Fortress' Caelum subsidiary reports MTD for CAEL-101 in AL amyloidosis

The Caelum Biosciences Inc. subsidiary of Fortress Biotech Inc. (NASDAQ:FBIO) said data from a U.S. Phase Ia/Ib trial established 500 mg/m^{2 as} the maximum tolerated dose (MTD), the primary endpoint, of CAEL-101 (11-1F4) to treat amyloid light-chain (AL) amyloidosis. Caelum plans to start a Phase IIb/III trial next half.

The open-label, trial’s Phase Ia portion evaluated single ascending doses of IV CAEL-101 at a starting dose level of 0.5 mg/m² in eight patients. The Phase Ib portion enrolled 19 patients who received once-weekly 0.5-500 mg/m² IV CAEL-101 for four weeks...