Claims for Patent: 10,400,271

Summary for Patent: 10,400,271

Title:	Compositions and methods for genetic markers to identify risk of oral mucositis
Abstract:	The present invention provides methods and compositions involving genetic markers and their association with oral mucositis occurring in patients who are treated with cancer therapy and/or conditioning therapy for hematopoietic stem cell transplantation.
Inventor(s):	Mougeot; Jean-Luc C. (Charlotte, NC), Mougeot; Farah K. B. (Charlotte, NC)
Assignee:	The Charlotte-Mecklenburg Hospital Authority (Charlotte, NC)
Application Number:	16/285,819
Patent Claims:	1. A method of treating a subject who has undergone and/or will undergo hematopoietic stem cell transplantation (HSCT) and/or a subject who has undergone and/or will undergo chemotherapy and/or radiation therapy as having an increased risk of developing oral mucositis, comprising: a) obtaining a DNA sample from the subject; b) contacting the DNA sample from the subject with reagents to determine the presence or absence of each of the following risk alleles: 1) GG at single nucleotide polymorphism (SNP) site rs4847278; 2) GG at SNP site rs10797854 and GG at SNP site rs20560 and CC at SNP site rs944970 and CC at SNP site rs1062044 and AA at SNP site rs944971 and GG at SNP site rs6424888 and CC at SNP site rs20563 and CC at SNP site rs2333620; 3) AA at SNP site rs7373116: 4) GA at SNP site rs61742149; 5) AA at SNP site rs10935321; and 6) TT at SNP site rs111482845 and TT at SNP site rs11728441; and c) detecting one or more of: the single risk alleles of (1), (3), (4), or (5) or the multiple risk alleles of (2) or (6) in the DNA sample; and thereby identifying the subject as having an increased risk of developing ora mucositis d) administering to the subject having one or more of the single, risk alleles or multiple risk alleles in step c) at an increased risk of developing oral mucositis a treatment to optimize Wound healing, a probiotic diet to reduce levels of proinflammatory hydrogen sulfide and/or methylmercaptan produced by oral bacteria, an oral hygiene protocol, amifostine, palifermin, benzidiamine, calcium phosphate, cryotherapy, iseganan, a cryoprotective, a growth factor, topical polyvinylpyrrolidone, low power laser irradiation, gene therapy treatment, and any combination thereof. 2. The method of claim 1, further comprising the steps of: contacting the DNA sample with reagents to determine the presence of absence of each of the following risk alleles: 7) GG at SNP site rs147960186; 8) GG at SNP site rs11787880; 9) AA at SNP site rs10973387; and 10) AA at SNP site rs4030473 and GG at SNP site rs5915052; and detecting one or more of the single risk alleles of (7), (8) or (9) or the multiple risk alleles of (10) in the DNA sample. 3. The method of claim 1, wherein the cryoprotective is selected from sucralfate, oral glutamine, and hyaluronic acid.

Details for Patent 10,400,271

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	12/15/2004		2038-02-26