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SD Pharmaceuticals Inc. Reports Positive Efficacy Data on Its Non-Immunogenic Paclitaxel Formulation |
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25 Mar 2006 |
CARLSBAD, CA, USA | Mar 24, 2006 | SD Pharmaceuticals Inc. (SDP) today announced that it has completed a battery of pre-clinical studies on its novel nano-emulsion formulation of paclitaxel. This formulation is designated SDP-013 and is a proprietary nano-emulsion that does not contain any immunogenic solubilizer or macromolecule carrier. The battery of studies showed equal or superior efficacy in a mouse model of human ovarian cancer (SK-OV-3 cell line), a very favorable toxicity profile and a lack of immunogenicity compared to the existing Taxol(TM) formulation. The studies were conducted by an independent contracting laboratory and indicate that the SDP-013 paclitaxel is equivalent to Taxol(TM) and free of the immunogenicity associated with it and other paclitaxel formulations.
"Our business strategy of employing novel formulations to improve the safety profile and clinical utility of existing acute care drugs continues to produce successful results," stated SDP Chairman and CEO Dr. Paul J. Marangos. "While other formulations of paclitaxel have recently appeared we believe that SDP-013 is the first to be entirely free of immunogenic detergents and macromolecules and that it will be able to directly substitute for generic Taxol(TM)." Dr. Andrew X. Chen, Chief Scientific Officer at SDP, further commented, "The positive in vivo and stability test results further demonstrate the utility of our nano-emulsion technology for delivering drugs that are both insoluble and chemically unstable, such as paclitaxel."
The studies showed dose-dependant efficacy of SDP-013 in the mouse model, as judged by reduction in tumor burden, that were equal to or slightly better than the Taxol(TM) formulation with similar, if not superior side effect profiles. The immunosensitivity study showed no sensitization, which is a major problem associated with the currently marketed Taxol(TM) formulation.
SDP was founded by Drs. Paul J. Marangos and Andrew X. Chen to remedy specific formulation related toxicities of therapeutically important acute care drugs carrying black box safety warnings. The Company has devised multiple novel nano-emulsion formulations of five widely used acute care intravenous drugs that eliminate the severe toxicities such as anaphylactic shock, vein irritation and phlebitis associated with the currently marketed formulations; these include vinorelbine, docetaxel, paclitaxel, clarithromycin and vancomycin. SDP expects that these new formulations may reach the market through a simplified regulatory path (505b2 filing). More information on SDP is at www.sdpharma.com.
SOURCE: SD Pharmaceuticals Inc |
