Kurume University Cancer Vaccine Trial Termination Announcement

Official Trial Closure Notice

• November 7, 2019

Kurume University announced official termination of peptide cancer vaccine clinical trial program, effective January 31, 2020.

Trial Background

Kurume University's personalized peptide cancer vaccine program attracted significant patient enrollment, particularly from Taiwan. Phase II trial enrolled treatment-experienced patients with continued enrollment until July 2019.

Clinical Trial Outcomes

Phase III trials in two cancer types demonstrated:

• Prostate Cancer Phase III: Failed to meet primary overall survival extension endpoint
• Glioblastoma Phase III: Failed to meet primary overall survival extension endpoint

Based on these negative efficacy results and regulatory requirements under new clinical research law, the Cancer Vaccine Center Steering Committee and independent safety monitoring committee recommended trial termination.

Regulatory Status

Trial termination due to:

1. Failure to demonstrate survival benefit
2. Non-compliance with new Clinical Research Law (effective April 2020)

Final Treatment Date

January 31, 2020 represents final date for vaccine administration.

Continuing patients previously enrolled may transition to alternative protocols as clinically appropriate.

Trial Leadership

Center Director: Shigeru Yuya, MD, Kurume University Cancer Vaccine Center Announcement Date: October 28, 2019

Clinical Conclusions

Although peptide vaccine approach demonstrated theoretical promise, Phase III efficacy data did not support continued clinical development in prostate cancer or glioblastoma populations.

Data Source

Kurume University Cancer Vaccine Center Official Notice

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

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