of ourselves made possible by the decoding of the human genome and an evolving understanding of, and ability to manipulate, our own genetic makeup. The aftermarket options now in development are already astonishing: While Sweeney's team is working on muscle regeneration, others are looking at ways of genetically, permanently boosting red-blood-cell count (and thus aerobic endurance), creating whole-body tans (to ward off skin cancer), controlling metabolism and hunger hormones (to prevent obesity), spurring hair growth, and mimicking the effects of Viagra (on an on-demand basis). Researchers are saying that it may be possible in the next two decades to increase the body's healing power, induce it to regenerate lost limbs or organs, even to slow or halt human aging.

Obviously, such treatments could change us forever. University of Florida associate professor Sergei Zolotukhin, for example, called obesity gene therapy "the couch potato's dream." But the Body 2.0 isn't here yet. Gene therapy--which simply means altering the genes of a living person--isn't even considered safe; clinical trials have caused the deaths of at least seven people. But the writing is on the wall. More than 800 clinical gene-therapy (GT) trials have been approved so far. GT products are projected to account for $125 million in sales in 2006--primarily to researchers and universities looking for ways to apply them. By 2011, analysts expect GT products to be approved for clinical use, and the market to swell to $6.5 billion.

Style Thyself

The prospect that tailored genes might cure disease drives research around the globe, targeting illnesses as diverse as cancer, Parkinson's disease, and diabetes. At the same time, scientists are learning to make changes at more-precise locations in the human genome, with a lower risk of side effects and greater control over the genes' activity once they're inserted. Meanwhile, gene-sequencing power is increasing exponentially, speeding up the rate at which researchers can identify the functions of our 20,000 to 25,000 genes. Sequencing the first human genome cost $3 billion; today the cost has dropped to $20 million; by 2014, the goal is to pull it off for $1,000. Gradually--inevitably, it seems--we're acquiring the power to alter our genes to cause specific effects.

How will society react to this kind of power? A quick tour of your local drugstore or spam filter provides a pretty good guess. Just about anything that claims to boost vitality, roll back the aging process, increase breast size or sexual stamina, build muscle, or melt away unwanted pounds sells like crazy. In 2004, the Institute of Medicine estimated that consumers spend at least $16 billion a year on dietary supplements alone, a market with some 29,000 different (and sometimes dodgy) products.

The voracious demand is equally evident in the statistics on cosmetic surgery and newer nonsurgical procedures such as Botox injections. The number of all cosmetic procedures rose from about 2.1 million in 1997 to 11.9 million, one for every 25 people, in 2004. That's a 465% increase in seven years and a 44% rise between 2003 and 2004 alone. Nonsurgical procedures alone grew by a staggering 764% between 1997 and 2004, and 51% between 2003 and 2004. Botox treatments, the most popular of all, were performed 2.8 million times in 2004, versus 478,000 cases of the most popular surgical procedure, liposuction.

It seems safe to say that Americans are not immune to the allure of flawless skin and tight buns--and we're not too proud to pay for them. And the easier, safer, and cheaper we can get there, the more of us will line up. Gene therapy, then, with its promise of a single, transformational injection, has the blockbuster potential of a thousand Viagras.

So is the country turning into one mammoth Baywatch episode, with everyone jiggling and rippling in perfect harmony? Not necessarily. We may be famous (and widely lampooned) for our desire to stay young and look beautiful, but we also have a deep-seated urge to stand out, especially when we're in our late teens and early twenties. A 2003 Harris Poll found that 16% of American adults, and 36% of those ages 25 to 29, have at least one tattoo; and an Eastern Michigan University poll in 2003 found that about 30% of the student population had at least one body piercing (not including the ears). In other words, parents may want to look like movie stars and athletes, but their kids want to look more like MTV stars.

Designer muscles are just one potential feature of the Body 2.0, a new, customizable version of ourselves.

Well, biotech aims to please: If the revolution is turned loose, today's tongue studs and Maori warrior tattoos are going to look about as edgy as a pair of Dockers. In the course of evaluating a GT baldness cure, San Diego researcher Robert Hoffman and his colleagues developed a test using a gene for a green fluorescent protein--only to discover they'd inadvertently found a way to make human skin or hair glow under black light, a technique that could be used on a tattoo or anywhere else on a person's body, temporarily or permanently. And because the brilliant reds, blues, and yellows of tropical birds, fish, and flowers are all products of protein dyes created by genes, GT injections could one day turn your hair blue, your skin red, your eyes yellow. Most of us aren't looking to make that kind of splash, but you can be sure there's a freshman at NYU or USC who'd jump at the chance.

As a society, we'd better get used to the idea that money can buy health and beauty (even more than it can today) and that individuals can design their own appearances (even more than they can today). But there may well be even more dramatic consequences of the biotech surge. At Southern Illinois University, for example, Andrzej Bartke has genetically engineered mice that live nearly twice as long, to an average human-equivalent age of 180 years, and as old as 200. Researchers at Stanford have genetically engineered naturally occurring vaginal bacteria to protect against HIV, while other researchers have found a rare mutation in the CCR5 gene that grants near immunity to HIV to around 1% of humans descended from Northern Europeans. Pathologist Ellen Heber-Katz is working to identify the gene that gives a rare breed of mouse the ability to regenerate from wounds--including injuries to heart muscle--no other mammal can survive. And others are looking at the genes that affect our minds: At Princeton, Joe Tsien created a breed of mouse that can learn twice as quickly.

As the formation of the president's bioethics council suggests, these sorts of changes will bring up myriad questions about policy and ethics: Who should have access to these technologies? Should insurance cover them? What are the social costs and benefits if people live 50 or 100 years longer than they do today?

Such a world might also evoke more visceral reactions. Entirely new sorts of prejudice, even hostility, may emerge in us, based on a rejection of the humanity of people who can do things no previous human could--or, conversely, on a rejection of the "unenhanced" as somehow inferior. The very shape and structure of society could change, with the rich growing older and older (beautifully and, perhaps, gracefully), while those with fewer resources remain subject to the same implacable biological truths they face now. Life expectancy could become increasingly tied to economic class.

Gene therapy to slow aging could save hundreds of billions in medical costs as well as the pain and suffering of an extended illness.

At the same time, the benefits to society of these technologies are not to be underestimated. Animals whose life spans have been genetically lengthened tend to live long, healthy lives and die without a protracted struggle. If the same is true in humans, gene therapy to slow aging could save hundreds of billions in medical costs as well as the pain and suffering of an extended illness. Greater longevity could also enrich society as scientists, artists, and professionals are given more time to learn, create, and build. And GT that boosts mental performance could increase economic productivity, leading to further scientific discoveries, better products, and more effective medicines.

Even so, a backlash against these technologies, and a political battle over their control, are inevitable results of this kind of transformation. The subtext of the bioethics hearings is that ethical people need to say no to the temptations of technology lest they be enticed into a new, nonhuman state. Just as President Bush's administration acted to restrict funding for stem-cell research in the United States, only to be partially rebuffed by California, we can expect plenty of wrangling over genetic technologies.

Legalize It

Trying to stop people from using products they clearly want is a pretty dubious exercise, however. Prohibition would simply create a black market, raising prices, eliminating effective regulatory oversight, and hindering long-term safety studies. As Steven Hyman, former director of the National Institute of Mental Health, has said, "Regulation that flies in the face of reality . . . decreases respect for regulation, and fails."

We're right to be cautious of new biological technologies until they've proven themselves, of course. Artificial limbs, pacemakers, birth-control pills, organ transplants, in vitro fertilization, even vaccinations--all took time to be accepted. But once they're proven to be safe, and to reduce pain, increase health and well-being, or just make climbing into a bathing suit a happier experience, we come to see them merely as products, weighing the costs and benefits accordingly. And, as Hyman says, if "we can find medications that will enhance our performance, lengthen our life, decrease the stress," then "no regulation in the world" will keep us from getting at them.

Ramez Naam is the author of More Than Human (Broadway Books, 2005). He helped lead the development of Outlook and Internet Explorer for Microsoft, where he is director of program management at MSN Search.


Copyright © 2006 Mansueto Ventures LLC. All rights reserved.
Fast Company, 375 Lexington Avenue.,New York , NY 10017
http://www.fastcompany.com/magazine/103/essay-body.html

•"Health Care for All: Is the DreamPossible?"

OCT.31

"Health Care for All: Is the DreamPossible?"Symposium. 8:30 a.m.-4:30 p.m. Dr. S. Jerome & Judith D. Tamkin Student Lecture Building, UC Irvine School of Medicine. www.uci.edu/campusmap. $50 includes parking, breakfast and lunch. Registration: 949-824-8909.


http://www.ocregister.com/ocregister/healthscience/article_1333056.php

The Baltimore Sun Dan Rodricks Column: Stem Cell Ideology Trumps Reason



By Dan Rodricks, The Baltimore Sun

Oct. 29--Stem cell ideology tops reason this season

Last year, the House of Representatives passed a bill that would have expanded funding for embryonic stem cell research and given Americans who had embryos frozen for fertility treatments the option of donating them to medical science. The bill received wide support from intelligent people, particularly scientists who see promise in the research. Fifty-one Republicans sided with Democrats to approve the measure. Nancy Reagan, queen mum of the Republican Party, supported efforts to expand research for its potential as a cure for Alzheimer's disease.

But this year, after the Senate approved the measure, President Bush vetoed the bill, saying in July: "If this bill were to become law, American taxpayers would, for the first time in our history, be compelled to fund the deliberate destruction of human embryos, and I'm not going to allow it."

Bush called the new production of embryonic stem cells the "taking of human life," even if the embryos used in research would otherwise be discarded by fertility clinics.

The opposition to embryonic stem cell research is grounded in the religious view that life begins at conception, the same argument used against abortion.

The professional quarterback Kurt Warner, who used to play for the St. Louis Rams, went on television last week to oppose a Missouri constitutional amendment to allow embryonic stem cell research in that state.

"To pass an amendment that allows for the opportunity to abort and to kill a life to me makes no sense," Warner said. "It contradicts everything I believe, everything that I stand for and I think everything that Missouri stands for. ... It becomes aborting after conception, aborting fetuses, using for research purposes. It also has to do with the fertilization of eggs for the sole purpose of killing them and doing research."

Warner's language is strong and familiar, based in ideology and not science. But you know exactly how this devout Christian feels. He uses his celebrity status to help opponents of embryonic stem cell research just as the actor Michael J. Fox, who has Parkinson's disease, uses his to help U.S. Senate candidate Ben Cardin, a supporter of embryonic stem cell research, win over Michael Steele here in Maryland.

The other day, the Steele campaign countered with an ad of its own, featuring the candidate's younger sister, Monica Turner. Turner is a pediatrician, and she reveals in the spot that she has multiple sclerosis.

"There's something you should know about Michael Steele," Turner says. "He does support stem cell research, and he cares deeply for those who suffer from disease." Of course, Steele cares about people with disease -- and he loves puppies. But he doesn't exactly support stem cell research to the degree his sister suggests. He doesn't support the use of embryos to develop new stem cell lines, to replace some of the 60 that researchers say they have found contaminated or unusable.

Soon after Bush's veto last summer, Steele refused to answer reporters' questions about how he would have voted on the bill, but he ultimately stated his support for the president's position. During one of the most dull-headed moments of his campaign, Steele likened embryonic stem cell research to Nazi medical experiments. Though he apologized for the statement, it was clear that Steele, an anti-abortion Catholic, opposes the area of stem cell research that experts in the field believe the government should support.

His opponent, Cardin, backed expansion of the research.

That was the choice of science over ideology.

That was the choice of a government informed by science over a government limiting the cause of science because of religious beliefs.

Michael Steele and some Republicans might not like that Michael Fox and the Democrats boxed them into that corner, but they were there already. Fox merely flashed a light on it.

Since this new area of stem cell research started to emerge in the late 1990s, it has been controlled by the government and assessed a number of times by prestigious panels of scientists who reported findings to Congress. Many Republican leaders, such as Arlen Specter and Bill Frist, gave it careful consideration before deciding to back the research.

The stem cell issue didn't cross a moral boundary, as President Bush stated; it crossed a partisan one, and though many Republicans joined the president in his bow to the GOP's conservative base, many others were listening to science -- and to their constituents. Now, stem cell research could be a real wedge issue in next week's election.

The quest for knowledge and understanding fuels the arc of progress of American society, and a society that values brilliance, ingenuity and innovation should not be erecting obstacles to science in the public interest. That doesn't mean we ignore ethical questions. But it means that, ultimately, we separate the interests of church from the interests of state. It means we respect and defer to those who know better than we do -- the men and women in the lab coats, the ones who have the knowledge, understanding and integrity to take us to a healthier future. It means we hold objective science to be a precious national resource and demand a government informed by it.

dan.rodricks@baltsun.com

Hear Dan Rodricks Tuesday and Thursday from 11:30 a.m. to 2 p.m. on WBAL Radio (1090 AM) and read his blog at baltimoresun.com/rodricks. And try your luck at Dan's Maryland Politics Quiz at baltimoresun.com/rodricksquiz.

-----

Copyright (c) 2006, The Baltimore Sun

Distributed by McClatchy-Tribune Business News.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.
Story from REDORBIT NEWS:
http://www.redorbit.com/news/display/?id=711270

Published: 2006/10/29 06:01:36 CST

© RedOrbit 2005

http://www.redorbit.com/news/health/711270/the_baltimore_sun_dan_rodricks_column_stem_cell_ideology_trumps/index.html?source=r_health

Sunday, October 29, 2006

BRAIN TECHNOLOGY AND SCIENCE NEWS, BrainTechSci

BRAIN TECHNOLOGY AND SCIENCE NEWS, BrainTechSci
http://braintechsci.blogspot.com/

NeuroVax

NeuroVax

Spelman Research Initiates Coverage of The Immune Response ...
Earthtimes.org - USA
In the Spelman report, Mr. Mitu writes, "The drug candidates -- IR103 (HIV) and NeuroVax(TM) (MS) -- are based on innovative technologies that do not have ...




FTY720

Pharma Sector: Few Newsmakers Of The Week - Novartis, Abbott ...
Trading Markets - Los Angeles,CA,USA
... Novartis' FTY720, which is in phase III trial could become the first oral therapy for multiple sclerosis if the company files for approval of the drug in 2009 ...



Tysabri

Elan loss rises as it misses Q3 sales targets
Unison.ie - Bray,Ireland
... Revenue at Elan, which reintroduced its multiple sclerosis treatment Tysabri in the summer, fell 4pc to $123.3m. The company began ...

Elan improves full-year guidance; to file Tysabri for Crohn's by ...
Forbes - NY,USA
LONDON (AFX) - Elan Corp said it expects annual losses, excluding the cost of relaunching Multiple Sclerosis treatment Tysabri, to be smaller than previously ...



Saturday, October 28, 2006

New data presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain,

New data presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that antibodies to COPAXONE® (glatiramer acetate injection) developed in all patients with multiple sclerosis (MS) treated with COPAXONE®, but did not interfere with the efficacy of the drug...

To read the full article, please go to:
http://www.medicalnewstoday.com/medicalnews.php?newsid=53469

Institute unveils full atlas of mouse brain - Science - MSNBC.com

Friday, October 27, 2006

Tysabri


Tysabri found to maintain remission in Crohn's patients
Pharmaceutical Business Review - USA
Elan Corporation and Biogen Idec have reported research that suggests that their drug Tysabri can provide sustained remission in Crohn's disease patients for ...
See all stories on this topic

News Page 3 : Elan off Q3 targets
Irish Independent - Dublin,Ireland
... shortages of the drug. Revenue at Elan, which reintroduced its multiple sclerosis treatment Tysabri in the summer, fell 4pc to $123.3m.
See all stories on this topic

rituximab Multiple Sclerosis

Millennium Pharmaceuticals Q3 2006 Earnings Call Transcript
Seeking Alpha - New York,NY,USA
... III trial of VELCADE in combination with Rituximab in follicular ... significant with applications in rheumatoid arthritis, multiple sclerosis, chronic obstructive ...

ILRU: Independent Living Research Utilization Project at TIRR - About ILRU

Anxiety Disorders Tied to Physical Illness

TUESDAY, Oct. 24 (HealthDay News) -- Anxiety disorders are linked to a number of physical problems, including arthritis, migraine headaches, respiratory disease, gastrointestinal issues, allergies, and thyroid disease, a new study finds.

Experts have long recognized an association between depression and physical illness, while evidence of a link between anxiety and physical health is more recent, according to background information in the article.

In this study, Canadian researchers analyzed data on nearly 4,200 people who took part in the German Health Survey between 1997 and 1999. The participants had a physical examination and filled out a questionnaire that asked them about 44 specific health conditions. They also filled out a quality of life survey that measured factors such as physical functioning, pain, and general health.

The participants also underwent psychiatric interviews designed to detect anxiety disorders, such as panic disorder, social phobia, obsessive-compulsive disorder, and agoraphobia (fear of being in a situation where anxiety or panic may occur and it may be difficult to escape from the situation).

Of the study participants, 8.4 percent had had an anxiety disorder within the previous month and 60.8 percent had had a physical problem. The researchers found that having an anxiety disorder was associated with having any type of physical condition.

Most people with both an anxiety disorder and a physical problem developed the anxiety disorder first and they tended to have a poorer quality of life than people with either an anxiety disorder or physical condition alone.

"The mechanisms of association between anxiety disorders and physical conditions remain unknown, although several possibilities should be considered," the study authors wrote in the Oct. 23 issue of the journal Archives of Internal Medicine.

For example, having a physical illness may cause worry and anxiety that eventually becomes serious enough to qualify as an anxiety disorder; having an anxiety disorder may trigger biological changes that contribute to physical illness; or a third condition, such as a substance abuse disorder, could be linked with both anxiety disorder and physical illness.

"Although there have been increased efforts to recognize and treat depression in the medically ill, our findings underscore the need to create similar programs to recognize and treat anxiety disorders in the medically ill," the authors wrote.

More information

Find out more about anxiety disorders at the Anxiety Disorders Association of America (www.adaa.org ).

Thursday, October 26, 2006

Top court strikes down pot crusader's conviction


Updated Thu. Oct. 26 2006 10:21 AM ET

CTV.ca News Staff

The country's top court granted a new trial on Thursday to a medicinal marijuana crusader facing charges of pot possession.

In a 7-0 judgment, The Supreme Court of Canada overturned Grant Krieger's conviction on charges of possessing unlawfully produced cannabis for purposes of trafficking.

Krieger argues that he should be able to distribute marijuana to chronically ill patients who smoke pot to ease their pain and suffering.

Krieger, who himself suffers from multiple sclerosis and has legal permission to smoke pot for medical purposes, doesn't have permission from the government to supply it to others.

But he has freely admitted that he distributes the marijuana anyway.

The judge at Krieger's 2003 trial told the jurors that they had no choice under the law but to find him guilty.

Two jurors asked to be excused from the case, one on religious grounds and the other on grounds of conscience, but the judge turned down their request.

The jury returned with a guilty verdict and their verdict was upheld on appeal.

The Supreme Court found that the 2003 trial judge deprived Krieger of his constitutional right to a trial by jury when he instructed the jurors to find the accused guilty.

"The trial judge's direction was not a 'slip of the tongue' to be evaluated in the context of the charge as a whole; nor is this a matter of assessing the impact of subtle language susceptible to different interpretations," the judgment says,

"The judge's purpose was as clear as the words he used to achieve it. He evidently considered it his duty to order the jury to convict and to make it plain to the jurors that they were not free to reach any other conclusion."

In the absence of a guilty plea, the verdict must be that of the jury, the ruling says.

"Not the judge -- unless the judge finds the evidence insufficient and directs a verdict of acquittal on that ground."


http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20061026/scoc_pot_061026

Zenapax, Multiple Sclerosis


Micromet Presents New Anti-IL-2 Antibody with Unique Mode of ...
PharmaLive.com (press release) - Newtown,PA,USA
... of marketed products including monoclonal antibodies (eg, Zenapax(R), Simulect(R ... for the treatment of T cell leukemia, multiple sclerosis, rheumatoid arthritis ...

Micromet Presents New Anti-IL-2 Antibody with Unique Mode of ...
Market Wire (press release) - USA
... of marketed products including monoclonal antibodies (eg, Zenapax®, Simulect®) as ... the treatment of T cell leukemia, multiple sclerosis, rheumatoid arthritis ...

Schering Receives Expanded Approval for MS Drug

Schering Receives Expanded Approval for MS Drug
RedNova Tue, 24 Oct 2006 1:08 PM PDT
Berlex, a US affiliate of Schering AG, has said that the FDA has expanded the indication of Betaseron to include patients with multiple sclerosis who have experienced their first clinical episode.

Link discovered between common cold viruses and Alzheimer's disease
News-Medical-Net Tue, 24 Oct 2006 12:13 PM PDT
According to new research memory loss and Alzheimer's disease may be linked to the very viruses which cause the common cold.



Tysabri

Analog Devices cuts 4th quarter revenue forecast
Boston Globe - United States
... (AP). Elan Corp. said its Tysabri treatment for multiple sclerosis was effective in treating Crohn's disease. About 86 percent of ...

Elan's Q3 losses worse than expected
RTE.ie - Ireland
The quarter saw the redistribution of its multiple sclerosis drug Tysabri for the first time since it was withdrawn in February 2005. ...
See all stories on this topic

Market report: Wed latest
This is Money - UK
... UBS is forecasting a net loss of $61.7m for Elan but the key focus will be on the likely uptake for its key Tysabri drug in the US and Europe. ...

Morning business news
RTE.ie - Ireland
SOLID START FOR TYSABRI SALES - Pharmaceuticals company Elan has this morning issued its third quarter figures to the end of September which show the company's ...

Elan Reports Third Quarter 2006 Financial Results
Genetic Engineering News (press release) - New Rochelle,NY,USA
... We are encouraged by the initial results in the relaunch of Tysabri for MS in the US market and the launch in the European markets. ...

Elan Q3 Loss Widens, Revenues Decline On Maxipime Supply Shortages ...
Trading Markets - Los Angeles,CA,USA
... The company is encouraged by the initial results from the relaunch of its Tysabri drug for multiple scleroris and sees a significant growth in Tysabri revenues ...
See all stories on this topic

Elan falls on Tysabri fears
Unison.ie - Bray,Ireland
... drugmaker Elan finished down 20c at the €12.10 level in Dublin yesterday as US doctors are proving wary about the company's multiple sclerosis drug, Tysabri. ...

Elan says 75% of Tysabri patients switched from other drugs
MarketWatch - USA
PLC (ELN) Wednesday said around 75% of patients now taking its multiple sclerosis drug Tysabri in both the US and EU have switched from other drug treatments. ...
See all stories on this topic

Wednesday, October 25, 2006

Bob Geldof In T.O. Boosting Stem Cell Research

Wednesday October 25, 2006
Sir Bob Geldof has an amazing history.

He went from rock star to world crusader, creating the first super group to aid hunger in Africa. Since his "We Are The World Days" he's been the world, adding Live Aid, Live 8 and other major fundraisers to his inventory.

So what could bring this icon to Toronto on Wednesday?

The answer is the opening of the McEwen Centre for Regenerative Medicine. It's headed by one of the world's leading experts on the controversial area of stem cells, Dr. Gordon Keller.

And it's become another pet cause for the former Boomtown Rat, who has friends with Alzheimer's disease and Multiple Sclerosis, conditions that experts believe can both be helped and alleviated with stem cells.

They're essentially cells that haven't decided what they want to be when they grow up. And that means they can be used to repair and regrow almost any tissue in the body, something akin to human spare parts.

"Here you have a cell that you can tell to make any cell type in our body in a culture dish," explains Keller.

Geldof is impressed and is advocating for more widespread use of the technology. "You can tangibly feel the unfolding century when you come to places like this," he marvels.

But not everyone agrees it's such a big step forward, especially for those who have religious concerns. They complain that the cells come from unborn embryos. And that makes the harvesting mortally wrong.

"Embryonic stem cell research has been unsuccessful," argues Natalie Hudson of the Right To Life. "We can't use it in human patients. It's diverting resources away from adult stem cell research, which is much more viable."

The dispute has been ongoing for years and despite Geldof's hearty endorsement and assurances from many medical experts that it may be the so-called magic bullet that can cure a host of diseases, it remains mired in controversy and stuck in an ethical limbo.

Family depending on stem cells for help


http://www.citynews.ca/news/news_4733.aspx

Government Rejects Vaccine Petition

Tuesday, October 24, 2006
http://www.foxnews.com/wires/2006Oct24/0,4670,MercuryVaccines,00.html
By ANDREW BRIDGES, Associated Press Writer

WASHINGTON — Federal health officials won't put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.

A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.

"Only a small number of licensed and approved products still contain thimerosal, and the available evidence supports FDA's conclusion that all currently licensed vaccines and other pharmaceutical drug products containing thimerosal are safe,"Dr. Jeffrey Shuren, the FDA's assistant commissioner for policy, wrote in denying the petition.

"We're not accepting that answer,"said Dr. Mark Geier, one of the petitioners. The group now plans to seek a court order that would force the FDA to withdraw thimerosal from all vaccines and medicines unless the agency can show the preservative is safe, Geier said.

Thimerosal, about 50 percent mercury by weight, has been used since the 1930s to kill microbes in vaccines. There have been suspicions that thimerosal causes autism. However, studies that tracked thousands of children consistently have found no association between the brain disorder and the mercury-based preservative. Critics contend the studies are flawed.

Since 2001, all vaccines given to children 6 and younger have been either thimerosal-free or contained only trace amounts of the preservative. Thimerosal has been phased out of some, but not all, adult vaccines as well.

Most doses of the flu vaccine still contain thimerosal, though manufacturers produce versions free of the preservative for use in children. The FDA said it was in discussions with those manufacturers to increase the supply of thimerosal-free flu vaccine.

There also are minute amounts of mercury, as thimerosal or phenylmercuric acetate, in roughly 45 eye ointments, nasal sprays and nasal solutions, the FDA said. Various antivenoms for black widow and snake bites also contain thimerosal.

___

On the Net:

Thimerosal petition and response:http://www.fda.gov/ohrms/dockets/dockets/04p0349/04p0349.htm

Thimerosal in vaccines:http://www.fda.gov/cber/vaccine/thimerosal.htm

Tysabri.


Elan, Biogen present positive Tysabri data for Crohn's disease ...
Forbes - NY,USA
LONDON (AFX) - Elan Corporation PLC and Biogen Idec said conference data presented this week shows that their Tysabri drug maintained remission in Crohn's ...
See all stories on this topic

ISEQ up as Elan confidence drops
Ireland Online - Dublin,Ireland
Elan lost 30c (2.4%) to €12.00, after a survey in the US found that doctors are wary of prescribing the company’s multiple sclerosis drug Tysabri. ...

Testosterone gel may help men with MS

04:22 PM PDT on Sunday, October 22, 2006

JEAN ENERSEN / KING 5 News

Jeffrey Steenberg loves the outdoors, but when doctors diagnosed him with multiple sclerosis four years ago, even the simple tasks became exhausting.

"Just finding myself extremely tired a lot. I couldn't make it through a day without napping," he said.

About half of all MS patients also have memory problems.

"I definitely noticed some of the memory going. Calling somebody immediately after calling them and not knowing who was on the phone anymore," he said.

Neurologist Rhonda Voskuhl says there's no approved treatment to prevent memory failure.

"What we don't have are drugs that would be going to the brain or spinal cord and protecting those nerves," she said.

A testosterone gel might help. In a small study, 10 men with MS applied it to their shoulders once a day for a year.

"What they reported most is that they felt better, that they had more energy and less fatigue," said Voskuhl.

The gel improved their immune systems and all the patients performed better on memory tests. MRI scans also showed parts of the brain that normally decline in MS actually slowed.

"We're excited about these findings because we're actually would be describing the first neural protective drugs for MS," said Voskuhl.

Steenberg noticed a difference.

"The increased energy and mental alertness were the biggest, the biggest changes for me," he said.

Researchers are expected to study whether estrogen provides the same memory benefits in female patients.

http://www.king5.com/health/stories/NW_102206HEKmsgelSW.648a1f8c.html

Monday, October 23, 2006

Tysabri


Doctors still wary of Elan's Tysabri - survey
RTE.ie - Ireland
US doctors are proving more wary than many had expected about prescribing Elan's multiple sclerosis drug Tysabri, which was relaunched in July after being ...
See all stories on this topic

International Approvals: Sebivo and Tysabri
Medscape (subscription) - USA
... On October 5, Health Canada approved natalizumab intravenous infusion (Tysabri, made by Biogen Idec and Elan Corporation, plc) as monotherapy to delay the ...

Natalizumab (Tysabri) for the Treatment of Multiple Sclerosis in Canada

On October 5, Health Canada approved natalizumab intravenous infusion (Tysabri, made by Biogen Idec and Elan Corporation, plc) as monotherapy to delay the progression of disability, reduce the frequency of relapses, and to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) in patients with relapsing-remitting multiple sclerosis (MS). The drug is intended for use in patients with high disease activity despite treatment with a beta-interferon and in those with rapidly evolving severe disease.

The Canadian approval was based primarily on data from the 2-year, randomized, multicenter, double-blind Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study of 942 patients showing that use of natalizumab decreased the rate of clinical relapses by 68% and the risk for MS-related sustained disability progression by 42% compared with placebo (P < .001 for both). Natalizumab therapy also yielded sustained and statistically significant reductions in brain lesion activity as measured by MRI.

Natalizumab has been linked to an increased risk for progressive multifocal leukoencephalopathy (PML); cases have included patients who received the drug for more than 2 years or who received intermittent doses over an 18-month period. In clinical trials, 2 cases occurred in 1869 patients with MS who had been treated for a median of 120 weeks; a third case occurred among 1043 patients with Crohn's disease after the patient had received 8 doses. All 3 patients had received concomitant treatment with immunomodulators (eg, interferon beta) or were immunocompromised due to immunosuppressant therapy (eg, azathioprine).

According to a company news release, patients receiving natalizumab therapy are encouraged to enroll in the TYSABRI Care Program, which ensures that appropriate physicians and infusion centers are able to prescribe or infuse the product. The comprehensive program is intended optimize treatment through improved compliance, standardize infusion treatment at clinics, support safety through rigorous education and ongoing surveillance, and provide reimbursement and patient support to ease the administrative burden associated with therapy.

Natalizumab was previously approved by the US Food and Drug Administration and the European Commission in November 2004 and June 2006, respectively, as monotherapy to delay the progression of disability and reduce the frequency of relapses in MS patients.

Although natalizumab was withdrawn from the US market in February 2005 due to concern regarding the potential associated risk for PML, it was reintroduced in June 2006 with labeling revisions and a restricted distribution program (TYSABRI Outreach: Unified Commitment to Health [TOUCH]) after a comprehensive safety evaluation (N > 3000) yielded no new cases of the disease.



Related Links

Resource Centers

Hepatitis B
Multiple Sclerosis (MS)
http://www.medscape.com/viewarticle/546424

Sunday, October 22, 2006

Tysabri

Tysabri

New drugs often fail to match the hype
The News Journal - Wilmington,DE,USA
Members of a Food and Drug Administration advisory panel listen to a discussion on whether the MS drug Tysabri should be allowed to return to the market. ...


FTY720

Novartis Delivers Dynamic Sales and Earnings Growth in the First ...
PharmaLive.com (press release) - Newtown,PA,USA
... FTY720 (fingolimod), an oral once-daily treatment for relapsing-remitting multiple sclerosis (MS), has shown sustained benefits over two years in patients in ...

Title of Article: Designing for disability



Article:

Aging consumers plan ahead with easy-to-use appliances

STACY DOWNS

McClatchy Newspapers

This stove, with its front-mounted control knobs, is a universal design that meets the needs of people with diverse physical abilities.

John Mutrux/McClatchy -Tribune photos

This stove, with its front-mounted control knobs, is a universal design that meets the needs of people with diverse physical abilities.

When shopping for an appliance, the typical considerations are energy efficiency, affordability, attractiveness and size. But today's consumers and manufacturers are placing equal importance on another consideration: Ease of use.

They are looking beyond today, too, and considering how easy the appliance will be to operate when the consumer ages or becomes disabled. Some appliances, after all, have a life span of 20 years or more.

Jan Jasper recently bought a stove with front-mounted control knobs, eliminating the need to reach over hot burners. Her old stove had controls in back.

"It's so much easier to use," said Jasper, who has multiple sclerosis and uses a cane and wheelchair. "I don't have to worry about burning myself."

Universal design, which meets the needs of people with diverse physical abilities, satisfies Americans With Disabilities Act standards. The percentage of Americans older than 50 is growing, and as the population ages, universal design becomes more important.

"People probably won't notice they have a product with universal design features, but they'll use it in a way that's more effortless," said Marc Hottenroth, industrial design leader for GE, a company that has made more appliances with easy-to-use features in recent years. He says many older appliances were poorly designed.

Migette Kaup, associate professor of interior design at Kansas State University in Manhattan, cited several appliance features that are difficult for people to use. A person using a wheelchair or cane, for instance, has to struggle to pull racks in and out of an oven that opens from the top.

Kaup, who teaches universal design in her classes, says some new appliances are easier to use because of universal design features. "That's refreshing because upper-body strength is the first thing to go for men and women as they age," she said.

Dishwasher drawers, Kaup says, eliminate the need to stoop. The drawers, made by companies such as Fisher & Paykel and Miele, are coming down in price. New refrigerator drawers have the same advantage, but they're still too expensive for the mainstream consumer, she says.

More microwaves have bigger numbers and scrolling guides to help people through the process. People who are visually impaired can get Braille kits from the manufacturers. Another solution, Kaup says, is placing raised-number stickers from an office supply store over the controls.

BETTER DESIGNED APPLIANCES

Dishwashers

• Dish drawers or a raised dishwasher are good for no-stoop, no-bend loading.

Washers & Dryers

• Look for front-mounted controls that can eliminate reaching.

• There's no need to stoop with raised platforms for front-loading machines.

• Look for drums that are tilted up to prevent excessive reaching.

Stoves & Ovens

• Look for a stove with front-mounted controls, which eliminate the need to reach over burners.

• Consider a smooth electric cooktop that allows easy movement of pots and pans and easy cleanup.

• Wall ovens should open from the side and be installed with the middle shelf at counter height.

Microwaves

• A countertop microwave (instead of a wall-mounted one) is best because it has a landing space for hot dishes and allows access for someone who uses a wheelchair.

Refrigerators

• A side-by-side, frost-free refrigerator/

freezer allows full access for everyone.

• Having a freezer drawer on the bottom is the second best option. It provides better access than having a freezer on top.

7 PRINCIPLES OF UNIVERSAL DESIGN

EQUITABLE USE: The appliance should be accessible and appealing to all in the home.

FLEXIBILITY IN USE: The appliance should allow for both right-hand and left-hand use, and accommodate people with functional limitations.

SIMPLE AND INTUITIVE: The appliance should be easy to understand and use.

PERCEPTIBLE INFORMATION: The appliance can accommodate people with impaired vision. It may have visual or audible cues for easy operation.

TOLERANCE FOR ERROR: The appliance has safety features, such as child locks.

LOW PHYSICAL EFFORT: The appliance controls can be activated with minimal pressure.

SIZE AND SPACE FOR APPROACH AND USE: The appliance is easily accessible to someone who uses a wheelchair. A tall person wouldn't have to bend or stoop extremely to use it.

-- SOURCES: N.C. State University Center for Universal Design; GE

DGV Source: http://www.charlotte.com/mld/charlotte/living/home/15810864.htm

Stem Cells Transformed Into Immune Cells

By Randy Dotinga
HealthDay Reporter

FRIDAY, July 7 (HealthDay News) -- New research into embryonic stem cells suggests great potential for medical advances but also confirms that big breakthroughs aren't waiting just around the corner.

Scientists at the University of California, Los Angeles, reported this week that they coaxed stem cells into becoming T-cells, a crucial part of the immune system. If T-cells could be manufactured, doctors would have a powerful new weapon against AIDS and other diseases at their disposal, the investigators said.

But the research "is not ready for prime time," cautioned study co-author Dr. Jerome Zack, a UCLA professor of medicine, microbiology, immunology and molecular genetics. It will take several years just to prepare for testing in humans, and even that process will take a while, he said.

Still, "the potential is huge," Zack said. "We have to see if it lives up to that potential."

At the center of the research are embryonic stem cells, which have been hugely controversial in recent years. Stem cells have the ability to transform themselves into a variety of cells, a fact that thrills scientists who think their manipulation could restore or boost ailing parts of the body.

In the new research, Zack and colleagues tested what happened when blood-forming stem cells were injected into a human thymus that had been implanted into a mouse.

The findings of the federally funded study were released in this week's issue of the Proceedings of the National Academy of Sciences.

The thymus, part of the human immune system, converted the stem cells into T-cells.

In another positive sign, the research suggests that scientists can piggyback a gene onto stem cells, delivering it to a diseased organ.

That ability would allow a treatment to not only create new immune cells but also target a diseased part of the body with gene therapy, Zack explained.

Potentially, the stem-cell therapy could fight any disease that robs the immune system of its ability to function properly.

There are hurdles to overcome. For one, the body may reject the stem cells. Also, government restrictions on stem cell research may pose problems because of the limitations of existing stem cell lines, Zack said.

Still, it's possible that the research could lead to ways to use adult stem cells to create T-cells, said Paul Sanberg, director of the Center of Excellence for Aging and Brain Repair at the University of South Florida.

"The caveat in all of these types of studies is that it is still an early laboratory study, and does not mean that this is a treatment," he said. The public should "realize that such treatments may be years away."

More information

Learn more about stem cells from the National Institutes of Health (stemcells.nih.gov ).

SOURCES: Jerome Zack, Ph.D., professor, medicine, microbiology, immunology and molecular genetics, University of California, Los Angeles; Paul R. Sanberg, Ph.D., D.Sc., director, Center of Excellence for Aging and Brain Repair, University of South Florida College of Medicine, Tampa, Fla. July 3-7, 2006, Proceedings of the National Academy of Sciences online
http://www.whotv.com/Global/story.asp?S=5126532&nav=LotC

Researchers identify source of nerve damage in multiple sclerosis

Researchers identify source of nerve damage in multiple sclerosis
Orange County Register Fri, 20 Oct 2006 6:46 PM PDT
The damage to nerve fibers that accompanies multiple sclerosis is caused, in part, by the body's own immune system.

AVONEX(R), The #1 Prescribed Multiple Sclerosis Therapy Worldwide, Improves Patient Convenience
RedNova Fri, 20 Oct 2006 12:11 PM PDT
AVONEX® (Interferon beta-1a), the most prescribed multiple sclerosis (MS) therapy worldwide, may now be stored at room temperature (up to 77°F or 25°C) in its prefilled formulation for a period up to 7 days.

Handling The Ups And Downs Of Multiple Sclerosis - Book That Deals Exclusively With The Emotional Impact Of Multiple
Medical News Today Fri, 20 Oct 2006 2:07 PM PDT
The emotional impacts of MS are serious and widespread. Over 50% of MS patients suffer from depression and up to 90% experience anxiety. Handling the ups and downs of MS can be both physically and emotionally challenging. In fact, many find the emotional impact of the disease more debilitating than the physical symptoms. Yet, to date, no book has focused solely on this important topic, until


GW Pharma files Sativex in Canada for cancer pain
PharmaBiz Fri, 20 Oct 2006 9:49 PM PDT
GW Pharmaceuticals plc and Bayer HealthCare, Pharmaceuticals Division - Canada (Bayer) announce that GW has submitted a regulatory application in Canada for Sativex to seek approval for a new indication for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.

Saturday, October 21, 2006

Stem Cell Potential


Stem cell therapy may not offer a cure, but it can improve the
recovery of stroke and CP patients.

By Toni Baker

A single dose of adult donor stem cells given to animals that have
neurological damage similar to that experienced by adults with a
stroke or newborns with cerebral palsy can significantly enhance
recovery from these types of injuries, according to research
findings presented earlier this month at the Annual Meeting of the
American Academy of Neurology in San Diego.

Using a commonly utilized animal model for stroke, researchers from
the Medical College of Georgia (MCG) administered a dose of 200,000
to 400,000 human stem cells into the brain of animals that had
experienced significant loss of mobility and other functions. stem
cells used in the study were a recently discovered type,
referred to as multipotent adult progenitor cells.

Treated animals experienced at least 25 percent greater improvement
in motor and neurological performance than controls
, reports Cesario
Borlongan, PhD, a neuroscientist at MCG and the Veterans Affairs
Medical Center in Augusta, Ga.

The findings hopefully will translate to incremental but important
recovery advances in humans, says study co-author David Hess, MD,
chair of the MCG Department of Neurology. He hopes stem cell
therapy, along with aggressive physical therapy and possibly the
clot-busting drug tissue plasminogen activator (tPA), one day can
work synergistically to reduce disability due to stroke, which is
the single largest cause of disability among American adults.

"These are not going to be cures, but this level of recovery is
significant and could help get somebody out of a bed and into a
wheelchair, out of a wheelchair to walking with a cane, or from a
cane to walking unassisted. We look at that as a big improvement,"
Dr. Hess says.

Researchers tested adult animals across a range of standardized
tasks, before and after undergoing a surgically-induced stroke, and
measured their performance. Control animals and those that received
a single injection of stem cells then were evaluated for two months.

The animals treated with stem cells had greater recovery of injured
tissue and enhanced performance across the range of tests examining
strength, balance, agility and fine motor skills.

"A single dose of the cells produced robust behavioral recovery at
an early period post-transplantation, and the recovery was durable,
lasting up to two months, which was the length of this study," Dr.
Borlongan says. "Furthermore, animals continued to show improvement
over time."


In the newborn model of ischemic injury, enhanced recovery occurred
within two weeks. Even though less than 1 percent of the
transplanted cells were present two months later, animals receiving
treatment developed new neurons.

"Up to this point, no treatment approaches can get rid of that
ischemic core," Dr. Borlongan says. "But outside of that core is a
lining called the penumbra. If you do not treat it over time, the
penumbra becomes part of the core. We are able to increase the
number of cells surviving along that penumbra even one week after a
stroke."

Animals in the cerebral palsy model also experienced at least a 25
percent improvement over controls. Cerebral palsy is a condition
caused by an ischemic injury similar to stroke but occurring before
or during birth. A larger percentage of donated cells survived and
within two weeks matured into neurons in the young, more pliable
brains.


Close donor matching seemed unnecessary, Dr. Borlongan says.
Unmatched transplants from the same species and genetically
identical transplants yielded essentially equal results.

"Given the number of stroke victims each year, it would be a big
step forward if a safe and effective stem cell therapy could be
produced, conveniently stored, and efficiently delivered on a
widespread basis," comments Gil Van Bokkelen, PhD, chairman and CEO
of Athersys Inc., a biopharmaceutical company in Cleveland, that
funded the research.

In extensive animal testing the mature stem cells have been shown to
be safe and do not form tumors or other abnormal tissue, a potential
problem seen with embryonic stem cells. In addition, the use of
immunosuppressive drugs does not appear to be required, in contrast
to other types of stem cell treatment.

The researchers already are working with the U.S. Food and Drug
Administration with the goal of beginning clinical trials within the
next few years.


Researchers are working toward delivering the stem cells
intravenously, an approach they believe will work because the cells
naturally migrate to an injury site.

Toni Baker is director of media relations at the Medical College of
Georgia.
________________________________________________________

AVONEX(R), The #1 Prescribed Multiple Sclerosis Therapy Worldwide, Improves Patient Convenience
Business Wire via Yahoo! Finance Fri, 20 Oct 2006 6:58 AM PDT
CAMBRIDGE, Mass.----AVONEX® , the most prescribed multiple sclerosis therapy worldwide, may now be stored at room temperature in its prefilled formulation for a period up to 7 days.


Cause Of Nerve Fiber Damage In Multiple Sclerosis Identified
Medical News Today Thu, 19 Oct 2006 1:07 PM PDT
Researchers have identified how the body's own immune system contributes to the nerve fiber damage caused by multiple sclerosis, a finding that can potentially aid earlier diagnosis and improved treatment for this chronic disease. [click link for full article]

Devoted husband gets suspended sentence for helping wife to die
Guardian Unlimited Fri, 20 Oct 2006 1:14 AM PDT
A man who helped his seriously ill wife commit suicide after she had struggled with multiple sclerosis for 20 years was spared jail at the Old Bailey yesterday.

Iranian scientists produce MS medicine
IranMania.com Fri, 20 Oct 2006 0:39 AM PDT
LONDON, October 20 (IranMania) - Iranian researchers have accomplished synthesis of the first chemical substances used in the treatment of patients with Multiple Sclerosis (MS), MNA reported.

Husband gets suspended sentence for helping wife to die
Guardian Unlimited Fri, 20 Oct 2006 1:04 AM PDT
Court accepts plea of guilty to aiding suicide.

Cuts in Medicare Hurt Wheelchair Users
Newsday Thu, 19 Oct 2006 4:05 PM PDT
Patricia Meier, a 63-year-old quadriplegic and Medicare recipient, needs to replace the wheelchair she has used for five years. Normally, Meier could simply use her Medicare benefits to replace the power wheelchair, which adjusts her position to prevent sores, with another one from WestMed Rehab Inc., a medical supplier near her home in Box Elder, S.D. But WestMed, along with several other

fampridine acorda

IPO Watch: Hot Drug Properties
Red Herring - CA,USA
... Over the weekend of September 22, Acorda announced it had received a positive result from its Phase III clinical trial for its lead MS drug, Fampridine-SR. ...

Acorda (ACOR) Expands Sales Force to 65
StreetInsider.com (subscription) - Birmingham,MI,USA
... Shares of Acorda have surged recently following positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis.



FTY720

Novartis Delivers Dynamic Sales and Earnings Growth in the First ...
Market Wire (press release) - USA
... Tasigna was specifically designed to be a more selective inhibitor of Bcr-Abl and its mutations. -- FTY720 (fingolimod), an oral once-daily treatment for ...
See all stories on this topic

Multiple Sclerosis :: Oral fingolimod, FTY720 for relapsing MS ...
SpiritIndia - New Delhi,New Delhi,India
Data on fingolimod (FTY720), a new oral immunomodulating drug, reported recently in the New England Journal Medicine shows a relapse rate reduction of more ...


tysabri

Newest drugs not always the best
USA Today - USA
... Based on advice from the staff of specially trained pharmacists, Kaiser never added Vioxx, the arthritis drug, or Tysabri, a multiple sclerosis drug, to its ...

fampridine acorda

Acorda Therapeutics (ACOR) Higher on Positive Analyst Note
StreetInsider.com (subscription) - Birmingham,MI,USA
... Acorda has benefited tremendously recently from positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis. ...

Acorda Therapeutics Announces Expansion of Zanaflex Capsules™ ...
Business Wire (press release) - San Francisco,CA,USA
... com. Acorda’s lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's ...
See all stories on this topic

Market Report -- Short Stories (ACOR)
MSN Money - USA
Acorda Therapeutics Lazard Captial reiterates Buy. ... their tgt on ACOR to $22 from $14 saying they hosted a dinner to discuss the Phase III Fampridine SR data ...
FTY720

Pharma Earnings On Tap-Upcoming Week In Earnings
Trading Markets - Los Angeles,CA,USA
... Late-September, the company revealed new Phase II data on its developmental oral therapy FTY720, stating the medicine to have sustained benefits over two years ...


Friday, October 20, 2006

Medicare to Cease Automatic Enrollment

By KEVIN FREKING, Associated
Press Writer
Wednesday, October 18, 2006
(10-18) 13:20 PDT WASHINGTON, (AP) --
The federal government has told about 632,000 elderly and disabled
people they won't be automatically enrolled in a Medicare drug plan next
year.
These people are still eligible to participate in the drug benefit, but
they will have to shop for a plan and then enroll on their own rather
than the government doing it for them. To afford the benefit, many will
also need to apply for a low-income subsidy.
Some advocates are concerned that many of the 632,000 could fall through
the cracks, not knowing they don't have coverage for their medicine
until they show up at their local pharmacy in January.
"We're very concerned. We believe many, if not most of the people,
simply won't respond to a letter," said James Firman, president and CEO
of the National Council on Aging. "Many won't read the letter, they
won't understand the letter, they won't know how to fill out the
application form."
During the first year of the drug benefit, the so-called "dual
eligibles" were automatically enrolled because they participated in both
Medicaid and Medicare and represented the sickest and most vulnerable
among the elderly and disabled. The federal government wanted to ensure
that they did not lose access to prescription drugs.
But states have informed the federal government that some of those
beneficiaries no longer are enrolled in their Medicaid programs, thus
they will no longer be automatically enrolled in a drug plan.
The Centers for Medicare and Medicaid Services recognizes that some in
the group may miss signing up for a drug plan during the next open
enrollment period — Nov. 15 though Dec. 31. It has granted the group
an extra three months to enroll in a plan without the prospect of a
penalty for late enrollment, said Kathleen Harrington, director of
external affairs for the agency.
Harrington said the group was also told in the letter last month that
they should apply for the low-income subsidy, which could give them
access to a drug plan with little or no monthly premium. She also said
that the insurers themselves have been told who will need to apply on
their own.
"It's very much in the interest of the plans to keep them in coverage,"
Harrington said.
Firman has worked closely with federal officials to enroll low-income
seniors in the drug benefit. He has not been critical of the program, so
his qualms cannot be dismissed as just more criticism from an outspoken
opponent.
The beneficiaries he is concerned about qualify for Medicare because of
their age or disability. They also had previously qualified for Medicaid
because of their incomes.
In some cases, the people who lost their Medicaid coverage may have lost
eligibility because they're making more money and no longer qualify for
the extra help.
"But it's more likely that some states tightened eligibility
requirements, or the individual did not complete all the paperwork
needed to be recertified for Medicaid," Firman said.
Firman said that his organization's experience in reaching out to
low-income seniors is that about 20 percent will respond to a letter.
"We're talking about a population that's sick, may have low literacy.
There are a lot of challenges," he said. "What they need is one-on-one
assistance from trusted intermediaries."
He said he hoped that insurers would take some follow-up steps, too.
"We believe the plans themselves should have responsibility for helping
their customers do this. It also makes good business sense because they
could lose these customers," Firman said.
Harrington said there are no plans to follow the letter up with calls,
but advocacy groups and other government agencies will undertake
outreach efforts in communities deemed to have a large number of seniors
eligible for the low-income subsidy.
___
On the Net:
National Council on Aging:
Medicare:
www.ncoa.org
www.medicare.gov
URL:
http://sfgate.com/cgi-bin/article.cgi?file=/n/a/2006/10/18/national/w121530D45.DTL
©2006 Associated Press
__._,_.___

Medicare to Cease Automatic Enrollment

By KEVIN FREKING, Associated
Press Writer
Wednesday, October 18, 2006
(10-18) 13:20 PDT WASHINGTON, (AP) --
The federal government has told about 632,000 elderly and disabled
people they won't be automatically enrolled in a Medicare drug plan next
year.
These people are still eligible to participate in the drug benefit, but
they will have to shop for a plan and then enroll on their own rather
than the government doing it for them. To afford the benefit, many will
also need to apply for a low-income subsidy.
Some advocates are concerned that many of the 632,000 could fall through
the cracks, not knowing they don't have coverage for their medicine
until they show up at their local pharmacy in January.
"We're very concerned. We believe many, if not most of the people,
simply won't respond to a letter," said James Firman, president and CEO
of the National Council on Aging. "Many won't read the letter, they
won't understand the letter, they won't know how to fill out the
application form."
During the first year of the drug benefit, the so-called "dual
eligibles" were automatically enrolled because they participated in both
Medicaid and Medicare and represented the sickest and most vulnerable
among the elderly and disabled. The federal government wanted to ensure
that they did not lose access to prescription drugs.
But states have informed the federal government that some of those
beneficiaries no longer are enrolled in their Medicaid programs, thus
they will no longer be automatically enrolled in a drug plan.
The Centers for Medicare and Medicaid Services recognizes that some in
the group may miss signing up for a drug plan during the next open
enrollment period — Nov. 15 though Dec. 31. It has granted the group
an extra three months to enroll in a plan without the prospect of a
penalty for late enrollment, said Kathleen Harrington, director of
external affairs for the agency.
Harrington said the group was also told in the letter last month that
they should apply for the low-income subsidy, which could give them
access to a drug plan with little or no monthly premium. She also said
that the insurers themselves have been told who will need to apply on
their own.
"It's very much in the interest of the plans to keep them in coverage,"
Harrington said.
Firman has worked closely with federal officials to enroll low-income
seniors in the drug benefit. He has not been critical of the program, so
his qualms cannot be dismissed as just more criticism from an outspoken
opponent.
The beneficiaries he is concerned about qualify for Medicare because of
their age or disability. They also had previously qualified for Medicaid
because of their incomes.
In some cases, the people who lost their Medicaid coverage may have lost
eligibility because they're making more money and no longer qualify for
the extra help.
"But it's more likely that some states tightened eligibility
requirements, or the individual did not complete all the paperwork
needed to be recertified for Medicaid," Firman said.
Firman said that his organization's experience in reaching out to
low-income seniors is that about 20 percent will respond to a letter.
"We're talking about a population that's sick, may have low literacy.
There are a lot of challenges," he said. "What they need is one-on-one
assistance from trusted intermediaries."
He said he hoped that insurers would take some follow-up steps, too.
"We believe the plans themselves should have responsibility for helping
their customers do this. It also makes good business sense because they
could lose these customers," Firman said.
Harrington said there are no plans to follow the letter up with calls,
but advocacy groups and other government agencies will undertake
outreach efforts in communities deemed to have a large number of seniors
eligible for the low-income subsidy.
___
On the Net:
National Council on Aging:
Medicare:
www.ncoa.org
www.medicare.gov
URL:
http://sfgate.com/cgi-bin/article.cgi?file=/n/a/2006/10/18/national/w121530D45.DTL
©2006 Associated Press
__._,_.___

Medicare to Cease Automatic Enrollment

By KEVIN FREKING, Associated
Press Writer
Wednesday, October 18, 2006
(10-18) 13:20 PDT WASHINGTON, (AP) --
The federal government has told about 632,000 elderly and disabled
people they won't be automatically enrolled in a Medicare drug plan next
year.
These people are still eligible to participate in the drug benefit, but
they will have to shop for a plan and then enroll on their own rather
than the government doing it for them. To afford the benefit, many will
also need to apply for a low-income subsidy.
Some advocates are concerned that many of the 632,000 could fall through
the cracks, not knowing they don't have coverage for their medicine
until they show up at their local pharmacy in January.
"We're very concerned. We believe many, if not most of the people,
simply won't respond to a letter," said James Firman, president and CEO
of the National Council on Aging. "Many won't read the letter, they
won't understand the letter, they won't know how to fill out the
application form."
During the first year of the drug benefit, the so-called "dual
eligibles" were automatically enrolled because they participated in both
Medicaid and Medicare and represented the sickest and most vulnerable
among the elderly and disabled. The federal government wanted to ensure
that they did not lose access to prescription drugs.
But states have informed the federal government that some of those
beneficiaries no longer are enrolled in their Medicaid programs, thus
they will no longer be automatically enrolled in a drug plan.
The Centers for Medicare and Medicaid Services recognizes that some in
the group may miss signing up for a drug plan during the next open
enrollment period — Nov. 15 though Dec. 31. It has granted the group
an extra three months to enroll in a plan without the prospect of a
penalty for late enrollment, said Kathleen Harrington, director of
external affairs for the agency.
Harrington said the group was also told in the letter last month that
they should apply for the low-income subsidy, which could give them
access to a drug plan with little or no monthly premium. She also said
that the insurers themselves have been told who will need to apply on
their own.
"It's very much in the interest of the plans to keep them in coverage,"
Harrington said.
Firman has worked closely with federal officials to enroll low-income
seniors in the drug benefit. He has not been critical of the program, so
his qualms cannot be dismissed as just more criticism from an outspoken
opponent.
The beneficiaries he is concerned about qualify for Medicare because of
their age or disability. They also had previously qualified for Medicaid
because of their incomes.
In some cases, the people who lost their Medicaid coverage may have lost
eligibility because they're making more money and no longer qualify for
the extra help.
"But it's more likely that some states tightened eligibility
requirements, or the individual did not complete all the paperwork
needed to be recertified for Medicaid," Firman said.
Firman said that his organization's experience in reaching out to
low-income seniors is that about 20 percent will respond to a letter.
"We're talking about a population that's sick, may have low literacy.
There are a lot of challenges," he said. "What they need is one-on-one
assistance from trusted intermediaries."
He said he hoped that insurers would take some follow-up steps, too.
"We believe the plans themselves should have responsibility for helping
their customers do this. It also makes good business sense because they
could lose these customers," Firman said.
Harrington said there are no plans to follow the letter up with calls,
but advocacy groups and other government agencies will undertake
outreach efforts in communities deemed to have a large number of seniors
eligible for the low-income subsidy.
___
On the Net:
National Council on Aging:
Medicare:
www.ncoa.org
www.medicare.gov
URL:
http://sfgate.com/cgi-bin/article.cgi?file=/n/a/2006/10/18/national/w121530D45.DTL
©2006 Associated Press
__._,_.___

Wednesday, October 18, 2006

Cause of nerve fiber damage in multiple sclerosis identified

http://www.physorg.com/news80230112.html

Researchers have identified how the body's own immune system contributes to the nerve fiber damage caused by multiple sclerosis, a finding that can potentially aid earlier diagnosis and improved treatment for this chronic disease.
The study reveals how immune system B-cells damage axons during MS attacks by inhibiting energy production in these nerve fiber cells, ultimately causing them to degenerate and die. Study results appear in the Oct. 15 issue of the Journal of Immunology.

B-cell-axon activity is an emerging area of MS research, one that is changing how scientists and clinicians can look at this disease. In this study, Dr. Yufen Qin and fellow researchers from UC Irvine's School of Medicine analyzed spinal fluid and tissue samples from MS patients to identify substances that stimulate a B-cell immune response. They noted an increased level of B-cell antibodies on lesions and in spinal fluid bound to two specific enzymes -- GAPDH and TPI.

These two enzymes are essential for efficient energy production. The researchers believe that the binding of these antibodies to these enzymes -- GAPDH, in particular -- may lower the amounts of ATP -- the chemical fuel for cells -- available in cells, which eventually can lead to axon cell degeneration and death. In addition to the energy-production function, GAPDH is involved with a number of genetic activities, such as RNA translocation, DNA replication and DNA repair.

Other recent studies have shown that binding of inhibitors to GAPDH and TPI causes decreased ATP production in neurons, followed by progressive neuronal degeneration and death. Moreover, patients with TPI deficiency can develop progressive neurological disorders.

"This research is exciting and potentially important for future treatments because it identifies new antibodies associated with MS that can be targeted with emerging therapies," said Qin, an assistant professor of neurology. "Significantly, these are the first antibodies to be identified with axon activity, which is a new area researchers are exploring in the pathology of MS."


MS is a chronic central nervous system disease that can cause blurred vision, poor coordination, slurred speech, numbness, acute fatigue and, in its most extreme form, blindness and paralysis. Some 400,000 Americans have this disease. Its causes are unknown, and symptoms are unpredictable and vary greatly in severity.

Much MS research is focused on an autoimmune process in which T-cells attack and damage myelin, the fatty insulating tissue of axons. These T-cells do not attack axons themselves; the process of demyelination interrupts electrical impulses that run through these nerve fibers, thus causing MS symptoms. Demyelination has been considered the central feature of MS.

Recently, however, Qin has been among a group of researchers who have discovered that B-cells too are involved with the autoimmune response to MS. Instead of targeting myelin, these B-cells attack axons directly. Axons are the long, slender fibers of a neuron that serve as the primary transmission lines of the nervous system, and as bundles they help make up nerves.

Research at UCI and elsewhere has shown that myelin grows back if the T-cell autoimmune response is turned off, and drugs exist or are in development to block demyelination. Axons, in turn, repair very slowly, which implies that B-cell attacks on axons may have a significant impact on the chronic central nervous system damage caused by MS.

"Since this area of research is in its early stage, it's important to understand the process by which these B-cell responses happen," Qin said. "Hopefully, by identifying these two crucial enzymes, it will lead to a greater understanding of MS and lead to more effective treatments for people who live with this disease."

Source: University of California - Irvine




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