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News - Biotechnology

Life-changing celluar medicine for patients with auto-immune disease

Health Industry Hub | September 9, 2019 |

Globally more than 2 million people suffer from Crohn’s Disease (40,000 in Australia) – a debilitating auto-immune disorder characterised by chronic, and sometimes life-threatening gut inflammation. It’s estimated that each year Crohn’s disease costs the global economy more than US$7.5b, with drawbacks to current treatments including serious side-effects and daily administration.

Isopogen is a privately-owned company developing life-changing cellular medicines. The patented StemSmart technology improves the clinical efficacy of mesenchymal stem cells (MSC), offering a powerful competitive advantage against other MSC products.

Derived from donor bone barrow, mesenchymal stem cells (MSCs) are isolated and grown, before applying the patented StemSmart technology to improve the cells’ clinical efficacy. This manufacturing is completed under a Therapeutic Goods Administration (TGA) license in accordance with Good Manufacturing Practice (GMP). The resulting proprietary cellular medicine is a non-invasive, universal treatment (does not require patient tissue matching) that can be frozen until use.

By moderating the patient’s immune system and supporting tissue regeneration, these products can be a life-changing treatment for patients suffering from some of the most debilitating inflammatory and auto-immune conditions.

Already more than 150 patients have been safely treated with products created using the StemSmart technology in Clinical Trials and under Special Access Arrangements. These results have been widely published, including an impressive 80% clinical response and 53% clinical remission in life-threatening (refractory) Crohn’s patients (Phase II study), making the StemSmart created product the only MSC treatment clinically-proven to treat this condition.

Led by internationally renowned cellular scientist Dr Marian Sturm, in 2020 Isopogen will work to submit its product application for life-threatening Crohn’s to Australia’s TGA. If successful, this will ensure wider distribution of this life-changing treatment, and will provide a foundation for international licensing opportunities – potentially helping Crohn’s sufferers globally.

Coupled with its patented StemSmart manufacturing technology that can be licensed to MSC manufacturers globally, Isopogen aims to maximise the benefits of cellular therapies to patients worldwide.


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