Matinas BioPharma Holdings announces results from an additional in vivo study in healthy mice with an oral LNC formulation of docetaxel, a well-established chemotherapeutic agent used in the management of multiple metastatic and unresectable tumors. Docetaxel is currently only administered intravenously and is frequently associated with significant side effects and treatment-limiting toxicities. The goal of this study was to determine whether an oral LNC formulation of docetaxel could improve the overall safety profile of conventional IV-administered docetaxel. The study included healthy BALB/c mice divided into three treatment groups: Control animals treated with oral saline. IV-docetaxel administered once a week for three weeks. Oral LNC-docetaxel administered once daily over three weeks. The primary endpoint was change in body weight over the treatment period. Through Day 22, the total amount of docetaxel administered with the oral LNC-docetaxel formulation was more than 8x greater than with IV-docetaxel. All mice treated with IV-docetaxel lost a significant amount of weight, with an average peak loss of 20% of their original body weight. Mice treated with oral LNC-docetaxel maintained their body weight, which was statistically no different than the weight of control mice treated with oral saline. One mouse in the IV-docetaxel group died prior to the conclusion of the study and was censored from the analysis, the curve of the IV-docetaxel group also reflects the expected 7-day recovery following an IV dose of docetaxel. The daily administered oral LNC-docetaxel dose was 50% higher, and the total amount of drug administered was 3.5x greater, than the LNC-docetaxel dose administered in a previous study that demonstrated anti-tumor activity comparable to IV-docetaxel in a syngeneic mouse melanoma model.
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