This solicited Phase II proposal builds on L-Nutra?s successful Phase I results which identified a dietary formulation (Chemolieve) that protects mice against the toxicity of chemotherapy drugs and retards the growth of cancer masses while enhancing the efficacy of chemotherapy. The proposed Phase II studies include aims to provide the necessary pre-clinical evidence to determine the efficacy of Chemolieve in protecting normal cells but sensitizing the most common tumors to standard chemotherapy drugs in mouse models. Another goal is to characterize the effect of Chemolieve on DNA damage and mutagenesis caused by chemotherapy to both normal and cancer cells. Also proposed is a clinical trial to test the safety of Chemolieve and its role in reducing the side effects and increasing the efficacy of the standard chemotherapy cocktail adopted for breast cancer treatment. In summary, these studies can: (1) demonstrate that Chemolieve is effective in improving the therapeutic index of a wide variety of chemotherapy drugs on the most common tumors;and (2) demonstrate clinically that Chemolieve can be effective in support of the standard chemotherapy used to treat breast cancer. A positive outcome for these studies will allow L-Nutra to begin sales of Chemolieve.
