Method and apparatus for testing near infrared-photoimmunotherapy treatment
Inventors
Kobayashi, Hisataka • Nishimura, Masayuki
Assignees
Shimadzu Corp • US Department of Health and Human Services
Publication Number
US-12228582-B2
Publication Date
2025-02-18
Expiration Date
2039-06-20
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Abstract
A method and treatment for testing efficiency and effectiveness of a near infrared photoimmunotherapy treatment includes injecting an antibody photosensitizer conjugate (APC) into a patient, applying radiation to the patient, thereby causing the APC to release a ligand, which is excreted in the patient's urine, detecting the presence of the ligand with liquid chromatography-mass spectrometry, measuring and quantifying an amount of the ligand present in the patient's urine based on analytical results of the liquid chromatography-mass spectrometry, and determining the effectiveness of the near infrared photo-immunotherapy treatment based on the measured quantified amount of the ligand present in the patient's urine so as to determine an amount of APC remaining in the patient.
Core Innovation
The invention provides a method and treatment for testing the efficiency and effectiveness of near infrared photo-immunotherapy (NIR-PIT) treatments. This involves injecting an antibody photosensitizer conjugate (APC) into a patient and applying near-infrared radiation to cause the APC to release a ligand that is excreted in the patient's urine. The ligand is then detected and quantified using liquid chromatography-mass spectrometry (LCMS), and the amount of ligand present in the urine informs the determination of the treatment's effectiveness based on the amount of APC remaining in the patient.
The problem being solved arises from the need for effective cancer therapies for aggressive cancers such as mesothelioma, pancreatic, and ovarian cancer, which are often unresponsive to traditional therapies like surgery or chemotherapy. NIR-PIT is a revolutionary treatment using near-infrared light to selectively destroy cancer cells via APCs that bind to cancer cell antigens and cause rapid necrosis upon light exposure. However, because NIR-PIT is relatively new and carries risks such as patient shock from destroying too many cancer cells at once, there is a critical need for methods to evaluate treatment efficiency and optimize dosing.
This disclosure addresses the gap in knowledge about the efficiency of NIR-PIT by providing a method to quantitatively measure a ligand released from the photosensitizer component of the APC after light activation, using LCMS or related mass spectrometry techniques. This quantitative measurement helps healthcare providers determine treatment effectiveness and the amount of APC remaining, enabling informed decisions for subsequent NIR-PIT treatments, particularly important for managing large tumors with multiple treatment sessions and avoiding patient risk.
Claims Coverage
The patent includes two independent provisions covering methods and treatment for testing and administering near infrared photo-immunotherapy, with inventive features focused on ligand detection and dosage adjustment based on measured ligand amounts.
Method for testing NIR-PIT efficiency via ligand detection in urine
A method comprising injecting an antibody photosensitizer conjugate with a specific phthalocyanine dye into a patient, applying radiation to cause release of a defined ligand (C14H33NO10S3Si) excreted in urine, detecting this ligand using liquid chromatography-mass spectrometry, and quantifying the ligand to determine treatment efficiency, wherein ligand amount inversely correspond to remaining APC and positively corresponds to treatment effectiveness.
Near infrared photo-immunotherapy treatment with dosing based on ligand quantification
A treatment method including injecting a first amount of APC containing the defined phthalocyanine dye, applying radiation to release and detect the ligand in urine by LCMS, determining the effectiveness and amount of APC remaining, subsequently injecting a second dose of APC based on the measured remaining APC, and applying radiation again causing ligand release, thus allowing treatment adjustment based on ligand quantification.
These inventive features provide quantitative and iterative approaches for assessing NIR-PIT treatment effectiveness through ligand detection and adjusting APC dosing accordingly, enhancing treatment management and safety.
Stated Advantages
Enables quantitative determination of NIR-PIT treatment efficiency through measurement of a specific ligand in patient urine.
Provides information to determine the amount of APC remaining in a patient, allowing personalized adjustment of subsequent treatment doses.
Helps avoid patient risk such as shock by informing appropriate dosing for treating large tumors through multiple NIR-PIT sessions.
Uses non-invasive urine testing combined with established mass spectrometry techniques for practical clinical monitoring.
Documented Applications
Treatment of aggressive human cancers including mesothelioma, pancreatic cancer, and ovarian cancer using near infrared photo-immunotherapy.
Monitoring and optimizing NIR-PIT treatment effectiveness via ligand detection in patient urine.
Planning multiple NIR-PIT treatment sessions with dose adjustment based on measured APC remaining to avoid health risks.
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