Alofisel: how was the first human dose set?

The public FDA and EMA reviews of Alofisel don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

FDA expects preclinical proof-of-concept and toxicology studies to identify active dose levels and support the choice of starting dose and escalation. The 2013 guidance gives no numeric formula or scaling rule for the starting dose.

NOAEL / key findings: Perianal doses up to 2.5x10^6 cells/rat well tolerated; IV 10x10^6 cells caused fatal pulmonary embolism (EMA assessment report, p. 23)

Full method, every step sourced →