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news.PixarBio has filed an application with the US FDA Office of Orphan Products Development, for orphan drug status of its NeuroRelease SCI (NR-SCI) a novel drug candidate for the treatment of Spinal Cord Injury (SCI).
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"Changes at InVivo Therapeutics after I left the company in August of 2013 have permanently limited wide market adoption of my first generation of NeuroScaffolds. PixarBio’s Novel NR-SCI is an injectable self-assembling NeuroScaffold for acute spinal cord injury with clinical studies planned for Late 2018. Our submission to the FDA represents a significant advancement over NVIV’s product. Minimally invasive and patent protected to deliver drugs, biologics and cells, we will lead the spinal cord injury industry forward."
"This submission to the FDA represents a new phase of SCI industry growth where minimally invasive products for spinal cord injury will fill R&D portfolios. NR-SCI, is a New Drug injected to treat the onset of paralysis after a traumatic spinal cord injury, also known as "the secondary injury."
Up to 90% of patients are NOT paralyzed from their primary injury, but instead they are paralyzed over a 21-day post-injury inflammation process that results in scar tissue formation. We will disrupt scar tissue formation."
PixarBio CEO Frank Reynolds said: "We will mitigate secondary injury with NeuroRelease SCI. We will extend the brand into my NeuroRelease Stem Cell treatment for the Chronic SCI patients and we intend to regenerate spinal cord tissue for the first time in history.
The USFDA grants Orphan Drug Designation status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
A successful designation of NeuroRelease SCI as an Orphan Drug would provide PixarBio with a 7-year period of market exclusivity in the U.S. upon approval of the drug, as well as tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, assistance from the FDA in the drug development process and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
The decision to seek an Orphan Drug Designation submission is part of PixarBio Corporation’s plan to move forward with the preparation of an Investigative New Drug Application (NDA) for Spinal Cord Injury.