Treatment of epithelial cysts by intracystic injection of antineoplastic particles

Patent metadata

Field	Value
Publication number	US-11523983-B2
Application number	US-202117315804-A
Country	US
Kind code	B2
Filing date	May 10, 2021
Priority date	Jun 9, 2017
Publication date	Dec 13, 2022
Grant date	Dec 13, 2022

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

The invention claimed is:

1. A method for treating a benign epithelial cyst, the method comprising injecting a composition comprising an effective amount of paclitaxel particles and an aqueous liquid carrier directly into the benign epithelial cyst, thereby treating the benign epithelial cyst,
wherein the paclitaxel particles comprise at least 95% of the paclitaxel,
wherein the paclitaxel particles have a specific surface area (SSA) of at least 18 m 2 /g,
wherein the paclitaxel particles have a mean particle size (number) of from 0.1 microns to 5 microns,
wherein the composition comprises a suspension of the paclitaxel particles dispersed in the carrier, and
wherein the composition does not contain ethanol.

2. The method of claim 1 , wherein the carrier comprises 0.9% saline solution.

3. The method of claim 1 , wherein the carrier comprises a surfactant.

4. The method of claim 3 , wherein the surfactant is a polysorbate.

5. The method of claim 4 , 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.

6. The method of claim 1 , wherein the composition further comprises a diluent, wherein the carrier and the diluent form a mixture, and wherein the composition is a suspension of the paclitaxel particles dispersed in the carrier/diluent mixture.

7. The method of claim 6 , wherein the diluent comprises 0.9% saline solution.

8. The method of claim 1 , wherein the paclitaxel particles have a bulk density (not tapped) of 0.05 g/cm 3 to 0.15 g/cm 3 .

9. The method of claim 1 , wherein the concentration of the paclitaxel particles in the composition is between about 6 mg/mL and about 15 mg/mL.

10. The method of claim 1 , wherein the paclitaxel particles have a mean particle size (number) of from 0.1 microns to 1.5 microns.

11. The method of claim 1 , wherein the paclitaxel particles are crystalline particles.

12. The method of claim 1 , wherein the composition and paclitaxel particles exclude albumin.

13. The method of claim 1 , wherein cyst fluid is withdrawn from the benign epithelial cyst prior to injecting the composition.

14. The method of claim 13 , wherein the volume of the composition injected into the benign epithelial cyst is equal to the volume of cyst fluid removed from the benign epithelial cyst.

15. The method of claim 1 , wherein the benign epithelial cyst is a benign pancreatic cyst.

16. The method of claim 15 , wherein the benign pancreatic cyst is a benign mucinous pancreatic cyst.

17. The method of claim 1 , wherein the injection of the composition is conducted by endoscopic ultrasound-guided fine needle injection (EUS-FNI).

18. The method of claim 1 , wherein the benign epithelial cyst is reduced in volume/size, is eliminated, or is ablated after injection of the composition, and/or wherein pain associated with the benign 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

• A61K9/14

  Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)} · CPC title

• A61B8/0841

  for locating instruments · CPC title

• 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

• 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