Talaris Therapeutics Reports Patient Death In Late-Stage Trial Of Experimental Drug For Graft vs Host Disease

• Talaris Therapeutics Inc (NASDAQ: TALS) received a report of a patient death, which triggered a pre-specified, temporary stopping requirement and review by the FREEDOM-1 Data Monitoring Committee (DMC).

• After their review, the DMC determined that trial enrollment and dosing may continue. The company has reported this event and the DMC's recommendation to the FDA.

• Related: Talaris Therapeutics Reveals COVID-19 Outcomes Among Kidney Transplant Patients Treated With FCR001.

• As reported, the deceased patient was also diagnosed with moderate chronic GvHD responding to treatment at the time of the update. The patient was recently hospitalized with grade IV GvHD, which was complicated by serious infections leading to respiratory and renal failure and, ultimately, death.

• The company reported that the incidence of GvHD in FCR001 subjects was correlated with high CD34+ cell counts and high total nucleated cell counts in the FCR001 product.

• It also noted a correlation between the use of plerixafor as a donor mobilizing agent and an increased risk of GvHD, as plerixafor significantly increased CD34+ and total nucleated cell counts in the FCR001 product.

• Price Action: TALS shares are down 43.8% at $1.36 on the last check Thursday.

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