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The cells have been used many times over the years via early-phase clinical trials, studies and on compassionate grounds, with promising results.
Later in the year, NeuroScientific expects to receive the interim results from its latest compassionate access program involving patients with difficult-to-treat fistulising Crohn’s disease, in which an open wound develops from a gut flare-up that extends out to the skin.
A successful clinical outcome will help the company validate its proprietary StemSmart technology in this patient group, which otherwise has limited treatment options.
NeuroScientific is fast building towards regulatory approvals and commercialisation for StemSmart. This month, it announced two heavy-hitting appointments. The company has appointed Melbourne-based Smith’s as its chief executive officer and well-regarded Perth-based paediatric haematologist and oncologist Dr Catherine Cole as its chief medical officer.
Smith has extensive experience in cell and gene therapies in senior commercial, operational and strategic roles in Australia and the United States, which should prove invaluable as the company navigates the regulatory and commercial pathways for its innovative StemSmart technology.
The company says Smith’s deep expertise in good manufacturing practice (GMP) will be critical for converting the biotechnology startup into a scaled-up commercial stem cell company.
Cole has held clinical and academic leadership roles across Australia and overseas, including head of haematology and oncology at Perth Children’s Hospital and professor of paediatric haematology and oncology at The University of Western Australia.
She is also the former director of stem cell transplantation at Perth Children’s Hospital, placing her front and centre in NeuroScientific’s race to employ stem cell therapy to treat some of the most debilitating transplant complications and autoimmune diseases.
The high-level executive duo join a strong leadership team, which also includes Perth-based haematology medical scientist Dr Marian Sturm as NeuroScientific’s chief scientific officer. Sturm pioneered the use of the MSC used in StemSmart over the past 20 years in her former role as facility director of Royal Perth Hospital’s Cell and Tissue Therapies centre.
While competition in the stem cell space is fierce, the upside is enormous. StemSmart’s progress and results over decades of development position the product closer to near-term commercialisation than some others also in the pipeline, which will be helped along by NeuroScientific’s healthy bank balance.
A $3.5 million capital raise handed the company a $7.5 million war chest to support further trials and development and help it generate plenty of momentum towards its long-term goal of partial or full registration for StemSmart, first up as a Crohn’s treatment.
NeuroScientific’s progress in the field of stem cell therapy has certainly got the tongues wagging recently. The soaring share price has hardly taken a breather, clocking in with an eye-watering 360 per cent rise to 23.5 cent a share in the last two months alone.
As StemSmart edges closer to regulatory approval and potential commercial rollout starts to take shape - starting with the pressing need in Crohn’s disease - NeuroScientific appears poised to carve out a meaningful niche in the high-stakes world of advanced cell therapies.
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