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Thread: InVivo Therapeutics Announces Bioengineered Neural Trails? Program for Chronic Spinal

  1. #1

    InVivo Therapeutics Announces Bioengineered Neural Trails? Program for Chronic Spinal

    InVivo Therapeutics Announces Bioengineered Neural Trails? Program for Chronic Spinal Cord Injury
    New Intellectual Property to Support Minimally Invasive Transplantation of Trails of Neural Stem Cells
    - Executed Agreements with University of California, San Diego and Dr. James Guest -
    - InVivo Provisional Patent Application Filed -

    CAMBRIDGE, Mass. (Dec 2, 2015) ? InVivo Therapeutics Holdings Corp. (NVIV) today announced an innovative strategy for the treatment of chronic spinal cord injury (SCI). The company will focus its research efforts for chronic SCI on Bioengineered Neural Trails?. Bioengineered Neural Trails are injectable combinations of biomaterials and neural stem cells (NSCs) delivered using minimally-invasive surgical instrumentation and techniques to create trails across the chronic injury site. To support this strategy, InVivo has entered into agreements with the University of California, San Diego (UC San Diego) and James Guest, M.D., Ph.D., to expand the company?s intellectual property portfolio. InVivo entered into an exclusive license agreement with UC San Diego for issued patent US 9,011,410 titled ?Spinal Multisegmental Cell and Drug Delivery System,? and into an assignment agreement with Dr. Guest for issued patent US 7,666,177 titled ?Method and System for Cellular Transplantation in the Spinal Cord.? InVivo also has filed a provisional application in support of the Bioengineered Neural Trails program titled ?Methods and Systems for Delivery of a Trail of a Therapeutic Substance.?

    ?Our goal is to restore neuronal connectivity and thereby promote neurological recovery in people with chronic SCI,? said Tom Ulich, M.D., Chief Scientific Officer of InVivo. ?Our minimally-invasive therapeutic approach is to bridge the spinal cord lesion at the time of implantation with a trail of NSCs delivered in an injectable and biodegradable soft, gel-like scaffold. We look forward to presenting our preclinical results in the spinal cords of small and large animals during the Key Opinion Leader Event and Company Update on Thursday."

    Mark Perrin, Chief Executive Officer and Chairman of InVivo, said, ?We are excited about our novel Bioengineered Neural Trails program for the treatment of chronic spinal cord injury. The newly secured patents along with our provisional patent application provide the intellectual property foundation for our Bioengineered Neural Trails program.?

    The company will discuss its innovative strategy for the treatment of chronic SCI during the KOL Event and Company Update webcast at 5:15PM ET on Thursday. The webcast will be broadly accessible through http://lifesci.rampard.com/20151203.

    To learn more about our approach to chronic spinal cord injury, visit the InVivo Therapeutics website: http://www.invivotherapeutics.com/re...neural-trails/

    About Bioengineered Neural Trails?
    Bioengineered Neural Trails are injectable combinations of biomaterials and neural stem cells (NSCs) delivered using minimally invasive surgical instrumentation and techniques to create trails across the chronic spinal cord injury site. InVivo?s Bioengineered Neural Trails program is currently being advanced preclinically by the Research and Development team at InVivo for the treatment of chronic spinal cord injury.

    About InVivo Therapeutics
    InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children?s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company?s investigational Neuro-Spinal Scaffold? received the 2015 Becker?s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

    Safe Harbor Statement
    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect," ?designed to,? ?potentially,? and similar expressions, and include statements regarding the expected impact of the company?s Bioengineered Neural Trails program for the treatment of chronic SCI. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company?s ability to execute on its development strategy and to obtain FDA approval for future clinical studies; the expected benefits and efficacy of the company?s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company?s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company?s Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company?s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

    ###
    hmmm -_-

  2. #2
    Senior Member PC720's Avatar
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    I wonder if that would help with myelomalacia

  3. #3
    Senior Member lunasicc42's Avatar
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    invivos interesting webcast http://lifesci.rampard.com/20151203/index.jsp
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  4. #4
    Minimally invasive, no! We have to get right into the injury site. No matter how you do it I wouldn't call exposing the spinal cord minimally invasiv. Let's pray they're not just injecting it into the spinal Fluid

  5. #5
    Quote Originally Posted by lunasicc42 View Post
    Is there still an agreement between MP and Invivo? MP is running their own trial, Invivo is running their own trial and pursuing their own cells; and doing the trial in Dr. Young's hospital. What was the agreement for between MP and Invivo?

    I do truly feel a bit excited about all of these. Kind a feel like that great-atom-bomb of figuring-it-all-out is about go off. But it still seems there are a lot of independent wheels turning, none of them connected to each other or the same wagon.
    please . . .test what you already know; and give us what you have. we may not be dying, but we certainly are not living either

  6. #6
    eLedbetter
    Guest
    so are they taking this into clinical trials? Or are they announcing results?

  7. #7
    InVivo in 2016: Looking Ahead ? December 17, 2015
    http://www.invivotherapeutics.com/ab...o-perspective/


    CEO?s Perspective

    View Archives

    InVivo in 2016: Looking Ahead ? December 17, 2015

    This year was one of tremendous progress for InVivo. In 2015, we uplisted to a major stock exchange, completed enrollment of the pilot stage of the pivotal probable benefit INSPIRE study, communicated encouraging early clinical data, and engineered an accelerated regulatory plan to bring the Neuro-Spinal Scaffold? that much closer to commercialization. However, as we are on a mission ?to redefine the life of the spinal cord injury (SCI) patient? ? and realizing the ultimate goal is still in front of us ? I?d like to outline what lies ahead for 2016 and how we plan to continue to create fundamental value for our most important partners: shareholders and patients.

    Propelling through the INSPIRE study

    We have continued to foster a collaborative and fruitful relationship with the Food and Drug Administration (FDA) that has allowed us to dramatically shorten traditional clinical development timelines. In December 2015, we unveiled our plan for the INSPIRE study, including the conversion of our pilot study into a pivotal probable benefit study. Having laid the critical groundwork for INSPIRE, in 2016 we will set out to:

    Announce an Objective Performance Criterion (OPC) for INSPIRE
    Expand the INSPIRE study to the full 20 patients
    Announce at least 10 new INSPIRE sites, with 7 coming on board in the first half of the year
    Approach full enrollment of INSPIRE by the end of the year
    Announce results from the INSPIRE study as appropriate
    Obtaining marketing approval for the Neuro-Spinal Scaffold is inherently different from obtaining marketing approval for many devices because of the accelerated regulatory pathway we have chosen ? Humanitarian Device Exemption (HDE). Unlike a Premarket Approval (PMA), for which a sponsor usually has to power and conduct a pivotal study that demonstrates the investigational product is statistically superior to a control, an HDE only requires the demonstration of safety and probable benefit, which is a lower regulatory hurdle. In order to assess probable benefit, HDE sponsors can establish an Objective Performance Criterion (OPC) to prospectively define success in an uncontrolled study. We are in late-stage discussions with the FDA regarding the definition of the OPC, using historical benchmarks from large, well-established natural history databases as a guide. Once the OPC is agreed upon, we should have a clear view of the likely path to commercialization. Of course, the OPC is not the only variable that the FDA evaluates when reviewing an HDE application. Approval is not guaranteed if the OPC is met, and even if the OPC is not met, the FDA may approve a therapy if safety and probable benefit is supported by a comprehensive review of all clinical endpoints and preclinical results.

    In parallel to the OPC discussions with FDA, we will continue to enroll patients, and we expect the FDA will authorize us to expand the number of patients to the full 20 in 2016. We hope to be approaching full enrollment by the end of the year, which will hinge upon a steady ramp-up of clinical sites. We are targeting as many as 10 new sites by year-end, with 7 coming on board in the first half of the year. In addition to several more sites in the U.S., we plan to open our first ex-U.S. sites in Canada and the United Kingdom.

    It is extraordinary to think that just over a year after enrolling the first patient in our study, we are now running a pivotal trial with planned international expansion and the potential to file an application for HDE approval in just two years.

    Value Beyond INSPIRE ? Cervical SCI and Bioengineered Neural Trails?

    In addition to all of the exciting progress with the INSPIRE study in which we are investigating the Neuro-Spinal Scaffold in patients with acute, neurologically complete thoracic SCI, we also expect to make significant progress in 2016 with our programs dedicated to cervical and chronic SCI. To that end, we recently announced our plans to initiate in mid-2016 a study for acute, neurologically complete cervical SCI. The importance of moving higher in the spinal cord cannot be overemphasized, as cervical SCI represents a higher-risk/higher-reward condition than thoracic SCI. In general, gaining or losing a single neurological level in patients with thoracic injuries may have minimal impact on the patient?s overall function and quality of life. However, in the cervical cord, a single level often makes a dramatic difference. We are highly encouraged by the safety profile of the Neuro-Spinal Scaffold in the INSPIRE study to date, and we look forward to testing the Neuro-Spinal Scaffold in injuries where small changes in neuronal preservation or regrowth may have substantial impact on function. I?ll devote an entire CEO?s Perspective on the importance of pursuing a treatment for cervical SCI when we officially launch the program (mid-2016).

    We are also devoting significant resources to advancing our Bioengineered Neural Trails program for the 276,000 patients in the U.S. currently living with chronic SCI. Recently, we announced the acquisition and filing of foundational intellectual property for this exciting new approach to stem cell therapy for chronic SCI. We?ll continue to update the public with our progress in this area and are targeting a pre-IND (Investigational New Drug) meeting with the FDA by the end of 2016, which will help inform our development and clinical plans for the program.

    This has been a fantastic year of progress for InVivo, but I believe that 2016 will be even more exciting as we continue to move closer to our goal of redefining the life of the spinal cord injury patient.

    Mark Perrin, CEO and Chairman
    December 17, 2015
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  8. #8
    It appears to me that they are the only company that really wants to take the risk of solving this problem. Go InVivo!

  9. #9
    Quote Originally Posted by eLedbetter View Post
    so are they taking this into clinical trials? Or are they announcing results?
    Neither one.

    All they did was announce the acquisition and filing of foundational intellectual property (patents) for the stem cell therapy for chronic SCI (bioengineered neural trails). They're talking to the FDA and working on it pre-clinically..

  10. #10
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by ineedmyelin View Post
    InVivo in 2016: Looking Ahead ? December 17, 2015
    http://www.invivotherapeutics.com/ab...o-perspective/


    CEO?s Perspective

    View Archives

    InVivo in 2016: Looking Ahead ? December 17, 2015

    This year was one of tremendous progress for InVivo. In 2015, we uplisted to a major stock exchange, completed enrollment of the pilot stage of the pivotal probable benefit INSPIRE study, communicated encouraging early clinical data, and engineered an accelerated regulatory plan to bring the Neuro-Spinal Scaffold? that much closer to commercialization. However, as we are on a mission ?to redefine the life of the spinal cord injury (SCI) patient? ? and realizing the ultimate goal is still in front of us ? I?d like to outline what lies ahead for 2016 and how we plan to continue to create fundamental value for our most important partners: shareholders and patients.

    Propelling through the INSPIRE study

    We have continued to foster a collaborative and fruitful relationship with the Food and Drug Administration (FDA) that has allowed us to dramatically shorten traditional clinical development timelines. In December 2015, we unveiled our plan for the INSPIRE study, including the conversion of our pilot study into a pivotal probable benefit study. Having laid the critical groundwork for INSPIRE, in 2016 we will set out to:

    Announce an Objective Performance Criterion (OPC) for INSPIRE
    Expand the INSPIRE study to the full 20 patients
    Announce at least 10 new INSPIRE sites, with 7 coming on board in the first half of the year
    Approach full enrollment of INSPIRE by the end of the year
    Announce results from the INSPIRE study as appropriate
    Obtaining marketing approval for the Neuro-Spinal Scaffold is inherently different from obtaining marketing approval for many devices because of the accelerated regulatory pathway we have chosen ? Humanitarian Device Exemption (HDE). Unlike a Premarket Approval (PMA), for which a sponsor usually has to power and conduct a pivotal study that demonstrates the investigational product is statistically superior to a control, an HDE only requires the demonstration of safety and probable benefit, which is a lower regulatory hurdle. In order to assess probable benefit, HDE sponsors can establish an Objective Performance Criterion (OPC) to prospectively define success in an uncontrolled study. We are in late-stage discussions with the FDA regarding the definition of the OPC, using historical benchmarks from large, well-established natural history databases as a guide. Once the OPC is agreed upon, we should have a clear view of the likely path to commercialization. Of course, the OPC is not the only variable that the FDA evaluates when reviewing an HDE application. Approval is not guaranteed if the OPC is met, and even if the OPC is not met, the FDA may approve a therapy if safety and probable benefit is supported by a comprehensive review of all clinical endpoints and preclinical results.

    In parallel to the OPC discussions with FDA, we will continue to enroll patients, and we expect the FDA will authorize us to expand the number of patients to the full 20 in 2016. We hope to be approaching full enrollment by the end of the year, which will hinge upon a steady ramp-up of clinical sites. We are targeting as many as 10 new sites by year-end, with 7 coming on board in the first half of the year. In addition to several more sites in the U.S., we plan to open our first ex-U.S. sites in Canada and the United Kingdom.

    It is extraordinary to think that just over a year after enrolling the first patient in our study, we are now running a pivotal trial with planned international expansion and the potential to file an application for HDE approval in just two years.

    Value Beyond INSPIRE ? Cervical SCI and Bioengineered Neural Trails?

    In addition to all of the exciting progress with the INSPIRE study in which we are investigating the Neuro-Spinal Scaffold in patients with acute, neurologically complete thoracic SCI, we also expect to make significant progress in 2016 with our programs dedicated to cervical and chronic SCI. To that end, we recently announced our plans to initiate in mid-2016 a study for acute, neurologically complete cervical SCI. The importance of moving higher in the spinal cord cannot be overemphasized, as cervical SCI represents a higher-risk/higher-reward condition than thoracic SCI. In general, gaining or losing a single neurological level in patients with thoracic injuries may have minimal impact on the patient?s overall function and quality of life. However, in the cervical cord, a single level often makes a dramatic difference. We are highly encouraged by the safety profile of the Neuro-Spinal Scaffold in the INSPIRE study to date, and we look forward to testing the Neuro-Spinal Scaffold in injuries where small changes in neuronal preservation or regrowth may have substantial impact on function. I?ll devote an entire CEO?s Perspective on the importance of pursuing a treatment for cervical SCI when we officially launch the program (mid-2016).

    We are also devoting significant resources to advancing our Bioengineered Neural Trails program for the 276,000 patients in the U.S. currently living with chronic SCI. Recently, we announced the acquisition and filing of foundational intellectual property for this exciting new approach to stem cell therapy for chronic SCI. We?ll continue to update the public with our progress in this area and are targeting a pre-IND (Investigational New Drug) meeting with the FDA by the end of 2016, which will help inform our development and clinical plans for the program.

    This has been a fantastic year of progress for InVivo, but I believe that 2016 will be even more exciting as we continue to move closer to our goal of redefining the life of the spinal cord injury patient.

    Mark Perrin, CEO and Chairman
    December 17, 2015

    Nice
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

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