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As part of the "Early-stage and Exploratory Clinical Trial Center Project" sponsored by the Health, Labour, and Welfare Ministry, under the agreement with Ono Pharmaceutical Co., Ltd., from June 2015, Osaka University, will begin a physician-driven clinical trial (a phase I/II clinical trial) using low-molecular compound ONO-1301 extended-release microsphere, YS-1402, in patients with severe cardiac failure associated with ischemic cardiomyopathy.

In patients with ischemic cardiomyopathy such as angina and myocardial infarction, blood flow is hampered by narrowed or clogged coronary artery, which may cause cardiac failure. In case of severe cardiac failure that cannot be cured by medical procedures such as medical therapy or implanting a pacemaker, surgical procedures such as catheter treatment, coronary-artery bypass surgery, or cardiac transplantation are needed. Recently, a method for cultivating and transplanting cells taken from patients into the ischemic myocardium is being carried out.

ONO-1301, YS-1402's active pharmaceutical ingredient, was originally developed as an oral antiplatelet agent. As research progressed, its various pharmacological effects were found. The development of new sustained-release formulation YS-1402 has enabled use for other diseases, meaning "drug repositioning" was conducted.

It was confirmed that applying YS-1402 as a skin patch onto ischemic myocardium improved the heart function in non-clinical trials. YS-1402 is an agent using a mechanism of regenerative medicine and is expected to play a part in drug development using regenerative medicine.

In this human phase I/II a clinical trial, in an coronary-artery bypass surgery in patients with severe ischemic cardiomyopathy, by applying a sheet infiltrated YS-1402 onto the ischemic myocardium, effects on function of the heart in which blood flow was not able to improve by bypass surgery and the agent's safety will be evaluated.

This clinical trial will lead to the possible development of myocardial regeneration therapy using low-molecular compounds, which are more effective in emergency and general versatility compared with existing therapies.

The effectiveness of YS-1402 for cardiac failure such as ischemic cardiomyopathy and dilated cardiomyopathy, chronic kidney disease (CKD), chronic obstructive lung disease (COPD), cerebral infarction, pulmonary hypertension, pulmonary fibrosis, arteriosclerosis obliterans (ASO) in non-clinical trial research has been reported.

Osaka University will complete this clinical trial by January 2018 and evaluate the safety and exploratory effectiveness of YS-1402 in patients. Following this clinical trial, based on the results of this trial, Ono Pharmaceutical Co., Ltd. will review if they will conduct further clinical trials.

Figure 1. YS1402

Figure 2. YS1402 skin patch drug

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