Treatment of Epithelial Cysts by Intracystic Injection of Antineoplastic Particles

Patent metadata

Field	Value
Publication number	US-2023111288-A1
Application number	US-202218046002-A
Country	US
Kind code	A1
Filing date	Oct 12, 2022
Priority date	Jun 9, 2017
Publication date	Apr 13, 2023
Grant 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.

First claim

1 .- 39 . (canceled)

40 . A method for treating an epithelial cyst, the method comprising injecting a composition comprising an effective amount of paclitaxel particles directly into the epithelial cyst, thereby treating the epithelial cyst,
wherein the paclitaxel particles comprise at least 95% be weight of paclitaxel, wherein the paclitaxel particles have a specific surface area (SSA) of at least 18 m 2 /g, and wherein the paclitaxel particles have a mean particle size (number) of from 0.1 microns to 5 microns.

41 . The method of claim 40 , wherein the composition further comprises an aqueous liquid carrier.

42 . The method of claim 41 , wherein the aqueous liquid carrier comprises 0.9% saline solution.

43 . The method of claim 41 , wherein the aqueous liquid carrier comprises a surfactant.

44 . The method of claim 43 , wherein the surfactant is a polysorbate.

45 . The method of claim 44 , wherein the polysorbate is polysorbate 80, and wherein the polysorbate 80 is present in the aqueous carrier at a concentration of between about 0.01% v/v and about 1% v/v.

46 . The method of claim 41 , wherein the composition further comprises a diluent,
wherein the aqueous liquid carrier and the diluent form a mixture, and wherein the composition is a suspension of the paclitaxel particles dispersed in the aqueous liquid carrier/diluent mixture.

47 . The method of claim 46 , wherein the diluent comprises 0.9% saline solution.

48 . The method of claim 40 , wherein the paclitaxel particles have a bulk density (not tapped) of 0.05 g/cm 3 to 0.15 g/cm 3 .

49 . The method of claim 40 , wherein the concentration of the paclitaxel particles in the composition is between about 6 mg/mL and about 15 mg/mL.

50 . The method of claim 40 , wherein the paclitaxel particles have a mean particle size (number) of from 0.1 microns to 1.5 microns.

51 . The method of claim 40 , wherein the paclitaxel particles are crystalline particles.

52 . The method of claim 40 , wherein the composition and paclitaxel particles exclude albumin.

53 . The method of claim 40 , wherein cyst fluid is withdrawn from the epithelial cyst prior to injecting the composition.

54 . The method of claim 53 , wherein the volume of the composition injected into the epithelial cyst is equal to the volume of cyst fluid removed from the epithelial cyst.

55 . The method of claim 40 , wherein the epithelial cyst is a pancreatic cyst.

56 . The method of claim 55 , wherein the pancreatic cyst is a mucinous pancreatic cyst.

57 . The method of claim 40 , wherein the injecting of the composition is conducted by endoscopic ultrasound-guided fine needle injection (EUS-FNI).

58 . The method of claim 40 , wherein the epithelial cyst is reduced in volume/size, is eliminated, or is ablated after injection of the composition, and/or wherein pain associated with the epithelial cyst is reduced.

Assignees

• Crititech Inc

Inventors

• Dizerega Gere S
• Baltezor Michael
• Decedue Charles J
• Campbell Sam
• Mcclorey Matthew
• Iacobucci Marc
• Maulhardt Holly

Classifications

• A61K9/1688

  resulting in pure drug agglomerate optionally containing up to 5% of excipient · CPC title

• A61K31/337

  having four-membered rings, e.g. taxol · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K9/0019 Primary

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title