US2022040130A1PendingUtilityA1

Methods for treating familial adenomatous polyposis

59
Assignee: CANCER PREVENTION PHARMACEUTICALS INCPriority: May 17, 2019Filed: Mar 15, 2021Published: Feb 10, 2022
Est. expiryMay 17, 2039(~12.8 yrs left)· nominal 20-yr term from priority
Inventors:Eugene GernerAlfred CohenMichelle Boytim
A61K 31/198A61K 31/192A61K 9/20A61P 1/00
59
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Claims

Abstract

Provided are methods for preventing or delaying the need for surgical intervention in a patient having familial adenomatous polyposis (FAP) and an at least partially intact lower gastrointestinal tract. Also provided are methods for preventing or delaying the formation of neoplasia and/or cancer in a patient having FAP. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine and sulindac to a patient having FAP and an intact lower gastrointestinal tract.

Claims

exact text as granted — not AI-modified
1 . A method of inducing or maintaining polyp regression in a patient having familial adenomatous polyposis (FAP), the method comprising administering to the patient a pharmaceutical therapy comprising a combined effective amount of eflornithine and sulindac, wherein the patient has an at least partially intact lower gastrointestinal tract. 
     
     
         2 - 3 . (canceled) 
     
     
         4 . The method of  claim 1 , wherein the method delays or prevents the need for excisional intervention. 
     
     
         5 . The method of  claim 1 , wherein the method delays or prevents the development of adenomas. 
     
     
         6 . The method of  claim 5 , wherein the adenomas are high risk adenomas. 
     
     
         7 . The method of  claim 1 , wherein the method delays polyposis progression. 
     
     
         8 . The method of  claim 7 , wherein the method delays the need for endoscopic excision or surgical resection. 
     
     
         9 . The method of  claim 1 , wherein the method prevents polyposis progression. 
     
     
         10 . The method of  claim 9 , wherein the method prevents the need for endoscopic excision or surgical resection. 
     
     
         11 . The method of  claim 1 , wherein the method delays the formation of colorectal cancer in the patient. 
     
     
         12 . The method of  claim 1 , wherein the method prevents the formation of colorectal cancer in the patient. 
     
     
         13 . The method of  claim 1 , wherein the patient has a colorectum, a retained rectum, or an ileal pouch. 
     
     
         14 . The method of  claim 1 , wherein the combined effective amount of eflornithine and sulindac comprises 750 mg/day eflornithine and 150 mg/day sulindac. 
     
     
         15 . The method of  claim 14 , wherein the eflornithine and sulindac are administered in a single formulation. 
     
     
         16 . The method of  claim 15 , wherein the single formulation comprises about 375 mg of eflornithine hydrochloride monohydrate. 
     
     
         17 . The method of  claim 15 , wherein the single formulation comprises about 288.6 mg of eflornithine in its anhydrous, free base form. 
     
     
         18 . The method of  claim 15 , wherein the single formulation comprises about 75 mg of sulindac. 
     
     
         19 . The method of  claim 15 , wherein the single formulation is in the form of a tablet. 
     
     
         20 . The method of  claim 15 , wherein the patient is administered two units of the single formulation per day. 
     
     
         21 . The method of  claim 5 , wherein the adenomas are at risk for becoming high risk adenomas.

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