Thinly traded micro cap Asterias Biotherapeutics (AST +12.4%) perks up on light volume in response to its update on its ongoing SciStar Phase 1/2a clinical trial assessing the 10M-cell dose of AST-OPC1 (oligodendrocyte progenitor cells) in patients with sub-acute C-5 to C-7 cervical spinal cord injury (SCI). Data on the sixth and final patient in the AIS-A (complete injury, no motor function below the injury site) 10M cell cohort showed upper extremity motor function improvement at month 3 and further improvement in month 6. The results were consistent with the five previous patients. Upper extremity motor function is the most desirable functional improvement in the quadriplegic population. CEO Steve Cartt says, "These results are quite encouraging, and suggest that there are meaningful improvements in the recovery of functional ability in patients treated with the 10 million cell dose of AST-OPC1 versus spontaneous recovery rates observed in a closely matched untreated patient population. We look forward to reporting additional efficacy and safety data for this cohort, as well as for the currently-enrolling AIS-A 20 million cell and AIS-B 10 million cell cohorts, later this year." Read this article: Asterias Bio's cell therapy continues to demonstrate treatment effect in spinal cord injury … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV)today announced that it has submitted its first module containing nonclinical studies to the U.S. Food and Drug Administration (FDA) as part of its Humanitarian Device Exemption (HDE) modular submission and review process for the Neuro-Spinal Scaffold. InVivos modular HDE process is based on a submission of three modules to the FDA that constitute a complete HDE submission once all have been submitted: a nonclinical studies module, a manufacturing module, and a clinical data module. This process allows the FDA to review each module separately and provide timely feedback, typically within 90 days of submission, thereby allowing the applicant the opportunity to resolve any deficiencies earlier in the review process compared to a traditional HDE application. The submission of our nonclinical studies module marks the accomplishment of another major milestone for the INSPIRE Study, Mark Perrin, InVivos Chief Executive Officer and Chairman, said. We expect to receive acceptance of the nonclinical module in the third quarter of this year, and plan to submit the manufacturing module in the second half of 2017 and the clinical module in 2018, all as part of our strategy to pursue accelerated approval for the Neuro-Spinal Scaffold. About the … Continue reading →

A Texas Criminal Court of Appeals decision stunned brain injury advocates when it ruled last week that a State of Texas dedicated fund, which provides medically-necessary services to Texans with brain and spinal cord injuries, is unconstitutional. The result is a catastrophic loss of funding required to continue a brain injury treatment program. Austin, Texas (PRWEB) March 21, 2017 A Texas Criminal Court of Appeals decision stunned brain injury advocates when it ruled last week that a State of Texas dedicated fund, which provides medically-necessary services to Texans with brain and spinal cord injuries, is unconstitutional. The Comprehensive Rehabilitation Services (CRS) program is administered by the Health & Human Services Commission, and benefits all Texans impacted by brain injury including crime victims and veterans. The Court agreed with the appellant, Orlando Salinas, finding the dedicated fund directing revenue to the CRS program from misdemeanor and felony court costs to be an unlawful tax, and therefore unconstitutional. In a ruling on Wednesday, March 8, the Court ordered districts to stop collections for CRS and one other that offers counseling to abused children within 40 days. This loss of funding is an immediate threat to the CRS program and may result in … Continue reading →