PHARMACEUTICALLY ACCEPTABLE SALTS OF BETA-GUANIDINOPROPIONIC ACID WITH IMPROVED PROPERTIES AND USES THEREOF
The present invention relates to new pharmaceutical salts of β-GPA which exhibit improved physical properties. In particular, the invention relates to salts of β-GPA with improved flow properties (e.g., improved Carr's index and/or Hausner ratio) such as fumarate salts, succinate salts, and oxalate salts. The invention also relates to pharmaceutical compositions including a pharmaceutically effective amount of one or more salts of β-GPA, as well as methods of treating cancer including administration of a formulation including a β-GPA salt of the invention to a subject in need thereof.
1 . A method of treating cancer in a subject in need thereof, the method comprising administering an effective amount of a pharmaceutically acceptable salt of β-guanidinopropionic acid to the subject, wherein the pharmaceutically acceptable salt of β-guanidinopropionic acid is a 2:1 succinate salt, wherein the cancer is gastrointestinal, esophageal, colorectal, liver, pancreatic, or gastric cancer, or the cancer expresses CKB.
2 . The method of claim 1 , wherein the cancer is gastrointestinal cancer.
3 . The method of claim 2 , wherein the gastrointestinal cancer expresses CKB.
4 . The method of claim 1 , wherein the cancer is esophageal cancer.
5 . The method of claim 1 , wherein the cancer is colorectal cancer.
6 . The method of claim 1 , wherein the cancer is liver cancer.
7 . The method of claim 1 , wherein the cancer is pancreatic cancer.
8 . The method of claim 1 , wherein the cancer is gastric cancer.
9 . The method of claim 1 , wherein the cancer expresses CKB.
10 . The method of claim 1 , wherein the cancer is metastatic cancer.
11 . The method of claim 10 , wherein the effective amount comprises an amount effective to suppress metastatic colonization of the cancer.
12 . The method of claim 1 , wherein the 2:1 succinate salt is administered prior to one or more therapeutically effective treatments or medical procedures.
13 . The method of claim 1 , wherein the 2:1 succinate salt is administered subsequent to one or more therapeutically effective treatments or medical procedures.
14 . The method of claim 12 , wherein the one or more therapeutically effective treatments comprises irinotecan, leucovorin, oxaliplatin, and/or 5-FU.
15 . The method of claim 13 , wherein the one or more therapeutically effective treatments comprises irinotecan, leucovorin, oxaliplatin, and/or 5-FU.