Neuralstem has dosed its first patient in Phase 1b of its ongoing trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of major depressive disorder (MDD).
NSI-189, a proprietary new chemical entity, stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD as well as other diseases and conditions.
Neuralstem board director and chief scientific officer, Karl Johe, said the company are beginning to test the safety of NSI-189 in depression patients.
"We believe it could help patients who suffer from depression via a new mechanism that does not seek to modulate brain chemistry, but rather stimulates new neuron growth in the hippocampus and increases hippocampal volume, thereby potentially addressing the problem at the source," Johe added.
The 1a Phase of the randomised, double-blind, placebo-controlled NSI-189 / MDD trial tested escalating doses of single administration of NSI-189 in healthy patients.
The 1b Phase of the multiple-dose escalating trial, which is expected to take six months to complete, will test the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients.
Neuralstem's technology will facilitate the creation of neural stem cell lines from several areas of the human CNS, including the hippocampus, according to the company.
Neuralstem has created a number of mature human neurons and glia in laboratory dishes from its hippocampal neural stem cell lines, which can be used to imitate the natural brain environment in order to test drug effects.