Compositions including pafolacianine for the identification of malignant lesions
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Assignees
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Publication Number
US-11986540-B2
Publication Date
2024-05-21
Expiration Date
Abstract
A composition is configured to be administered to a subject undergoing a malignant lesion resection procedure. The composition comprises a pharmaceutically effective amount of pafolacianine or a pharmaceutically acceptable salt thereof. The pafolacianine or a pharmaceutically acceptable salt thereof is configured to bind one or more malignant lesions and emit an optical signal.
Core Innovation
The disclosure describes pafolacianine and pharmaceutically acceptable salt forms, including pafolacianine sodium, as an optical imaging agent for identifying malignant lesions during a malignant lesion resection procedure. A composition is administered to a subject undergoing malignant lesion resection, where pafolacianine or a pharmaceutically acceptable salt binds to at least one malignant lesion and emits an optical signal detectable during illumination with excitation light absorbable by pafolacianine.
The disclosed composition is an injectable solution containing pafolacianine or a pharmaceutically acceptable salt in a defined per-volume amount, together with sodium chloride and phosphate buffers comprising potassium phosphate monobasic and sodium phosphate dibasic heptahydrate. The composition has a pH between about 7.1 and 7.8 and is characterized for optical detection with excitation and emission characteristics compatible with fluorescence-based visualization in the near-infrared range.
The disclosure frames the need to identify malignant lesions during resection and provides rationale that pafolacianine binds to folate receptors associated with malignant lesions. Supporting characterization includes an off-target binding screen and specificity evidence comparing folate receptor positive versus folate receptor negative tumor models, together with fluorescence-based detection evaluations, tumor-to-background ratio, lesion detection proportion, false positive rate, pharmacokinetics, safety/adverse reactions, and camera sensitivity/specificity evaluations.
Claims Coverage
Two independent claims are identified. The claim set provides an optical imaging composition for malignant lesion resection and a corresponding method that administers the composition, illuminates malignant lesions with excitation light absorbable by pafolacianine, and detects emitted optical signals.
Malignant lesion resection optical imaging composition
A composition to be administered to a subject undergoing a malignant lesion resection procedure, comprising a pharmaceutically effective amount of pafolacianine or pharmaceutically acceptable salt thereof, sodium chloride, potassium phosphate monobasic, and sodium phosphate dibasic heptahydrate, with a pH between about 7.1 and 7.8, wherein the pafolacianine or pharmaceutically acceptable salt thereof binds to at least one malignant lesion and emits an optical signal.
Administer, illuminate with absorbable excitation, and detect emitted optical signals
A method of treating a subject undergoing a malignant lesion resection procedure comprising administering the composition, wherein pafolacianine or pharmaceutically acceptable salt thereof distributes in at least a portion of one or more malignant lesions, illuminating the one or more malignant lesions with excitation light absorbable by pafolacianine or pharmaceutically acceptable salt thereof, and detecting the optical signals emitted by pafolacianine or pharmaceutically acceptable salt thereof.
Overall, the independent claims center on a defined pafolacianine-containing injectable composition for malignant lesion resection and a method that relies on illumination with absorbable excitation light and detection of pafolacianine-emitted optical signals from lesions where pafolacianine distributes.
Stated Advantages
Enables identification of malignant lesions during resection based on pafolacianine binding and optical signal emission.
Provides fluorescence-based visualization using near-infrared optical signals from pafolacianine upon light exposure.
Supports specificity and characterization relative to folate receptor positive versus folate receptor negative tumor models.
Reported evaluations include lesion detection performance, tumor-to-background ratio, pharmacokinetics, safety/adverse reactions, and camera sensitivity/specificity.
Documented Applications
Identifying malignant lesions during malignant lesion resection in a subject, including use in ovarian cancer detection.
Identifying malignant lesions during malignant lesion resection in a subject, including use in lung cancer detection.
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