Presented at the World Stroke Congress in Brazil
CMXI's safety data from the first 10 patients in the P2 RECOVER stroke study of ALD-401 <in the initial part of the study> was designed to assess the safety of ALD-401 … which showed no severe adverse events.
The study was expanded to a target enrollment of 100 patients following a review of these initial data by an independent Data Safety Monitoring Board (DSMB) earlier this year.
10 patients who had suffered MCA ischemic stroke were enrolled and randomized to 1 of 2 groups: a bone marrow harvest followed by intra-carotid infusion of purified ALDHbr cells or a sham harvest followed by sham angiography. This was a randomized, double-blind, intra-arterial stem cell trial and patients were monitored very closely for any adverse effects. Safety of the procedure was assessed by laboratory studies, neurological examinations and serial neuroimaging.
The ongoing expanded P2 RECOVER-Stroke trial will enroll an additional 90 patients at up to 15 US clinical sites. Again, it is designed to assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22 when administered between 13 and 19 days post the ischemic event.
The Bottom Line: This stroke trial with ALD-401 is being developed as a therapeutic benefit 2 weeks … after the initial event. The expanded RECOVER-Stroke trial was designed to give more insight into the product's safety and efficacy. ALD-401 is the population of ALDHbr stem cells produced to sort a specified quantity of bone marrow collected from the patient. These adult stem cells express high levels of the enzyme ALDH, and pre-clinical research suggested that they may promote the repair of ischemic tissue damage. Investigators have completed pre-clinical research showed improvements in motor function, improvements in the slowing of decrease in brain volume, the reversal of decline in stroke-induced cell viability and improved blood flow, or perfusion, in the brain. It is early but valued by their broader platform.
CMXI is trading Flat at $0.88 but, these preliminary pre-clinical results speak to the safety and potential efficacy. This is a positive and actionable result … which hasn't been recognized as multiple early trials are on-going. CMXI hasn't seen much traction in the past weeks and months … but, this under a $1.00 value just … reeks of investor apathy. CMXI should be trading in the $1.10 to at least the $1.25 value!
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.