KORTUC Launches Global Cervical Cancer Study, Expanding Pipeline to Second Indication
Led by the University of California San Diego, the clinical trial evaluates the safety and efficacy of KRC-01, a radiosensitizer designed to make solid tumors more susceptible to radiation, under a study protocol reviewed by the U.S. Food and Drug Administration
PALO ALTO, Calif., June 02, 2026 (GLOBE NEWSWIRE) -- KORTUC Inc, a global oncology biotech company, today announced that it has launched enrollment into its Phase 1/2 clinical study evaluating KRC-01, a proprietary intratumoral radiosensitizer, in patients with locally advanced cervical cancer. The study examines the impact of Kortuc’s compound in low-oxygen (hypoxic) tumors, which generally do not respond to therapeutic radiation doses. The announcement comes after its trial protocol was reviewed by the U.S. Food and Drug Administration and a $20 million funding round, led by Midas Capital.
Cervical cancer is the fourth most common cancer among women globally, with an estimated 604,000 new cases and 342,000 deaths in 2020. About 90 percent of new cases and deaths occur in low- and middle-income countries.
Hypoxia - low oxygen levels - inside a cancer cell undermines the efficacy of radiation therapy by making cells more resistant. KRC-01 has shown significant promise in creating a more oxygen-rich environment to improve radiotherapy efficacy. Led by the University of California San Diego, the trial will examine whether adding KRC-01 to standard treatment (chemotherapy combined with radiation) can improve overall survival. A total of 70 patients will be enrolled, with planned expansion to the United Kingdom and India.
“Radiation therapy is a proven curative treatment of cervical cancer,” said Kazuyuki Matsuda, CEO of Kortuc. “But the unfortunate reality is about half of cervical cancer patients are unresponsive to this treatment due to hypoxic tumors. Our technology exists today, and it can lead to tangible positive impact on patients’ lives.”
KRC-01 is based on a well-understood mechanism of action. Hydrogen peroxide (H₂O₂), a simple and well-known compound with an established safety profile, serves as the active ingredient in the KRC-01 radiosensitizer. As the only agent known to inactivate antioxidative enzymes within tumors, it increases tumor oxygenation and reduces hypoxia, thereby enhancing sensitivity to radiation therapy. Sodium hyaluronate delays the decomposition of H₂O₂, maintaining elevated oxygen partial pressure within the tumor for up to 48 hours following intratumoral injection of KRC-01.
Preliminary results and studies have shown that the newly oxygenated environment makes cancer cells more susceptible to radiation therapy.
The phase 1/2 clinical trial is designed to move efficiently from safety testing to early evaluation of effectiveness.
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Phase 1 will include 10 patients and focus on determining the safest and most appropriate dosing schedule for KRC-01 when used alongside standard chemoradiotherapy. KRC-01 will be injected directly into the tumor shortly before radiation treatment.
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Phase 2 will enroll 60 additional patients and compare standard treatment alone with standard treatment plus KRC-01. This phase will explore whether KRC-01 may help extend overall survival.
All participants will receive the current standard of care for locally advanced cervical cancer, which includes radiation therapy combined with weekly chemotherapy, followed by brachytherapy (internal radiation).
In addition to cervical cancer, Kortuc is studying the use of its technology for other solid tumor indications, including breast cancer.
For more information on the study, visit Kortuc.com.
About KORTUC
KORTUC Inc. is a U.S.-based oncology biotechnology company headquartered in Palo Alto, California. Originally founded in Japan, KORTUC is focused on overcoming tumor hypoxia to improve the effectiveness of radiotherapy for solid tumors. With a proprietary radiosensitizer and global clinical collaborations, the company aims to make effective, affordable, and accessible cancer therapies available to patients worldwide. For more information, please visit https://kortuc.com/
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