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Amarantus Announces Preclinical Development Timeline for MANF Therapeutic

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By Business Wirevia The Motley Fool

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Amarantus Announces Preclinical Development Timeline for MANF Therapeutic

SUNNYVALE, Calif.–(BUSINESS WIRE)– Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today provided a timeline of key activities and milestones related to the preclinical development of MANF (Mesencephalic-Astrocyte-derived Neurotrophic Factor). The Company is currently focused on developing MANF across three broad categories: Parkinson’s disease and Traumatic Brain Injury; large systemic applications such as Ischemic Heart Disease and Diabetes; and orphan indications.

“We plan to move forward on a number of fronts this year with MANF, leading potentially to one or more Investigational New Drug (IND) filings in 2014,” said Gerald E. Commissiong, President and Chief Executive Officer of Amarantus. “The pace and scope of activities outlined today reflect the unique properties of MANF, the positive results reported earlier this year in neuroprotective and neurorestorative animal models of Parkinson’s disease and supportive data from the published literature.”

The upcoming activities related to Amarantus’ Parkinson’s disease program include:

  • Create mammalian GMP production processes for MANF; the Company has sourced the expertise for these activities, and has started development of the supporting analytical and bioanalytical assays;
  • Form a partnership agreement in the third quarter of 2013 with a firm specializing in Convection-enhanced delivery (CED) of drugs to the brain;
  • Initiate non-human primate pharmacology studies in Parkinson’s disease models in the second half of 2013 in order to establish an appropriate dosing regimen for human clinical studies;
  • Potentially evaluate MANF gene therapy based upon upcoming developments in the field of neurotrophic factors for Parkinson’s disease, and the Company’s current patent position whereby the Company owns exclusive rights to MANF gene therapy applications in all vector systems.

Additional planned activities are expected to include:

  • Conduct pharmacokinetic and pharmacodynamic (PK/PD) studies, with data available in the third quarter of 2013, to evaluate the biological properties of MANF when administered systemically, with data to be released as it becomes available;
  • Conduct pharmacology studies in traumatic brain injury, ischemic heart disease, diabetes and certain other animal models in the third quarter of 2013, with data to be released as it becomes available;
  • Evaluate MANF in a

    From: http://www.dailyfinance.com/2013/04/11/amarantus-announces-preclinical-development-timeli/

Business, Finance, Occupation & Industry

InVivo Therapeutics Reports 2012 Financial Results, Provides Business Update

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By Business Wirevia The Motley Fool

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InVivo Therapeutics Reports 2012 Financial Results, Provides Business Update

CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today reported financial results for the year ended December 31, 2012 and provided a business update.

InVivo has pioneered a new treatment platform utilizing a variety of biocompatible polymer-based devices to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving functional recovery and prognosis after a traumatic SCI. Today there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion.

“The year 2012 has quickly become our most productive. We grew our research and development teams to support a pipeline that now exceeds seven new treatment options for neurotrauma, and we’ve established a GMP manufacturing facility capable of manufacturing our scaffold and hydrogels for human use,” said Frank Reynolds, InVivo Chief Executive Officer. “We’re ready to start a first-in-man clinical trial of our biopolymer scaffolding in acute SCI patients, and we expect as many as five products to be either on the market or in clinical studies by the end of 2014. We have built an outstanding regulatory team to support our R&D capabilities in neurotrauma, and are poised to continue developing new applications for our hydrogels in other areas of the body.”

Recent Corporate Highlights

Biopolymer Scaffolding for SCI:

  • InVivo submitted an updated Investigational Device Exemption to the FDA in February 2013, requesting permission to begin a human study to test its biopolymer scaffolding to treat acute SCI. The study will be an open label study and will evaluate the safety and efficacy of the biopolymer scaffolding in five SCI patients with thoracic injuries. The Company is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device, a designation that InVivo expects will create a faster path to market.
  • InVivo is the first company to successfully demonstrate functional improvement in non-human primates paralyzed after a SCI model. Recent data compiled from InVivo’s 2011 non-human primate study confirm that the functional recovery observed in the treatment group was attributable to the biopolymer …read more
    Source: FULL ARTICLE at DailyFinance
Business, Finance, Occupation & Industry

Sahajanand Medical Technologies Benefits from Comprehensive Video and Situation Intelligence Solutio

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By Business Wirevia The Motley Fool

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Sahajanand Medical Technologies Benefits from Comprehensive Video and Situation Intelligence Solution from Verint

Leading Manufacturer of Medical Devices Leverages Nextiva Portfolio to Help Ensure Safe Manufacturing and Quality Environment

Verint Partner Innovative Telecom & Software Provides Technical Expertise and Support, Helping Drive Customer Success

GUJARAT, India & MELVILLE, N.Y.–(BUSINESS WIRE)– Verint® Systems Inc. (NAS: VRNT) today announced that Sahajanand Medical Technologies Pvt. Ltd. (SMT), a leading developer and manufacturer of minimally invasive coronary stent systems in India, is using its Nextiva® video and situation intelligence solutions at its Surat-based manufacturing facility to help enhance the safety and security of employees. By monitoring and capturing video, the Nextiva solution also is helping SMT adhere to compliance and quality standards, as well as enhance overall operational efficiency.

Sahajanand Medical Technologies offers one of the broadest product portfolios in the cardiovascular medical devices industry. Committed to the welfare of all patients, it delivers products around the world and maintains a focus on providing the best products to help in the fight against cardiovascular disease. SMT‘s state-of-the-art manufacturing facility is GMP (good manufacturing practice) certified and carries both ISO 9001 and ISO 13485 certifications.

To help meet stringent security requirements for its manufacturing facility, as well as compliance and quality requisites, SMT selected Innovative Telecom & Software to help design the architecture of its video surveillance system, source the technology, provide systems integration and implementation services, and deliver post-implementation service and support. As part of the process, Verint’s Nextiva solution was selected in 2011 as the standard.

Today, SMT‘s main campus continues to benefit from the comprehensive Nextiva portfolio—including its video management software, IP cameras and encoders—which provide a powerful, reliable and highly scalable security solution based on leading-edge IP video technology.

“We are extremely pleased with the partnership that Innovative Telecom & Software and Verint have demonstrated by deploying a proven, robust and reliable solution to meet our security requirements,” says Jayanti Vaghasia, director, Sahajanand Group. “The Nextiva solution is a key part of our infrastructure, helping us execute against our security strategy to further advance safety and security across our facility, adhere to government regulations and evolve with changing operational requirements.”

Commenting on the partnership, Mihir Chahwala, Innovative Telecom & Software …read more
Source: FULL ARTICLE at DailyFinance