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Calando Pharmaceuticals Lead siRNA Anti-Cancer Therapeutic Candidate Shown to be well Tolerated in Non-Human Primate Safety Study

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At the Second Annual Meeting of the Oligonucleotide Therapeutic Society, Dr. Jeremy Heidel, Chief Scientific Officer, will present data from the study showing that the therapeutic candidate is well tolerated at doses significantly higher than those shown to be efficacious in previous studies using a similar formulation.

The formulation investigated contains Calandos proprietary delivery technology with an siRNA duplex targeting the M2 subunit of ribonucleotide reductase, a well-established cancer target. This duplex, developed at Calando, demonstrates potent anti-proliferative activity across multiple types of cancer cells.

The objective of this escalating-dose pilot study was to assess numerous safety-related parameters for this formulation in primates.

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 Ewings sarcoma, a rare form of cancer affecting mainly children and young adults (Cancer Res 65 (19):8984-8892).

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.

These results keep us on track to be the first in the clinic with a targeted siRNA therapeutic, said John Petrovich, Calandos Chief Executive Officer.

"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.