Therapeutic methods and compositions for treating pancreatic cancer using 6,8-bis-benzylthio-octanoic acid
Inventors
Luther, Sanjeev • Shorr, Robert G. L.
Assignees
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Publication Number
US-11622950-B2
Publication Date
2023-04-11
Expiration Date
Abstract
The invention provides methods, compositions, and medical kits for treating pancreatic cancer using (i) 6,8-bis(benzylsulfanyl)octanoic acid or a pharmaceutically acceptable salt thereof in combination with (ii) gemcitabine or a pharmaceutically acceptable salt thereof, and (iii) nab-paclitaxel.
Core Innovation
The patent describes a method for treating pancreatic cancer using a combination of a first therapeutic agent comprising 6,8-bis(benzylsulfanyl)octanoic acid (CPI-613) or a pharmaceutically acceptable salt, a second therapeutic agent comprising gemcitabine or a pharmaceutically acceptable salt, and a third therapeutic agent comprising nab-paclitaxel. The treatment is described in relation to pancreatic cancer including metastatic or locally advanced forms, and the method includes administering the first, second, and third therapeutic agents on days 1, 8, and 15 of a twenty-eight day cycle.
The patent further describes therapeutic and formulation aspects for CPI-613 in combination with gemcitabine and nab-paclitaxel, including administration routes. CPI-613 is discussed as being administered intravenously (IV) or orally, and formulation aspects include CPI-613 as pharmaceutically acceptable salts and ion pairs, including a triethanolamine ion pair.
The patent also describes pharmaceutical composition and kit aspects, including medical kit and pharmaceutical composition types. It further provides framework for treatment performance in phase II/phase III settings using efficacy and safety targets described in the document, and includes support for oral efficacy and oral bioavailability using xenograft models and discussion of oral formulation technologies, including spray-dried dispersions with polymers such as Eudragit L100 and HPMCAS-M.
Claims Coverage
The independent claim establishes a combination-therapy regimen with three inventive features: a specific three-agent drug combination (CPI-613, gemcitabine, and nab-paclitaxel), a defined administration schedule within a 28-day cycle (days 1, 8, and 15), and a specified dosing level selection for the first therapeutic agent (about 500, about 1000, or about 1500 mg/m2). Dependent claims further refine the cancer stage and add scheduling constraints and additional dose ranges for the second and third therapeutic agents.
Three-agent pancreatic cancer combination including CPI-613, gemcitabine, and nab-paclitaxel
Administering to a patient in need thereof a therapeutically effective amount of (i) a first therapeutic agent comprising 6,8-bis(benzylsulfanyl)octanoic acid or a pharmaceutically acceptable salt thereof, (ii) a second therapeutic agent comprising gemcitabine or a pharmaceutically acceptable salt thereof, and (iii) a third therapeutic agent comprising nab-paclitaxel, in order to treat the pancreatic cancer.
28-day cycle dosing on days 1, 8, and 15
Administering the first therapeutic agent, the second therapeutic agent, and the third therapeutic agent to the patient on days 1, 8, and 15 of a twenty-eight day cycle.
Selected first-agent dosage levels for CPI-613 administration days
Administering the first therapeutic agent at a dosage of about 500 mg/m2, about 1000 mg/m2, or about 1500 mg/m2 on any day the first therapeutic agent is administered to the patient.
Metastatic pancreatic cancer treatment refinement
The method is applied to metastatic pancreatic cancer.
Locally advanced pancreatic cancer treatment refinement
The method is used for pancreatic cancer that is locally advanced.
First-agent dosing frequency constraint
Administering the first therapeutic agent no more than once in any seven-day period.
Second-agent dosage range on administration days
Administering the second therapeutic agent at a dosage of about 650 mg/m2 to about 800 mg/m2 on each day it is administered.
Third-agent dosage range on administration days
Administering the third therapeutic agent at a dosage of about 80 mg/m2 to about 100 mg/m2 on each day it is given.
Across the independent claim and its dependents, the coverage centers on treating pancreatic cancer with a specific CPI-613 (6,8-bis(benzylsulfanyl)octanoic acid) plus gemcitabine plus nab-paclitaxel regimen, delivered on days 1, 8, and 15 of a 28-day cycle, with specified CPI-613 dosage levels. Dependent claims refine use to metastatic and/or locally advanced pancreatic cancer and add constraints and dose ranges for the second and third therapeutic agents.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating pancreatic cancer, including metastatic pancreatic cancer and locally advanced pancreatic cancer.
Not explicitly described in patent.
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