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Neuralstem Obtains FDA Approval To Begin Phase II Stem Cell Trial In ALS

Posted: Published on April 17th, 2013

By RTT News, April 17, 2013, 08:11:00 AM EDT (RTTNews.com) - Neuralstem Inc. ( CUR ) announced Wednesday that it has received approval from the Food and Drug Administration or FDA to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis or ALS or Lou Gehrig's disease. The company noted that the Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution. According to the company, The trial is designed to treat up to 15 patients, in five different dosing cohorts. All of the patients will be ambulatory and reside within close geographic proximity to the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients will receive both cervical and lumbar injections. "The aim of this Phase II trial is to obtain the maximum … Continue reading

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PRESS RELEASE: Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne …

Posted: Published on April 16th, 2013

-1 of 2- 16 Apr 2013 05:15:00 UTC *DJ Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne Muscular Dystrophy (MORE TO FOLLOW) Dow Jones Newswires April 16, 2013 01:15 ET (05:15 GMT)- - 01 15 AM EDT 04-16-13 -2 of 2- 16 Apr 2013 05:15:00 UTC PRESS RELEASE: Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne Muscular Dystrophy Santhera Pharmaceuticals Holding AG / Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne Muscular Dystrophy . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Liestal, Switzerland, April 16, 2013 - Santhera Pharmaceuticals (SIX: SANN) announced today that the Phase III DELOS study of orally administered Catena(R) in patients with Duchenne Muscular Dystrophy (DMD) successfully passed a planned futility and safety analysis. The independent Data Safety Monitoring Board (DSMB) for DELOS informed Santhera that the study has a reasonable chance of achieving its primary endpoint for improving or delaying the loss of respiratory function in Duchenne patients not using corticosteroids and since no safety issues were detected, recommended that the study should continue as planned. "I am very … Continue reading

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Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena® in Duchenne Muscular Dystrophy

Posted: Published on April 16th, 2013

Liestal, Switzerland, April16, 2013 - Santhera Pharmaceuticals (SANN.SW) announced today that the PhaseIII DELOS study of orally administered Catenain patients with Duchenne Muscular Dystrophy (DMD) successfully passed a planned futility and safety analysis. The independent Data Safety Monitoring Board (DSMB) for DELOS informed Santhera that the study has a reasonable chance of achieving its primary endpoint for improving or delaying the loss of respiratory function in Duchenne patients not using corticosteroids and since no safety issues were detected, recommended that the study should continue as planned. "I am very enthusiastic about this news, which is important for the DMD community as it indicates that Catena eventually may evolve into a real treatment for all patients with this devastating disease. Importantly it suggests that the DELOS data are consistent with the outcome of the PhaseII DELPHI study, which showed that treatment with Catena resulted in a significant increase in peak expiratory flow and may improve early signs of respiratory weakness and dysfunction" commented Gunnar Buyse M.D., Ph.D., Professor of Child Neurology at the University Hospitals Leuven (Belgium) and Principal Investigator for the DELOS study. "Some promising therapies for DMD have failed to demonstrate clinical benefit in late-stage development, so it is … Continue reading

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Autism Society of North Carolina Launches Get Autism

Posted: Published on April 16th, 2013

RALEIGH, N.C., April 15, 2013 /PRNewswire/ --One of every 70 children born in North Carolina will be affected by Autism Spectrum Disorder (ASD). In recognition that April is World Autism Awareness Month, the Autism Society of North Carolina (ASNC) launched Get Autism, a campaign to raise awareness of Autism on all levels in society and to help increase understanding of this growing population. Autism Spectrum Disorder is a lifelong developmental disability that typically appears during the first three years of life. According to a recent study, the rate of prevalence in North Carolina is higher than the national rate of 1 of every 88. A Centers for Disease Control and Prevention report, states that ASD could affect at least one million children in the U.S. ASD is more common than childhood cancer, juvenile diabetes and pediatric AIDS combined. It is the fastest-growing developmental disability in the world. "We want our society as a whole to get educated about Autism and understand the individuals who have a diagnosis. Get Autism means understand, get to know and see whom individuals with Autism really are. As individuals we all see who we want to see. We can see someone with Autism and just … Continue reading

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Autism Science Foundation Announces 2013 Grant Recipients

Posted: Published on April 16th, 2013

Nine new autism research projects to be funded. New York, NY (PRWEB) April 15, 2013 The autism community has demanded more research to understand what is causing autism and to develop better treatments, said ASF President Alison Singer. We are proud to be able to increase our research funding in response to this national health crisis and we are especially grateful to all our donors and volunteers who have come together to support autism research and make these grants possible. This year, the Autism Science Foundation will fund just over $350,000 in grants. In its four years of operation, ASF has funded over $1.1 million in grants. ASF attracts outstanding applicants across the board, representing a broad range of perspectives on autism science, said Dr. Matthew State, Chair of the ASF Scientific Advisory Board and Chairman of the Psychiatry Department at the University of California, San Francisco. These projects show great potential to move the field forward. The following projects were selected for 2013 funding: 3-Year Early Career Award: Multi-Site, Randomized, Controlled Implementation Trial of an Evidence-Based, Adult and Peer-Mediated Social Skills Intervention for Elementary School Children with Autism Spectrum Disorder Co-funded with the FAR Fund Treatment Grant: Go here … Continue reading

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Step By Step Inc. to Provide Intensive Summer Program to Assist those Affected by Autism

Posted: Published on April 16th, 2013

Step By Steps intensive summer program will give participants access to the best autism treatment in Central Ohio provided by the nations most skilled behavior therapists, licensed social workers and speech pathologists. Worthington, Ohio (PRWEB) April 16, 2013 As part of Step By Steps Intensive Summer Program, children with ASD and other developmental disorders will have access to a comprehensive mental health support team comprised of a Certified Behavior Analyst, Social Worker, and Behavior Technician. Additional support treatment services may be provided by a Psychologist and/or Psychiatrist if recommended. Step By Steps intensive summer program will provide your child or adolescent with up to 30 hours a week of intensive behavioral intervention for up to 6 weeks. Using evidenced-based practices and principles of Applied Behavior Analysis (ABA) therapy to reach treatment goals and objectives, this program is designed to: Children and adolescents with ASD necessitate additional therapies and treatment to develop skills that allow them to function successfully in their environments, said Michele LaMarche, BCBA, Executive Director of Step By Step. We are pleased to be able to offer a program that will allow individuals with ASD to access appropriate treatment options outside of the traditional school year. In addition, … Continue reading

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Acorda Therapeutics Announces Positive AMPYRA® (dalfampridine) Phase 2 Data in People with Post-Stroke Deficits

Posted: Published on April 16th, 2013

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that a proof-of-concept trial found dalfampridine extended release (ER) tablets, marketed as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, improved walking in people with post-stroke deficits. Post-stroke deficits refer to chronic neurological deficits, such as impaired walking, motor and sensory function and manual dexterity that persist in people who have had a stroke. There were clear efficacy signals in the dalfampridine-ER post-stroke deficits trial and we therefore plan to proceed with a clinical development program for this indication. A top-line analysis of the data found dalfampridine-ER improved walking for people with mobility impairment resulting from ischemic stroke. Dalfampridine-ER treatment was also associated with a positive change versus placebo on a scale of functional independence in this study, said Ron Cohen, M.D., Acordas President and Chief Executive Officer. We are analyzing the data further to better understand the entirety of the results. After we complete the analysis, we plan to discuss the development program with the FDA. There are more than seven million stroke survivors in the United States, and approximately half of them have some lasting mobility impairment. There are no medications currently available for these patients, so new therapies … Continue reading

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Acorda's MS Drug Ampyra Helps Stroke Patients Walk

Posted: Published on April 16th, 2013

Editor's Choice Main Category: Stroke Also Included In: Neurology / Neuroscience Article Date: 15 Apr 2013 - 11:00 PDT Current ratings for: Acorda's MS Drug Ampyra Helps Stroke Patients Walk 5 (1 votes) In a proof-of- concept Phase II study, Ampyra (dalfampridine extended release 10mg tablets) significantly improved walking in patients with post-stroke deficits. Post-stroke deficits include impaired walking, motor and sensory function, as well as manual dexterity - collectively known as chronic neurological deficits. These deficits often persist in stroke victims. Ron Cohen, M.D., President and Chief Executive Officer, Acorda Therapeutic Incorporated, said: We are analyzing the data further to better understand the entirety of the results. After we complete the analysis, we plan to discuss the development program with the FDA. There are more than seven million stroke survivors in the United States, and approximately half of them have some lasting mobility impairment. There are no medications currently available for these patients, so new therapies are desperately needed." The trial involved 83 people who had had an ischemic stroke at least six months before enrollment. They all had chronic motor deficits. The participants received dalfampridine-ER 10 mg for 14 days and then placebo for 14 days, or vice-versa. … Continue reading

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Football coach's battle with Parkinson's inspires a line of dress shirts

Posted: Published on April 16th, 2013

Maura Horton vividly recalls the day four years ago that her husband, former North Carolina State assistant football coach Don Horton, couldn't button his shirt in the locker room after a game. The effect of Parkinson's disease had impaired his dexterity to the point that he couldn't dress quickly. Embarrassed, he'd had to ask one of his players, Russell Wilson, now a Seattle Seahawks quarterback, for help. "I knew something was wrong when he came home," she said. "I thought maybe it was a bad game." After he told her what happened, she felt compelled to find a solution for her husband's challenge. "I didn't want him to feel that way ever again," she said. She began looking for dress shirts that could close more easily. Online, she saw ones with Velcro closures, but the quality seemed poor. She thought magnets might do a better job. If the approach worked, she realized she could create a line of high-end shirts that would allow others with disabling conditions such as Parkinson's disease, multiple sclerosis or arthritis to dress independently. Related story: 89-year-old grandmother hits Kickstarter goal Horton, who once designed children's clothing, tore apart one of her husband's dress shirts and … Continue reading

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Battle with Parkinson's inspires winning shirt

Posted: Published on April 16th, 2013

Maura Horton designed MagnaReady shirts to close with washable magnets so her football coach husband could dress independently. NEW YORK (CNNMoney) The effect of Parkinson's disease had impaired his dexterity to the point that he couldn't dress quickly. Embarrassed, he'd had to ask one of his players, Russell Wilson, now a Seattle Seahawks quarterback, for help. "I knew something was wrong when he came home," she said. "I thought maybe it was a bad game." After he told her what happened, she felt compelled to find a solution for her husband's challenge. "I didn't want him to feel that way ever again," she said. She began looking for dress shirts that could close more easily. Online, she saw ones with Velcro closures, but the quality seemed poor. She thought magnets might do a better job. If the approach worked, she realized she could create a line of high-end shirts that would allow others with disabling conditions such as Parkinson's disease, multiple sclerosis or arthritis to dress independently. Related story: 89-year-old grandmother hits Kickstarter goal Horton, who once designed children's clothing, tore apart one of her husband's dress shirts and got cracking on a prototype that would substitute magnets for the … Continue reading

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