The siRNA therapeutic is developed to target cancer. The therapeutic candidate was well tolerated at doses significantly higher than those shown to be successful in previous studies.
Calando believes that it is on track to be the first company with a targeted siRNA candidate.
The data show that this formulation is well tolerated in non-human primates at doses well above doses of a similar formulation shown to have anti-tumor effects when tested in a metastatic mouse model of Ewing’s sarcoma, a rare form of cancer affecting mainly children and young adults.
One area of concern in translating any siRNA-containing formulation from animals to the clinic is the potential for immune responses to the siRNA duplex itself. Another concern is antibody generation to the formulation, including the targeting components. The Calando study examined both of these issues, and the results suggest that repetitive dosing in humans will be feasible with this formulation.
“We plan to initiate a phase I clinical trial by the end of 2007 with this lead formulation to investigate its safety, tolerability and pharmacokinetics in patients with solid tumors of multiple types,” said John Petrovich, Calando’s CEO.