Immix Biopharma (IMMX) said Monday that the US Food and Drug Administration has granted regenerative medicine advanced therapy designation to NXC-201 as a potential treatment for relapsed/refractory AL amyloidosis.
The company said the designation is intended to accelerate the development and review of promising advanced regenerative medicines that target serious medical conditions.
Immix Biopharma said it is accelerating the enrollment for a phase 1b/2 trial of NXC-201 in AL amyloidosis, expecting to enroll 40 patients. The study's primary endpoints are complete response rate and overall response rate, with an update on the study scheduled for release in the first half of the year, the company added.
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