Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), has announced that the European Patent Office (EPO) granted a process patent for its novel stem-cell based drug Stempeucel. Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors.
The company’s proprietary pooling technology enhances the curative potential of the drug through stable and consistent secretion of growth factors of wider repertoire by the pooled cells compared to the cells from a single donor. This technology also allows more than one million clinical doses from a single set of master cell banks, which is unique in regenerative medicine. Also the novel pooling and manufacturing technology will make the product more affordable.
Stempeucel will initially be used for the treatment of CLI and is a breakthrough treatment option which directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself. CLI is a progressive form of peripheral arterial disease, which blocks the arteries in the lower extremities, resulting into reduction of the blood flow. It is a debilitating disease which manifested with severe unmanageable pain in the feet or toes of patients. Insufficient supply of blood flow results in the development of sores and wounds in legs and feet. If left untreated, patients may finally have to undergo amputation of the affected limb. Globally, the most common treatments for CLI are characterized by high rates of primary amputations, multiple procedures and high rates of procedure-related complications. In severe cases of CLI, the disease not only affects the quality of life but also increases the economic burden of patients and their family.
Commenting on the EU patent, B N Manohar, chief executive officer of Stempeutics said, “The patent granted by EPO is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores the global leadership on pooling technology of MSCs for allogeneic therapy. We believe that the Stempeucel product is a game-changer in offering an advanced therapeutic treatment for millions of patient suffering with this debilitating disease.”
Dr Ranjan Pai, chief executive officer of MEMG said, “Through Manipal Group’s investment in Stempeutics, we are demonstrating a firm commitment in bringing the next generation of biologics in order to address unmet medical needs. With this novel Stempeucel technology, we are supporting Stempeutics discovery of the first-of-its-kind treatment in the field of regenerative medicine. It is a significant milestone for Stempeutics and a satisfying journey for Manipal Education and Medical Group”.