Patent AU-2013203600-C1 (AU)
Title: A method of treating androgen receptor (AR)-positive breast cancers with selective androgen receptor modulator (SARMS)
Inventor: DALTON JAMES T
IPC: A01N37/34
Filed: 2013-03-07
Granted: 2016-11-24
Abstract: (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date W O 2014/011220 A2 16 January 2014 (16.01.2014) W I P0 I P CT (51) International Patent Classification: (74) Agent: COHEN, Mark, S.; PEARL COHEN ZEDEK C07C271/02 (2006.01) A61K45/06 (2006.01) LATZER, LLP, 1500 Broadway, 12th Floor, New York, A61K 31/325 (2006.01) NY 10036 (US). (21) International Application Number: (81) Designated States (unless otherwise indicated, for every PCT/US2013/029667 kind of national protection available): AE, AG, AL, AM, (22) International Filing Date: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, ( Interntiona Filing Date3 BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, 7 March 2013 (07.03.2013) DO, DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GH, GM, GT, (25) Filing Language: English HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (26) Publication Language: English ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (30) Priority Data: NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, 61/671,366 13 July 2012 (13.07.2012) US RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, 61/726,274 14 November 2012 (14.11.2012) US TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant: GTX, INC. [ /US]; 175 Toyota Plaza, 7th Floor, Memphis, TN 38103 (US). (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (72) Inventors; and GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (71) Applicants : DALTON, James, T. [US/US]; 9896 Rue UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, Bienville Place, Lakeland, TN 38002 (US). STEINER, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, Mitchell, S. [US/US]; 2600 Forest-hill Irene Road, Ger- EE, ES, Fl, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, mantown, TN 38139 (US). NARAYANAN, Ramesh MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, [US/US]; 487 Herring Lane, Cordova, TN 38018 (US). TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, AHN, Sunjoo [US/US]; 5395 Bentley Place, Memphis, TN ML, MR, NE, SN, TD, TG). 38120 (US). [Continued on next page] (54) Title: A METHOD OF TREATING ANDROGEN RECEPTOR (AR)-POSITIVE BREAST CANCERS WITH SELECTIVE ANDROGEN RECEPTOR MODULATOR (SARMS) 5: v Vehicle P0 5/wk 1400 a Vehicle PO 5/wk 0 30 mg/kg formula Vill PO 5/wk 0 30 mg/kg formula Vill PO 5/wk - %~ 200 -0- 0 7 14 2 28 3 0 7 '4 '1 23 35 Time (days) Time (days) (57) Abstract: This invention relates to the treatment of androgen receptor-positive breast cancer in a subject, for example a female f subject. Accordingly, this invention provides methods of: a) treating a subject suffering from breast cancer; b) treating a subject suf f4 fering from metastatic breast cancer; c) treating a subject suffering from refractory breast cancer; d) treating a subject suffering from AR-positive breast cancer; e) treating a subject suffering from AR-positive refractory breast cancer; f) treating a subject suffering from AR-positive metastatic breast cancer; g) treating a subject suffering from AR-positive and ER-positive breast cancer; h) treating a subject suffering from triple negative breast cancer; i) treating a subject suffering from advanced breast cancer; j) treating a subject suffering from breast cancer that has failed SERM (tamoxifen, toremifene), aromatase inhibitor, trastuzumab (Herceptin, ado-trastu zumab emtansine), pertuzumab (Perjeta), lapatinib, exemestane (Aromasin), bevacizumab (Avastin), and/or fulvestrant treatments; k) f4 treating, preventing, suppressing or inhibiting metastasis in a subject suffering from breast cancer; 1) prolonging survival of a subject with breast cancer, and/or m) prolonging the progression-free survival of a subject with breast cancer; comprising administering to the subject a therapeutically effective amount of a selective androgen receptor modulator (SARM) compound, comprising adminis tering to the subject a therapeutically effective amount of a SARM compound of this invention. W O 2 0 14/0 1 12 2 0 A 2 ||IllllI||ll||IlIlIlllllIIll|||I||I|I||||I||I||||||||||| I|I|DI||||D|||||||||||||||||I| Published: - without international search report and to be republished upon receipt of that report (Rule 48.2(g))