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Через несколко лет появится лекарсто от РС и вылечат всех! и детей Обамы тоже! (Если вдруг они заболеют!). Да...

View printer-friendly version << Back Acorda Therapeutics Announces Interim Analysis of Two-Year Efficacy and Safety Data from Phase 3 Fampridine-SR Extension Study Retention Rate in the Open-Label Study was 82.9% After One Year and 75% After Two Years Sustained Walking Speed Improvement Seen After Two Years in Responder Group HAWTHORNE, N.Y.--(BUSINESS WIRE)--Sep. 10, 2009-- Data from a long-term open-label extension study from the first Phase 3 Fampridine-SR trial, known as MS-F203, showed that 24.9% of extension study participants with multiple sclerosis (MS) met the criteria as Extension Timed Walk Responders (ETWRs) after one year of treatment and demonstrated improved walking speed over a two year period. In addition, the safety profile of Fampridine-SR observed over two years in this study was consistent with previous placebo-controlled trials. The data were presented today at the 25th Congress of the European Committee for Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany. “Long-term data for Fampridine-SR are important because this medicine is potentially a chronic therapy for people with multiple sclerosis,” said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester, who presented the data. “The data suggest that Fampridine-SR can produce a sustained, clinically meaningful improvement in walking speed for a subset of people with MS over a two year period.” Trial Design In the 14-week placebo-controlled portion of the MS-F203 study, 34.8% of subjects were defined as Timed Walk Responders in the Fampridine-SR group compared to 8.3% of subjects in the Placebo group. Following the placebo-controlled study, 269 of the 283 participants who completed the study, including those defined as Timed Walk Responders, Non-Responders and participants from the Placebo group, enrolled in the open-label extension study. All participants in the extension study were treated with Fampridine-SR at 10 mg twice daily, and assessed in the clinic at 2, 14, 26, 52, 78 and 104 weeks. Timed walk response in the extension study was defined as walking faster in the majority of the first four open-label visits (2, 14, 26 and 52 weeks) compared to the fastest off-treatment speed, which was measured at seven separate time points during the placebo-controlled trial and at screening for the extension study. Walking speed was measured using the Timed 25-Foot Walk (T25FW). As of the cut-off date for this analysis (November 30, 2008), participants had been treated with Fampridine-SR for up to 3 years, with an average exposure of 2.1 years and a total exposure of 565 patient-years. More than half of the study participants were diagnosed with secondary-progressive MS (52.8%), with the remainder of diagnosed with relapsing-remitting MS (28.6%), primary-progressive MS (14.9%) or progressive relapsing MS (3.7%). Safety and Efficacy Results A total of 187 of the 269 (69.7%) subjects who enrolled in the extension trial were still enrolled at the time of the analysis, with an average exposure of 2.1 years. There were 82 discontinuations (30.5%), 29 of which were due to adverse events (10.8%). The most commonly reported adverse events in the study were: urinary tract infection (34.6%), MS relapse (31.2%), fall (29.7%), arthralgia (16.4%) and asthenia (16.0%). Over two years of treatment, 63 study participants (23.4%) experienced at least one serious adverse event. The most frequent serious adverse events were; MS relapse (4.1%), cellulitis (1.9%) and convulsion (1.1%). There were four seizure-related events reported in the MS-F203 extension trial, including one complex partial seizure and three patients with convulsion. The incidence of seizure at 10 mg twice daily dose from a pooled analysis of all three ongoing extension studies of Fampridine-SR was 0.41 per 100 patient-years. The expected incidence of first seizure in the general MS population is approximately 0.35 (± 0.15) per 100 patient-years1. A total of 66 of 269 (24.9%) study participants were Extension Timed Walk Responders (ETWRs) after one year of treatment with Fampridine-SR 10 mg twice daily. ETWRs showed a mean improvement of >30% in walking speed visit after 12 months of treatment and 22% improvement at 24 months compared to their baseline speed (the average speed of their first four off-drug visits during the placebo-controlled study). Extension Timed Walk Non-Responders showed a decline in mean walking speed of 8% over 24 months. There were also statistically significant improvements in patient and clinician global impression scales for ETWRs compared to Non-Responders (p<0.005). Among participants previously defined as Timed Walk Responders in the placebo-controlled trial, 42.9% met the criteria for ETWRs after one year in the extension study. In addition, 19.7% of participants defined as Timed Walk Non-Responders in the placebo-controlled trial met the criteria as ETWRs and 16.2% of subjects receiving placebo in the placebo-controlled trial met the criteria for ETWRs. All study participants were evaluated for overall disability using the Expanded Disability Status Scale (EDSS) at the beginning of the placebo-controlled trial, and then reassessed after two years in the extension study. The mean EDSS score at baseline was 5.76, representing significant disability. After two years in the extension study, the change from EDSS baseline in ETWRs was -0.1 compared to +0.4 in non-responders (p=0.018). Increases in EDSS scores indicate a worsening of disability. About Fampridine-SR Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed and commercialized by Acorda Therapeutics in the United States. A New Drug Application (NDA) for Fampridine-SR has been filed and assigned priority review by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009; the PDUFA date is the target date for FDA to complete its review of Fampridine-SR. In markets outside of the United States, Fampridine-SR will be developed and commercialized by Biogen Idec under a license from Acorda Therapeutics. Biogen Idec expects to file for approval by the European Medicines Agency (EMEA) in early 2010. About Acorda Therapeutics Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex Capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release. Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex Capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release. 1 Eriksson M, et al. Mult Scler. 2002;8:495-499. Source: Acorda Therapeutics Acorda Therapeutics Jeff Macdonald, 914-347-4300 ext. 232 jmacdonald@acorda.com

Эх. нравится мне Покров! Хороший городок!

Ну вот! англичане тоже одобрили Тайсабри! они-то на всем привывыкли экономить!

Национальный институт здоровья Великобритании рекомендовал применение препарата Tysabri при тяжелых формах рассеянного склероза Ирландская биотехнологическая компания Elan (ELN) сообщила во вторник, что Национальный институт здоровья и качества медицинской помощи, NIHCE, Великобритании рекомендовал применение лекарственного препарата Tysabri при лечении тяжелых рецидивно-ремиттирующих форм рассеянного склероза. Расходы на лечение этим препаратом будут возмещаться из бюджетных средств. По мнению экспертов NICE, несмотря на высокую стоимость, Tysabri позволяет в целом сократить расходы на лечение больных с рассеянным склерозом. “Tysabri стал первым в истории препаратом для лечения рассеянного склероза, применение которого было рекомендовано NICE и является важным шагом вперед в лечении пациентов, страдающих рассеянным склерозом”, - говорится в специальном сообщении, опубликованном компанией Elan во вторник. Tysabri был разработан Elan совместно с американской биотехнологической компанией Biogen (BIIB). По итогам I квартала 2007 года объем продаж этого препарата составил $30 млн.

Юлек, мне, например, псхиоапия, к сожалению, не помогает!

Это означает,что никто не аинтересован в том, чтоы мы выздоровли! -печально...

На каком месте будет Россия? Как вы думете? От кого это зависит? Кого надо тихо благодарить за то, что у нас нет этого препарата?

25 мая 2009 просмотров: 55 По результатам постмаркетингового исследования, риск развития прогрессирующей мультифокальной лейкоэнцефалопатии (ПМЛ) у больных рассеянным склерозом, получавших терапию натализумабом (Тисабри) оказался значительно ниже, чем предполагалось ранее. По данным контролируемых исследований риск развития ПМЛ у больных, получавших терапию Тисабри, оценивался на уровне 1 случай на 1000 пролеченных больных. Согласно новым данным, представленным на Конгрессе Американской Академии Неврологии, риск развития ПМЛ составляет 1.2 случая на 10000 пациентов, получавших данную терапию. В настоящее время натализумаб разрешен более чем в 40 странах (США, Канада, Австралия, страны Европейского Союза, многие страны Латинской Америки, Израиль) для лечения рассеянного склероза у пациентов с недостаточной эффективностью других препаратов. В Соединенных Штатах препарат разрешен также для лечения болезни Крона. По данным на конец марта 2009 года терапию Тисабри уже получили более 52 тысяч пациентов во всем мире. Из них 24900 пациентов получали препарат более 12 месяце, 14400 – более 18 месяцев и 6800 – более двух лет. Источник: rscleros.ru

http://www.mssociety.org.uk/news_events/index.html 14 Aug 2009 The government announced yesterday that a vaccine for swine flu is expected to be ready in the autumn. People with MS and their families are among the priority groups for vaccination. People with MS are due to receive the vaccine as a first priority, alongside other groups normally at risk for seasonal flu. Pregnant women are in a second priority group and people who live with somebody in the first priority group (including people who live with a person with MS) are classified as being third in the priority rankings.

Пусть цвтут все цвты!

Говорите Вы все правильно! Просто тобы человек на Вас рботал, у Вас дожно быть нечто выдающееся, например положение в общеастве или ораторский талант или много денег!

Интресно, а олько процентов людей с РС способны открыть "свое дело"? У меня таких знакомх нет! Вот люди с БАС - сплошь прирожденные Хозяева!

Это важно только для бюрократов!

Ну некоторе болезни победили!

Свет- понимаю! Надо пытаться объяснить всем, от кого зависит выход этого лекрства , что оно прошло все неообходиые исследования.

Валерий! Нельзя же не доверять всем! Американцы - таие же люди и они так же хотят быть здоровыми! 22 октября 2009 в США появится это лекарство.

Сережа - полностью согласен! Только людям - больным РС нужно это лекарство! Все остальные с интересом (или без интереса) наблюдают! (со стороны).

Идея очень хорошая! Готов принять участие!

Для некоторых людей эта информация очень даже важнна!- как говорил один небезизвестный персонаж "трясти надо!". Ели это лекарсто не появится одновремено в России это будет означать одно - геноцид! по отношению к людям, больным РС!

22 октября 2009 в США появися это лекарство. Acorda Therapeutics Announces Positive Data from Second Phase 3 Study of Fampridine-SR on Walking Ability in People with Multiple Sclerosis Company Plans to File New Drug Application (NDA) in First Quarter of 2009 Investor Conference Call and Webcast Today at 8:30 A.M. ET HAWTHORNE, N.Y.--(BUSINESS WIRE)--June 2, 2008--Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced positive results from its second Phase 3 clinical trial of Fampridine-SR (MS-F204) on walking ability in people with multiple sclerosis (MS). A significantly greater proportion of people taking Fampridine-SR in the trial had a consistent improvement in walking speed compared to people taking placebo (42.9% vs. 9.3%), as measured by the Timed 25-Foot Walk (p less than 0.001). Consistent improvement in walking speed was the primary endpoint of the study as outlined in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). "With the success of this trial, we have achieved a critical milestone for Fampridine-SR. We have now completed two successful Phase 3 trials demonstrating improved walking ability in people with MS," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "We believe that, subject to FDA review, the results of our two Phase 3 trials are adequate to support an NDA. We expect to submit this application in the first quarter of 2009 and plan to request priority review." The study's only prospectively defined secondary outcome measure, leg strength, showed a statistically significant increase in the Fampridine-SR Timed Walk responders compared to placebo (p = 0.028). There was a small improvement in leg strength for Fampridine-SR Timed Walk non-responders compared to placebo that was not statistically significant. Additional measures in this study were consistent with the results of the first Phase 3 Fampridine-SR trial. The average increase in walking speed over eight weeks of treatment compared to baseline was 24.7 percent for the Fampridine-SR Timed Walk responders compared to 7.7 percent for the placebo group. The 12-Item Walking Scale (MSWS-12), a self-rated assessment of walking disability, was improved in Timed Walk responders compared to non-responders. Also, an increased response rate on the Timed 25-Foot Walk was seen across all four types of MS. The Company intends to present comprehensive data from this trial at an upcoming medical meeting. "Difficulties with walking are among the most pervasive and debilitating problems faced by people with MS. Walking disability affects their ability to accomplish daily tasks and limits their independence," said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester. "Because there are currently no therapies indicated to improve walking impairment in MS, clinicians are limited in their ability to address this aspect of the disease. The results of this study indicate that Fampridine-SR could represent an important new way to treat people with MS." Study Design The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The primary endpoint of the study was response on the Timed 25-Foot Walk. A Fampridine-SR Timed Walk responder was defined as a study participant whose walking speed was faster at a majority of the four on-drug visits than any speed measured during the five off-drug visits. The trial, which enrolled 240 individuals at 39 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. Subjects were randomized to treatment with Fampridine-SR (n=120), at a dose of 10mg twice a day, or placebo (n=119), and the study was open to people with all four major types of MS: primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including immunomodulators. Safety Statement In this study, adverse events were generally mild to moderate and largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS. The most common adverse events reported in the Fampridine-SR treatment group compared to the placebo group included: urinary tract infection (17.5% vs. 8.4%), falls (11.7% vs. 16.8%), insomnia (10.0% vs. 1.7%), headache (9.2% vs. 0.8%), asthenia (8.3% vs. 4.2%), dizziness (8.3% vs. 0.8%), nausea (8.3% vs. 0.8%), back pain (5.8% vs. 2.5%), balance disorder (5.8% vs. 1.7%), upper respiratory tract infection (5.8% vs. 6.7%), arthralgia (5.0% vs. 4.2%), nasopharyngitis (5.0% vs. 4.2%) and paraesthesia (5.0% vs. 1.7%). There were three serious adverse events (SAEs) that led to discontinuation: two in the placebo group and one in the Fampridine-SR group. In the placebo group, one participant experienced a possible complex partial seizure and another experienced a combination of chest tightness and gastric reflux. Both of these events were judged by investigators, who were blinded at the time, to be possibly related to treatment. In the Fampridine-SR group, one participant had a patellar fracture, which was judged not to be treatment related. In addition, one participant treated with Fampridine-SR experienced an episode of syncope (fainting) one day after completing the treatment phase of the study. This was judged to be possibly related to treatment, but the participant was not discontinued from the trial. Follow-up assessment by the clinical investigators determined that these SAEs resolved completely with no residual effects. No deaths occurred during the study. As of June 2, 2008, the total exposure in our MS studies to Fampridine-SR at 10mg twice a day, including both double-blind and open-label studies, is approximately 1,100 patient years. The incidence of seizures in these studies at the 10mg dose has been within the rates reported for placebo-treated groups in long-term controlled studies of immunomodulator drugs in MS patients. These rates have ranged up to two percent of patients in a two-year study, or one seizure per 100 patient years. The overall incidence of seizure appears to be dose-related. About MS Multiple sclerosis is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord. Over 400,000 Americans have MS, and someone is newly diagnosed with MS every hour in the United States. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals. According to the National Multiple Sclerosis Society (NMSS), the direct costs of medical care for MS patients in the United States exceed $6 billion annually. Additionally, a NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common daily activities. For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments. Approximately 85 percent of people with MS experience some form of walking impairment. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and, in later stages, up to a third of patients are unable to walk. About Fampridine-SR Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics and manufactured by Elan Corporation plc. Fampridine-SR and MS A nerve cell has one extension, called an axon, which it uses to communicate via electrical signals to other nerve cells. All but the smallest axons have a special covering of a fatty substance called myelin that acts as insulation to preserve and speed these nerve signals, much like the insulating cover of an electrical cord helps preserve the transmission of electricity. In MS, the myelin becomes damaged and the axon cannot effectively transmit electrical impulses. Specifically, the damaged myelin exposes channels in the membrane of the axon, which allow potassium ions to leak from the axon, dissipating the electrical current. In published studies, fampridine has been shown to block these exposed channels and help the electrical signals to pass through areas of damage. Conference Call and Audio Webcast Acorda will hold a conference call and audio webcast today at 8:30 a.m. ET to discuss the top-line results from the trial. To access the call, please dial 866-578-5801(domestic) or 617-213-8058 (international) and provide the access code 57594133. To access the audio webcast, please go to the Investor Relations "Calendar of Events" section of the Acorda website at www.acorda.com, or you may use the link: http://phx.corporate-ir.net/phoenix.zhtml?...eventID=1866966 . (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.) A replay of the call will be available from 10:30 a.m. ET on June 2, 2008 until 11:59 p.m. ET on July 2, 2008. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the access code 37448849. An archived version of the webcast will be available for 90 days on the Acorda website in the Investor Relations section. Patient Information Line Patients with questions regarding the results of this study or who want to join Acorda's mailing list to be kept informed of future company news may call 877-617-2494, toll-free, weekdays from 10:00 a.m. to 5:00 p.m. ET. About Acorda Therapeutics Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical product, Fampridine-SR, has completed two Phase 3 clinical trials to evaluate its safety and efficacy to improve walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the nervous system. About Elan Drug Technologies Elan's Drug Technologies group has developed Fampridine-SR tablets using one of its proprietary Oral Controlled Release Technologies, the MXDAS (MatriX Drug Absorption System) Technology. Elan Drug Technologies (EDT) is an established, profitable and growing specialty pharmaceutical business unit of Elan Corporation plc. For nearly 40 years, EDT has been applying its skills and knowledge to enhance the performance of dozens of drugs that have been marketed worldwide. EDT is focused on using its extensive experience, proprietary drug delivery technologies and licensing capabilities to develop innovative products that deliver clinically meaningful benefits to patients. More information about EDT's broad range of technologies including their Oral Controlled Release and NanoCrystal® Technology Platforms, their patent estate and range of services is available at www.elan.com/EDT. Acorda Therapeutics, Inc. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules®, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release. CONTACT: Acorda Therapeutics Media: Jeff Macdonald, 914-347-4300 ext. 232 jmacdonald@acorda.com or Investor Relations: Molly Newton, 914-347-4300 ext. 203 mnewton@acorda.com SOURCE: Acorda Therapeutics, Inc.

А почему после АТСК нельзя колоть бтаферон? Павел Кална из Питера колол ведь!

Кто переходил с копаксона на бтаферон? Расскажите!

Для затравки - американцы пишут - обострения РС не будет - а я опасаюсь! Есть и опубликваные опасения - данные исследований о том, что вакцинация может привести к обострению. "Flu Vaccination OK for MS", say US Doctors. Vaccinations do not appear to increase the short-term risk of causing relapses in MS. These are the findings of two major studies prompted by concerns that vaccination might lead to relapse. The first study was for the International Multi-Centre Vaccines in Multiple Sclerosis (VACCIMUS) in the US. The results showed no increase in specific risk of relapse linked with tetanus, hepatitis B or influenza vaccination. The second case-controlled study of two nurses in the United States was done by Harvard University School of Public Health and followed 116,671 women since 1989. Ref: From the MS Information Source Book provided by the Information Resource Center and Library of the US National Multiple Sclerosis Society.

Что можно делать при РС? кто знает?