Indication: Human Osteoarthritis
Technology Platform: Allogeneic off-the-shelf adipose-derived mesenchymal stem cells (MSCs)
Progenza is our lead cell therapy technology being developed for the treatment of osteoarthritis and other musculoskeletal disorders. It also has the potential to be used for other inflammatory conditions.
Progenza is made from expanded allogeneic MSCs from human adipose tissue and contains the bioactive secretions of the cells which have shown increased therapeutic benefit. Progenza works by reducing inflammation and promoting healing and repair in the damaged or diseased tissue. Progenza cells are adult stem cells and are not reprogrammed or genetically altered in any way during the manufacturing process.
Progenza is currently in a Phase 1 clinical trial for the treatment of knee osteoarthritis. For further information on this clinical trial, please refer to our Trials page.
Points of difference
Progenza is one of the new generation cell therapy treatments for osteoarthritis. Very few companies are targeting osteoarthritis. Progenza differentiates from other MSC therapies due to the inclusion of secretions from cells which improve the functionality of the MSCs post-thawing. The MSCs secrete cytokines and growth factors that reduce inflammation and pain and promote healing and repair of the damaged or diseased tissue. Further, the use of MSCs from adipose tissue assists in scaling the manufacture of the cells. Progenza manufacture has the demonstrated capability to produce millions of doses of cells from a single donor. A single donor will streamline the regulatory approval pathway.
Next steps for Progenza
We have identified Japan as a key target market for partnering clinical development, manufacturing and commercialisation of Progenza. Japan has positioned itself as a leader in regenerative medicine including establishing an accelerated approval process specifically designed for regenerative medicine products like Progenza.
We have entered into a strategic collaboration and licensing agreement with AGC Asahi Glass, Japan's leading biopharmaceutical contract manufacturer, for the manufacture, clinical development and commercialisation of Progenza for the Japanese market.
We have commenced preparations for the development of Progenza for the planned Phase 2 clinical trial of Progenza for osteoarthritis in Japan and its development for other major markets.
Related ASX announcements
- 29/12/16 Regeneus and AGC Asahi Glass to collaborate on Progenza regenerative medicine therapy in Japan
- 16/05/16 Enrolment completed and positive safety review in Progenza stem cell trial for osteoarthritis
- 12/01/16 Positive safety of first cohort in Progenza stem cell trial for knee osteoarthritis
- 11/11/15 Key patent granted for allogeneic stem cell technology platform
- 10/08/15 First patient treated in Progenza stem cell trial for knee osteoarthritis
- 22/04/15 Regeneus receives approval for Progenza stem cell trial for osteoarthritis
- 07/04/15 Regeneus achieves key stem cell manufacturing milestone for clinical trial
- 09/03/15 Regeneus reports positive preclinical results for off-the-shelf cell therapy treatment for osteoarthritis
- 19/12/14 Patent granted for protecting cryopreserved stem cells
- 26/11/14 New regenerative medicine laws to fast track cell therapy approvals take effect in Japan
- 21/08/14 Regeneus and Cryosite partner for the development and manufacture of human stem cell products
- 08/04/14 Regeneus receives ethics approval for collecting stem cells from human donors for first-in-man safety trial of its off-the-shelf treatment for osteoarthritis
- 25/11/13 Regeneus to fast-track human cells under new Japanese laws