Calando is performing toxicity studies in rats and monkeys in preparation for the filing of an investigational new drug application with the FDA. Upon FDA approval, Calando plans to conduct an open-label, dose-escalation phase I clinical trial in patients with unresectable or metastatic solid tumors. Based upon the evaluation of the results from this study, Calando plans to conduct separate, disease-specific phase II trials.
R Bruce Stewart, Arrowhead’s chairman, said: “We expect that Calando will be first to human trials with a targeted, formulated siRNA therapeutic designed for the treatment of cancer.”
Small interfering RNAs (siRNA) induce RNA interference, or RNAi, a naturally occurring mechanism within cells to selectively silence and regulate specific genes. CALAA-01 uses Calando’s nano-engineered delivery technology to protect the siRNA from degradation and attack by the immune system as it travels through the body to the cancer cells.