Stepahead Australia Ltd
For the 2023/2024 project financial year we have continued our efforts in the following areas: Working in collaboration with international biotech and clinical research partners, Melbournebased investigators supported by our charity have been researching the benefits of infusing a naturally occurring protein called Decorin for treatment of traumatic spinal cord injury. As previously reported for the 2022/2023 project financial years, we have continued working with the Melbournebased Spinal Cord Injury Research (SCIR) team in supporting the clinical development and translation of Decorin from the laboratory to use in humans. As reported at the very end of the 2022/2023 project financial year, the pharmaceutical grade human recombinant Decorin protein (HrDecorin) originally developed by the SCIR team and USbased biotech partners has passed all necessary safety testing required for FDA IND (Investigational New Drug) approval for use in humans. This financial year the USbased biotech partners were awarded $3 million USD in funding from the US Department of Defense to support manufacturing of hrDecorin for clinical trials. The SCIR team have been working with USbased biotech partners to secure funding for human clinical trials with HrDecorin. A challenge is the considerable expense of conducting neurological disorder clinical trials compared to most other health disorders. Fortunately, in addition to treating spinal cord injuries and other neurological disorders, HrDecorin also has applications for treating burns and skin disorders such as Dystrophic Epidermolysis Bullosa. Notably a $1.2 million dollar LifeArc grant for a first in human trial for treatment of DEB with HrDecorin has recently been secured by UKbased clinical partners. This is a further vitally important step that will demonstrate safety and efficacy of HrDecorin in humans and accelerate the approval of pharmaceutical grade HrDecorin for treating neurological disorders in Australia. Also as previously reported, the SCIR team has continued to build a collaboration with a Sydneybased company called Isodynamics Reviver Corporation that is focused on conducting clinical trials to determine the optimum means of combining exercise rehab with HrDecorin infusion treatment to further enhance recovery of neurological function after traumatic spinal cord injury. The activities of our charity have therefore continued to focus on supporting clinically relevant scientific research that has a clear path to clinical trials for neurological disorders in humans.
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