Bemdaneprocel, a cell therapy developed for Parkinson’s disease by Bluerock Therapeutics, helped people control symptoms, according to trial data.
The Phase 1 trial included 12 adults with Parkinson’s who were given a high or low dose of the therapy. The medication was safe and well tolerated for up to 24 months, data showed.
“We are very excited to share the 24-month data from the exPDite trial which shows that bemdaneprocel could be a potentially meaningful treatment option for individuals living with Parkinson’s disease,” Amit Rakhit, chief development and medical officer at Bluerock, said in a press release.
The company presented data at the International Congress of Parkinson’s Disease and Movement Disorders, held Sept. 27-Oct.1 in Philadelphia.
In the study, the median age of participants was 67 years. Randomly, participants either got a low dose (0.9 million cells) or a high dose (2.7 million cells) of bemdaneprocel, which was put into the putamen, a part of the brain that contributes to movement control. Participants received a one-year course of immunosuppression to prevent the immune system from attacking the transplanted cells.
Participants in the high-dose group had a mean increase of 1.8 hours in good on state when compared to the start of the study. Good on state refers to periods of time when a patient gains satisfactory control of their motor symptoms. Those in the high-dose group had less time in the off state, and were better able to perform daily tasks.
Next up for those participants is to shift into a five-year study that would monitor their outcomes. The company is planning a placebo-controlled Phase 2 trial that should begin enrolling later this year.
Parkinson’s occurs when nerve cells that make dopamine become damaged and die over time. Dopamine is a chemical that has a role in controlling movement. Usually, people with the disease get Levodopa, but sometimes its effectiveness wears off before the next dose creating “off” times.
Bemdaneprocel, which was formerly known as BRT-DA01, transplants dopamine-producing nerve cells into the brain through surgery. These cells, derived from human embryonic stem cells, generate new neurons to help alleviate symptoms.
“There is considerable momentum in the concept of restoring dopamine inputs in the brain using transplanted cells, and the positive results from the exPDite trial leads the drive forward,” Claire Henchcliffe, MD, professor and chair of neurology at the University of California, Irvine, a part of the research team, added.
