Chitosan-derived compositions
Inventors
Hode, Tomas • Nordquist, Robert E. • Chen, Wei R. • Carubelli, Raoul • Alleruzzo, Luciano • Jenkins, Peter • Waynant, Kristopher • Raker, Joseph
Assignees
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Publication Number
US-12398215-B2
Publication Date
2025-08-26
Expiration Date
Abstract
Therapeutic compositions comprising chitosan-derived compositions are useful agents when administered in connection with methods for treating neoplasms, such as for instance, malignant lung, thyroid and kidney neoplasms, and other types of malignant neoplasms, and other medical disorders.
Core Innovation
The invention relates to chitosan-derived therapeutic compositions and methods for treating neoplasms using a glycated chitosan pharmaceutical formulation administered by injection. The approach centers on viscoelastic glycated chitosan polymers characterized by defined molecular weight, degree of deacetylation, and degree of glycation of free amino groups.
The disclosed compositions provide an injectable therapeutic composition for treating malignant neoplasms while enabling efficient sterile filtration and improved manufacturability. The disclosed compositions emphasize control of polymer properties associated with viscosity and rheology through specific glycation levels of the free amino groups together with defined molecular weight and deacetylation.
The glycated chitosan has a molecular weight of about 100,000 to about 300,000 Daltons, a degree of deacetylation of about 75% to about 99%, and a degree of glycation of free amino groups of about 0.1% to about 30%. The document describes embodiments intended to yield unexpectedly improved viscosity/rheology enabling injectability and greatly improved sterile filtration and manufacturing.
Claims Coverage
Independent claim clm-00001 covers a treatment method for a selected list of cancers by injection of a pharmaceutical formulation containing glycated chitosan, where the glycated chitosan is defined by three quantitative inventive parameters. The main claimed inventive features are the cancer selection/administration by injection and the defined GC structural/chemical parameter ranges.
Injection-based cancer treatment with glycated chitosan formulation
A method of treating a cancer selected from colon cancer, lung cancer, mammary sarcoma, skin cancer, kidney cancer, breast cancer, prostate cancer, bladder cancer, and head-and-neck cancer, in a patient in need thereof, comprising administering by injection a pharmaceutical formulation comprising a glycated chitosan to the patient, wherein the cancer comprises a malignant neoplasm.
Molecular weight-defined glycated chitosan
The glycated chitosan has a molecular weight of about 100,000 to about 300,000 Daltons.
Deacetylation-defined glycated chitosan
The glycated chitosan has a degree of deacetylation of about 75% to about 99%.
Free-amino glycation-defined glycated chitosan
The glycated chitosan has a degree of glycation of free amino groups of about 0.1% to about 30%.
The claim coverage is grounded in clm-00001 by defining an injection method for treating malignant neoplasms using glycated chitosan whose molecular weight, degree of deacetylation, and degree of glycation of free amino groups fall within stated ranges. Dependent claims refine those parameters by specifying particular values and narrow the cancer indication, including non-small cell lung cancer.
Stated Advantages
Unexpectedly improved viscosity/rheology that supports injectability.
Greatly improved sterile filtration and manufacturing (cGMP-suitable).
Documented Applications
Treating advanced breast cancer, described with clinical efficacy referenced as RECIST responses in a metastatic breast cancer trial.
Preclinical antitumor/immunotherapy synergy models involving laser-assisted immunotherapy (LIT) and combinations with photodynamic therapy (PDT) are referenced.
Sterile filtration feasibility and performance are described for an embodiment involving sterile filtration at about 0.22 μm and a sterile filtration recirculation study is referenced.
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