Non-invasive biomarker to identify subject at risk of preterm delivery
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
G01N-033/573
A61K-031/4166
A61K-031/5575
A61K-031/454
A61K-045/06
G01N-033/68
A61K-031/137
A61K-031/195
A61K-031/44
출원번호
US-0438110
(2013-10-24)
등록번호
US-9797903
(2017-10-24)
국제출원번호
PCT/US2013/066490
(2013-10-24)
국제공개번호
WO2014/066568
(2014-05-01)
발명자
/ 주소
Ragolia, Louis
출원인 / 주소
WINTHROP-UNIVERSITY HOSPITAL
대리인 / 주소
Amster, Rothstein & Ebenstein LLP
인용정보
피인용 횟수 :
0인용 특허 :
81
초록
Methods for diagnosis to allow prediction of the likelihood of preterm birth based upon the concentration of lipocalin-type prostaglandin D2 synthase (L-PGDS) in cervical vaginal secretions. In addition, specific prostaglandin D2 receptor antagonists may represent novel tocolytic therapeutics.
대표청구항▼
1. A method for assessing the likelihood of preterm delivery for a pregnant woman with an intact amniotic membrane, the method comprising: receiving a cervical vaginal secretion sample collected from a pregnant woman, the cervical vaginal secretion sample being collected with an absorptive media and
1. A method for assessing the likelihood of preterm delivery for a pregnant woman with an intact amniotic membrane, the method comprising: receiving a cervical vaginal secretion sample collected from a pregnant woman, the cervical vaginal secretion sample being collected with an absorptive media and treated with a protease inhibitor to reduce proteolysis;measuring lipocalin-type prostaglandin D2 synthase (L-PGDS) concentration from the cervical vaginal secretion sample;andadministering to the pregnant woman, selectively in dependence on the measured lipocalin-type prostaglandin D2 synthase (L-PGDS) concentration of at least 1.8 μg/ml, an effective amount of a therapeutic composition to avoid or mitigate preterm delivery, comprising at least one compound selected from the group consisting of:a prostaglandin DP1 receptor antagonist,a prostaglandin DP2 receptor antagonist, anda selective L-PGDS inhibitor. 2. The method of claim 1, wherein the cervical vaginal secretion is collected with a sponge. 3. The method of claim 1, wherein the prostaglandin DP1 receptor antagonist is administered in an effective amount as a tocolytic agent. 4. The method of claim 1, wherein the prostaglandin DP2 receptor antagonist is administered in an effective amount as a tocolytic agent. 5. The method of claim 1, wherein the selective L-PGDS inhibitor is administered in an effective amount as a tocolytic agent. 6. The method of claim 1, wherein the L-PGDS concentration is determined using an antibody sandwich Enzyme-Linked ImmunoSorbent Assay (ELISA). 7. The method of claim 1, wherein the L-PGDS concentration is normalized to protein levels in the cervical vaginal secretions for analysis. 8. The method according to claim 1, wherein the therapeutic composition comprises one or more compounds selected from the group consisting of AM156 ({2′-[(cyclopropanecarbonyl-ethyl-amino)-methyl]-6-methoxy-4′-trifluoro-methyl-biphenyl-3-yl}-acetic acid, sodium salt), and AM206 (5-{2-[(benzoyloxycarbonyl-ethyl-amino)-methyl]-4-trifluoromethyl-phenyl}-pyridin-3-yl)-acetic acid, sodium salt), MK-0524 ([(3R)-4-(4-Chloro-benzyl)-7-fluoro-5-(methylsulfonyl)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl]-acetic Acid), AM-853 (2-(4-(4-(tert-butylcarbamoyl)-2-(2-chloro-4-cyclopropylphenyl sulfonamido)phenoxy)-5-chloro-2-fluorophenyl)acetic acid), BW868C (3-benzyl-5-(6-carbohexyl)-1-(2-cyclohexyl-2-hydroxyethylamino)-hydantoin), S-5751 ((Z)-7-[(1R,2R,3S,5S)-2-(5-hydroxy benzo[b]thiophen-3-ylcarbonylamino)-10-norpinan-3-yl]hept-5-enoic acid), and BAY-u3405 (Ramatroban, 3(R)-[[(4-fluorophenyl) sulphonyl]amino]-1,2,3,4-tetrahydro-9H-carbazole-9-propanoic acid). 9. The method according to claim 1, wherein the therapeutic composition comprises AT-56 (4-dibenzo[a,d]cyclohepten-5-ylidene-1-[4-(2H-tetrazol-5-yl)-butyl]-piperidine). 10. The method according to claim 1, wherein the therapeutic composition is administered orally. 11. The method according to claim 1, wherein the therapeutic composition is administered by at least one of the group consisting of by inhalation, through a mucous membrane, transdermally, topically and rectally. 12. The method according to claim 1, wherein the therapeutic composition is administered parenterally. 13. The method according to claim 1, wherein the therapeutic composition is administered to achieve concurrent therapeutic effect with a coadminstered tocolytic agent which is not a prostaglandin D2 receptor antagonist and is not an L-PGDS inhibitor. 14. The method according to claim 13, wherein the coadministered tocolytic agent comprises a β2 receptor agonist. 15. The method according to claim 13, wherein the β2 receptor agonist is at least one compound selected from the group consisting of terbutaline, Ritodrine, Fenoterol, and Salbutamol. 16. The method according to claim 13, wherein the coadministered tocolytic agent comprises a non-steroidal anti-inflammatory drug cyclooxygenase inhibitor. 17. The method of claim 1, wherein the therapeutic composition comprises a DP2 receptor antagonist. 18. The method of claim 1, wherein the therapeutic composition comprises a DP1 receptor antagonist. 19. The method of claim 1, wherein the therapeutic composition comprises a selective L-PGDS inhibitor.
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