NeuroScientific Appoints Dr. Cathy Cole to Lead Stem Cell Therapy Development for Crohn’s Disease
NeuroScientific brings Dr. Cole onboard as it advances stem cell research and prepares for clinical trials.
NeuroScientific Biopharmaceuticals has appointed Dr. Cathy Cole to its management team, a move the company says will strengthen its ongoing program focused on special access scheme (SAS) fistulas in Crohn’s disease. SAS is similar to the USA’s expanded access program; it allows providers to access unapproved therapies on a case-by-case basis.
About a month ago, Australian biotech company NeuroScientific Bio acquired a company called Isopogen WA, which developed and patented a bone marrow-derived mesenchymal stem cell therapy named StemSmart.
Key Points:
- StemSmart has gone through Phase 2 trials in refractory Crohn’s disease, and the results reportedly showed that it’s a potent, efficacious, and safe therapy for the condition.
- It’s derived from adult human bone marrow, the mesenchymal stem cells (MSCs) are isolated and grown in culture (expanded), and they apply their patented manufacturing process to “improve the cells’ clinical efficacy”
- StemSmart works by interacting with a patient’s immune system to module the responses
- Patients both locally and interstate have already received StemSmart™ MSC therapy on
compassionate grounds, for a variety of serious and life-threatening clinical conditions,
with multiple strong positive clinical responses.
The MSCs used in StemSmart were developed over the past two decades by Dr. Marian Sturm, a haematology medical scientist and NeuroScientific’s incoming chief scientific officer, during her tenure as facility director at Royal Perth Hospital’s Cell and Tissue Therapies centre. The underlying platform technology and manufacturing processes were developed and refined at Royal Perth Hospital.
The company notes that these cells have been administered in early-phase clinical trials, research studies, and under compassionate use protocols, with promising results observed.
If NeuroScientific’s current SAS trial in fistulizing Crohn’s disease meets its endpoints, the company intends to move forward with phase 1/2 clinical trials and pursue the necessary regulatory and funding approvals for broader rollout.
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