Supporting an extremely high safety margin Below, that was for TLD1433 in 2015. So considering that Rutherrin is composed of TLD1433 + transferrin, safety should not be an issue. But it will be interesting to compare with those, in due time.
2015:
In the dog toxicology study, NOAEL was determined to be 6 mg/ml (30 mg/kg) for dog bladder infusion. Within 24 hours after instillation, the maximum level of TLD-1433 detected in blood was 0.03 ug/mL. This value is 200,000 times less than the instilled dose, indicating an ultra-low level of seepage into the blood stream supporting an extremely high safety margin. 7 days after infusion, the maximum level of TLD-1433 detected in blood was 0.002 ug/mL. This value is 3 million times less than the instilled dose, indicating a barely detectable level of TLD-1433 in the blood stream. This supports the conclusion that an infusion of 6 mg/ml of TLD-1433 (high human dose) into the bladder will be almost completely removed from the blood stream within 7 days. Thus the patient may be light sensitive for up to 7 days, which is significantly less than 30 to 90 days for Photofrin®.
In summary, the maximum detected dose in the blood stream within 24 hours after Beagle bladder infusion is 40,000 times lower than the IV NOAEL and 600,000 lower in 7 days, making bladder infusion an extremely safe route of administration for patients presenting with NMIBC.