Progenza is an allogeneic off-the-shelf stem cell technology platform developed for the treatment of knee osteoarthritis and other inflammatory conditions.
The classification was granted by the European Medicines Agency’s Committee for Advanced Therapies following consultation with the European Commission.
“Important to have regulatory clarity”
John Martin, chief executive officer, said “The granting of the ATMP classification for Progenza, is a step towards bringing Progenza to Europe as a novel cell therapy treatment for osteoarthritis.
“It’s important to have regulatory clarity as we invest in the development of Progenza.”
ATMP classified products are novel regenerative therapies that combine aspects of medicine, cell biology, science and engineering.
They are presented as having properties with a view to regenerating, repairing or replacing a human tissue.
ATMPs comprise cell and gene therapies and tissue-engineered products.
10-15% of all adults over 60 are affected
The World Health Organisation estimates that 10-15% of all adults over 60 have some degree of osteoarthritis, with prevalence higher in women than men.
Given that there are few preventative and therapeutic options for osteoarthritis and that the European population is ageing, the burden of osteoarthritis is predicted to rise.
Safety trial meets primary endpoints
Results of a phase I safety trial of Progenza in knee osteoarthritis met primary endpoints of safety and tolerability.
Secondary endpoints showed a significant, rapid and sustained reduction in knee pain, and significant improvement in cartilage volume compared to placebo, with positive signs of disease modification.
Reduced inflammation and pain
The Progenza cells work by secreting cytokines, growth factors and exosomes that act in concert to reduce inflammation and pain and encourage accelerated healing and repair of damaged or diseased tissue.
Progenza is produced from expanded mesenchymal stem cells (MSCs) extracted from adipose (fat) tissue from a healthy donor who has been extensively screened.
Unlike other stem cell products, Progenza includes secretions from MSCs that improve viability and functionality of the cells during the freezing and thawing process.
Regeneus has shown that the combination of cells and secretions has a more powerful therapeutic effect than cells alone.
The company has demonstrated the capacity to produce millions of therapeutic doses of Progenza from a single donor which helps avoid the need to pool donor material and seek multiple donors.
Regeneus is a Sydney-based clinical-stage regenerative medicine company using stem cell and immuno-oncology technologies to develop a portfolio of innovative cell-based therapies.
These are aimed at addressing significant unmet medical needs in the human and animal health markets with a focus on osteoarthritis and other musculoskeletal disorders, oncology and dermatology.