SD Pharma completes preclinical study on novel docetaxel form

California, USA-based SD Pharmaceuticals says that it has completed a third preclinical efficacy study on its novel non-immunogenic formulation of docetaxel (SDP-014). This is a proprietary lyophilized nano-emulsion that does not contain the immunogenic solubilizer polysorbate 80 which is present in the currently marketed Taxotere (docetaxel). This study was a dose-ranging trial in a xenografted nude mouse animal model of human breast cancer (MDAMB-435). The study findings confirm dose dependant efficacy of SDP-014 that was equal or superior to the currently-marketed Taxotere with an improved side effect profile. The latter is one of the largest-selling cancer drugs with worldwide sales approaching $2.0 billion a year.

The current evaluation was the final efficacy study in a series of three, which compared the safety and efficacy of the SDP-014 formulation. In all three tumor models, the SDP-014 formulation was of equal or superior efficacy as an anti-tumor therapeutic when compared to Taxotere and was better tolerated and non-immunogenic. Immunogenicity is a major problem associated with the Taxotere formulation and requires that patients receiving that drug be pre-treated with steroidal immunosuppressants.