KORTUC Completes Enrollment in Pivotal Phase II Breast Cancer Trial

KORTUC today announced the completion of patient enrollment in its pivotal Phase II clinical trial evaluating KRC-01, a novel radiosensitizer, in patients with locally advanced or recurrent breast cancer. The study enrolled its planned target of 184 patients. The trial is led by The Institute of Cancer Research (ICR) in the United Kingdom and is being conducted across clinical centers in the United Kingdom and India. Many solid tumors develop hypoxic regions that can reduce the effectiveness of radiotherapy. KRC-01 is a novel radiosensitizer designed to enhance the effect of radiotherapy by supplying oxygen to tumors and inactivating antioxidant enzymes that contribute to radiation resistance. Locally advanced or recurrent breast cancer can cause ulceration, bleeding, odor, and severe pain, significantly affecting patients’ quality of life. Radiotherapy is used to control these local tumors, and KRC-01 is being developed to potentially enhance its therapeutic effect. “Completing enrollment in this pivotal Phase II trial is an important milestone for KORTUC and the development of KRC-01,” said Kazu Matsuda, CEO of KORTUC. “Breast cancer is the first indication for KRC-01, and we are very pleased to have reached this important stage. We are deeply grateful to the patients and their families who participated in this study, as well as to the investigators and clinical teams whose commitment made this milestone possible. We will continue working to advance KRC-01 with the goal of bringing this treatment to patients as soon as possible.” Study Overview Patient population: Locally advanced or locally recurrent breast cancer Study design: Randomized, open-label comparative Phase II trial Primary endpoint: Clinical Complete Response(cCR) rate Target enrollment: 184 patients ClinicalTrials.gov: NCT03946202 About KORTUC KORTUC is a biotechnology company developing KRC-01, a novel radiosensitizer based on technology invented by Dr. Yasuhiro Ogawa, Professor Emeritus at Kochi University in Japan. The company relocated its headquarters to California in 2023 and is advancing KRC-01 across multiple solid tumor indications, including breast, rectal, and cervical cancers.

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