This ongoing development program is establishing methods to isolate and expand human nTregs for large scale manufacturing to enable early clinical trials. We are exploring potential relationships with key leaders and academic investigators with sufficient preclinical data to support an IND application. We plan to investigate the clinical feasibility of nTreg-based therapeutics to prevent and/or treat type 1 diabetes, graft vs. host disease, steroid resistant asthma, lupus, multiple sclerosis and solid organ transplant rejection and expect to file an IND with the FDA in 2013 to commence human clinical studies in one of these disease indications.
Progenitor Cell Therapy -
NeoStem is rapidly emerging as a technology and market leading company in the fast developing cell therapy market. Our multifaceted business strategy includes Progenitor Cell Therapy (PCT), a state-of-the-art contract development and manufacturing organization (CDMO) . PCT increased revenues over 40% in 2012 from 2011. Acquisition of this contract development and manufacturing business brought cell therapy expertise in-house and allows us to cost-effectively develop cellular therapies for chronic unmet medical needs for both clients and for internal development. PCT has provided services to over 100 clients in its 14-year history, and is the only contract manufacturing organization to have worked with a client's product (Dendreon, Inc.'s Provenge) through all of the phases of clinical trials and ultimately to FDA approval. PCT offers its clients and NeoStem cell processing and development capabilities on both the East and West Coasts of the U.S and has plans to expand internationally. PCT has also built a strong foundation of services that cater to the industry as a whole, reducing our reliance on the success of our own varied technology platforms in that we still have the opportunity to capture growing revenues from industry growth. Furthermore, PCT's manufacturing revenues would increase significantly should a client progress through Phase I, II, and III trials and select us to be their commercialization partner where larger numbers of cell products are needed.