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.
A Phase I trial has been completed successfully with the primary safety endpoints met and efficacy showing significant reduction in knee pain and improvement in cartilage volume in STEP trial for Progenza.
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 commercialization 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.
Regeneus is in advanced negotiations for a commercial licensing partner for Progenza OA in Japan.
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.