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Category Archives: Spinal Cord Injury Treatment

Acorda Therapeutics Announces Hatch-Waxman Extension of AMPYRA® (dalfampridine) Sustained-Release Formulation Patent

Posted: Published on October 16th, 2012

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (ACOR) today announced that theU.S. Patent and Trademark Office (USPTO) has determined that U.S. Patent No. 5,540,938 (the 938 patent) is entitled to a full five year patent term extension under the patent restoration provisions of the Hatch Waxman Act. The claims of the 938 patent relate to methods for treating a neurological disease, such as multiple sclerosis (MS), and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS.With a five year patent term extension, the 938 patent wouldexpire in 2018. Acorda also has a granted U.S. patent and an allowed U.S. patent application covering the use of AMPYRA in improving walking in people with MS.The granted U.S. patent will expire in 2027, and the allowed U.S. patent application, once granted, is expected to expire in 2025 plus any additional term determined by the USPTO based on patent term adjustment provisions. AMPYRA is approved by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with MS. This was demonstrated by an improvement in walking speed. Important Safety Information Do not take AMPYRA … Continue reading

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Realizing the potential of stem cell therapy: Studies report progress in developing treatments for diseases and injuries

Posted: Published on October 16th, 2012

ScienceDaily (Oct. 15, 2012) New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today. The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage. The studies focused on using stem cells to produce neurons -- essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease. Today's new findings show that: Other recent findings discussed show that: "As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an … Continue reading

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New findings could help speed recovery, alleviate pain associated with spinal cord injury

Posted: Published on October 16th, 2012

ScienceDaily (Oct. 15, 2012) Research released today demonstrates how new scientific knowledge is driving innovative treatments for spinal cord injuries. Spinal cord damage is debilitating and life-altering, limiting or preventing movement and feeling for millions worldwide, and leading to chronic health conditions and pain. The new studies suggest potential therapies for managing the aftermath of pain and pressure sores, repairing nervous system damage, and speeding recovery. The findings were presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health. In the United States, approximately 12,000 people are hospitalized for spinal cord injury (SCI) each year, and at least 270,000 people live with it. The initial injury is usually compounded by a wave of immune activity that can extend the initial nervous system damage, and complications of SCI may include pain and pressure sores that compromise the quality of life. New research is tackling all of these dimensions of SCI. Today's new findings show that: "While the damage of SCI can appear to be immediate and dramatic, the biological events that lead to extensive nerve and tissue damage are complex, and injuries evolve over time," said … Continue reading

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InVivo Therapeutics Releases Letter to Shareholders

Posted: Published on October 12th, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma, today released a letter to Shareholders. To Our Shareholders and Potential Shareholders: InVivo has been making excellent progress in the past months and we are firing on all cylinders. I wanted to use this letter as a forum to provide an important update on how we are using InVivos resources to create and capture shareholder value. We expect the next six months to mark a major inflection point in our growth. The FDA has not put up any roadblocks or requested additional information that will delay the start of the study for the use of our biopolymer scaffolding to treat spinal cord injuries (SCI). Before the end of 2012, we expect to validate our clean room and then manufacture GMP batches which will be submitted to the FDA as part of the IDE application. We expect FDA approval to start the clinical study in early 2013. We are disappointed with our recent stock price performance. The 50% decline since the end of August 2012 is unwarranted and seems to have been driven by unsubstantiated internet rumors. We … Continue reading

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InVivo CEO: Our stock is undervalued

Posted: Published on October 12th, 2012

Cambridge spinal cord injury treatment startup InVivo Therapeutics Holdings Corp, which received a $2 million loan from MassDevelopment this week, released a letter to shareholders today expressing frustration with the companys lackluster stock performance. Though InVivo is firing on all cylinders, the companys 50 percent stock drop since the end of August is unwarranted and seems to have been driven by unsubstantiated Internet rumors, said CEO Frank Reynolds. We believe our stock is undervalued and has significant near-term catalysts that should drive valuation, he said. In this years range of prices, InVivo stock has been trading between 60 cents and $3.23 a share, reaching a high today of $1.78. The company now has more than 30 employees in its new 21,000-square-foot Kendall Square headquarters. In the letter, Reynolds added the company expects the next six months to mark a major inflection point in our growth. The FDA has not put up any roadblocks or requested additional information that will delay the start of the study for the use of our biopolymer scaffolding to treat spinal cord injuries, he said. Before the end of 2012, we expect to validate our clean room and then manufacture GMP (Good Manufacturing Practices) batches which … Continue reading

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Neuralstem To Present Preclinical Data At Neuroscience 2012, 42nd Annual Meeting Of The Society For Neuroscience

Posted: Published on October 10th, 2012

ROCKVILLE, Md., Oct. 10, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that it will present preclinical data in five poster presentations at Neuroscience 2012, the 42nd Annual Meeting for the Society for Neuroscience., October 13-17, in New Orleans (http://www.sfn.org/AM2012/). These posters will cover new data pertaining to Neuralstem's NSI-566 spinal cord stem cell line for cell therapy, and its patented, neurogenic small molecule compounds: NSI-144, NSI-150, NSI-158 and NSI-189. Abstracts of the poster are available at http://www.sfn.org/am2012/index.aspx?pagename=final_program (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO ) NSI-566 is in a Phase I trial to test the safety of the cells and procedure in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The last patient was treated in August, 2012. Neuralstem was recently approved to commence a NSI-566 trial in stroke in China, through its Chinese subsidiary, Neuralstem China, and has submitted an IND to the FDA to commence a trial in spinal cord injury with the same cells in the U.S. NSI-144, NSI-150, NSI-158 and NSI-189 are small molecule, orally active compounds that stimulate new neuron growth in the hippocampus. NSI-189 is currently in a Phase Ib clinical trial testing its safety for the treatment of major depressive disorder (MDD). The titles … Continue reading

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InVivo Therapeutics Awarded $2 Million Loan from MassDevelopment

Posted: Published on October 10th, 2012

CAMBRIDGE, Mass. & BOSTON--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), and MassDevelopment announced today that MassDevelopment has awarded InVivo Therapeutics a $2 million loan from its Emerging Technology Fund to help fund the commercialization of InVivo's groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions. InVivo will use the proceeds from this low cost, seven year term loan for general working capital purposes and to purchase equipment for the expansion of manufacturing and research capabilities at its new facility in Cambridge MA. As InVivo's business grows, the Company expects to substantially increase employment in manufacturing, sales, marketing, clinical, and regulatory positions over the next two years. Through its 10-year, $1 billion Life Sciences Initiative, the Patrick-Murray Administration has nurtured our life sciences industry in Massachusetts into a world-leader and a key part of our economic recovery, said Greg Bialecki, the Secretary of Housing and Economic Development and MassDevelopment Board Chair. Continuing to support our innovation economy is a leading focus in the Administrations long-term economic development plan, and we applaud MassDevelopments financing of a vibrant, growing business in Massachusetts. InVivos treatment of spinal cord injuries typifies the Commonwealths highly innovative life sciences companies, said MassDevelopment … Continue reading

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New Rehabilitation Research Demonstrates Functional Improvements in Patients with Spinal Cord Injuries

Posted: Published on October 8th, 2012

Newswise STONY BROOK, N.Y., October 8, 2012 A series of rehabilitation studies published in the September 2012 issue of the Archives of Physical Medicine & Rehabilitation demonstrate that innovative treatments for individuals with spinal cord injuries can lead to significant functional improvements in patients and a higher quality of life. Sue Ann Sisto, PT, MA, PhD, Professor of Physical Therapy, Research Director, Division of Rehabilitation Sciences, Director of the Rehabilitation Research and Movement Performance (RRAMP) Laboratory, Stony Brook University School of Health Technology and Management (SHTM), and Co-Director of the Christopher & Dana Reeve Foundation NeuroRecovery Network (NRN), says the findings suggest that a shift in both protocol and policy is needed at rehabilitation centers across the nation to advance and standardize rehabilitation care for patients with spinal cord injuries. These studies provide scientific and clinical evidence from hundreds of patients that long-term rehabilitation practices such as locomotor training, exercise, and wellness activities for patients with full or partial spinal cord injuries lead to improved health and function in patients, summarized Dr. Sisto, a co-author on several of the 11 studies published in Archives. While a majority of the studies evaluate activity-based rehabilitative practices involving the assessment and improvement of … Continue reading

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Spaulding Selected by NIDRR as both TBI and Burn Injury Model System Sites

Posted: Published on October 4th, 2012

BOSTON, Oct. 3, 2012 /PRNewswire-USNewswire/ -- Spaulding Rehabilitation Hospital announced today that both its Traumatic Brain Injury (TBI) Program and Burn Injury Rehabilitation Program have been selected as Model System sites by the National Institute on Disability and Rehabilitation Research (NIDRR). These selections combined with last year's selection of Spaulding as a Spinal Cord Injury Model System Site make Spaulding one of only two providers nationally to be selected as a Model System in all three specialties at the same time. These grants are awarded in five year cycles by NIDRR through an extremely selective process with only 21 national sites for TBI and only 5 for Burn Injury. NIDRR awards Model Systems grants to institutions that are national leaders in medical research and patient care. Each site provides the highest level of comprehensive specialty services, from the point of injury through rehabilitation and community reentry. Dr. Joe Giacino will serve as Program Director for the TBI Model System Site and Dr. Jeffrey Schneider will serve as Program Director for the Burn Injury Model System site. Dr. Ross Zafonte will serve as Administrative Co-Director for both. "Our selection by NIDRR as only the second provider in the nation to serve … Continue reading

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InVivo to Present at 2012 Aegis Healthcare Conference

Posted: Published on September 28th, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma, today announced that CEO Frank Reynolds is scheduled to present at the 2012 Aegis Healthcare Conference to be held September 27-29, 2012 at The Wynn, Las Vegas. The Companys presentation will be on Friday, September 28th at 9:30 a.m. PDT (12:30 pm EDT). About InVivo Therapeutics InVivo Therapeutics Holdings Corp. is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious 2011 David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, MA. For more details, visit http://www.invivotherapeutics.com. Safe Harbor Statement Certain statements contained in this press release that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 … Continue reading

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