Investigators have completed preclinical research in which a group of mice treated with ALD-401 two weeks after an induced stroke showed statistically significant improvement in motor function of 41% compared to the improvement of 11% in an untreated group. Researchers also saw statistically significant improvements in the slowing of decrease in brain volume and the reversal of decline in stroke-induced cell viability in the ALD-401 group compared to the untreated group. In another study, researchers assessed the amount of blood flow, or perfusion, in the brains of mice treated with ALDHbr cells two weeks after an induced stroke compared with mice treated only with a neutral delivery vehicle. Four weeks after the treatment, the brains of the mice that received the delivery vehicle remained impaired, but perfusion in the mice that had received ALDHbr cells had returned to normal levels.
We have received clearance of an investigational new drug application, or IND, with the U.S. Food and Drug Administration, or FDA, and to proceed with a Phase 2 trial of ALD-401.
