Nano Carrier IR report 2017

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Clinical Development Topics ▶Pancreatic cancer (Phase III clinical trial)On February 9, 2017, an interim analysis of the effectiveness and safety of this trial was conducted by the Data and Safety Monitoring Board, a third-party evaluation committee. The continuance of the trials was recom-mended.Micelle formulation that encapsulates cispla-tin, a platinum-based anti-cancer agent, by coordinate bond. It accumulates selectively in tumors and gradually release cisplatin by substitution of chloride anions in the body. This ensures drug time-dependency to main-tain an effective concentration in the blood and demonstrate anti-tumor effect.Micelle formulation that encapsulates epirubi-cin by pH-sensitive bond. It accumulates selectively in tumors, and releases epirubicin intracellularly after being absorbed into cancer cells. This reduces the side effects and enhances the anti-tumor activity of epirubicin and enables continuance of treatment. 4Clinical development continues to steadily advance step by step toward commercialization. Progress report on NC-6004 and NC-6300, the main pipeline of NanoCarrier.NC‐6004NC‐6300Phase III Pancreatic cancerPhase II Phase IPreclinicalBasic researchJapan/AsiaPhase III Non-small-cell lung cancerBile duct cancerBladder cancerPhase II Phase IPreclinicalBasic researchU.S./EuropePhase III Phase II Phase IPreclinicalBasic researchHead and neck cancerTaiwanPhase III Phase II Phase IPreclinicalBasic researchSoft tissue sarcomaU.S.Phase III Head and neck cancePhase II Phase IPreclinicalBasic researchU.S./EuropeA tendency to suppress the side effects characteristic of epirubicin was observed, and the recommended dosage was determined to be 170 mg/m2, significantly higher than the standard dosage for epirubicin.No tendency to reduce cardiac function was observed, and the drug was administered for over twelve months in some cases. We are seeking out the potential for continuous treatment.●●Determined recommended dosage of 135mg/m2 for U.S. patients for the indication of solid cancers.Even when the drug was administered at a dosage of 1.5 times the recommended dosage for existing drugs, no clinically problematic issues were observed.Safety and efficacy were demonstrated even in patients in which the efficacy of existing platinum-based anti-cancer agents was no longer observed. ●●●Determined recommended dosage of 90mg/m2 for Japanese patients for the indication of solid cancers.Disease control in 81.8% of casesConfirmed reduction of adverse effectsConfirmed that acute kidney damage is reduced to 30%.●●●●Phase III clinical study in Asia is currently underway with Japan participatingPhase II clinical study is currently underwaywith Expansion to EuropeOn December 30, 2016, we filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for Phase I/II clinical studies in the U.S. for the indica-tion of soft tissue sarcoma, a rare cancer. We aim at early approval by taking measures such as making use of the system for accelerated review. Accelerating in-house developmentPreparations underway for registration of patients*Diagram showing drug releasePancreatic cancerNon-small-cell lung cancer, bile duct cancer, bladder cancerCombination therapy with gemcitabine