• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

SD Pharmaceuticals Completes Pivotal Pre-Clinical Efficacy Study on Its Novel and Less Toxic Docetaxel Formulation

Posted on: Wednesday, 11 January 2006, 09:00 CST

SD Pharmaceuticals Inc. (SDP) today announced that it has completed a third pre-clinical efficacy study on its novel non-immunogenic formulation of docetaxel (SDP-014). SDP-014 is a proprietary lyophilized nano-emulsion that does not contain the immunogenic solubilizer polysorbate 80 which is present in the currently marketed Taxotere(R). The current 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(R) with an improved side effect profile. Taxotere is one of the largest cancer drugs with worldwide sales approaching $2 billion per year.

The current GLP study was the final efficacy study in a series of three studies, which compared the safety and efficacy of the non-immunogenic SDP-014 formulation of docetaxel with the Taxotere(R) formulation. In all three tumor models, two of which were previously announced on December 14 2005, the SDP-014 formulation was of equal or superior efficacy as an anti-tumor therapeutic when compared to Taxotere(R) and was better tolerated and non-immunogenic. Immunogenicity is a major problem associated with the Taxotere(R) formulation and requires that patients receiving Taxotere(R) be pretreated with steroidal immuno-suppressants. The currently reported studies were conducted by Dr. Yang Bo in the Dept. of Pharmacology and Toxicology at Zhejiang University in China.

"We now have a critical mass of rigorous GLP pre-clinical efficacy and safety data that supports the significant advantage of our SDP-014 docetaxel formulation when compared to Taxotere(R) and we are excited about the prospects of this potential new product as we move towards establishing its clinical bio-equivalence with the currently marketed product," stated Paul J. Marangos, PhD, Chairman & CEO of SD Pharmaceuticals.

Andrew X. Chen, PhD, the Company's Chief Scientific Officer, further commented, "Docetaxel is a significant formulation challenge and we appear to have the right preparation with SDP-014 which combines extended shelf life, lack of immunogenic detergents, lower toxicity and equal or superior efficacy to the existing formulation in three different pre-clinical models."

SD Pharmaceuticals Inc. is focused on the remediation of 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 a number of clinically significant toxicities such as anaphylactic shock, vein irritation and phlebitis associated with the currently marketed formulations. Many of these formulation related safety problems can be dose limiting and their resolution may therefore permit not only enhanced safety but may also enhance efficacy. The product candidates in the company's portfolio include novel formulations of vinorelbine, paclitaxel, docetaxel, clarithromycin and vancomycin. SDP has filed worldwide patents on all of its formulations 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: Business Wire

More News in this Category