Acquisition includes Phase II-ready autologous bone marrow stem cell product for acute myocardial infarction.
NeoStem is acquiring Amorcyte in a shares-based deal that has already been agreed to by holders of more than 50% of the latter’s shares. Amorcyte is a cell therapy company with a lead product poised to start in Phase II studies for the treatment of acute myocardial infarction.
Amorcyte is focused on developing treatments for cardiovascular disease. Initial candidate AMR–001 is an autologous bone marrow-derived, CD 34-positive selected stem cell product for the treatment of damaged heart muscle following acute myocardial infarction. Amorcyte says the treatment works by increasing microvascular blood flow in the myocardium via neoangiogenesis, to help reverse post-infarct ischemia .
The company is currently assessing the safety and efficacy of AMR–001 in patients who have suffered a severe AMI and who are at risk of further adverse events. A completed 31 patient Phase I trial demonstrated the treatment to be safe, and identified the threshold dose for efficacy. Patients receiving 10 million cells or more showed statistically significant improvements in perfusion/RTSS and trends toward improvements in measures of cardiac function measures. A proposed Phase II study with AMR-001 will include 230 patients.
U.S.-based NeoStem is focused on accelerating the development of cellular therapies and positioning itself as a source for the collection, storage, manufacturing, therapeutic development, and transportation of cells for cell-based medicine and regenerative science globally.
Neostem’s acquisition of Amorcyte follows on from its January acquisition of U.S.-based cell therapy manufacturing firm Progenitor Cell Therapy, which provided Neostem with both contract manufacturing facilities and a platform for evaluating, developing, and registering autologous, allogeneic immunomodulatory and vaccine-based therapeutics. NeoStem says the PCT acquisition will enable it to focus on growing the cord blood and adult stem cell banking, cellular manufacturing, and therapeutic business, as well as expanding its presence in Asia and other countries.
Neostem also owns 80% of Athelos, which is developing a T-cell therapeutic for autoimmune conditions, and has a worldwide exclusive license to very small embryonic-like (VSEL™) stem cell technology. The firm is bolstering its Chinese presence by establishing an operations lab for cell-based manufacturing in China, and also holds a 51% stake in Chinese generics firm Suzhou Erye Pharmaceutical.
Through its Stem for Life Foundation, Neostem is working alongside the Vatican’s Pontifical Council for Culture’s Science, Theology and the Ontological Question (STOQ) International initiative, to advance adult stem cell research. The partnership aims to foster scientific research and lay the groundwork for a collaborative networks of scientists.