SONIRE Announces First Patient Enrolled in Randomized Phase 2 Study of Its Novel HIFU Therapy System for Unresectable Pancreatic Cancer Patients in Japan

TOKYO,Feb. 2,2023 --SONIRE Therapeutics Inc. (hereinafter referred to as "SONIRE"),based in Tokyo,announces that it has commenced a randomized phase 2 study for the treatment ofunresectable pancreatic cancer with SONIRE's next-generation High-IntensityFocused Ultrasound (HIFU) therapy system (development code: Suizenji).

Logo:

https://kyodonewsprwire.jp/prwfile/release/M107547/202301272458/_prw_PI1fl_1823Ko1T.jpg

The 5-year survival rate of pancreatic cancer is very low at 8.5%,and thenumber of deaths from it in Japan was estimated to be 37,677 patients in 2020,ranking fourth after lung cancer,colorectal cancer,and stomach cancer,and isincreasing every year (*). In addition,treatment options for pancreatic cancerare limited,and there is a strong need for innovative treatment modalities. Inthis clinical trial,the efficacy of Suizenji in combination with second-linechemotherapy will be evaluated in patients with unresectable pancreatic cancerwho are refractory or intolerant to first-line chemotherapy,with overallsurvival as the primary endpoint (expected enrollment: 90 participants).

(*) Data from "Pancreatic,Statistical Information by Cancer Type," National Cancer Center's Cancer Information Service (updated on October 5,2022)

Image:

https://kyodonewsprwire.jp/prwfile/release/M107547/202301272458/_prw_PI2fl_PRk6da4c.jpeg

Details of the study can be found on the following websites:

- Japan Registry of Clinical Trials:

https://jrct.niph.go.jp/en-latest-detail/jRCT2032220428

- U.S. National Library of Medicine's ClinicalTrials.gov:

https://clinicaltrials.gov/ct2/show/NCT05601323?term=NCT05601323&draw=2&rank=1

SONIRE was established in February 2020 to develop a next-generation ultrasound-guided HIFU therapy system by utilizing the technology and clinicalknow-how established by Tokyo Women's Medical University,Tohoku University andTokyo Medical University over the past years. HIFU therapy is expected tobecome a new treatment modality for cancer because it is minimally invasive,less burdensome to the body,and can be performed repeatedly without radiationexposure. SONIRE is developing the HIFU therapy system as a new treatmentmodality for pancreatic cancer,which is one of the most difficult-to-treatcancers.

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