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Saturday, April 19, 2008

Medicare Plans Affected by Rising Drug Costs

Medicare Plans Affected by Rising Drug Costs


Published: April 19, 2008

Employers and patients in corporate health plans are not the only ones affected by the soaring prices of specialty drugs. Enrollees in Medicare drug plans are also feeling the pressure.

Many leading pharmacy benefit managers and drug insurers that oversee employer plans also offer coverage through the Medicare Part D drug insurance program, and so are profiting from federal spending on specialty drugs and from Medicare patients’ own high out-of-pocket co-payments.

Driven in part by specialty drugs, the prices of medicines heavily used by the elderly have risen more than 24 percent since June 2006, two senior health economists at Harvard reported in January in the policy journal Health Affairs.

In that article the economists, Richard G. Frank and Joseph E. Newhouse, said single-source unique drugs have the potential to present “important new pressures on the federal budget.”

>>>>>>> Click here to continue reading


Thursday, April 17, 2008

BEYOND and PRECISE Results Suggest Equivalence for Multiple Sclerosis Treatments

Medscape Medical News


BEYOND and PRECISE Results Suggest Equivalence for Multiple Sclerosis Treatments
By : Susan Jeffrey

April 17, 2008 (Chicago) — Final results of the largest multiple sclerosis (MS) trial to date suggest that, in terms of clinical effects, treatment with both 250- and 500-µg doses of interferon beta-1b (Betaferon/Betaseron, Bayer Healthcare Pharmaceuticals) as well as glatiramer acetate (Copaxone, Teva Pharmaceutical Industries) were essentially equivalent in the risk of relapse in patients with relapsing-remitting MS.

Although there was some indication of reduced T2-lesion volume and number with interferon beta-1b, the researchers note, the long-term significance of this difference is unclear.

In a separate presentation, researchers reported full results of a randomized trial of glatiramer acetate vs placebo to prevent conversion to clinically definite MS in patients with clinically isolated syndromes (CIS). They report that fewer patients converted to clinically definite MS with treatment and those who did took longer to do so.

The full results of these studies, the Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose (BEYOND) and PRECISE trials, were presented here at the American Academy of Neurology 60th Annual Meeting. Top-line results from the studies, both company-sponsored trials, were previously announced by the companies in October and December of 2007, respectively.

BEYOND Trial

The BEYOND trial compared the efficacy of 2 doses of interferon beta-1b, 250 and 500 µg, given subcutaneously every other day, with glatiramer acetate in patients with relapsing-remitting MS. This trial was funded by Bayer Schering Pharma AG, Berlin, Germany.

"The hypothesis was that the double dose of Betaseron would be more efficacious than the single dose, 500 µg better than 250 µg, in terms of efficacy, with comparable safety and tolerability," Paul O'Connor, MD, from the University of Toronto and St. Michael's Hospital, in Ontario, told Medscape Neurology & Neurosurgery. The 250-µg dose is currently approved in this indication.

A secondary hypothesis was to compare interferon beta-1b in these 2 doses with glatiramer acetate in terms of efficacy, safety, and tolerability, he said.

Patients eligible for the trial were relapsing-remitting MS patients with Expanded Disability Status Scale (EDSS) scores of 5.0 or less and 1 or more relapses in the year prior to study entry; all were treatment naive. A total of 2244 patients were randomized in a 2:2:1 ratio to the 500-µg dose (n=899), to the 250-µg dose (n=899), or to glatiramer acetate in a dose of 20 mg daily (n=448), also given subcutaneously for > 104 weeks. The average time of follow-up in the trial was about 2.3 years, Dr. O'Connor noted. Patients were evaluated clinically every 3 months and received a magnetic resonance imaging (MRI) scan every 12 months.

The primary end point was relapse risk. Results for this end point, he said, "showed that the performance of all 3 drugs was the same in terms of recurrent relapses, whether you did an intent-to-treat analysis or a per-protocol analysis."

The annualized relapse rate (ARR), a supportive end point, fell by almost 80% compared with the year prior to study entry, but without any intergroup differences, the authors note.

Other secondary end points, including time to confirmed disability and progression or change in "black-hole" volume on MRI, again showed no differences between groups, Dr. O'Connor added.

Some MRI end points did show differences favoring the interferon beta-1b treatment, he noted. The cumulative number of T2 lesions up to the last scan was greater with glatiramer acetate than with either the 500-µg dose (P = .001) or the 250-µg dose (P = .017) of interferon beta-1b. The relative increase in T2-lesion volume was also larger in patients on glatiramer acetate than in the 500-µg (P = .001) or the 250-µg groups (P < .001).

However, the authors write, the longer-term significance of these changes, "if any," is "unclear."

Dropout rates were highest in the high-dose interferon beta-1b group, at 19%; lowest with the lower dose, at 13%; and intermediate, at 17%, with glatiramer acetate. Adverse events were similar to the known profiles of these drugs — notably, flulike symptoms were more common with interferon beta-1b, and injection-site reactions including pain and pruritus were more common with glatiramer acetate.

Beyond the minor MRI differences and slightly different profile of adverse events, Dr. O'Connor noted, "the major message is really the similarity in behavior on efficacy measures of the 2 drugs.

"What this does is that it allows the patient and the doctor to decide more on the basis of items such as how often do you want to get injected or what matters more to you, a flu-like symptom vs some soreness where you were injected?" he concluded. "In other words, you can choose on the basis of adverse events as differentiating features."

>> Read Complete Story

Wednesday, April 16, 2008

INJECTION SITE Tips for the MS Patient

From About.com

When to Massage Injection Sites
Massaging your injection sites can really help with some of the inflammation caused by the disease-modifying medications for MS. However, timing is crucial and depends on which medication you are injecting.

Read the full article When to Massage Injection sites for People with MS

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Ease the Pain of Injections by Finding a Helper
Maybe you threw your back out last time you tried to reach that "certain spot back there." Maybe you still haven't worked up the nerve to go against your God-given instincts not to stick a needle into your skin. Maybe you just don't feel like doing it yourself. Any of these are good reasons to find someone to give you your injections, either on a temporary or more permanent basis. I've compiled a list of reasons why helpers can be a huge asset to the injecting process, as well as some tips to make sure the relationship between the injector and the injectee is a smooth one.

Read the full article Ease the Pain of Injections by Finding a Helper

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Click here to read other Tips from About.com

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Xanthus' Symadex Reverses Disease in Preclinical Mouse Models of Multiple Sclerosis

Centre Daily.com
Wednesday, Apr. 16, 2008

Results Presented at the 60th American Academy of Neurology Annual Meeting -

Xanthus Pharmaceuticals, Inc. presented data demonstrating that Symadex(TM), a selective FLT3 inhibitor, acted to reverse disease in mouse models of both acute and chronic multiple sclerosis. Biomarkers of macrophage and dendritic cells showed a significant correction back towards the baseline levels found in healthy control animals. The results were presented in a poster session by Stephen J. Karlik, Ph.D., Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus at the 60th American Academy of Neurology Meeting in Chicago, IL.

Using the experimental autoimmune encephalomyelitis (EAE) model, the effect of Symadex was evaluated during both the acute and chronic phases of EAE in the mouse models. A partial, concentration-dependant decrease in clinical signs was observed in the acute prevention experiment, and chronic treatment resulted in a dose-dependent reduction of clinical scores. Plasma titers in a combined treatment group versus disease controls showed significant changes with a trend towards restoring baseline levels of biomarkers found in naive controls. Symadex has previously shown therapeutic benefit in both the acute and chronic stages of the guinea pig EAE model as well as a similar effect on innate cell biomarkers.

"This study adds to the growing body of work supporting the ability of Symadex to potentially prevent and reverse chronic disease in animal models of multiple sclerosis," said Dr. Karlik. "The evidence that Symadex targets innate immune cell function in the treatment of MS is encouraging and is a foundation for the Company's continued work on Symadex in autoimmune models."

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. Xanthus is exploring the use of Symadex and follow-on compounds for the treatment of a number of autoimmune diseases, such as multiple sclerosis and inflammatory bowel disease. Early preclinical data has shown encouraging signs of activity in models of autoimmune disease. Given the compound's safety profile and oral availability, Xanthus believes Symadex represents an exciting drug opportunity.

About Xanthus Pharmaceuticals, Inc.

Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule therapeutic 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 to advance its current pipeline to address significant unmet medical need in oncology and autoimmune diseases.

Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at 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.

MacDougall Biomedical Communications, Inc. Kari Watson, 781-235-3060 kwatson@macbiocom.com or Xanthus Pharmaceuticals, Inc. Lisa Terry, 617-225-0522, x 105 lisa.terry@xanthus.com

Tuesday, April 15, 2008

First oral drug could benefit many with the autoimmune disease, -Multiple Sclerosis

Info provided by Eddie Abboud in Miami

Pill Reduces Relapses in MS Patients

First oral drug could benefit many with the autoimmune disease, researchers say

By Steven Reinberg, HealthDay Reporter
First oral drug could benefit many with the autoimmune disease, researchers say.

TUESDAY, April 15 (HealthDay News) -- The first pill designed to reduce the number of attacks in people with multiple sclerosis appears to be effective in early tests, Italian researchers report.

The pill was effective in preventing relapses in more than 60 percent of patients who took the pill for three years, according to research that was expected to be presented April 15 the American Academy of Neurology annual meeting, in Chicago.

"All of the current treatments for MS must be injected, so having a pill you can swallow with a glass of water would be a welcome improvement for many people," lead researcher Dr. Giancarlo Comi, from Vita-Salute San Raffaele University in Milan, said in a prepared statement.

In the study, Comi's team treated 281 people with relapsing MS with FTY720 (fingolimod) or a placebo. After six months, two-thirds of the patients who received FTY720 had more than 50 percent fewer relapses, compared with those receiving placebo.

During the three years of the trial, more than 67 percent of the 173 people receiving FTY720 were free of relapses. In addition, 89 percent of the patients were free of disease activity and 75 percent did not develop new lesions or see their lesions enlarge. This was confirmed by MRI scans, the researchers stated.

"The first-line treatments for MS, beta interferon and glatiramer acetate, reduce the relapse rate by only about 30 percent, so this is a significant development for people with MS," Comi said in a statement.

The most commonly reported side effects of FTY720 were headache, flu and cold symptoms.

The drug works by binding to receptors on immune cells, isolating them in the lymph nodes, thereby reducing their ability to cause the damage associated with MS symptoms.

The study was paid for by Novartis Pharma AG, maker of FTY720.

One expert thinks this preliminary data is encouraging, but a lot more needs to be done to prove the drug's effectiveness.

"This is a new drug that has a very strong scientific rationale why it could work," said Dr. John Richert, executive vice president of the National Multiple Sclerosis Society. "Certainly, everything we've seen so far continues to keep us optimistic."

Richert noted that over three years, 77 patients receiving the drug dropped out of the study. "You're left wondering if a more severe adverse event led to the dropouts," he said.

The six-month data where the drug was tested against placebo looks promising, Richert said. "If this turns out to be a safe oral drug that has substantial benefit, that will be very important for many people with MS," he added.

More information

For more on MS, visit the National Multiple Sclerosis Society.

content by:
Healthday
SOURCES: John Richert, M.D., executive vice president, National Multiple Sclerosis Society, New York City; April 15, 2008, presentation, American Academy of Neurology annual meeting, Chicago

Good News for the MAESTRO-03 - pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS

Yahoo Finance

Press Release:

BioMS Medical's phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board
Tuesday April 15, 8:00 am ET


Toronto Stock Exchange Symbol: MS

EDMONTON, April 15 /PRNewswire-FirstCall/ - BioMS Medical Corp. , a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company's on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue.

This was the second of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

To date, more than 65% of the total number of required patients have been enrolled in the Company's MAESTRO-03 clinical trial, with full enrollment anticipated for the end of the first half of 2008.

About MAESTRO-03

----------------

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

About BioMS Medical Corp.

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298 in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.

This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that MBP8298 will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.



Source: BioMS Medical Corp.

Rituxan Medicine for Multiple Sclerosis Fails to Slow MS (Update2)

Bloomberg News

By Luke Timmerman

April 15 (Bloomberg) -- Genentech Inc. and Biogen Idec Inc.'s cancer drug Rituxan failed to slow the disabling effects of the most difficult-to-treat form of multiple sclerosis in a large clinical trial.

Rituxan didn't reach its main goal of slowing disability for people with primary progressive multiple sclerosis after almost two years of treatment, compared with a placebo, the companies said in a statement. If the trial had succeeded, it would have made Rituxan the first drug to work against the primary progressive form of MS, or PPMS.

Rituxan, a blood-cancer drug that's also approved for rheumatoid arthritis, generated $2.29 billion in U.S. sales in 2007. It is designed to work by killing inflammatory B cells, a different approach than approved MS drugs. About 400,000 people in the U.S. have MS, and one in 10 have the primary progressive form that gradually damages nerve fibers over time without remissions, according to the National MS Society.

``While the primary results are not what we had hoped, we continue to believe in the potential of B cell therapy for patients living with MS,'' said Michael Panzara, Biogen's vice president and chief medical officer of its neurology strategic business unit.

Genentech, majority-owned by Switzerland's Roche Holding AG, fell 71 cents to $73.98 at 10:16 a.m. on the New York Stock Exchange. Cambridge, Massachusetts-based Biogen, a co-promoter of the drug, rose 35 cents to $64.07 on the Nasdaq Stock Market.

Revenue Opportunity

``This would have presented a revenue opportunity of more than 500 million Swiss francs for Roche but was not included in our model or consensus estimates,'' Deutsche Bank analysts including Michael Leuchten said in a note to investors today. ``PPMS is a tough part of MS to treat and nothing has worked in this setting so far.''

Multiple sclerosis is diagnosed when the body's immune system goes awry and begins attacking the fatty insulating tissue around nerve fibers, called myelin, according to the National MS Society.

The Rituxan trial, called Olympus, followed 439 patients for two years after they took an infusion of Rituxan or a placebo. Patients took a repeat course of Rituxan every six months, said Craig Smith, neurology lead clinical scientist in the immunology department at Genentech, in a telephone interview before the announcement.

Side Effects

Patients were monitored for the status of their disability, to see, for example, whether they were losing their ability to walk, see clearly, or maintain strength in their arms, Smith said. A secondary goal of the study looked at whether the drug reduced brain lesions.

More patients had serious side effects on Rituxan than on placebo, Genentech and Biogen said. The rate of serious side effects was about 16.4 percent in the Rituxan group, compared with 13.6 percent on placebo. About 4.5 percent of Rituxan patients had serious infections, compared with 1 percent on placebo. There was some evidence that the drug was working biologically, although the companies didn't specify how much in the statement.

Genentech and Biogen plan to continue analyzing the results and submit them at a future medical meeting, the companies said.

Double Vision

People in the trial were about 48 years old on average, and had been diagnosed with primary progressive MS four to 10 years before enrolling in the study, Smith said. They entered the study with an average disability score of 4 on a scale of 1 to 10, meaning they lacked some coordination, or had some double vision or weakness, although were still able to walk without assistance, he said.

Previously, Rituxan was studied for patients with the most common form of MS, the relapsing, remitting form. That study, called Hermes, found that one in five patients on Rituxan relapsed, while twice as many on placebo had a recurrence in a 48-week clinical trial, according to research published in February in the New England Journal of Medicine.

Existing drugs, including Biogen's Avonex, Bayer AG's Betaseron, Merck KGaA's Rebif and Teva Pharmaceutical Industries Ltd.'s Copaxone, work differently than Rituxan by blunting the attack of immune system T cells. None of the drugs have shown a benefit for patients with the primary progressive form of the disease, Smith said.

Next Steps

The market for MS drugs exceeded $5.5 billion in 2006 and is expected to double by 2013, according to market-research firm Frost & Sullivan in New York. Rituxan costs $20,514 a year for two infusions for patients with rheumatoid arthritis, said Genentech spokeswoman Nikki Levy.

``Right now we are reviewing all the data from Olympus and determining next steps regarding our development program,'' Levy said yesterday in an e-mail.

The company still plans a mid-stage clinical trial of ocrelizumab, a second-generation drug that blocks the same protein on B cells as Rituxan. The newer drug will be studied against the relapsing, remitting form of MS, Levy said.

To contact the reporters on this story: Luke Timmerman in San Francisco at ltimmerman@bloomberg.net

Last Updated: April 15, 2008 10:25 EDT


An MS Story - POST HIATUS ( 3rd story in this series)

Submitted by: Stuart Schlossman
April 15, 2008


This (new) "Post Hiatus Story" now follows the Original
My Hiatus - the pros and cons and The Follow-up (2nd Story)

It now being 3 weeks since recommencing my medication, I want to again reinforce the importance of remaining on your DMD (Disease Modifying Drug). This mention, is not just for those doing MS medication but can also be told (and should be told) to anybody doing any medication for any disease, where-in a prescribed drug was designed to lessen the progression.


So now, let's go back to me and what is happening since re-starting my MS Medication.
Well the first two weeks didn't really show that I was getting better. But now, (3) weeks-in,
you can see and hear how I am beginning to climb back from the downward slope that happened from NOT doing my MS medication.

My humor levels have reclaimed the negativity. I again have the ability to get back into the public: going to stores, visiting friends and family. I am again able to look at my checkbook and decipher what the numbers (dollars and cents) indicate. My head (and brain) are not spinning nearly as much as 3 and 4 weeks ago. My right arm and leg are moving more freely and my vision is not as nearly blurred or seeing double as they had become.

Yes, all of the above negatives, came-about, when that BLAM effect hit me. To know what the BLAM is, you need to read (or re-read), "My Hiatus" .

I am far from feeling as good as I was in January. I am still experiencing bouts of vertigo, but now this is more just like nausea or feeling off-kiltered. I still have some problems with my hands (especially while typing). Could you imagine, me not being able to type?
My right leg remains feeling stiff. Headaches are still abundant, but much less clustered than before. Fatigue continues to be a factor each early afternoon and with the fatigue, comes the cognitive dysfunction.


Although I know that I was exacerbating just a few weeks ago, I opted to not push the issue to be put on Steroids. This may have been another bad choice, but after months of trying to lose weight, I didn't want to now be gaining weight.

Instead, I opted to get lots of rest and to ritually take my medication as needed.

Each of my stories concerning this error in judgement, needs to be circulated throughout the MS Community(ies) as we need to make sure that under no circumstance are you (or should you), stop doing your medication without the knowledge and guidance of your Medical Doctor.
Last year, it was reported that for those who stopped doing Tysabri, that they would experience an increase in disease activity.

After reading my essays (of what I have gone thru), I hope that you now realize that this same negative-effect (an increase of disease activity) can happen, regardless of the name of the medication that you are using.

Again I am on the correct path and I only hope that thousands of 'others' will be educated by what I wrote

You have my permission to pass along this vital information.



Sincerely,

Stuart Schlossman

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Monday, April 14, 2008

Simple Screening tool for Alzheimer's and using alligator blood?

NON-MS Related - Medical Updates:

Alligator Blood Could Be New Antibiotic For Superbugs
09 Apr 2008


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The Cost for MS Medications May Soon Begin to Skyrocket

Co-Payments for Expensive Drugs Soar

Published: April 14, 2008

Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases.


With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month.

The system means that the burden of expensive health care can now affect insured people, too.

No one knows how many patients are affected, but hundreds of drugs are priced this new way. They are used to treat diseases that may be fairly common, including multiple sclerosis, rheumatoid arthritis, hemophilia, hepatitis C and some cancers. There are no cheaper equivalents for these drugs, so patients are forced to pay the price or do without.

Click here to read complete article



Sunday, April 13, 2008

New Conference For Healthcare Professionals Addresses The Complexities Of Multiple Sclerosis

Article Date: 11 Apr 2008 - 3:00 PDT

A nationally recognized faculty will present their latest multiple sclerosis related research findings and treatment protocols to medical professionals at the first annual MS 2008: Maximizing Care Strategies. Scheduled for May 3 at the Hyatt Regency Phoenix, the objectives of this multi-disciplinary conference are to expand the professionals' knowledge of MS and enhance their practice skills.

The National MS Society, Arizona Chapter and Banner Health have partnered to offer this one-day program to neurologists, physicians, gynecologists, ophthalmologists, nurses, occupational therapists, physical therapists, social workers, speech language pathologists and other medical professionals. Attendees will receive continuing medical education or continuing education units at the conference.

"We have found, through our professional relationships with MS clinics, that the most effective plan of quality health care delivery is to promote a comprehensive care model incorporating networks of multidisciplinary providers," said Philip Carll, Program Director with the Arizona Chapter.

Topics to be presented include:

- MS Research Update: T cells, B cells and Emerging Treatment Options
- MS Genetics: What Have We Learned After 50 Years of Study?
- Relationship Busters: A Psychosocial Perspective on MS and Families
- Neuromyelitis Optica
- Sex is not Just a Three Letter Word
- Assessment and Treatment of Cognitive Difficulties with MS
- MS and the World of Work: Key Employment Concerns and Strategies
- Going 'Green': The Global Picture of Energy Conservation in Gait
- Cultural Diversity Matters: A Mind, Body, Spirit Approach
- Who Me? Conflicts of Interest in MS Research

There is a $95 registration fee for allied health, and a $150 registration fee for physicians. Registration is available online at http://nationalMSsociety.org/MS2008 or by phone at 1-800-344-4867, option 2.

About Multiple Sclerosis

Multiple sclerosis interrupts the flow of information between the brain and the body and it stops people from moving. Every hour in the United States, someone is newly diagnosed with MS, an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with more than twice as many women as men being diagnosed with the disease. MS affects more than 400,000 people in the U.S., and 2.5 million worldwide.

About the National Multiple Sclerosis Society

MS stops people from moving. The National MS Society exists to make sure it doesn't. We help each person address the challenges of living with MS. In 2006 alone, through our home office and 50 state network of chapters, we devoted nearly $126 million to programs that enhanced more than one million lives to move us closer to a world free of MS. The Society also invested more than $46 million to support 380 research projects around the world. We are people who want to do something about MS NOW.

National Multiple Sclerosis Society

E2007 a New Oral Drug, in Study for Parkinson's, Multiple Sclerosis and other

In Medical News Today


Status Of The E2007 (perampanel) Development Program

E2007 (perampanel) is a first-in-class, orally administered, highly selective non-competitive AMPA-type glutamate receptor antagonist, in development by Eisai for several indications, including Parkinson's disease, neuropathic pain, epilepsy, multiple sclerosis and migraine prophylaxis.

The AMPA receptor is widely present in almost all excitatory neuronal synapses. It is believed to play a role in a large number of central nervous system (CNS) diseases with different underlying pathophysiology, including neurodegenerative disorders, movement disorders, pain and psychiatric disorders. Eisai has been pursuing development of perampanel for several CNS indications, some of which are currently in Phase II and Phase III. The most advanced indication is Parkinson's disease for which Eisai has been conducting three global Phase III studies (Studies 301, 302 and 309) with perampanel as add-on therapy to levodopa in patients with late-stage disease. Additionally, Eisai is preparing for global Phase III studies for epilepsy and conducting two Phase II studies for neuropathic pain.

Following the completion of the first Phase III Study 301, we recently completed the second Phase III Study 302, which was primarily conducted in North America. Study 302 is a 20-week, double-blind, placebo-controlled study comparing two doses of 2mg and 4mg of perampanel to placebo. The results, compared with placebo, did not show a significant difference in the primary endpoint of reduction of "off" time (time when signs and symptoms of Parkinson's disease return as the effect of levodopa wears off). Perampanel was generally well tolerated. After analyzing the data, Eisai has decided to discontinue the Parkinson's disease program and not pursue regulatory submissions for this indication. Eisai will focus resources on two other ongoing indications, epilepsy and neuropathic pain, both of which have different pathophysiology from that of Parkinson's disease and robust scientific rationale.

Following the decision to terminate the Parkinson's disease indication, Eisai has also decided to terminate the third Parkinson's disease Phase III study (Study 309) and open label treatment extension studies. Perampanel was generally well tolerated throughout the program in this mostly elderly population. The decision to terminate the Parkinson's disease program is due to lack of efficacy over placebo seen in the recently completed two Phase III studies only, and is not predictive of activity in the other indications including epilepsy and neuropathic pain.

In preclinical models in Parkinson's disease, perampanel improved the effect of levodopa, and a Phase II study suggested that perampanel improved benefits with increasing doses. Responding to unmet medical need, Eisai pursued development of perampanel in Parkinson's disease as a first-in-class oral AMPA antagonist with a non-dopaminergic mechanism, which is different from that of existing drugs. The reason for the lack of statistical significance in effectiveness observed in the two completed Phase III studies for Parkinson's disease is being investigated carefully, but because the mechanism of perampanel is different from that of dopaminergic drugs such as levodopa and dopamine agonists, in-depth review will be necessary.

The pharmacological rationale for perampanel in Parkinson's disease is the therapeutic augmentation of levodopa. However in neuropathic pain and epilepsy, the rationale is to direct parampanel's demonstrated activity as an AMPA receptor antagonist toward inhibition of the neuronal excitability and sensitization caused by glutamate.

Testing in various established animal models has suggested that perampanel has a potential antiepileptic effect. The five animal seizure models tested (maximal electroshock, 6Hz psychomotor, pentylenetetrazole, audiogenic and kindling seizure models) suggested that perampanel may be effective in treating epilepsy. Three Phase II studies (Study 203, 206 and 208), which include doses to be used in Phase III, suggest that perampanel is generally well tolerated with a dose-dependent efficacy in patients with refractory partial seizures.

The most recently completed Phase II Study 208 evaluated maximum tolerated dose (MTD) and safety of perampanel as adjunctive therapy in subjects with refractory partial seizures. This was a 16-week, placebo-controlled, dose- escalation (to a maximum of 12 mg/day), parallel-group study conducted in Europe. Perampanel showed an increasing trend in activity up to 12 mg/day in epilepsy patients with refractory partial seizures. There was a 40% median seizure reduction in the perampanel arm and a 2% median seizure increase in the placebo arm. The responder rate, defined as a proportion of patients with more than 50% seizure reduction, was 40% in the perampanel arm and 22% in the placebo arm.

Eisai is preparing to initiate global Phase III studies with perampanel as add-on therapy in patients with refractory partial seizures in the first quarter of fiscal year 2008. The regulatory submission is planned for fiscal year 2012.

Several pre-clinical models have also suggested that perampanel may be effective in treating neuropathic pain. The Phase II POC Study 227 in painful diabetic neuropathy (PDN) completed enrollment in March and is expected to provide top-line results in September 2008. A Phase III program will start soon afterwards, with regulatory submission for an indication in PDN planned in fiscal year 2010. A Phase II study in a second neuropathic pain indication, post-herpetic neuralgia (PHN), was initiated in January 2008.

Both the Phase III programs in neuropathic pain and in epilepsy plan to investigate a wider range of doses up to 12mg.

Perampanel has been generally well tolerated, as confirmed in the clinical dataset of over 2,300 patients.

Eisai remains strongly committed to the further development of perampanel, as it has the potential to be a well tolerated first-in-class drug for neuropathic pain, epilepsy, and possibly other CNS diseases, with a well differentiated profile of value, for the benefit of many patients and their families.

Terminology

(1) Dopaminergic Drug

Dopaminergic drugs such as levodopa and dopamine agonists act directly at dopaminergic receptors, or improve the efficacy of dopamine by regulating its mechanism.

(2) Non-dopaminergic Drug

Drugs that show efficacy by a mechanism other than direct effects on the dopamine receptor or dopamine metabolism. They include the current Parkinson's disease treatments such as anti-cholinergic agents, NMDA inhibitors, etc.

Eisai is a Human Health Care Corporation striving for innovative solutions in prevention, cure and care for the health and well-being of people worldwide. We combine our talents to understand and meet the needs of patients and their families to enhance the quality of life.

Eisai Co., Ltd.
http://www.eisai.co.jp

Potential Treatment For Multiple Sclerosis Begins Clinical Trials

A potential treatment for multiple sclerosis (MS), developed by University of Greenwich in association with Kings College, London, has begun clinical trials.

The life sciences company BTG plc, which has licensed the research, is running the trials on a new compound, known as BGC20-0134.

Dr Laurence Harbige and Dr Mike Leach, from the Biomedical & Drug Discovery Research Group in the University of Greenwich School of Science, developed the new treatment following many years of research.

Dr Laurence Harbige explains: "Although the cause of multiple sclerosis is unknown, there is strong evidence that it involves the regulation of the immune system through molecules in our bodies called cytokines. In MS, the balance of these cytokines is altered, leading to inflammation in the brain which can result in serious disability."

Dr Mike Leach adds: "This new treatment should encourage the immune system to rebalance itself, by inhibiting the production of inflammatory cytokines while promoting the production of helpful anti-inflammatory ones."

These initial trials, in volunteers, will look at how the new treatment works in the body and whether it leads to an increase in the helpful cytokines. A pilot study of a prototype treatment developed by the University of Greenwich team, which is related to this compound, has already shown promising results. It demonstrated clinical benefits in patients with a common form of multiple sclerosis, called relapsing-remitting. It led to decreases in relapse rates, disability and pain, along with improvements in quality of life. Preclinical research on the new compound, BGC20-0134, indicates that it may be three times as potent as this prototype.

Professor Tom Barnes, Pro Vice-Chancellor for Research & Enterprise at the University of Greenwich, congratulates the team behind the discovery: "It is very good news that this research is now in clinical trials. Our university aims to carry out work which is useful to society and this discovery is a classic example of that. It highlights the excellence of the research staff at Greenwich and also the business orientation of the university, through this partnership with BTG plc. Drs Harbige and Leach are to be congratulated on this important milestone."

Louise Makin, BTG's Chief Executive Officer, comments: "The effective treatment of multiple sclerosis remains a significant unmet need. We are pleased to have started clinical development of BGC20-0134, which has the potential to address different forms of the disease and has the advantage of being an oral product."

GREENWICH UNIVERSITY
Old Royal Naval College
Park Row, Greenwich
London
SE10 9LS
http://www.gre.ac.uk

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info submitted by: Stuart Schlossman