Treatment of epithelial cysts by intracystic injection of antineoplastic particles
Inventors
diZerega, Gere S. • BALTEZOR, Michael • DECEDUE, Charles J. • Campbell, Sam • MCCLOREY, Matthew • Iacobucci, Marc • MAULHARDT, Holly
Assignees
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Publication Number
US-11737972-B2
Publication Date
2023-08-29
Expiration Date
Abstract
Disclosed herein are methods for treating epithelial cysts, including pancreatic cysts, in a subject by intracystic injection of compositions comprising antineoplastic particles, including taxane particles such as paclitaxel particles and docetaxel particles.
Core Innovation
The disclosed invention relates to a method for treating an epithelial cyst by directly injecting a composition comprising an effective amount of paclitaxel particles and an aqueous liquid carrier into the epithelial cyst. The composition treats the epithelial cyst via an intracystic depot effect caused by dispersing paclitaxel particles in the carrier. The paclitaxel particles are highly paclitaxel-pure, with at least 95% paclitaxel by weight, and are characterized by a specific surface area and mean particle size range.
The paclitaxel particles have a specific surface area of at least 18 m2/g and a mean particle size (number) from 0.1 microns to 5 microns. The composition is a suspension of the paclitaxel particles dispersed in an aqueous liquid carrier and includes embodiments that do not contain ethanol. Additional disclosed refinements include crystalline paclitaxel particles and formulation constraints such as excluding albumin.
The background motivation addressed by the patent is the treatment of epithelial cystic neoplasms, including mucinous pancreatic cysts, using intracystic antineoplastic taxane particles. The document emphasizes that solid particle suspensions persist longer in the cyst than drug solutions, providing prolonged local exposure and reduced systemic toxicity. The disclosed approach is associated with outcomes such as cyst stabilization, reduction in cyst volume or size, elimination or ablation of cysts, and reduction of pain.
Claims Coverage
The provided material includes one independent claim. This independent claim covers a directly intracystic treatment using a suspension of high-purity paclitaxel particles in an ethanol-free aqueous liquid carrier, with defined particle purity, specific surface area, and mean particle size.
Intracystic injection of paclitaxel particle suspension into an epithelial cyst
Injecting a composition comprising an effective amount of paclitaxel particles and an aqueous liquid carrier directly into the epithelial cyst to treat the epithelial cyst, wherein the composition comprises a suspension of the paclitaxel particles dispersed in the carrier.
High paclitaxel purity paclitaxel particles
The paclitaxel particles comprise at least 95% paclitaxel by weight.
High specific surface area paclitaxel particles
The paclitaxel particles have a specific surface area of at least 18 m2/g.
Defined mean particle size (number) range
The paclitaxel particles have a mean particle size (number) of from 0.1 microns to 5 microns.
Ethanol-free composition
The composition does not contain ethanol.
Across the independent claim, the core coverage is defined by direct intracystic injection of an ethanol-free aqueous suspension containing high-purity paclitaxel particles, where the particles meet specified specific surface area and mean particle size limitations.
Stated Advantages
Prolonged local exposure in the cyst.
Reduced systemic toxicity.
Cyst volume or size reduction.
Cyst stabilization.
Elimination or ablation of cysts.
Reduction of pain.
Documented Applications
Treating epithelial cystic neoplasms, including mucinous pancreatic cysts, including mucinous pancreatic cystic neoplasms such as mucinous cystic neoplasms and intraductal papillary mucinous neoplasms.
Phase 2 clinical results for intracystic paclitaxel particles in mucinous pancreatic cystic neoplasms, including cyst stabilization and volume reductions with measured PK.
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