BlueRock Therapeutics Announces Closeout of First Cohort in Phase 1 Trial in Patients with Advanced Parkinson’s Disease
Excerpt from the Press Release:
CAMBRIDGE, Mass., Jan. 6, 2022 /PRNewswire/ — BlueRock Therapeutics, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, announced the closeout of the first of two cohorts in its ongoing Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with advanced Parkinson’s disease. The purpose of the Ph1 clinical trial is to evaluate the safety, tolerability and preliminary efficacy of DA01 in patients with Parkinson’s disease.
Enrollment of the first cohort of patients was completed at three active sites in the United States and Canada: Weill Cornell Medicine, University of California, Irvine and University Health Network. Patients in the first cohort received a bilateral surgery to transplant dopaminergic neurons in the midbrain region. No severe adverse events were observed in any participating patients.
“By replacing lost neurons in the midbrain region of patients with Parkinson’s disease, we have the potential to regenerate lost function and possibly improve and reverse the disease,” states Joachim Fruebis, Ph.D., Chief Development Officer of BlueRock Therapeutics. “This is an incredible step forward as we execute on our goal of bringing authentic cellular medicines to patients in desperate need of treatment.”
About the DA01 Phase 1 Trial
Enrollment is currently open for the second and final high-dose cohort in both the United States and Canada. The primary objective of the Ph1 trial is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the trial are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.
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