CellBead Neuro
We are developing a Drug-Eluting Bead for the treatment of neurological trauma and neurological degeneration. The bead will release a proprietary Glucagon Like Peptide (GLP-1), whose activity against programmed cell death has been established in pre-clinical work at the International Neuroscience Institute (INI) in Hannover. A clinical trial protocol has been developed with INI and a regulatory submission has been made that, if approved, would allow the start of a Phase I/II trial for the treatment of Intra-Cerebral Haemorrhage (ICH), a severe form of stroke. A response from the regulatory authorities is expected during the course of 2007.
Every year 125 000 people in the US and the five leading European countries suffer an ICH and treatment options are limited.
Despite the number of people affected, CellMed’s stroke programme has very limited competition. In recent years, the most valuable developments have been improved patient management protocols, rather than new therapeutic agents whose progress has been consistently disappointing. Cellmed aims to be the first company to treat a stroke patient with a stem cell product. At least two other companies have stem cell programmes for stroke and at least seven other companies have announced that they are close to the start of a clinical trial for a stem cell product in indications that include stroke, diabetes and cancer. The scientific and regulatory challenge to this type of technology remains considerable for all companies.