Saturday, September 30, 2006

Tysabri


Tysabri Delays MS Relapse: Data
TheStreet.com - USA
Biogen Idec (BIIB - commentary - Cramer's Take) and Elan (ELN - commentary - Cramer's Take) presented new data this week showing that Tysabri improved the ...
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Biogen's Tysabri sustains effect for 3 years-study
Reuters - USA
... company Biogen Idec (BIIB.O: Quote, Profile, Research) said on Friday that data from an extended trial of its multiple sclerosis drug Tysabri showed that the ...

Biogen, Elan Unveil New Tysabri Data and Imclone Shares Up
Financial News USA (press release) - La Puente,CA,USA
... (NYSE:ELN) said Thursday data from a late-stage study of Tysabri showed it was effective in reducing cognitive degeneration in multiple sclerosis patients. ...



fingolimod

FTY720 Reduces Multiple Sclerosis Symptoms By 77% - Sustained Over ...
Medical News Today (press release) - UK
The developmental oral therapy FTY720 (fingolimod) has demonstrated sustained benefits over two years in patients suffering from relapsing multiple sclerosis ...


fampridine

Acordia Proves That Biotech Investing is Volatile, Unpredictable ...
Seeking Alpha - New York,NY,USA
... ACOR) absolutely skyrocketed Monday, by more than 280% by day's end, after the company announced that its Multiple Sclerosis drug Fampridine-SR significantly ...

Ahead of the Bell: Acorda Therapeutics
Houston Chronicle - United States
... In a note to clients, she said she expects the new drug, called Fampridine-SR, will need additional testing, which could take a year. ...

Positive Phase 3 Fampridine-SR Study In People With Multiple ...
eMaxHealth.com - Hickory,NC,USA
Acorda Therapeutics, Inc. announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis (MS). ...

Hawthorne biotech company's study brings hope to thousands with MS
The Journal News.com - Westchester,NY,USA
Results from a Phase 3 trial of the drug, known as Fampridine-SR, showed that a greater proportion of people had consistently improved walking speed than ...

Piper Jaffray upgrades Acorda Therapeutics (ACOR) to Outperform
StreetInsider.com (subscription) - Birmingham,MI,USA
Acorda has risen significantly this week after announcing positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple ...


rituximab Multiple Sclerosis

FDA Approves Two New Indications for Rituxan(R) in Patients With ...
Yahoo! News (press release) - USA
... Priority Review, two additional uses for Rituxan® (Rituximab) for patients ... including systemic lupus erythematosus, lupus nephritis, multiple sclerosis and ANCA ...
See all stories on this topic




Friday, September 29, 2006

Xanthus' Symadex(TM) Remyelination


Xanthus' Symadex Can Reverse Disease in Preclinical Multiple ...
Yahoo! News (press release) - USA
... company, today presented data that Symadex(TM) reverses the ... Alfred Ajami, PhD, Chief Scientific Officer at Xanthus. Symadex (formerly C-1311) is the lead ...
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http://biz.yahoo.com/prnews/060928/neth010.html?.v=70
Press Release Source: Xanthus Pharmaceuticals, Inc.

Xanthus' Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model
Thursday September 28, 9:30 am ET

- Results Presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis -


CAMBRIDGE, Mass., Sept. 28 /PRNewswire/ -- Xanthus Pharmaceuticals, Inc., a privately-held drug development company, today presented data that Symadex(TM) reverses the clinical and pathological signs of chronic disease in an animal model for multiple sclerosis (MS). The presentation was made by Stephen J. Karlik, PhD, Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus in a poster session at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid, Spain.

Dr. Karlik used a model of experimental allergic encephalomyelitis (EAE) for the study. This same model was used by Dr. Karlik and his colleagues for published studies with natalizumab and related molecules. The study demonstrated that Symadex can reverse the clinical and pathological signs of chronic disease and that it can permit nerve remyelination. In addition, longer dosing resulted in continued benefit and the pathological changes including inflammation and vascular abnormalities were reversed. Importantly, Symadex did not affect circulating immune cell numbers, suggesting that it is not a general immunosuppressive agent.

"We believe that Symadex has a distinct activity profile in the field of MS therapies. Interestingly, we found that Symadex has no effect on the acute, T-cell mediated portion of the disease process which is the target of most proposed new therapies for MS," stated Alfred Ajami, PhD, Chief Scientific Officer at Xanthus.

About Symadex(TM)

Symadex (formerly C-1311) is the lead compound in clinical development from a new series of agents, the imidazoacridinones, which have shown in

vitro to be potent and selective FLT3 receptor tyrosine kinase inhibitors. Symadex is currently in Phase 2 clinical trials in oncology indications. Xanthus is also exploring the use of Symadex for the treatment of a number of autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis, where early preclinical data has shown encouraging signs of activity.

About Xanthus Pharmaceuticals, Inc.

Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule oncology candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. The Company is applying its expertise both to advance its current pipeline and expand it into indications of unmet medical need beyond oncology.

Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at http://www.xanthus.com.

This press release contains forward-looking statements concerning Xanthus that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Xanthus' actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in early clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future clinical trials or warrant additional trials; whether products based on Xanthus' technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the company will have the cash resources to develop and commercialize its products; and whether the patent and patent applications owned or licensed by Xanthus will protect the Company's technology and prevent others from infringing it. Xanthus disclaims any intention or obligation to update any forward-looking statements.

Contacts:

Kari Watson, MacDougall Biomedical Communications, Inc. -- kwatson@macbiocom.com or (508) 647-0209

Lisa Terry, Xanthus Pharmaceuticals, Inc. -- lisa.terry@xanthus.com or (617) 225-0522, x 105



Source: Xanthus Pharmaceuticals, Inc.
Tysabri

Drug Holds Promise for MS Sufferers
KSL-TV - Salt Lake City,UT,USA
In trials, participants who took the drug, called Tysabri, with another drug, experienced a 54% reduction in the rate of clinical relapses. ...

Market Report -- Short Stories (BIIB)
MSN Money - USA
Target $50. Credit Suisse initiates BIIB with a Neutral and a $50 tgt saying long-term Tysabri sales difficult to predict. The firm ...

Market Report -- In Play (BIIB)
MSN Money - USA
Biogen Idec announces new data on Tysabri demonstrate significant improvement in cognitive function in patients with multiple sclerosis Co and and Elan Corp ...

Elan buys into new Alzheimer treatment
Unison.ie - Bray,Ireland
Elan, which is the manufacturer of the Tysabri multiple sclerosis treatment, is to link up with Toronto-based Transition Therapeutics, for the joint ...
See all stories on this topic

Biogen, Elan Unveil New Tysabri Data
Houston Chronicle - United States
and Elan Corp. said Thursday data from a late-stage study of Tysabri showed it was effective in reducing cognitive degeneration in multiple sclerosis patients. ...
See all stories on this topic

Say farewell to Click Commerce
MSN Money - USA
... Elan (ELN, news, msgs) has been treading water since getting Tysabri re-approved in the US and Europe. In October, when the company ...



Rituximab Multiple Sclerosis

Rituxan is effective in relapsing-remitting multiple sclerosis
Xagena.it - Italy
A Phase II study of Rituximab ( Rituxan ) for relapsing-remitting multiple sclerosis ( RRMS ) met its primary endpoint. The study ...


Fingolimod

European Commodity Stocks May Rise as Oil and Copper Advances
Bloomberg - USA
... disease. Novartis said its experimental multiple sclerosis drug, fingolimod, held the disease at bay for two years in a clinical trial. ...


FREEDOMS Phase III Multiple Sclerosis

New Data for FTY720 -- Aiming to Become the First Orally Effective ...
Yahoo! News (press release) - USA
... This includes a Phase III clinical trials program called FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis). ...


Fampridine

Acorda stock jumps on promising drug trial data
Reuters - USA
... The drug, Fampridine-SR, is designed to improve walking speed in patients with multiple sclerosis, a degenerative disease of the nervous system that can lead ...

Market Report -- In Play (ACOR)
MSN Money - USA
Acorda Therapeutics announces positive results of Phase 3 Study of Fampridine-SR on walking in people with multiple sclerosis Co announces positive results ...

Acorda Shares Triple on MS Drug Data
MSN Money - USA
... The company released results from its Phase III study of Fampridine-SR showing that nearly 35 percent of patients taking the drug improved their walking speed ...

Acorda says MS drug improves walking
United Press International - USA
25 (UPI) -- US firm Acorda Therapeutics said Monday it has seen positive results from a phase 3 study of Fampridine-SR for multiple sclerosis. ...

Study: Drug helps MS patients walk
Newsday - Long Island,NY,USA
... sclerosis is an autoimmune disease that affects the central nervous system.Krupp said she first heard about the substance, now called Fampridine-SR, more than ...
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Acorda Announces Positive Phase 3 Fampridine-SR Study In People ...
Medical News Today (press release) - UK
(Nasdaq: ACOR) today announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis (MS). ...
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Acorda Drug Helps MS Patients in Walking; Shares Soar (Update5)
Bloomberg - USA
... rose almost fourfold after the company said its experimental Fampridine drug helped people with multiple sclerosis walk faster. ...

Giant Step for MS Drug
Smartmoney.com - USA
The big bounce comes after Acorda's Fampridine-SR drug proved in Phase III testing to help MS sufferers who'd already lost some walking ability to the ...

Fampridine-SR Improves Walking Ability in MS Patients
Genetic Engineering News (press release) - New Rochelle,NY,USA
Acorda Therapeutics reported positive results from its Phase III trial of Fampridine-SR on walking in people with multiple sclerosis (MS). ...


Wednesday, September 27, 2006

Elan


Elan to Pay $200 Million to Develop Alzheimer's Drug (Update1)
Bloomberg - USA
... 27 (Bloomberg) -- Elan Corp., the maker of the Tysabri multiple sclerosis treatment, will pay as much as $200 million to add an experimental treatment to its ...


Fampridine

StreetInsider.com Pre-Open Movers 09/27
StreetInsider.com (subscription) - Birmingham,MI,USA
... profit taking following today's 29% run-up and yesterday's 283% run-up after announcing positive results from its Phase 3 clinical trial of Fampridine-SR on ...
See all stories on this topic

Acorda Therapeutics "buy," target price raised
newratings.com - USA
... this morning, the analyst mentions that the upward revision in the target price reflects a rise in the probability of the success of Fampridine-SR from 25% to ...
See all stories on this topic


Elan to Pay $200 Million to Develop Alzheimer's Drug (Update1)
Bloomberg.com Wed, 27 Sep 2006 4:11 AM PDT
Sept. 27 (Bloomberg) -- Elan Corp., the maker of the Tysabri multiple sclerosis treatment, will pay as much as $200 million to add an experimental treatment to its Alzheimer's disease program.

Vitamin B3 may be useful against MS: animal study
Reuters via Yahoo! News Tue, 26 Sep 2006 11:43 AM PDT
Boosting concentrations in the nervous system of a vital compound called NAD, by giving its chemical precursor, nicotinamide, a form of vitamin B3, has shown considerable therapeutic potential in a mouse model of multiple sclerosis (MS).

Drug helps some MS victims walk better
Lexington Herald-Leader Wed, 27 Sep 2006 0:16 AM PDT
An experimental drug for multiple sclerosis is helping some patients walk better, results from a new study show. Scientists at Acorda Therapeutics, in Hawthorne, N.Y., announced their results Monday after finishing analysis of the study over the weekend. Patients on the medicine were walking consistently faster over a 14-week period than those on a placebo. Their leg muscles also seemed stronger.

Free health talks
Burlington Post Wed, 27 Sep 2006 9:03 AM PDT
Naturopathic medicine and alternative therapies will be the subject of two free seminars hosted by local naturopath Andrea Hornyak next week.

Stem Cell Research Debated at UH Campus: State Legislators Hear From People on All Sides of the Hot-Button Issue
RedNova Wed, 27 Sep 2006 6:10 AM PDT
By Todd Ackerman, Houston Chronicle Sep. 27--State legislators brought the debate over whether Texas should expand or outlaw embryonic stem cell research to Houston on Tuesday.

NeuroMedix creates Medical and Scientific Advisory Board of distinguished academic and drug development experts to
CNW Group via Yahoo! Finance Wed, 27 Sep 2006 5:00 AM PDT
NeuroMedix Inc. today announced that it has created a Medical and Scientific Advisory Board panel of experts to help guide the clinical development of Minozac, its lead compound for the treatment of Alzheimer's disease.

Health calendar
Gloucester Daily Times Tue, 26 Sep 2006 1:14 PM PDT
Chair Yoga, Wednesdays, 12:30 to 1:30 p.m., Rose Baker Senior Center. To register, call Lisa at the Council on Aging at 978-281-9765. Exercises for prevention and treatment of osteoporosis, Wednesdays, 2 to 3 p.m., Rose Baker Senior Center.

Paul Allen hopes brain map will help science
KING 5 Seattle Tue, 26 Sep 2006 2:08 PM PDT
A map of the mouse brain down to details of individual cells has been completed, the first project of an institute funded by Microsoft Corp. co-founder Paul G. Allen, it was announced Tuesday.

Qualified Canadians Still Able to Access Medical Marijuana from Health Canada
CNW Group via Yahoo! Finance Tue, 26 Sep 2006 1:02 PM PDT
Yesterday the Conservative government announced spending cuts scheduled over the next two years. Funding for academic medical marijuana research - originally made available through the Medical Marijuana Research Program , established in 2003 - was included in that list.

Seattle Times: 'Brain atlas' mapping brain down to cell level
KING 5 Seattle Tue, 26 Sep 2006 11:38 AM PDT
Seattle researchers backed by billionaire Paul Allen have created a map of a mouse brain down to the details of individual cells. The Allen Institute of Brain Science is putting the Allen Brain Atlas online free to other neuroscientists studying brain circuits and chemistry - and what goes wrong in cancer and other diseases.


http://ihavems.com/

Discovery Channel :: News - Animals :: Mouse Brain Mapped in Detail




Sept. 26, 2006 — A map of the mouse brain down to details of individual cells has been completed, the first project of an institute funded by Microsoft Corp. co-founder Paul G. Allen, it was announced Tuesday.

The new Allen Brain Atlas is being made available online without cost to neuroscientists studying brain circuits and chemistry, a potential boon to cancer and other disease research because of similarities between the brains of mice and human beings, according to a statement issued by the Allen Institute of Brain Science.

"We want people to use this and make discoveries," Dr. Allan Jones, the institute's chief scientific officer, told The Seattle Post-Intelligencer.
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A formal announcement was planned in Washington, D.C., with Allen and Sens. Patty Murray, D-Wash, and Ted Stevens, R-Alaska.

Because more than 90 percent of the same genes are found in mice and humans, the mouse brain map can be compared with genetic findings related to human neurological disorders.

Moreover, the mapping project has shown that 80 percent of the body's genes are switched on in the brain, compared with 60 percent to 70 percent in previous scientific estimates, Jones said.

Neurosurgeons at Swedish Medical Center in Seattle have begun using the atlas to study the genetics of brain cancers, said neuroscientist Marc Tessier-Lavigne, an institute science adviser who discovered the molecules that trigger connections between nerve cells.

"This really just bolts us ahead in our ability to understand brain function and brain disorder," Tessier-Lavigne told The Seattle Times.

Even before completion of the mouse brain map, the institute's work had become vital to scientists delving into the genetics of multiple sclerosis, which is caused by degeneration of nerve cells, said Dr. Ben Barres, a Stanford University neurology professor.

"We use it every day," Barres said. "I hope they have enough bandwidth when everyone else starts using it."

The institute says it now gets 4 million hits a month as about 250 scientists access it daily.

Mouse Brain Mapped in Detail
Associated Press
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[ page 2 of 2 ]

When access to the institute was interrupted some time ago, "I learned how much we've come to depend upon this," Barres said.

"Graduate students and postdoctoral fellows just came pouring into my office, worried that they had been cut off," he said. "We can't imagine life without this tool anymore."

Allen donated $100 million to start the lab in 2003 and the mouse brain atlas cost $41 million, well under the $50 million that had been budgeted, Jones said.
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The next project, Jones said, will be to develop a digital, three-dimensional, interactive map of the genes at work in a human brain's neocortex, the outer layer that is the seat of higher thought and emotion, using brains from cadavers as well as tissue removed during brain surgeries.

Scientists hope the brain-mapping research eventually will lead to new discoveries on brain function and disorders such as MS, Alzheimer's and Parkinson's diseases, epilepsy, schizophrenia and addiction, to cite just a few.

"There's been a lot of progress in understanding how the brain develops," Barres said. "The next frontier is figuring out the circuitry and how it actually works."

http://dsc.discovery.com/news/2006/09/26/mousebrain_hea.html?category=animals&guid=20060926133000&dcitc=w19-506-ak-0001

Tysabri


Tuesday's Health Winners & Losers
TheStreet.com - USA
... ELN - commentary - Cramer's Take) shares sank Tuesday after a Piper Jaffray analyst said sales of the company's multiple sclerosis drug Tysabri could be lower ...

Analyst Worries About Tysabri
TheStreet.com - USA
Tysabri, the multiple sclerosis treatment from Elan (ELN - commentary - Cramer's Take) and Biogen Idec (BIIB - commentary - Cramer's Take), appears to be ...


fampridine acorda

Four-Bagger Biotech in One Day
MSNBC - USA
... This is the area where Acorda might run into problems, since the Fampridine phase III trial consisted of only 301 patients taking the drug or a placebo over a ...
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StreetInsider.com After-Hours Movers 09/26
StreetInsider.com (subscription) - Birmingham,MI,USA
... Acorda Therapeutics, Inc. ... today's 29% run-up and yesterday's 283% run-up after announcing positive results from its Phase 3 clinical trial of Fampridine-SR on ...
See all stories on this topic



B3 multiple sclerosis mice

Vitamin B3 may be useful against MS: animal study
Reuters - USA
... precursor, nicotinamide, a form of vitamin B3, has shown ... potential in a mouse model of multiple sclerosis (MS ... In mice with the MS-like disease EAE, nicotinamide ...

Vitamin B3 may benefit MS patients
Salt Lake Tribune - United States
A form of vitamin B3 may eventually help protect people with multiple sclerosis (MS) from ... Program at Children's Hospital Boston worked with mice that had ...




Tuesday, September 26, 2006

Fampridine

Market Report -- In Play ()

MSN Money - USA
Gapping Up ACOR +161% (announces positive results of Phase 3 Study of Fampridine-SR on walking in people with multiple sclerosis), WARR +72.% (being acquired ...

StreetInsider.com Pre-Open Movers 09/25
StreetInsider.com (subscription) - Birmingham,MI,USA
(Nasdaq: ACOR) 154% HIGHER; announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis (MS). ...

Acorda Releases Positive Fampridine Data
MSN Money - USA
... The company said that significantly more people with MS improved their walking speed when taking Fampridine-SR compared with those taking placebo. ...
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Fampridine-acorda

Monday's Health Winners & Losers
TheStreet.com - USA
Acorda Therapeutics (ACOR - commentary - Cramer's Take) saw its shares soar after the ... a late-stage clinical trial of its multiple sclerosis drug Fampridine-SR. ...
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09/25 StreetInsider.com Unusual 11 Mid-Day Movers
StreetInsider.com (subscription) - Birmingham,MI,USA
Acorda Therapeutics, Inc. (Nasdaq: ACOR) 234% HIGHER; Announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with ...

StreetInsider.com After-Hours Movers 09/25
StreetInsider.com (subscription) - Birmingham,MI,USA
... Acorda Therapeutics, Inc ... ACOR) 4.7% HIGHER; continues today's 283% run-up after announcing positive results from its Phase 3 clinical trial of Fampridine-SR on ...

The Dow Gained 68 Points, Nasdaq Added 30
StreetInsider.com (subscription) - Birmingham,MI,USA
... stories, Acorda Therapeutics, Inc. (Nasdaq: ACOR) gained 283% today after announcing positive results from its Phase 3 clinical trial of Fampridine-SR on ...


Monday, September 25, 2006

Biogen Joins With Alnylam On RNAi Therapies For PML.

BIOWORLD Today - Sep. 23, 2006

Byline: Jennifer Boggs, Staff Writer

Biogen Idec Inc. and Alnylam signed a potential $56 million early stage deal to discover RNAi-based treatments targeting progressive multifocal leukoencephalopathy (PML), a brain infection linked in rare cases to the use of Biogen's multiple sclerosis drug Tysabri.

PML, a disease caused by the JC virus, typically occurs in patients who are immune-suppressed, either from drug treatment or disease, and is almost always fatal.

Last year, Biogen and partner Dublin, Ireland-based Elan Corp. plc voluntarily pulled Tysabri (natalizumab) from the market following two patient deaths from PML; however, the companies resubmitted the drug for approval after further study and, in June, the FDA granted Tysabri a second chance in a limited capacity in MS patients and with an accompanying risk-management plan. (See BioWorld Today, June 6, 2006.)

"This early stage research collaboration is one of many efforts that we've undertaken to understand and manage the risk of PML," said Jose Juves, spokesman for Cambridge, Mass.-based Biogen.

Joining forces with Alnylam will allow Biogen to look at RNAi-based therapies, "which we think might work by inhibiting the production of the JC viral proteins that cause PML," Juves added.

Alnylam, also of Cambridge, already has done extensive work in antiviral RNAi drugs. It has completed two Phase I trials with its lead program, ALN-RSV01, a drug aimed at respiratory syncytial virus infection by silencing a viral gene in infected lungs. Beyond that, the company is working on an RNAi antiviral against pandemic flu.

Alnylam "has deep expertise in developing antiviral RNAi therapeutics and also in delivering RNAi to [the central nervous system] -- both the brain and the periphery," Barry Greene, Alnylam's chief operating officer told BioWorld Today. So the Biogen collaboration "is a very synergistic program, from our perspective."

Terms of the deal call for Biogen to pay Alnylam a $5 million up-front fee and fund all research and development activities. Alnylam also would be entitled to up to $51 million for reaching certain preclinical and clinical milestones, plus royalties.

In addition, Alnylam would receive utilization fees for any product resulting from the collaboration, which Greene said was "a unique structure put in place" due to the small number of patients diagnosed with PML.

"Neither company was looking at significant monetary gains from this population," Greene said, estimating that the number of patients range anywhere from "the upper hundreds the low thousands," comprising patients on immunosuppressive drugs as well as those with immune system disorders, such as HIV.

The inclusion of use fees ensures that Alnylam "can recognize significant compensation for overall effort," he added.

Collaboration work will focus on the discovery and development of RNAi therapeutics that target the JC virus, a virus that has been well sequenced, with specific genes identified that are responsible for the virus' replication.

"So the strategy here is to identify highly conserved sequences of those genes," Greene said, and then "to develop siRNAs [small-interfering RNAs] against those viruses."

The first step will be to design and optimize an RNAi drug that can be directed specifically to the JC virus genome, and then move to preclinical work. Alnylam said it's too early to disclose a timeline for advancing a product into the clinic, but said it will be working with Biogen and the FDA to determine a regulatory pathway.

Biogen is the sixth major partner Alnylam has signed, and the "first classic biotech company" to enter the RNAi space, Greene said.

Alnylam's other collaborators include large pharma firms such as Basel, Switzerland-based Novartis AG and Whitehouse Station, N.J.-based Merck & Co. Inc., and medtech firm Medtronic Inc., of Minneapolis.

To date, its collaborations have brought Alnylam $115 million in cash and continue to provide funding that the company uses to "develop our overall pipeline of RNAi therapeutics," Greene said. "It really fits with our goal to build a long term and valuable company."

Alnylam reported a net loss of $9.9 million, or 31 cents per share, for the second quarter. As of June 30, the company had a cash position of $123.3 million.

Its shares (NASDAQ:ALNY) closed at $13.48 Thursday, down 54 cents.

Biogen's stock (NASDAQ:BIIB) closed at $43.66 Thursday, unchanged.

http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1089604&contentType=sentryarticle&channelID=30

Tysabri


Biogen Joins With Alnylam On RNAi Therapies For PML.
Therapeutics Daily (subscription) (press release) - Newtown,PA,USA
... targeting progressive multifocal leukoencephalopathy (PML), a brain infection linked in rare cases to the use of Biogen's multiple sclerosis drug Tysabri. ...


A possible advance in fight against multiple sclerosis
SouthCoastToday.com - New Bedford,MA,USA
... possible to protect people with multiple sclerosis from long ... Harvard Medical School, worked with mice that had ... nicotinamide— a form of vitamin B3, or niacin ...

Vitamin hope for multiple-sclerosis treatment
New Scientist (subscription) - UK
... damage in mice suffering from a multiple sclerosis-like illness, a new study reveals. As a result, the researchers hope that a form of vitamin B3 (nicotinamide ...


Friday, September 22, 2006

FTY720 Novartis MS Pill Study Unlikely To Boost Shr

Novartis MS Pill Study Unlikely To Boost Shr
newratings.com - USA
0710 GMT [Dow Jones] Novartis (NVS) will present a two-year study on its experimental multiple sclerosis pill FTY720 on September 28, but the data is "unlikely ...

tysabri

Fidelity creates retirement research institute in Hub
Boston Globe - United States
... Inc. to develop a treatment for a rare brain disease found in three patients taking Biogen Idec's multiple sclerosis drug Tysabri. ...


tovaxin

Opexa Commences Phase IIb Multiple Sclerosis Study; Reports ...
PipelineReview.com (press release) - Barcelona,Spain
Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun. More than 90 attendees from 35 clinical sites ...


Vitamin hope for multiple-sclerosis treatment

* 14:00 20 September 2006
* NewScientist.com news service
* Roxanne Khamsi

http://www.newscientist.com/article/dn10130?DCMP=NLC-nletter&nsref=dn10130

A simple vitamin has dramatically reduced neurological damage in mice suffering from a multiple sclerosis-like illness, a new study reveals.

As a result, the researchers hope that a form of vitamin B3 (nicotinamide), may help reduce long-term disability in people with multiple sclerosis.

MS is caused by the body’s immune system attacking the protective myelin sheath that coats nerve cells. Without this white, fatty material, electrical signals passing to and from the brain are disrupted, and sufferers become increasingly physically disabled. There is currently no cure.

Current drugs aim to reduce destruction of myelin by suppressing patients’ immune systems. However, this has a side effect of making them more prone to infection. And these drugs do nothing to conserve remaining nerves – even if they lack myelin – once the disease has progressed.
Late-stage help

In the new research, Shinjiro Kaneko at the Children’s Hospital Boston in Massachusetts, US, and colleagues gave a daily dose of nicotinamide to mice that had an MS-type disease, called experimental autoimmune encephalopathy (EAE).

The vitamin protected the mice from further myelin damage and improved the function of nerve cells that had lost myelin, suggesting that it could help people in late-stage MS. The more nicotinamide they gave the mice, the greater the protective effect, the team found.

Mice receiving daily injections of nicotinamide only showed slightly reduced mobility, such as the dragging of a hind leg. In contrast, mice in the no-treatment group had severe hind-limb weakness or paralysis.
Sight saving

“That’s an enormous difference,” says Peter Werner at the Albert Einstein Collage of Medicine in New York, US, who was not involved with the study. “It is the difference, for example, between a mouse that can reach its food and one that can’t."

“It’s highly desirable to hang on to functioning nerves as long as possible, even if they’re naked because they have no myelin,” Werner told New Scientist. He adds that doing so could potentially delay loss of mobility or sight in a patient with MS.

When nerves lose myelin they have to work harder to send signals, and this stress appears to damage them further, Werner explains.
Widely available

Kaneko believes that nicotinamide worked in the mice because it raises the level of a key nervous system chemical called nicotinamide adenine dinucleotide (NAD), which appears to improve the energy efficiency of nerve cells. And NAD may also inactivate the immune cells that attack myelin, Kaneko suggests.

Nicotinamide is widely available in health food stores and pharmacies as a form of vitamin B3. The proven safety and availability of the compound make it an appealing candidate to treat MS, experts say, particularly since the chemical is small enough to cross the blood-brain barrier.

And unlike current multiple sclerosis (MS) drugs, nicotinamide does not appear to have unpleasant side effects.

However, Kenneth Maiese at Wayne State University School of Medicine in Detroit, Michigan, US, points out that the doses given to the mice in the study were quite high. Similar doses in humans may prove toxic, he cautions.

For this reason, experts stress that MS patients should not take vitamin B3 for their illness until clinical trials show that it has an effect in humans.

Journal reference: Journal of Neuroscience (DOI: 10.1523/jneurosci.2116-06.2006)

Serono's Oral Cladribine for the Treatment of Multiple Sclerosis Awarded Fast Track Status By FDA


Serono's Oral Cladribine for the Treatment of Multiple Sclerosis Awarded Fast Track Status By FDA
RedNova Thu, 21 Sep 2006 1:10 AM PDT
GENEVA, Switzerland, September 21 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA) announced today that oral cladribine has been designated a Fast Track product by the US Food and Drug Administration (FDA). This designation covers patients with relapsing forms of multiple sclerosis.

FDA fast-tracks Serono's oral MS drug
AP via Yahoo! News Thu, 21 Sep 2006 4:32 AM PDT
Swiss biotech firm Serono SA, which earlier Thursday agreed to sell a majority stake in the company to German drugmaker Merck KGaA for $13.31 billion, said its oral cladribine treatment for multiple sclerosis has received "fast-track" status from the U.S. Food and Drug Administration.

FDA Fast-Tracks Serono's Oral MS Drug
CBS 13 Sacramento Thu, 21 Sep 2006 5:24 AM PDT
Swiss biotech firm Serono SA, which earlier Thursday agreed to sell a majority stake in the company to German drugmaker Merck KGaA for $13.31 billion, said its oral cladribine treatment for multiple sclerosis has received "fast-track" status from the U.S. Food and Drug Administration. CBS News Interactive: Timeline Of Vioxx-Related Events

Vitamin May Help Against MS Nerve Damage
RedNova Wed, 20 Sep 2006 4:09 PM PDT
A Children's Hospital Boston study finds strong evidence that nicotinamide, a form of vitamin B3, may protect against nerve damage in multiple sclerosis. A team led by Dr.

Vitamin B3 May Help MS
MedicineNet.com Wed, 20 Sep 2006 12:27 PM PDT
Title: Vitamin B3 May Help MS Category: Health News Created: 9/20/2006 Last Editorial Review: 9/20/2006

Vitamin Shows Promise for MS Patients
MedicineNet.com Wed, 20 Sep 2006 12:28 PM PDT
Title: Vitamin Shows Promise for MS Patients Category: Health News Created: 9/20/2006 2:05:00 AM Last Editorial Review: 9/20/2006 2:04:34 AM

rituximab Multiple Sclerosis

Genentech and Biogen Idec announce positive results from trial of ...
Therapeutics Daily (subscription) (press release) - Newtown,PA,USA
... (BIIB) announced that a Phase II study of Rituxan (Rituximab) for relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint. ...


tovaxin

Positive results for Opexa in ongoing MS study
Pharmaceutical Business Review - USA
Opexa Therapeutics has said that after positive data from a phase I/II trial assessing Tovaxin for the treatment of multiple sclerosis, it has initiated a ...

Opexa Commences Phase IIb Multiple Sclerosis Study; Reports ...
Genetic Engineering News (press release) - Larchmont,NY,USA
... Company's development including: -- Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun. More than ...

Market Report -- In Play (OPXA)
MSN Money - USA
... IIb Multiple Sclerosis Study; Reports Positive Phase I/II Data; Provides Update on Preclinical Progress Co announces its Phase IIb study with Tovaxin for the ...

Opexa launches phase 2b trial of MS drug
United Press International - USA
THE WOODLANDS, Texas, Sept. 18 (UPI) -- Opexa said Monday it has begun a US phase 2b study of Tovaxin T Cell vaccine for the treatment of multiple sclerosis. ...



tysabri

A Billionaire Sells His Biotech
Forbes - USA
... thanks largely to Rebif, a multiple sclerosis treatment that has done well in the wake of the safety issues that faced Biogen Idec's Tysabri, which was ...

Nutra Pharma Announces ReceptoPharm to Be a Featured Speaker at ...
PharmaLive.com (press release) - Newtown,PA,USA
... The most recently available drug, Tysabri, was voluntarily pulled from the marketplace in February 2005 by the drug's manufacturers, Biogen-Idec (Nasdaq: BIIB ...

Big Pharma's biotech strategy: Buy it
CNNMoney.com - USA
... close eye on MedImmune (Charts), maker of experimental heart disease treatment Numax, and Biogen, maker of the FDA-approved multiple sclerosis treatment Tysabri ...

Another Partner for Biogen
MSNBC - USA
... to Biogen investors, it's because PML is the ultra-rare condition, usually occurring in people with immune deficiencies, that caused Tysabri, the company's ...
See all stories on this topic


Thursday, September 21, 2006

FDA fast-tracks Serono's oral MS drug

Swiss biotech firm Serono SA, which earlier Thursday agreed to sell a majority stake in the company to German drugmaker Merck KGaA for $13.31 billion, said its oral cladribine treatment for multiple sclerosis has received "fast-track" status from the U.S. Food and Drug Administration.

This designation covers patients with relapsing forms of multiple sclerosis.

Serono's oral form of cladribine is currently being evaluated in a multi-center, multi-national Phase III study called CLARITY. It is a two-year, double-blind, placebo-controlled study involving more than 1,200 patients. Patient enrollment is planned to be completed by the end of 2006.

"Thanks to decades of research, there are injectible drugs available to treat some forms of MS, but there is certainly a need for more and even better therapies to treat all forms of the disease. Having an effective oral therapy for MS would be a major step forward in improving quality of life for people with MS," said John Richert, VP of research and clinical programs, at the National Multiple Sclerosis Society.

Fast-track programs are designed to facilitate the development and expedite the review of new drugs that could treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Oral cladribine is now eligible for priority review, and the FDA can review data as it is received, instead of waiting until Serono's new drug application is completed.

Cladribine interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the process of multiple sclerosis.

Multiple sclerosis is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. Multiple sclerosis affects about two million people worldwide. The relapsing forms of multiple sclerosis are the most common.

http://news.yahoo.com/s/ap/20060921/ap_on_he_me/serono_fda_1&printer=1;_ylt=AtmcJn_hHxl.ZLPKEqd5R8pa24cA;_ylu=X3oDMTA3MXN1bHE0BHNlYwN0bWE-

Geraldo At Large - Video Archive


September 20, 2006

> Watch Video High Low
MS Treatment
High doses of a cancer drug have given some Multiple Sclerosis patients their life back.

http://www.geraldoatlarge.com/video-archive.php


B3 multiple sclerosis mice

Daily Nicotinamide Shots May Protect Multiple Sclerosis Patients ...
Medical News Today - UK
Giving multiple sclerosis (MS) patients a daily shot of nicotinamide ... who managed to do this with mice with Experimental ... Nicotinamide is a form of vitamin B3. ...
See all stories on this topic

B Vitamin Prevents MS Disability in Mice
MedPage Today - Little Falls,NJ,USA
... and its close relative, vitamin B3, is already ... the doses used in the mice would translate ... The study was financed by National Multiple Sclerosis Society and the ...

Vitamin B3 may help patients with Multiple sclerosis
Earthtimes.org - USA
... which is a form of vitamin B3, may help individuals who are suffering from Multiple sclerosis. The study, which was conducted on mice suffering from a disease ...
See all stories on this topic


tysabri

RU-486, Why The Special Treatment?
Stop the ACLU - New Cumberland,PA,USA
by Oak Leaf on 09-20-06 @ 2:38 pm Filed under Abortion, News. Tysabri, used to treat MS, was pulled from the market following reports of one death. US Sen. ...




Pfizer's Lyrica(R) Approved In Europe For Difficult-to-Treat Nerve Pain
Medical News Today Tue, 19 Sep 2006 0:10 AM PDT
Pfizer Inc said today that the European Commission approved Lyrica(R) (pregabalin capsules) to treat central neuropathic (nerve) pain. This new approval broadens the current range of neuropathic pain that Lyrica is approved to treat in Europe to include nerve pain associated with conditions such as spinal cord injury, stroke, and multiple sclerosis. [click link for full article]

Positive Results for Opexa in Ongoing MS Study
RedNova Mon, 18 Sep 2006 12:19 PM PDT
Opexa Therapeutics has said that after positive data from a phase I/II trial assessing Tovaxin for the treatment of multiple sclerosis, it has initiated a phase IIb study. Phase I/II trials indicated that after 12 months, patients exhibited a relapse rate reduction of more than 90%.

Pfizer's Lyrica(R) Approved in Europe for Difficult-to-Treat Nerve Pain
campus med Mon, 18 Sep 2006 1:06 PM PDT
New York (ots/PRNewswire) - - Lyrica's neuropathic pain indication broadened to include central nerve pain; Central nerve pain is associated with conditions such as spinal cord injury, stroke, and multiple sclerosis - A robust and unprecedented clinical program involving more than 10,000 patients supports Lyrica's efficacy and safety in treating a broad range of neurological disorders - Medical

131 now have marijuana cards
The Providence Journal Mon, 18 Sep 2006 9:49 PM PDT
When Rhonda O'Donnell took her first puff of marijuana -- her first, that is, since her teen years -- the effect was immediate.


Wednesday, September 20, 2006

Vitamins Treat MS?


http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=14531
Reported September 20, 2006
(Ivanhoe Newswire) -- A form of vitamin B3 could one day help men and women stricken with severe multiple sclerosis. A new study reveals the vitamin disrupts the process of nerve fiber destruction caused by an MS-like disease in mice.

Researchers at Children's Hospital Boston tested the treatment on mice with experimental autoimmune encephalitis a disease that mirrors MS in humans. Mice treated with nicotinamide, a form of vitamin B3, were not as likely to suffer the same degeneration of nerve fibers mice not treated with the vitamin suffered.

Researchers report mice given a daily injection of the drug developed symptoms later than mice not given the drug.

These findings are important, report the researchers, because it is one of the first studies to look into protection of axons -- the nerve fibers. These fibers are usually protected by a myelin sheath. MS strips that sheath away, leaving the axon exposed and vulnerable. The autoimmune response of people with MS degenerates those exposed axons, but nicotinamide seems to slow that process.

Current therapies address the myelin sheath destruction and inflammation but not damage to the nerve fibers.

The researchers say this study is a step toward a treatment for men and women suffering from the chronic progressive phase of MS for which there is not an effective treatment.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

SOURCE: The Journal of Neuroscience, 2006;26:00-00

Patients with Moderate to Severe MS Show Improvement After High-Dose Chemotherapy Regimen at Stony Brook


Medical Center / Health Care Press Release

Contact: Lauren Sheprow · 631.444.1209 · FAX: 631.444.8852
Stony Brook University Hospital· Stony Brook, NY 11794-7755

Mon, 14 Aug 2006, 16:00:00
http://commcgi.cc.stonybrook.edu/artman/publish/article_1178.shtml

STONY BROOK, N.Y. -- High-dose chemotherapy has demonstrated significant potential in fighting the progression of multiple sclerosis (MS), and, unexpectedly, many patients enjoy marked improvement in their neurological functions according to a study by researchers at Stony Brook University. Results are reported in the August 14 online edition of the American Medical Association's Archives of Neurology and set for print publication in October.

A group of patients with moderate to severe MS who had stopped responding to therapy experienced improvements in quality of life and neurological functioning and showed no signs of advancing disease after taking high-dose cyclophosphamide (HDC). The intensive four-day regimen was administered by a team of physicians and specialists at Stony Brook University Hospital.

"While a majority of MS patients can have their disease controlled with standard medicines, some suffer from disease progression despite this intervention," says Douglas E. Gladstone, M.D., Assistant Professor of Hematology/Oncology in the Department of Medicine and lead investigator of the study. "It is for this group of patients that the novel therapy of HDC is promising and should continue to be studied."

The therapy is based on HDC killing white blood cells called lymphocytes. In normal individuals, lymphocytes fight infections and stave off cancer cells. But in patients with autoimmune diseases, such as MS, these cells target normal tissue for destruction. This disrupts the patient's muscular and neurological functions, which can sometimes lead to a debilitating state. In theory, by HDC eradicating abnormal lymphocytes, the person's autoimmune disease is turned off or even potentially cured.

According to the report, overall the treatment was found to be safe with minimal toxicity and morbidity and improved clinical outcomes. All of the patients had brain magnetic resonance imaging (MRI) and neuro-ophthalmologic evaluations at six month intervals, along with quarterly disability and quality-of-life assessments for up to two years after HDC treatment. No patient had a new lesion on brain MRI or showed enhanced brain lesions. In addition, patients reported improvement in all of the quality-of-life parameters measured, such as physical functioning, body pain, and mental health, and significant neurological improvements included changes in gait, bladder control and visual function.

Regarding the Expanded Disability Status Scale (EDSS), a standardized measure of neurologic disability (1= normal, 10=death) based upon clinical examination, no patients had an increased EDDS score by more than one. Five patients had a decreased EDSS score by one or more. The eight functional neurological systems examined for the EDSS are pyramidal, cerebellar, brain stem, sensory, bowel and bladder, optic, cerebral, and other.

Dr. Gladstone has also studied and published reports on the benefits of HDC for patients with other autoimmune diseases, such as lupus, Crohn's disease, and myasthemia gravis. At Stony Brook Dr. Gladstone will continue to evaluate MS patients for this treatment protocol. He says that further investigation of the HDC regimen for MS patients is necessary to determine the most appropriate patients for this treatment.

Co-investigators for the study, all from Stony Brook University Medical Center, include Kenneth W. Zamkoff, M.D.; Lauren Krupp, M.D.; Robert Peyster, M.D.; Patrick Sibony, M.D.; Christopher Christodoulou, Ph.D.; Emily Locher, R.N., and Patricia Coyle, M.D.

-30-

© Stony Brook University 2006

Tuesday, September 19, 2006

Tovaxin



Tuesday's Health Winners & Losers
TheStreet.com - USA
... The biopharmaceutical company reported positive phase I/II trial results on its multiple sclerosis treatment Tovaxin and has now begun a phase IIb trial of the ...

Opexa Therapeutics' (OPXA - commentary - Cramer's Take) shares jumped after the company released positive data from its clinical trials. The biopharmaceutical company reported positive phase I/II trial results on its multiple sclerosis treatment Tovaxin and has now begun a phase IIb trial of the drug. Shares were up 9.2% to $6.55.


Opexa Therapeutics shares on rise
Bizjournals.com - Charlotte,NC,USA
shares climbed by 6 percent Monday after the company posted positive clinical trial results of its multiple sclerosis treatment, Tovaxin. ...
See all stories on this topic

Monday, September 18, 2006

Fingolimod


Fingolimod

New treatment offers big hope to MS patients
CTV.ca - Canada
Research on Phase II trials of a new drug called fingolimod, published in the New England Journal of Medicine, shows promising results for patients being able ...




You beauty! City pioneers use Botox to fix bladder problems
The Scotsman Mon, 18 Sep 2006 6:21 AM PDT
PIONEERING surgeons are using the beauty treatment Botox to cure bladder problems in multiple sclerosis sufferers.

New treatment offers big hope to MS patients
CTV.ca Sun, 17 Sep 2006 7:33 PM PDT
A small pill is offering big hope -- and fewer needles -- to many of the 55,0000 Canadians with multiple sclerosis who depend on injections and intravenous treatment.

Bid to Stockpile Bioterror Drugs Stymied by Setbacks
New York Times Sun, 17 Sep 2006 9:14 PM PDT
Project BioShield, a $5.6 billion effort to expand the nation?s medical stockpile, has largely failed to deliver, critics say.

Peroxide sellers to lay off the health promises
Fort Worth Star-Telegram Mon, 18 Sep 2006 5:28 AM PDT
The FDA cracks down on claims that hydrogen peroxide can treat AIDS, cancer and other conditions.

Susan Yerkes: MS official sporting red for a good cause
San Antonio Express News Sun, 17 Sep 2006 10:15 PM PDT
Last Tuesday, Tony Ralf got a spectacular dye job — for a cause.

Opexa Therapeutics Begins Phase IIb Multiple Sclerosis Study ...
Trading Markets - Los Angeles,CA,USA
(OPXA | charts | news | PowerRating), a developer of cell therapies, announced that it has started its Phase IIb study with Tovaxin for the treatment of ...
See all stories on this topic

Tysabri

Analysis: Colitis market to hit $1.1B
United Press International - USA
... Lai said the drug is similar to Elan/Biogen Idec's multiple sclerosis treatment Tysabri, which was temporarily taken off the market when it was found to ...



Lehigh Valley Woman with Multiple Sclerosis to Battle Disease on Her Bike

Sun Sep 17, 8:00 AM ET

Breinigsville, PA (PRWEB) September 17, 2006 -- It all started in the summer of 1999 when Tania Kincaid went blind because of multiple sclerosis (MS). Since the light caused pain in her eyes, she tended to stay at home in the dark. Her husband’s supervisor, Stacey Asbell, issued a challenge to bike 150 miles to raise money in Tania’s name. He and four others accepted and started Team Tania with Stacey as Captain.


There were six people on Team Tania in 1999. Last year there were 220 on the team which ranked them the largest “Friends and Family Team” in the nation. This year there will be nearly 250 friends and family riding on Team Tania with a goal to raise $155,000. Over the years, that would make over $500,000 raised for the National Multiple Sclerosis Society.

Becoming the largest Friends and Family Team and raising a half million dollars is no small feat. However, what makes this year special is that it will be the fifth year that Tania will actually be riding with the team for all 150 miles. Her personal goal is to raise $1,000.

Over time, Tania’s eyesight returned. “Although,” she says, “there is still some residual effect.” “It’s like looking through a wet pane of glass at times,” she says. Over the years, she’s had bouts with her eyesight, muscle weakness, and fatigue – all classic symptoms of MS.

All of Tania’s friends and family know that she does not give in easily. She trains throughout the year riding her bike. She will cover 75 miles on Saturday from Cherry Hill, NJ to Ocean City, NJ. Then on Sunday, she will take the same route back for a round-trip of 150 miles.

The event is called the MS-150 City-to-Shore Bike Tour and benefits the National Multiple Sclerosis Society. This year it will be September 16th and 17th. There are breaks about every 15 to 20 miles with plenty of food and drink. The event, which is the largest charity event on the east coast, will draw nearly 6,000 other cyclists. The monies raised benefit MS patients in the Delaware and Lehigh Valley regions.

Tania’s mother, Lee Kaniuka (one of the original six), will be joining her again this year. She has since move to Florida with her husband Steve, but they come up for the event. She’s never missed a year since she started in 1999.

To prepare for her first attempt in 2002, she started riding her bike a few miles a day. Then she started riding up to 20 or more miles. As her friends found out, they joined her on Saturdays and even joined Team Tania. Now they have a “ladies ride” on Saturdays that leaves from Trexlertown towards Kutztown and back. They often stop at a local shop for coffee and a chance to chat. “What’s said on the ride stays on the ride,” jokes one of her friends.

Tania credits exercise and healthy meals for her ability to ride. She also credits her faith in God. “I’m thankful that with God, family and friends, I don’t have to go through this alone,” she says.

“She’s the inspiration for the team,” says Team Captain Stacey Asbell.

When Tania arrives in Cherry Hill in the pre-dawn darkness on Saturday morning, Stacey and 250 other “Team Tania-ites” will be there to greet her. She also knows that by riding and raising money for the MS Society, she is helping thousands of others like her.
For additional information about Tania or how you can sponsor her, contact Patrick Kincaid or visit www.TeamTania.com.

About multiple sclerosis: Multiple Sclerosis (MS) is a chronic disease of the central nervous system (the brain and spinal cord). MS causes destruction of myelin, the covering of nerve fibers that connect nerve cells in the central nervous system. When the myelin is damaged, communication between nerve cells is impacted. Lesions form where the myelin is damaged, and depending on the number of lesions formed and their location, symptoms like blindness, dizziness, and weakness result. Symptoms vary as the location and severity of damage is variable.

About Team Tania: Stacey Asbell (Captain) formed the team in 1999. Under her direction, Team Tania has garnered numerous awards over the years: Gold Team, Platinum Team, Best Jersey, Most Improved Team, Mission Possible Team, Chairman’s Cup Award, Tour of Champions Team, and Team Safety Award. Team Tania is also recognized as the largest MS Friends and Family Team in the nation. Ms. Asbell can be contacted at www.TeamTania.com
About the National Multiple Sclerosis Society: Founded in 1946, the National MS Society supports more MS research, offers more services for people with MS, provides more professional education programs, and furthers more MS advocacy than any MS organization in the world. For more information visit www.MS150BikeTour.org

Contact:
Patrick Kincaid
610-295-5573
http://www.TeamTania.com

###

Patrick Kincaid
610-295-5573
E-mail Information
Trackback URL: http://prweb.com/pingpr.php/WmV0YS1aZXRhLUVtcHQtSG9yci1JbnNlLVplcm8=

http://news.yahoo.com/s/prweb/20060917/bs_prweb/prweb438442_1

FTY Shows Significant Benefits in Helping MS Patients Over One Year in Phase II Data Published in New England Journal of Medicine

* Oral treatment for multiple sclerosis (MS) maintains significant reductions in inflammatory disease activity and clinical relapses for up to one year

* Comprehensive Phase III program now underway worldwide

* 24-month Phase II treatment data to be presented at European Congress for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September

* More than two million people estimated to suffer from multiple sclerosis, one of the leading causes of neurological disability in young adults[1]

BASEL, Switzerland, September 13, 2006 - Clinical trial results published in the New England Journal of Medicine showed significant benefits for patients suffering from relapsing multiple sclerosis (MS) who were treated with FTY720 (fingolimod), in development with potential to become the first orally effective compound to help patients with this debilitating neurological disease.

The Phase II trial data showed that FTY720 taken once-daily during the initial six months of treatment reduced the rate of inflammatory disease activity - as measured by magnetic resonance imaging (MRI) - by up to 80% and cut clinical relapses by more than 50% compared to placebo[2].

In patients who continued taking FTY720 during the subsequent six-month extension, low levels of disease activity were maintained as measured by both MRI and relapses. Both these measures also decreased in patients who switched from placebo to FTY720.




"These results demonstrate that once-daily oral FTY720 provides an improvement in MRI measures of inflammation as well as in relapse-related clinical endpoints in patients with relapsing multiple sclerosis," said Professor Ludwig Kappos, chief trial investigator and head of the Department of Neurology at the University Hospital in Basel, Switzerland. "If the magnitude of benefits shown in this Phase II study is confirmed in the larger-scale Phase III program, oral FTY720 could potentially have a major impact in the way MS will be treated in the future," said Professor Kappos.

Phase III clinical trials program underway Based on the positive Phase II results, Novartis launched earlier in 2006 a Phase III clinical trials program called FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis). This 24-month, randomized, double-blind, placebo-controlled study program is designed to include over 2,000 patients worldwide with the relapsing-remitting form of multiple sclerosis between ages 18 and 55. Study participants will be randomized equally to either receive once-daily treatment with 1.25 mg or 0.5 mg of FTY720 or placebo for up to 24 months.

MS affects more than two million people worldwide
More than two million people worldwide are estimated to suffer from MS, which is one of the leading causes of neurological disability in young adults. It is the most common inflammatory and neurodegenerative disorder of the central nervous system, including the brain, spinal cord and optic nerves[3].

The symptoms of MS can range from tingling, numbness, pain, slurred speech and blurred or double vision, to muscle weakness, poor balance or coordination, and tremors. These symptoms can have a significant impact on the patient's employment, social activities and overall quality of life.

Conventional first-line multiple sclerosis therapies offer an average reduction in relapse rates in the range of 30-35% in two-year studies. These medicines also require frequent injections, ranging from daily to weekly[4],[5],[6]

FTY720 is the first in a new class of disease-modifying treatments called sphingosine 1-phosphate receptor (S1P-R) modulators and has a novel mode of action different from all currently marketed MS therapies. FTY720 has been developed by Novartis and licensed from Mitsubishi Pharma Corporation.

An analysis of two-year Phase II data with FTY720 will be presented at the European Congress for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid in September 2006.

Phase II study results in NEJM
The Phase II study described in the New England Journal of Medicine was conducted at 32 centers in 11 countries (in Europe and Canada) to evaluate the effect of FTY720 on disease activity as measured by MRI and clinical relapses as well as safety and tolerability.

In the initial placebo-controlled phase, 281 patients were randomized equally to receive FTY720 (1.25 mg or 5 mg) or placebo once-daily for six months. Of the 255 patients who completed this part of the study, 98% volunteered to continue in the extension phase[7]. Patients in the placebo group were then re-randomized to receive either 1.25 mg or 5 mg of FTY720 and were blinded for an additional six months. Those already on FTY720 continued with their original treatment.

The study showed that oral FTY720 provided significant and rapid improvement in MRI measures of inflammation and in relapse-related clinical endpoints in patients with relapsing MS. Inflammatory disease activity as measured by the total cumulative number of gadolinium (Gd) enhancing MRI lesions was significantly reduced by up to 80% (p<0.001 p="0.009)" p="0.014)" p="0.007" p="0.01">Disclaimer
This release contains certain forward-looking statements relating to Novartis' business, which can be identified by the use of forward-looking terminology such as "to be presented", "potential to become", "if the magnitude of benefits.confirmed", "could potentially", "will", or similar expressions, or by express or implied discussions regarding potential future regulatory submissions or approvals or regarding potential future revenue from fingolimod. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with fingolimod to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that fingolimod will be submitted for approval or will be approved for sale for any indications or labeling in any market. Nor can there be any guarantee that fingolimod will achieve any sales or any particular level of sales. In particular, management's expectations regarding fingolimod could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data or new clinical data; unexpected regulatory actions or delays or government regulation generally; Novartis' ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, attention deficit/hyperactivity disorder, epilepsy, schizophrenia and migraine. Novartis continues to be active in the research and development of new compounds, and is committed to addressing unmet medical needs and to supporting patients and their families affected by these disorders.

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com <http://www.novartis.com/> .

References
1 Multiple Sclerosis International Federation ( http://www.msif.org/en/ms_the_disease/index.html <http://www.msif.org/en/ms_the_disease/symptoms_of_ms.html>
2 N Engl J Med, 355;11, www.NEJM.org <http://www.nejm.org/> , September 14, page 1130 (Table 2)
3 Multiple Sclerosis International Federation ( http://www.msif.org/en/ms_the_disease/index.html <http://www.msif.org/en/ms_the_disease/symptoms_of_ms.html>
4 L.D. Jacobs et al. Intramuscular Interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996, 39: 285-294. 5 IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993; 43: 655- 661.
6 K.P. Johnson et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: Results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology 1995; 45: 1268- 1276.

7 N Engl J Med, 355;11, www.NEJM.org, September 14, page 1128 (Figure 1)

8 N Engl J Med, 355;11, www.NEJM.org, September 14, page 1131 (Table 2B)

8 N Engl J Med, 355;11, www.NEJM.org, September 14, page 1133 (Table 3)

10 N Engl J Med, 355;11, www.NEJM.org, September 14, page 1134-1135 (Table 4 and 4B)

11 N Engl J Med, 355;11, www.NEJM.org, September 14, page 1136 (Table 5)


Media contacts

John Gilardi Novartis Global Media Relations +41 61 324 3018 (direct) +41 61 324 2200 (main) john.gilardi@novartis.com john.gilardi@novartis.com> irina.ferluga@novartis.com> Irina Ferluga Novartis Pharma Communications + 41 61 324 24 22 (direct) + 41 79 824 11 21 (mobile) irina.ferluga@novartis.com irina.ferluga@novartis.com> Investor Relations contacts International: +41 61 324 79 44 North America: +1 212 830 24 33 e-mail: investor.relations@novartis.com investor.relations@novartis.com>