Started in late July 2014, the Phase IIa trial is being conducted under an investigational new drug (IND) application filed by the company’s licensor, the Blanchette Rockefeller Neuroscience Institute (BRNI).
In preclinical in vivo models, Bryostatin has been shown to play a major role in slowing or reversing AD and restoring cognition, memory and motor skills.
The primary objective of the trial is to evaluate the safety and tolerability of a single dose of Bryostatin-1, while the secondary objectives include the preliminary evaluation of efficacy using a variety of clinical measures, including an assessment of improvements in cognition.
The company intends to report final results from the Phase IIa clinical trial of Bryostatin-1 in January 2015.
The company is currently developing a randomized, double-blind placebo controlled, multiple-dose clinical trial to further evaluate the efficacy and safety of Bryostatin-1 in the treatment of AD.