Bayer confirms the positive results of their Parkinson’s stem cell therapy initial trial developed by their subsidiary BlueRock Therapeutics. The trial was conducted on 12 patients which shows signs of reducing the Parkinson’s disease symptoms.
Earlier, Bayer announced the success of the trial but the details were withheld.
“Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, today announced positive top-line results from a Phase I clinical trial of investigational drug, bemdaneprocel (BRT-DA01), a potential first-in-class cell therapy for Parkinson’s disease. The trial showed that bemdaneprocel was well-tolerated in all 12 patients in the study to date, with no major safety events. In addition, an assessment of the study’s secondary endpoints demonstrated feasibility of transplantation and evidence of cell survival and engraftment in the brain through one year. Based on these results, planning is underway for a Phase II study that is expected to begin enrolling patients in H1 (first half) 2024.” – June 28, 2023
Bayer AG
Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today details of the positive data from the Phase I clinical trial for bemdaneprocel (BRT-DA01), a stem cell derived investigational therapy for treating Parkinson’s disease. The data were presented at the International Congress of Parkinson’s Disease and Movement Disorders® in Copenhagen, Denmark.
The study met the primary objective of demonstrating safety and tolerability in all 12 participants in the study’s low and high dose cohorts, with no serious adverse events (SAEs) reported related to bemdaneprocel through one year. There were two SAEs reported that were unrelated to bemdaneprocel, one seizure attributed to the surgical procedure and one COVID case. Both resolved without sequelae. In addition, 18F-DOPA PET imaging scans demonstrated evidence of cell survival and engraftment in both low and high dose cohorts. 18F-DOPA PET imaging is a neuroradiological technique used to visualize and assess dopaminergic activity in Parkinson’s disease. – August 28, 2023
Bayer AG
“The data from this Phase I open-label study are extremely encouraging,” said Claire Henchcliffe, one of the study’s Principal Investigators
Parkinson’s disease is a neurodegenerative ailment that progresses due to nerve cell destruction in the brain, resulting in decreasing dopamine levels. At the time of diagnosis, individuals are believed to have lost fifty to eighty per cent of their dopaminergic neurons. The degeneration of these neurons causes a gradual impairment of motor function.
Blurock’s experimental therapy uses stem cells, which are transformed into brain/nerve cells that produce dopamine. These cells act as a transplant to re-acquire the nerve cells damaged by Parkinson’s disease.
Source: Reuters, Bayers Global
Published: 28-August-2023
Updated:
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