US2012225925A1PendingUtilityA1

Micro-RNA Biomarkers and Methods of Using Same

35
Assignee: SOZZI GABRIELLAPriority: Feb 7, 2011Filed: Feb 7, 2012Published: Sep 6, 2012
Est. expiryFeb 7, 2031(~4.5 yrs left)· nominal 20-yr term from priority
Inventors:Gabriella SozziUgo PastorinoMattia Boeri
A61P 35/00A61P 3/00C12Q 2600/158C12Q 2600/178C12Q 1/6886C12Q 2600/118G16B 30/00
35
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

A procedure and an apparatus are described for identifying individuals at risk of pulmonary tumour and/or for diagnosing a pulmonary tumour using the study of levels of expression of miRNA in the blood or another biological fluid. Also described are a method and a compound for reducing or eliminating a risk of pulmonary tumour by rebalancing the miRNAs that are underexpressed or overexpressed.

Claims

exact text as granted — not AI-modified
1 . A method comprising:
 determining the level of expression of at least two miRNA from the miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc in a biological sample from a subject, and   comparing the level of expression of said miRNA from said sample from said subject to the level of expression of said miRNA from a control biological sample.   
     
     
         2 . The method of  claim 1 , comprising determining the level of expression of at least six miRNA from the miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc. 
     
     
         3 . A method comprising:
 determining the level of expression of at least two miRNA listed in Table Ib or Id in a biological sample from a subject, and   comparing the level of expression of said miRNA from said sample from said subject to the level of expression of said miRNA from a control biological sample,   wherein a change or deviation in the level of expression of said at least two miRNA in said biological sample from said control biological sample identifies a subject at risk of manifesting a tumor.   
     
     
         4 . The method of  claim 3 , comprising determining the level of expression of at least six miRNA listed in Table Ib or Id. 
     
     
         5 . The method of  claim 3 , wherein said miRNA are the miRNA listed in Table Ie. 
     
     
         6 . A method comprising:
 determining the level of expression of at least two miRNA listed in Table IIb or IId in a biological sample from a subject, and   comparing the level of expression of said miRNA from said sample from said subject to the level of expression of said miRNA from a control biological sample,   wherein a change or deviation in the level of expression of said at least two miRNA in said biological sample from said control biological sample identifies a subject at risk of manifesting an aggressive tumor.   
     
     
         7 . The method of  claim 6 , comprising determining the level of expression of the six miRNA listed in Table IIb or IId. 
     
     
         8 . The method of  claim 6 , wherein said miRNA are the miRNA listed in Table IIe, IIf or IIg. 
     
     
         9 . A method comprising:
 determining the level of expression of at least two miRNA listed in Table Vb or Vd in a biological sample from a subject, and   comparing the level of expression of said miRNA from said sample from said subject to the level of expression of said miRNA from a control biological sample,   wherein a change or deviation in the level of expression of said at least two miRNA in said biological sample from said control biological sample determines the presence of a tumor in said subject.   
     
     
         10 . The method of  claim 9 , comprising determining the level of expression of the six miRNA listed in Table Vb or Vd. 
     
     
         11 . The method of  claim 9 , wherein said miRNA are the miRNA listed in Tables Ve or Vf 
     
     
         12 . A method comprising:
 determining the level of expression of at least two miRNA listed in Table VIb or VId in a biological sample from a subject, and   comparing the level of expression of said miRNA from said sample from said subject to the level of expression of said miRNA from a control biological sample,   wherein a change or deviation in the level of expression of said at least two miRNA in said biological sample from said control biological sample determines the presence of an aggressive tumor in said subject.   
     
     
         13 . The method of  claim 12 , comprising determining the level of expression of the six miRNA listed in Table VIb or VId. 
     
     
         14 . The method of  claim 12 , wherein said miRNA are the miRNA listed in Tables VIe or VIf. 
     
     
         15 . The method of  claim 1 , further comprising
 calculating a plurality of real quotients by determining a ratio between the level of expression of at least one pair of miRNA from at least two miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc;   comparing each of the real quotients with a respective control value; and   determining the real quotients which deviate from the respective control quotient value.   
     
     
         16 . The method of  claim 15 , comprising determining a ratio between the level of expression of at least one pair of miRNA from at least six miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc. 
     
     
         17 . The method of  claim 15 , wherein said miRNA are the miRNA listed in Tables Ie, IIe, IIf, IIg, Ve, Vf, VIe or VIf. 
     
     
         18 . The method of  claim 15 , further comprising determining a number or percentage of real quotients which deviate from the respective control value. 
     
     
         19 . The method of  claim 15 , wherein for each of the calculated quotients a respective control quotient is associated, represented by a ratio of the levels of expression for the miRNA in a control biological sample relative to a biological sample of a same type. 
     
     
         20 . The method of  claim 15 , wherein calculating the plurality of real quotients comprises using the expression level of at least two miRNA from the miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc. 
     
     
         21 . The method of  claim 15 , wherein calculating the plurality of real quotients comprises determining a predetermined number or a predetermined percentage of quotients from among the levels of expression, wherein the quotients are selected from at least one of the quotients as listed in Tables IIIa, IIIc, IVa, IVc, VIIa, VIIc, VIIIa, or VIIIc. 
     
     
         22 . The method of  claim 21 , wherein the quotients are selected from at least six of the quotients as listed in Tables IIIa, IIIc, IVa, IVc, VIIa, VIIc, VIIIa, or VIIIc. 
     
     
         23 . An article comprising:
 a support having a plurality of sites, wherein each site is capable of receiving a quantity of a biological sample,   wherein each of the sites comprises at least one reagent capable of binding with at least one miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc.   
     
     
         24 . The article of  claim 23 , wherein each of the sites comprises at least one reagent capable of binding with at least two miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc. 
     
     
         25 . The article of  claim 23 , wherein each of the sites comprises at least one reagent capable of binding with at least six miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc. 
     
     
         26 . The article of  claim 23 , wherein the reagent is selected from group consisting of:
 a polynucleotide comprising a nucleotide sequence of at least one miRNA from the miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc;   a polynucleotide comprising a nucleotide sequence which is complementary to a sequence of at least one miRNA from the miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc; and   a molecular probe configured such as to recognize a sequence of at least one miRNA from the miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc.   
     
     
         27 . The article of  claim 26 , wherein comprising at least two miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc. 
     
     
         28 . The article of  claim 26 , wherein comprising at least six miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc. 
     
     
         27 . An article comprising:
 a support having a plurality of sites, wherein each site is capable of receiving a quantity of a biological sample,   wherein each of the sites comprises at least one reagent capable of binding with at least two miRNA listed in Tables Ib, Id, IIb, IId, Vb, Vd, VIb or VId.   
     
     
         28 . The article of  claim 27 , wherein each of the sites comprises at least one reagent capable of binding with at least six miRNA listed in Tables Ib, Id, IIb, IId, Vb, Vd, VIb or VId. 
     
     
         29 . The article of  claim 27 , wherein said miRNA are the miRNA listed in Tables Ie, IIe, IIf, IIg, Ve, Vf, VIe or VIf. 
     
     
         30 . An apparatus comprising:
 at least one unit capable of receiving at least one of the articles of  claim 23 ;   means for determining the level of expression of at least one miRNA from the miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc, and   means for calculating the real quotients from among the levels of expression of at least one pair of miRNA from the pairs of miRNA listed in Tables IIIa, IIIc, IVa, IVc, VIIa, VIIc, VIIIa, or VIIIc.   
     
     
         31 . The method of  claim 3 , further comprising altering the level of expression of at least one miRNA for which the level of expression changes or deviates, thereby reducing or eliminating the risk of developing a tumor in said subject. 
     
     
         32 . The method of  claim 6 , further comprising altering the level of expression of at least one miRNA for which the level of expression changes or deviates, thereby reducing or eliminating the risk of developing an aggressive tumor in said subject. 
     
     
         33 . The method of  claim 9 , further comprising altering the level of expression of at least one miRNA for which the level of expression changes or deviates, thereby treating a tumor in said subject. 
     
     
         34 . The method of  claim 12 , further comprising altering the level of expression of at least one miRNA for which the level of expression changes or deviates, thereby treating an aggressive tumor in said subject. 
     
     
         35 . The method of  claim 31 , wherein altering the level of expression of said at least one miRNA comprises
 administering to said subject a therapeutically effective amount of at least one miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc, or a chemically synthesized miRNA mimetic or recombinant thereof, if the level of expression of said at least one miRNA is lower than the control level of expression or   administering to said subject a therapeutically effective amount of a compound capable of inhibiting the expression of at least one miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc, if the level of expression of said at least one miRNA is higher than the control level of expression.   
     
     
         36 . The method of  claim 35 , comprising
 administering a therapeutically effective amount of a composition comprising at least one miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc, or a chemically synthesized miRNA mimetic or recombinant thereof or   administering a therapeutically effective amount of a composition comprising an inhibitor of at least one miRNA listed in Tables Ib, Id, IIb, Hd, Vb, Vd, VIb or VId.   
     
     
         37 . A pharmaceutical compound comprising:
 at least one miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc, chemically synthesized miRNA mimetic or recombinant thereof, or   an inhibitor of the expression of at least one miRNA listed in Tables Ia, Ic, IIa, IIe, Va, Vc, VIa, or VIc and a pharmaceutically acceptable carrier.   
     
     
         38 . The pharmaceutical compound of  claim 37  comprising at least two miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc 
     
     
         39 . The pharmaceutical compound of  claim 37  comprising at least six miRNA listed in Tables Ia, Ic, IIa, IIc, Va, Vc, VIa, or VIc 
     
     
         40 . A pharmaceutical compound comprising:
 at least one miRNA listed in Tables Ib, Id, IIb, IId, Vb, Vd, VIb or VId, chemically synthesized miRNA mimetic or recombinant thereof, or   an inhibitor of the expression of at least one miRNA listed in Tables Ib, Id, IIb, IId, Vb, Vd, VIb or VId and a pharmaceutically acceptable carrier.   
     
     
         41 . The pharmaceutical compound of  claim 40  comprising at least two miRNA listed in Tables Ib, Id, IIb, IId, Vb, Vd, VIb or VId 
     
     
         42 . The pharmaceutical compound of  claim 40  comprising at least six miRNA listed in Tables Ib, Id, IIb, IId, Vb, Vd, VIb or VId 
     
     
         43 . The pharmaceutical compound of  claim 40 , wherein said miRNA are the miRNA listed in Tables Ie, IIe, IIf, IIg, Ve, Vf, VIe or VIf

Join the waitlist — get patent alerts

Track US2012225925A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.