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"a new version of interferon beta that would do away with the need for injections"

CLICK HERE FOR COMPLETE STORYElan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that their ongoing safety evaluation of TYSABRI(R) (natalizumab) has led to a previously diagnosed case of malignant astrocytoma being reassessed as progressive multifocal leukoencephalopathy (PML), in a patient in an open label Crohn's disease clinical trial.

LINK: "In corporate news, Elan (down $3.88 to $3.10, Research) and Biogen Idec (down $3.78 to $34.57, Research) both sank after the companies said that a third patient taking their suspended multiple sclerosis drug Tysabri had contracted a rare neurological disease, making it unlikely the drug will return to the market anytime soon, if at all."

LINK: "'This is bad. And it's bad because this was a patient who was not evidently on Avonex,' said Alexander Hittle of A.G. Edwards. 'The best hope for the drug was that (the PML cases) was in some way the result of a combination of Tysabri with Avonex, and Tysabri could be brought back onto market as a stand alone therapy. This is going to make it very tough for them to get Tysabri back onto the market.'"

LINK>""This is bad. And it's bad because this was a patient who was not evidently on Avonex," said Alexander Hittle of A.G. Edwards. "The best hope for the drug was that (the PML cases) was in some way the result of a combination of Tysabri with Avonex, and Tysabri could be brought back onto market as a stand alone therapy. This is going to make it very tough for them to get Tysabri back onto the market."

CNN.com - Massachusetts Senate OKs stem cell bill - Mar 30, 2005

National Multiple Sclerosis Society - LINK

National Multiple Sclerosis Society - Bulletins - LINK

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LINKThis experimental treatment uses antibodies from the serum (the fluid portion of blood) of goats that have been inoculated with a variety of vaccines, to generate neutralizing antibodies. Antibodies are proteins produced by white blood cells in response to an antigen (foreign protein), to destroy/neutralize the antigen. The anti-inflammatory component of the serum is thought by researchers to be ‘potentially useful’ in the treatment of MS.

Daval International was cited for misleading advertising about Aimspro on its Web site in July 2004 by the UK Medicines and Healthcare Products Regulatory Agency, and the company responded by removing most of its claims for the product.

Evidence:
There is no research evidence or published information available to back up the anecdotal claims about goat serum.

Some individuals with MS in the United Kingdom had received goat serum outside of clinical trials through a program of informed consent from general practitioners. This program is no longer available, and no more people can receive this drug via informed consent.

Clinical trials:

A controlled trial (where half of the participants are receiving the treatment and half are on placebo (a dummy treatment) was begun St. George's Hospital in South London. Eighty participants with secondary-progressive MS are involved. A March 2, 2005 announcement by the manufacturer stated that this trial has been halted. No further information is available at this time.

Another clinical trial of Aimspro was conducted in Oxford in an unknown number of persons with optic neuritis. Results have not been published in a peer-reviewed medical journal.
 
Availability:
This drug is not available to the general public.


 

National Multiple Sclerosis Society -LINK

LINK

LINKThe Food and Drug Administration said Monday it has rejected a petition to remove the cholesterol drug Crestor from the market.

Sidney M. Wolfe, a doctor at the consumer group Public Citizen, had petitioned the agency to remove the drug from the market, citing reports of muscle toxicity and kidney damage. The drug is manufactured by AstraZeneca PLC.

The FDA said in its response that a review of several studies indicate that Crestor doesn't pose a greater risk of muscle damage than other cholesterol drugs, known as statins, on the market. In addition, Steven K. Galson, of the FDA's Center for Drug Evaluation and Research, said the agency found no convincing evidence that the drug poses a risk of serious kidney injury. he agency said, because many patients who take these drugs have diabetes, high blood pressure or heart disease, they already may be at higher risk for kidney failure. Overall, the FDA said it believes the benefits of statin drugs, when used as recommended, outweigh their potential risks.

PharmaLive: LINK"The US Food and Drug Administration has taken the precautionary measure of placing a clinical hold on investigational new drugs in the a4 integrin antagonist class being tested on human subjects, including the GlaxoSmithKline/Tanabe compound SB-683699/T-0047 that is in phase II development for Multiple Sclerosis (MS) and Crohn’s disease. The reason for the clinical hold as cited by the FDA is the uncertainty surrounding the cause of two reports of progressive multifocal leukoencephalopathy (PML) in patients who had been taking Tysabri (natalizumab), an MS biologic agent marketed by Biogen Idec and Elan Pharmaceuticals, in combination with Avonex (Interferon beta 1a) for longer than two years. At this point, there is insufficient information to draw conclusions about the link, if any, between a4 integrin inhibition and the onset of PML."

The New York Times: Published: March 17, 2005"Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said yesterday.The warning was another blow, though probably only a glancing one, to Biogen, which is already reeling from the halt in sales of its other multiple sclerosis drug, Tysabri, which was linked to a rare brain infection.

In a related development, GlaxoSmithKline said yesterday that the F.D.A. had ordered it to halt a trial of its multiple sclerosis drug, which works in a similar way as Tysabri.

A Glaxo spokesman said the company understood that a halt was made as a precaution in trials of all drugs in the same class as Tysabri. A spokeswoman for the F.D.A. said the agency could not comment because of confidentiality about clinical trials.

In a letter that was posted on the F.D.A. Web site, Biogen said that severe liver injury, including liver failure, "has been reported rarely in patients taking Avonex." It said doctors should especially consider the risk when Avonex is used along with other drugs that can cause liver damage, or by patients who drink alcohol.

Amy Ryan, a spokeswoman for Biogen, which is based in Cambridge, Mass., said there had been only a handful of cases among the 130,000 patients using Avonex, which has been on the market since 1996. She said a "minor update" was being made to the drug's label, upgrading liver damage from a "precaution" to a stronger "warning."

It is not uncommon to find new side effects of drugs as they are more widely used. The label of Rebif, a drug very similar to Avonex that is made by Serono, already comes with a warning about liver problems.

Still, with Tysabri off the market at least temporarily, Biogen will become more dependent for growth on Avonex, its biggest product, which had sales of $1.4 billion last year. Its shares fell 88 cents, to $37.19.

Both Ms. Ryan and Kathleen Quinn, a spokeswoman for the F.D.A., said that there was no connection between the Avonex warning and the Tysabri withdrawal, and that the timing was coincidental.

Biogen and Elan, its partner on Tysabri, suspended sales of that drug on Feb. 28 after two patients in clinical trials came down with a rare viral brain infection, progressive multifocal leukoencephalopathy. The two patients, one of whom died, had been taking both Tysabri and Avonex for more than two years in a clinical trial.

Tysabri, which was approved in November, works by stopping certain infection-fighting white blood cells from leaving the bloodstream to enter the brain. That helps stop the cells from attacking nerve cell insulation in people with multiple sclerosis but also might leave them more vulnerable to brain infections, some specialists say.

Glaxo was in Phase 2, the middle stage of testing, of its drug, 683699, which blocks the same protein as Tysabri. The drugs are different chemically and the Glaxo drug was not being tested in combination with Avonex.

Glaxo's drug, being developed with Tanabe Seiyaku of Japan, appears to be the most advanced in trials of drugs that work by blocking that protein, called alpha 4 integrin. Antisense Therapeutics, an Australian company, said last week that it was halting an early Phase 2 trial of its alpha 4 integrin drug, ATL1102, to assess the situation.

Pharmaprojects, a British database that tracks pharmaceutical development, said in a news release yesterday that 12 such drugs were in development, mostly for asthma; 5 are being developed for multiple sclerosis.

Meanwhile, Biogen's chief executive, James C. Mullen, said yesterday that there were "no other indications" of the viral infection beyond the first two patients. In a Webcast presentation at the SG Cowen Health Care Conference in Boston, he said that as time elapsed, "the absence of negative news one can view as positive."

Still, he said, it would take weeks to check the medical records of all the patients in Tysabri trials and to give them new MRI scans and other tests.

He did not say when, or if, he thought the drug could return to the market. But he said that if no more cases arose, the drug might be able to return without extensive new clinical trials. Biogen for now is keeping its sales force intact and continuing to manufacture Tysabri, though at a slower rate than before, he said."

FOXNews.com - linkA new blood test may soon allow doctors to detect multiple sclerosis (search) early with a single test rather than the battery of exams now required to definitively diagnose MS

The New York Times, By MARY DUENWALD, Published: March 15, 2005ysabri had been on the market such a short time that Jane Dentis was able to have only one intravenous treatment. But the drug seemed to diminish her symptoms of multiple sclerosis almost immediately. The persistent sensation of tremors - "like my whole body was shaking on the inside" - disappeared by the time she made the one-hour drive from Omaha to her home in Lincoln, Neb.Ms. Dentis, who is 40 and learned that she had M.S. four years ago, found Tysabri "absolutely miraculous," especially compared with the two other drugs she had tried.

Two weeks ago, Tysabri was pulled off the market, and Ms. Dentis's doctors canceled her second monthly treatment.

The companies that market Tysabri, Biogen Idec and Elan, halted sales and tests of the drug after two patients who had been taking it developed a rare but deadly neurological illness.The two, a man and a woman in their 40's, had been taking Tysabri, along with Avonex, an older multiple sclerosis treatment, for more than two years as part of a clinical trial. Both developed progressive multifocal leukoencephalopathy, or P.M.L., an illness, usually fatal, that impairs nerve function. One has died.

An estimated 5,000 patients who had been taking Tysabri since the Food and Drug Administration approved it in late November are now advised to see their doctors for physical examinations and to consider trying other drug treatments to keep their multiple sclerosis in check or perhaps returning to them.Those who had been in the clinical trial will be given magnetic resonance scans and other tests to check for P.M.L.

The good news, doctors say, is that most patients who took Tysabri alone and only since November are unlikely to develop progressive multifocal leukoencephalopathy.

"If there is any connection between Tysabri and the leukoencephalopathy, that risk should have been removed by stopping the drug," said Dr. Patricia Coyle, director of the multiple sclerosis clinic at the State University of New York at Stony Brook. "Patients don't have to worry that two months or six months from now they're going to come down with P.M.L."

The illness is caused by the JC virus, which is thought to live in 80 percent of people, but it becomes active in only about 1 in 200,000, typically, those whose immune systems are severely impaired by AIDS, for example, or by leukemia or lymphoma. It is not normally connected to multiple sclerosis, and that is why the two cases among some 3,000 people who were involved in clinical trials for Tysabri raised concern. "If you had a single case, you might argue it was a weird fluke," Dr. Coyle said. "But two cases in such a small number of patients to me really suggests some link."

One question is whether Tysabri with Avonex may have posed a special risk. Only about 500 patients had been taking both drugs for more than two years.

"There is a lot of work that now needs to be done to understand what happened and whether it is likely to happen again," said Dr. Nicholas LaRocca, director of health care delivery and policy research with the National Multiple Sclerosis Society. Only when those questions can be answered might Tysabri go back on the market, and that is disappointing not only for those who had been taking the drug, but for many who had planned to start.

"It's a huge setback because this is a drug that looked very, very promising," said Dr. Hillel Panitch, a neurologist at the University of Vermont, who took part in the clinical trials of Tysabri. "It looked like it was far and away the best drug so far, perhaps twice as good as anything else at stopping relapses."

In the early stages of M.S., most patients' symptoms - which include vision loss, loss of coordination, muscle weakness, trouble with memory and concentration and great fatigue - tend to disappear and then return repeatedly, as the body's immune system attacks the myelin coating on nerve cells in the brain and spinal cord. Tysabri is designed to keep recurrences to a minimum and to delay the point when some patients begin to experience a steady loss of function.

Several other drugs for multiple sclerosis have come on the market in the past 12 years. Three of them - Avonex, Betaseron and Rebif - are forms of interferon, which the patient injects into a muscle or below the skin. All can cause flulike side effects, including achy joints, fevers and chills. A fourth drug, Copaxone, which also can be injected, does not cause those problems.

"I know the loss of Tysabri is emotionally a very devastating blow," Dr. Coyle said. "But the good news is, we have other options."

LINK

Every hour of every day, someone is diagnosed with MS.This is why we walk....CLICK HERE TO PRE-REGISTER...& FOR MORE DETAILSLace up your tennis shoes, grab a friend and head outside......           
The MS events are a great way to enjoy the outdoors, spend time with family or friends, and help support a great cause - things anyone can do!  Whatever your reason for participating, you share a common goal with all the participants - to help support the thousands of men, women and children affected by this unpredictable disease!

Join us and hundreds of walkers for great days of fun in Phoenix and Tucson. Click on the link above to find out more!

LINKCONCLUSIONS: Empiric treatments with corticosteroids and/or vestibular suppressants should not be employed until all MS patients undergo a careful bedside examination, which includes diagnostic positional and, if indicated, particle repositioning maneuvers. Here we emphasize the pathophysiology of BPPV and illustrate the proper techniques for the diagnostic and therapeutic maneuvers.

LINK"The general counsel of Biogen Idec resigned abruptly yesterday as questions swirled about his sale of company stock on the same day that Biogen said it found out about serious safety problems with its multiple sclerosis drug, Tysabri."

LINKAmerican Journal of Neuroradiology

"LONG BEFORE I WAS DIAGNOSED WITH MS - I LOST THE VISION IN MY EYE WHENEVER I RAN"....Andrew Kinney


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"5 YEARS WAS HOW LONG IT TOOK FOR ME TO BE DIAGNOSED WITH MS"

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LINKhe makers of the multiple sclerosis drug Tysabri said yesterday that a second patient who used the drug had been confirmed to be suffering from a rare but deadly brain infection. The confirmed diagnosis is likely to somewhat diminish the chances that the drug will be able to return to the market.The brain infection, called progressive multifocal leukoencephalopathy, or P.M.L., is extremely rare, so even one confirmed case raised alarms, officials of the companies have said. The confirmation of a second case is stronger evidence that the disease is linked to the drug.

The two patients were among 500 people in a trial who had received both Tysabri and Avonex, another Biogen multiple sclerosis drug, for more than two years.

Biogen and Elan reiterated yesterday that they had received no reports of P.M.L. in patients who received Tysabri alone. Avonex has been on the market for years and has never been associated with the condition when used alone.

link

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LINK: TYSABRI: "Questions about the accelerated approval program were also raised earlier this week when the multiple sclerosis drug Tysabri was at least temporarily pulled from the market by its manufacturers after two patients developed rare brain infections and one died. Tysabri had been approved only three months earlier under accelerated approval."

'I WOULD LIKE TO AGAIN - THANK CHRIS UITHOVEN, PRESIDENT OF THE NATIONAL MULTIPLE SCLEROSIS SOCIETY, ARIZONA CHAPTER FOR GIVING US THIS BREAKING NEWS

CLICK HERE - and look for the MS Learn Online announcement.

'I WOULD LIKE TO THANK CHRIS UITHOVEN, PRESIDENT OF THE NATIONAL MULTIPLE SCLEROSIS SOCIETY, ARIZONA CHAPTER FOR THE FOLLOWING INFORMATION!" Stan Swartz, Publisher


This afternoon, March 1, 2005, at 5:30 EST, MS Learn Online will present a special webcast about the recent suspension of Tysabri. Presenters include:


        Dr. John Richert, Vice President of the Research and Clinical Programs Department of the National MS Society


        Dr. Aaron Miller, Chief Medical Officer of the National MS Society and Medical Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis in New York City


        Dr. Al Sandrock, Vice President for Medical Research for Biogen IDEC.


We will address common concerns and questions such as:

Why was Tysabri suspended?

What is PML?

Is PML due to Avonex, Tysabri, or the combination of both?


 Is PML related to MS? Should I be tested?


  Are clinical trials being stopped?


  What does the FDA have to say about this?


A written transcript of this webcast will be available on the MS Learn Online site by Thursday, March 3, 2005.


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Click here today at 5:30 p.m. EST to go to webcast. This program will be continuously available on our web site after 5:30 p.m., March 1, 2005.


For more general information about Tysabri, go to the FDA web site at http://www.fda.gov/cder/drug/infopage/
natalizumab/natalizumabQA_2_2005.htm.



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For more information or to access archived programs, please visit MS Learn


Online on our national website, http://www.nationalmssociety.org/.




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"...FDA continues to believe Tysabri offers great hope to MS patients," said Dr. Steven Galson, Acting Director, FDA's Center for Drug Evaluation and Research (CDER)....LINK TO COMPLETE ARTICLE"FDA worked with the company to make sure this information, even though preliminary, was given to physicians and patients as soon as possible and supports their decision to voluntarily suspend marketing as well as the use of the product in clinical trials. At the same time, FDA continues to believe Tysabri offers great hope to MS patients," said Dr. Steven Galson, Acting Director, FDA's Center for Drug Evaluation and Research (CDER). "Patients being treated with Tysabri should contact their physician to discuss appropriate alternative treatments while these reports are being evaluated," added Dr. Galson.