BioTime is a clinical-stage biotechnology company developing new cellular therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. Recently, BioTime announced the completion of its acquisition of Asterias Biotherapeutics, Inc., which added two cell therapy clinical stage programs to the Company’s pipeline.
BioTime’s programs are based on the Company’s proprietary cell-based therapy platform and associated development and manufacturing capabilities. With our platform we develop and manufacture specialized, terminally-differentiated human cells from our pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury, or administered as a means of helping the body mount an effective immune response to cancer.
BioTime is developing three cell therapy programs (see Pipeline):
- OpRegen® – a retinal pigment epithelium cell replacement therapy currently being tested in a Phase I/IIa multicenter clinical trial for the treatment of advanced dry-age-related macular degeneration (dry-AMD) with geographic atrophy. OpRegen has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA).
- OPC1 – an oligodendrocyte progenitor cell therapy currently being tested in a Phase I/IIa multicenter clinical trial (the “SciStar Study”) for the treatment of acute spinal cord injuries (SCI). The clinical development of OPC1 has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug Designation by the FDA.
- VAC2 – an allogeneic (non-patient-specific or “off-the-shelf”) cancer immunotherapy of antigen-presenting dendritic cells currently being tested in a Phase I clinical trial in non-small cell lung cancer (NSCLC) funded and conducted by Cancer Research UK, the world’s largest independent cancer research charity.
BioTime’s lead cell delivery clinical program is Renevia®, a medical device that was developed as a replacement for whole adipose tissue in cell assisted lipotransfer (CAL) procedures.
In 2018, the Company submitted a design dossier for European Union (EU) market clearance (CE Mark) for the use of Renevia® as a device to aid in transferring a patient’s own adipose tissue to treat certain forms of facial lipoatrophy, or fat loss. BioTime anticipates receiving feedback from the EU regulatory agency in 2019. If approved, the Company intends to identify an external partner for commercialization of Renevia in Europe (Read more about BioTime’s Cell/Drug Delivery Technology).
We are a publicly traded company listed on the NYSE MKT and TASE under the symbol BTX.