викинг

BIOMS MEDICAL COMPLETES PATIENT RECRUITMENT IN PHASE III U.S. MULTIPLE SCLEROSIS TRIAL Edmonton, Alberta, August 1, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that it has completed patient recruitment in its phase III clinical trial of MBP8298 (dirucotide) for the treatment of secondary progressive MS (SPMS). The trial, named MAESTRO-03, includes approximately 510 patients, and is being conducted at 68 trial sites in the U.S. “We have had great success in recruiting patients into the trial, which is a testament to the promise of our approach and the efforts of our investigators,” said Mr. Kevin Giese, President and CEO. “Since initiating this trial in June 2007 we have been delighted by the enthusiasm of the patients and clinical groups participating across the U.S.” MBP8298 (dirucotide) is currently being developed in three late-stage clinical trials: 1. MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe. 2. MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States. 3. MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe. About MAESTRO-03 The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 68 clinical sites who will be administered either MBP8298 (dirucotide) 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 MBP8298 (dirucotide) MBP8298 (dirucotide) is a synthetic peptide that consists of 17 amino acids having a sequence identical to that of a portion of human myelin basic protein (MBP). MBP8298 (dirucotide) is being developed for the potential treatment of multiple sclerosis (MS), an autoimmune disease caused by immune attack against normal components of the central nervous system. The sequence of MBP8298 is associated with the autoimmune process in MS patients with certain immune response genes (HLA types DR2 and/or DR4); MS patients having these genes represent 65 to 75 percent of all MS patients. The apparent mechanism of action of MBP8298 (dirucotide) is the induction or restoration of immunological tolerance with respect to ongoing immune attack as a result of high doses of peptide delivered periodically by the intravenous route. The potential benefit of MBP8298 (dirucotide) for any individual patient is therefore expected to be related to the role this peptide plays in that patient’s immune system. The degree of immunomodulation achieved will depend on the relationship among the peptide, HLA molecules and T cells. The results of phase II and long-term follow-up treatment of MS patients with MBP8298 (dirucotide), published in 2006 in the European Journal of Neurology (EJN), showed that MBP8298 (dirucotide) safely delayed median time to disease progression for five years (versus placebo) in progressive MS patients with HLA types DR2 and/or DR4. Thus, MBP8298 (dirucotide) has the potential to be used as a tailored therapy for patients genetically determined to express the appropriate HLA molecules. About Multiple Sclerosis Multiple sclerosis (MS) is thought to affect as many as 2.5 million people worldwide, including approximately 75,000 in Canada, 400,000 in the United States and more than 500,000 in Europe. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis. Approximately 40 percent of all MS patients have the secondary progressive form of the disease. 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 (dirucotide), 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 (dirucotide) 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 Corporation’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 Corporation’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 dirucotide (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. Ryan Giese VP Corporate Communications Phone: 780-413-7152 rgiese@biomsmedical.com Tony Hesby Executive VP Corporate Affairs Phone: 780-413-7152 tony.hesby@biomsmedical.com Amanda Stadel Investor Relations Manager Phone: 780-413-7152 astadel@biomsmedical.com BioMS News August 1, 2008 )

ПОФИГИСТЫ НИЧЕМ НЕ БОЛЕЮТ!!!

Вот это вопрос = нужно ли что-то делать после трансплантации? копаксон? бетаферон? ребиф? в клинике М ничего не говорят об этом!

Originally Released: March, 1998 Patient / Consumer Inquiries: 1-800-492-5538 Media Contact: 410-328-8919 NEW STUDY PROVIDES MORE EVIDENCE THAT COPAXONE CAN SLOW PROGRESSION OF MULTIPLE SCLEROSIS AND REDUCES ATTACKS A study published today in the March issue of the journal Neurology provides more evidence that the medication Copaxone, the only non-interferon treatment for multiple sclerosis, reduces the number of relapses and slows the progression of disability. The study is a one-year extension of research at 11 medical centers in the United States. "We find that the longer patients take Copaxone, the better the results, compared to a placebo," says Kenneth Johnson, M.D., professor and chairman of Neurology at the University of Maryland Medical Center in Baltimore, and principal investigator of the multicenter study. "With a follow-up of up to 35 months, we found that patients who took Copaxone had 32 percent fewer relapses compared to those taking a placebo," Dr. Johnson says. "After the first 24 months of the study, patients in the Copaxone group had 29 percent fewer relapses. "Each relapse can damage the nervous system and increase the likelihood of disability. Using a scientific measure of disability, we found that patients in the placebo group were 50 percent more likely to have increased disability than those taking Copaxone," Dr. Johnson adds. The study included 251 patients with relapsing-remitting multiple sclerosis. After approximately 33 months, all of the patients, including those taking the placebo, were offered Copaxone, 190 chose to take it and 170 patients are still on medication. Many have taken it for more than six years. "Multiple sclerosis therapy is a long-term, possibly life-long proposition, so the medication needs to be well-tolerated with few side effects," says Dr. Johnson. Copaxone, which was approved by the FDA in December 1996, is taken as a daily injection under the skin. Its generic name is glatiramer acetate for injection. The most common side effects are redness, pain, inflammation, itching or a lump at the site of the injection. Rare side effects are temporary episodes of flushing, chest pain, anxiety and shortness of breath, all of which disappear without any permanent damage. The new results, showing that the longer people were on Copaxone, the better they did in terms of relapses and disability, were good news to Melissa Hawkins-Holt. Hawkins-Holt always dreamed of being a doctor. Five years ago, during college, she suffered several mysterious attacks of numbness and blurred vision. It finally became so bad that she went to the hospital. A diagnosis of multiple sclerosis followed, leaving her wondering if her dream was out of reach. Today she is completing her first year of residency at the University of Maryland Medical Center. She joined the original trial of Copaxone to halt the progression of the disease, and she has now been on the drug for three years. "I haven't had a significant relapse since I have been taking Copaxone. It makes me feel like I am doing something to give myself the best chance of remaining relapse-free as long as possible," said Dr. Hawkins-Holt. Hawkins-Holt says taking Copaxone has become part of her life along with eating a healthy diet, exercising daily and trying to fit rest into her busy schedule. One day, she and her husband would like to have a family. She is able to sometimes even forget that she has multiple sclerosis as she focuses on reaching her goals. "The additional data gathered in this study reinforces that Copaxone is a first-line therapy for relapsing-remitting multiple sclerosis because it is well-tolerated, reduces the number of relapses and slows the progression of disability." said Dr. Johnson. "Unlike the interferon therapies, Copaxone does not produce flu-like side effects, occasional severe skin reactions or fatigue." The studies showed no evidence of neutralizing antibodies that may reduce the effectiveness of other multiple sclerosis therapies. "People with multiple sclerosis don't want their disease to run their lives. They want the same things you and I do," said Dr. Johnson. "This study shows increasing evidence that people with relapsing-remitting multiple sclerosis can lead lives with reduced relapses and slowed progression of disability." ### For patient inquiries, call 1-800-492-5538 or click here to make an appointment. This page was last updated on: May 27, 2008.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced new results from the PreCISe study, which demonstrated that early treatment with COPAXONE (glatiramer acetate injection) significantly reduced the risk of developing clinically definite multiple sclerosis (CDMS) by 45 percent compared to placebo (hazard ratio 0.55, p=0.0001). These data were presented as late-breaking science at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago.

Юлек! с Днём Рождения!

Jun 19, 2008 Laquinimod Results Published: Oral Drug Reduces Disease Activity in Phase 2 Study Treatment with oral laquinimod (Teva Pharmaceutical Industries) reduced disease activity by 40.4% compared with inactive placebo in a phase 2 study of 306 people with relapsing-remitting MS*. Laquinimod is believed to affect the immune attack on the brain and spinal cord that occurs in MS. Giancarlo Comi, MD (Scientific Institute San Raffaele, Milan) and colleagues, who originally reported the results at the Annual Meeting of the American Academy of Neurology in 2007, now publish these results in the Lancet (2008; 371: 2085–92). A phase 3 study of laquinimod is underway in 1000 people with relapsing-remitting MS. Background: Multiple sclerosis involves immune-system attacks against the central nervous system. Currently approved therapies for MS involve injections or infusions. Having an effective therapy in pill form would be a big step forward for people with MS. Laquinimod is an oral therapy that is thought to shift the balance of immune cells away from inflammation. The drug is related in structure to linomide, which showed early promise but in phase 3 clinical trials caused significant adverse events including cardiac toxicity. The Study: Dr. Comi and colleagues randomly assigned 306 people with MS to receive placebo, .3 mg/day, or laquinimod .6 mg/day. Participants underwent monthly brain MRI scans and clinical examinations from week 12 to week 36. The primary outcome tested was the number of active lesions (areas of active disease activity or damage) as observed on MRI. The Results: The cumulative average number of active lesions was significantly reduced by 40.4% in the group taking .6 mg compared with those taking placebo, but no benefit was seen in the .3 mg group. No significant reductions were seen in relapses; however the study was not designed to detect these differences. Both doses were considered well tolerated, and heart problems were not seen at either dose. Increases in liver enzymes occurred in 23.4% of the .6 mg group, 33% of the .3 mg group, and in 10.8% of the placebo group, with two patients in the .3 mg group discontinuing treatment due to these abnormalities. One patient in the .6 mg group developed Budd-Chiari syndrome (a partial blockage of blood outflow from the liver) after one month on treatment. This person had a pre-existing tendency toward blood clots, and the authors note that the possibility that such patients might be at increased risk of serious adverse events should be explored in further studies. In an accompanying editorial, B. Mark Keegan, MD, and Brian Weinshenker, MD (Mayo Clinic, Rochester, MN), write that this study may have been too short to reveal reductions in MS relapses, and that the two-year, phase 3 study should clarify this issue. They also suggest that head-to-head studies are needed to directly compare laquinimod with approved MS therapies to determine if the convenience of oral therapy is adequately matched by the drug’s effectiveness. “We are encouraged by the MRI data from this publication,” says John R. Richert, MD, Executive Vice President of Research & Clinical Programs for the National MS Society. “We look forward to seeing further clinical and safety data from the phase 3 study, which will help to determine if this treatment can be used safely and effectively in people with MS.”

22 July 2008 Biogen Idec and Elan Celebrate Second Anniversary of TYSABRI® for the Treatment of Multiple Sclerosis TYSABRI's Benefits Continue to Drive Product's Growth with More Than 31,800 Patients Receiving Treatment CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--July 22, 2008--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced the two-year anniversary of TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS), marking the reintroduction of the product in the United States (US) and the first international approval. The companies estimate that as of the end of June 2008, more than 31,800 patients worldwide are receiving TYSABRI treatment. Specifically, as of the end of June 2008: In the US, more than 17,800 patients are on TYSABRI commercially and more than 3,100 physicians have prescribed the therapy; Outside of the US, nearly 13,400 patients are on TYSABRI commercially; In global clinical trials, more than 600 patients are on TYSABRI; and, There have been no confirmed cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and the first international approval in July 2006. Cumulatively, in the combined clinical trial and post-marketing settings: More than 43,300 patients have been treated with TYSABRI; and Of those patients, nearly 13,900 have received at least one year of TYSABRI therapy and approximately 6,600 patients have been on therapy for 18 months or longer. "Since beginning TYSABRI therapy more than 18 months ago, I have experienced an improvement in my life and how I go about living with my MS every day," said patient Patricia Substelny. "The benefits have been significant in terms of reducing the number of exacerbations I have experienced. I can now confidently work in my garden, cook for my family and friends, and enjoy what life has to offer. I feel very fortunate to have TYSABRI as an option to help me manage my MS." In the two years since reintroduction in the US and the first international approval, the data continue to demonstrate the benefits of TYSABRI treatment for patients with relapsing forms of MS. Data showed that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of Phase III clinical trials presented at this year's American Academy of Neurology annual meeting. In addition, new data from a patient-reported outcomes survey was presented at the Consortium of Multiple Sclerosis Centers annual meeting showing that after only three months of treatment with TYSABRI, some patients reported improvements in overall quality of life, disease level, functional status and MS symptoms. Along with TYSABRI's well-established clinical efficacy, growing health economic data from across the globe has been presented and published endorsing the pharmacoeconomic benefits of TYSABRI in MS patients. Based on this data, local health agencies in countries including Australia, Austria, the Netherlands, the United Kingdom, Sweden, France and Germany have all recommended TYSABRI for reimbursement by government-run health agencies. "During the past two years, my patients who are being treated with TYSABRI appear to experience very positive benefits from the drug," said Dr. Thomas F. Scott, Professor of Neurology, Drexel University College of Medicine and Director, Allegheny MS Treatment Center in Pittsburgh. "Many of my patients tell me TYSABRI is helping them to regain control of their lives." About TOUCH™ , TYGRIS and CD INFORM Before initiating treatment, all US patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, other serious OIs, deaths and discontinuation of therapy on an ongoing basis. TYGRIS (TYSABRI Global ObseRvation Program In Safety) and CD INFORM (Crohn's Disease - Investigating Natalizumab through Further Observational Research and Monitoring) are part of the global risk management plan for TYSABRI. TYGRIS is expected to enroll 5,000 MS patients worldwide, including approximately 2,000 - 2,500 patients from TOUCH. CD INFORM is expected to enroll 2,000 Crohn's patients in the US. Patients in TYGRIS and CD INFORM are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies. Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner. About TYSABRI TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001). TYSABRI was recently approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. TYSABRI is approved in more than 35 countries. For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com or call 1-800-456-2255. About Biogen Idec Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com. About Elan Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com. Safe Harbor/Forward-Looking Statements This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by the FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, that the companies may encounter other unexpected hurdles, or that new therapies for MS with better efficacy or safety profiles or more convenient methods of administration are introduced into the market. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. CONTACT: MEDIA CONTACTS: Biogen Idec Shannon Altimari, 617-914-6524 or Elan Jonathan Birt, 212-850-5664 or +44 20 7269 7205 or Niamh Lyons, +353 1 663 3602 or INVESTOR CONTACTS: Biogen Idec Eric Hoffman, 617-679-2812 or Elan Chris Burns, 800-252-3526 or David Marshall, +353 1 709 4444 SOURCE: Biogen Idec and Elan Corporation, plc Click here for printable version

расскажите пожалуйста!

они и находят - это называется ремиссия

Aug 25, 2006 Results Reported on High-Dose Immunosuppressant for MS Researchers report that high-dose cyclophosphamide, a drug typically used to treat cancer, succeeded in stabilizing disease activity and improving quality of life in 12 people with severe multiple sclerosis unresponsive to other treatments. Douglas E. Gladstone, MD, and colleagues (State University of New York at Stony Brook) report their findings in the Archives of Neurology (Arch Neurol. 2006 Aug 14; [Epub ahead of print]). Cyclophosphamide (Cytoxan®) is a form of chemotherapy a potent immunosuppressive drug that is usually given to treat cancer. Since administering chemotherapeutic agents diminishes the numbers of immune cells, it should theoretically slow down or halt the immune attack on the brain and spinal cord in MS. Cyclophosphamide has been used for treating MS for many years, mostly in uncontrolled studies, where it was often but not always reported to improve the condition of people with primary- or secondary-progressive MS (people with a slow but nearly continuous worsening of MS from onset, or those with an initial period of relapsing-remitting MS, followed by a steadily worsening disease course). Possible short-term side effects with high doses are hair loss, nausea, bladder injury, and risk of infection. Possible long-term side effects include sterility, mutations, and increased risk of cancer. Dr. Gladstone's team administered 200 mg/kg of cyclophosphamide over 4 days to 12 people with severe MS that had been unresponsive to other treatments, including seven people with secondary-progressive MS and five people with relapsing-remitting MS. Participants were followed for two years afterwards, with periodic magnetic resonance imaging scans, neurologic examinations, EDSS (a scale that measures disability; the higher the EDSS score, the greater the level of physical disability) and quality-of-life evaluations. During follow-up, no patients increased their EDSS scores by more than 1.0. Five patients decreased their EDSS scores by 1.0 or more. No patient had new areas of tissue damage on brain MRI scans. No patient showed any active inflammation on MRI scans. Patients reported improvement in all quality-of-life parameters measured. Neurologic improvement was observed in gait, bladder control, and visual function. Common side effects, which were corrected without discontinuing treatment, included nausea and blood chemistry abnormalities. No patient required rehospitalization after discharge. This small, uncontrolled study provides further evidence that some people with very active forms of MS, which are unresponsive to other medications, do respond favorably to high-dose immunosuppressive therapy. This type of aggressive immune suppression carries risks, but in capable hands these risks can be largely circumvented. In the future, larger, controlled trials of high-dose cyclophosphamide should help determine how this treatment regimen might be most beneficial for people with MS.

Jun 05, 2008 Long-Term Study Yields Clues for Predicting Future Course of MS A long-term study that has been tracking individuals for over 20 years provides important clues that may help doctors predict the clinical course of some individuals’ multiple sclerosis, a notoriously unpredictable disease. Among their findings, the United Kingdom investigators reported that those with relatively rapid increases in brain lesion volume, as detected with MRI scans, during the first five years after their initial neurological episode were more likely to develop long-term disability than those with slower rates of lesion accumulation. The study, supported by the MS Society of Great Britain and Northern Ireland, appears in the March 2008 issue of the journal Brain (L. K. Fisniku et al, 131, 808-817). Details: For this study, Drs. Leonora Fisniku, David Miller (University College London Institute of Neurology, Queens Square, London) and colleagues followed up on a group of patients who had originally developed a first neurological episode (clinically isolated syndrome, or CIS), such as optic neuritis, in the 1980s. CIS can be a harbinger of future MS, but not all of those with CIS go on to develop definite MS. Researchers have been seeking ways to predict who of those experiencing a first episode will go on to develop MS to aid treatment decisions, and they are also searching for ways to predict the highly variable course of MS itself. One method employed is the use of periodic magnetic resonance imaging (MRI). The Queens Square research team previously conducted follow-ups on members of this group of patients after 5 years, 10 years, and 14 years. Results: Of the original 140 patients who had had MRI and clinical workups for CIS, the researchers were able to follow up on 107 individuals after an average of 20 years. Of the 107, 67 (63 %) had developed definite MS. Definite MS developed in 82% of those whose MRI scans showed abnormalities at the beginning of the study, and it also developed in 7 out of 34 (21%) of those whose original MRI scans were normal. One of the most important findings relates to long-term changes experienced by the patients. After the 20 years, 58% still had a relapsing-remitting course of MS (characterized by clearly defined flare-ups followed by complete or partial remissions), some quite mild, while 42% had developed secondary-progressive MS (characterized by an initial period of relapsing-remitting MS, followed by a steadily worsening disease course with or without occasional flare-ups or minor recoveries). Those individuals with secondary-progressive MS at the 20-year follow-up tended to have a steep increase in the total volume of brain lesions over the first five years of disease compared with those whose disease course remained relapsing-remitting. This finding, in the longest study to date of patients starting with CIS, suggests that steep increases in an individual’s MRI lesion load during the first five years of disease may predict a likelihood of a progressive, disabling course of disease. The authors point out that only four of the 107 patients had been on any approved MS therapies during the study, so the results represent for the most part what can be predicted when there is no intervention. What the study cannot predict is whether therapeutically preventing relapses can ultimately change the expected course of disability progression. Further research is needed to answer this very important question. “This study adds significant information to the complex effort to find ways to predict the course of MS and CIS in individuals,” explained John R. Richert, M.D., executive vice president of the National MS Society’s research and clinical programs department. “We need benchmarks like these that can help guide doctors in making treatment recommendations, and to speed clinical trials of new MS therapies,” he added.

.даже сфинкса египетского,говорят 10000лет назад сделали

все новое= хорошо забытое старое!!!

может это оттого, что наши врачи языкам не обучены... но это ведь АЗБУКА!!!

вот так! а в России об этом молчат!

May 18, 2007 Positive Results Published on Testosterone for Men with MS Researchers from the University of California, Los Angeles have published results from a small study, funded by the National MS Society and others, suggesting that one year of treatment with a gel containing the sex hormone testosterone (applied to the skin) in 10 men with relapsing-remitting multiple sclerosis resulted in significant improvements in cognitive function and in slowing brain tissue loss. Nancy Sicotte, MD, Rhonda Voskuhl, MD, and colleagues report these positive findings in the May 2007 issue of Archives of Neurology (2007;64:683-688). Further research involving larger numbers of patients and controls would help to confirm and expand these early results, and to ensure the safety and effectiveness of testosterone treatment in MS. Background: Sex hormones may contribute to MS susceptibility by influencing the immune attack on brain and spinal cord tissues. Laboratory studies have shown that the severity of EAE, an MS-like disease, is decreased when testosterone, a male sex hormone, is administered to male and female mice. Dr. Voskuhl was awarded funding from the National MS Society’s targeted research initiative on Gender Differences in MS to undertake a small study of testosterone gel in men with MS. Preliminary results of this study were originally presented at the 58th Annual Meeting of the American Academy of Neurology in April 2006. Study: Ten men with relapsing-remitting MS, ranging from 29 to 61 years of age, were studied. Relapsing-remitting MS is the most common form of the disease, involving clearly defined flare-ups followed by partial or complete recovery periods. After a six-month observation period, they were treated with testosterone gel applied to the skin (10 grams daily, containing 100 mgs of testosterone) for one year. None of the men were taking disease-modifying therapies. Clinical assessments including blood tests, as well as clinical measures of disease activity and cognitive function were completed every three months. Magnetic resonance imaging scans were taken before treatment and monthly to measure evidence of disease activity. The extent of brain tissue loss (atrophy) was assessed by determining normalized brain volumes using automated computer software. Since all 10 of the men received treatment and none received inactive placebo, the investigators compared measures taken before treatment versus after treatment. Testosterone levels were in the lower range of normal before treatment, and although they increased with treatment, remained in the normal range. After 12 months of testosterone treatment, measures of clinical disease activity remained stable, blood tests were normal, and no adverse events related to treatment were reported. The men showed significant improvements in performance on a test of cognitive function called the Paced Auditory Serial Addition Task (a test of processing speed and memory) compared to the pre-treatment period. The authors report that the improvement could not be accounted for by well-known “practice effects,” which had stabilized during the pre-treatment period. MRI scans showed no increases in disease activity or tissue damage during treatment, although the authors note that the patients began the study with relatively low levels of disease activity on MRI. Significantly, the rates of brain atrophy, measured by normalized brain volume, slowed by 67 percent during the last nine months of treatment. Muscle mass increased significantly during the study; testosterone is sometimes used for this purpose in other chronic diseases. This small study shows that testosterone treatment may have therapeutic benefit in men with relapsing-remitting MS. Further study involving larger numbers of patients and control groups is necessary to confirm these early results, and to ensure the safety and effectiveness of testosterone treatment for MS. “We’re gratified that these early, promising results stemmed from the National MS Society’s targeting of gender differences as an important area of research in MS,” said Dr. John R. Richert, the Society’s executive vice president of research. “It also demonstrates how basic laboratory findings can quickly translate into possible new therapeutic strategies.” Dr. Voskuhl and colleagues are already proceeding with a similar effort involving the sex hormone estriol: Based on a small, early-phase trial that showed decreases in disease activity in 12 women with MS, she is now launching a multicenter, controlled clinical trial of oral estriol (added to the approved MS therapy glatiramer acetate) in 130 women with relapsing-remitting MS.

всегда помним о нем

этим результатам стоит верить. Стойда = дочь Завалишина.

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 T

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BARACK OBAMA , STRONG SUPPORTER OF STEM CELL RESEARCH

In a statement, Elan said that Tysabri (natalizumab) will be available upon the completion of key activities related to the risk management plan, including finalization of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel. As such, Elan and Biogen Idec anticipate Tysabri will be available in July. The wholesale acquisition cost is $2184.62 per vial. Elan and Biogen Idec are committed to making TYSABRI accessible to appropriate patients who may benefit from therapy. To achieve this goal, programs have been developed to assist patients who are uninsured or who require financial assistance, the statement said.