Date: 2015-03-17
Type of information: Results
phase: 1-2
Announcement: results
Company: Neurotrope BioScience (USA - NJ)
Product: bryostatin 1
Action
mechanism: protein kinase C activator. Bryostatin is a potent activator of Protein Kinase C epsilon (PKCe). Neurotrope is approaching the treatment of Alzheimer’s disease through the activation of PKCe. In animal models of Alzheimer’s disease, activation of PKCe has been shown to improve learning and memory, induce synaptogenesis or growth of new synapses and prevent neurodegeneration. Neurotrope is developing bryostatin under a licensing agreement with the Blanchette Rockefeller Neuroscience Institute (BRNI).
Disease: Alzheimer\'s disease
Therapeutic area: Neurodegenerative diseases
Country: USA
Trial
details: This randomized, double-Blind, placebo-controlled, study evaluates the preliminary safety, efficacy, pharmacokinetics and pharmacodynamics of bryostatin 1 in patients with Alzheimer\'s disease. (NCT02221947)
Latest
news: * On March 17, 2015, Neurotrope announced secondary and exploratory endpoint results from its randomized, double-blind, placebo-controlled, single dose Phase 2a clinical trial evaluating bryostatin-1 for the treatment of Alzheimer’s disease (AD). Final analysis of this Phase 2a safety study, in nine Alzheimer’s patients with mild dementia as measured by MMSE-2 scores, confirms the previously announced result. The study has met its primary endpoint demonstrating preliminary safety and tolerability of bryostatin. No safety signals have been identified. As a secondary objective, the Phase 2a safety study examined the correlation of the changes in PKCe with plasma levels of bryostatin after a single dose. Preliminary assessment of PKCe levels in peripheral monocytes demonstrated a significant increase in total PKC protein levels at the end of the bryostatin infusion consistent with target engagement. An additional secondary objective of the study was the evaluation of efficacy following a single dose of bryostatin. As expected with a single dose of bryostatin, there was no measurable improvement in cognition in this mildly impaired patient population. It is important to note that in previous animal studies improvement of learning and memory was first observed following multiple doses of bryostatin. The company is now planning a Phase 2b, multi-site, double-blind, placebo controlled trial of approximately 150 patients in moderately severe to severe AD patients.
