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Regenerative medicine company, Regeneus (ASX:RGS), has secured a Chinese patent for the use of biomarkers to monitor disease progression in stem cell therapy patients.

The patent is tied to the use of a particular type of stem cell called mesenchymal stem cells (MSCs) and covers use in therapies for inflammatory conditions.

It will cover therapies in which the stem cell is taken from the patient, stored or treated and put back (autologous), and therapies where the stem cell is derived from another person or source (allogenic).

Regeneus CEO John Martin explained the significance of MSCs in stem cell therapy: “MSCs are multipotent stem cells that can differentiate into a variety of cell types, and their ability to produce more than one stem cell type makes them well suited to regenerative therapies.

“Furthermore, they can self-renew and differentiate into multiple tissues including bone, cartilage, tissue, muscle and fat cells.”

Regeneus derives its stem cells from adipose (fat) tissue. However, the patent is not limited to MSCs derived from adipose tissue, providing Regeneus with the ability to potentially licence the patent to other MSC therapies.

MSCs can be manufactured in various ways, including from bone marrow, placental tissue and manufactured from of induced pluripotent stem cells (iPSC), which have all the properties of an embryonic stem cell, without being an embryonic stem cell.  

Regeneus is not alone in developing therapies using MSCs. Other ASX-listed companies currently developing therapies using MSCs include Cynata Therapeutics (ASX:CYP), Orthocell (ASX:OCC) and Mesoblast (ASX:MSB).

MSCs have been recognised as having anti-inflammatory effects and have proven efficacy in a range of inflammatory conditions including graft versus host disease, Crohn’s disease, cardiovascular disease and osteoarthritis.

Biomarkers are a useful way to measure the effects of MSC therapies and can be analysed simply in a patient’s blood or other body fluids.

While the use of biomarkers is not new or novel, the use of biomarkers in tracking MSC therapies has not yet been patented – making Regeneus the first company to patent this method.

The patent adds to Regeneus’s existing patent protection in China for the use of Sygenus stem cell secretions in the topical treatment of acne.

“There is increasing interest in China for in-licensing cell therapy technology platforms like Progenza,” Mr Martin said.

“New legislation to accelerate the approval pathway for cell therapy products in China provides stem cell products, such as Progenza, with a favourable and fast pathway to get to market.”

Under the Chinese government’s new laws, cell therapy products only need to go through two clinical phases: the first phase is focused on safety, and the second is a confirmatory phase to demonstrate probable efficacy.

Regeneus’s Progenza has completed phase 1 trials in the treatment of knee osteoarthritis, proving its safety and tolerability, as well as clinically meaningful pain relief for patients.

Regeneus has already secured its first licensing partner in Japan with AGC Asahi Glass for the exclusive manufacture of Progenza, and is in the final stages of negotiation with a second Japanese partner for the Phase 2 trial and clinical development and commercialisation of Progenza.

Regeneus has more than 80 patents or patent applications across multiple patent families, giving the company’s product pipeline a significant competitive advantage.


Star Investing may have commercial partnership with companies mentioned in this article. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.