Isoflavonoid compositions and methods for the treatment of cancer

Patent metadata

Field	Value
Publication number	US-2024165073-A1
Application number	US-202318340308-A
Country	US
Kind code	A1
Filing date	Jun 23, 2023
Priority date	Nov 1, 2010
Publication date	May 23, 2024
Grant date	—

First claim

1 . A pharmaceutical composition comprising:
i) d-cis-3-4-hydroxyphenyl)-4-(4-hydroxyphenyl)-8-methylchroman-7-ol provided in at least 95% enantiomeric excess; ii) a cyclodextrin; and iii) a liquid vehicle.

2 .- 5 . (canceled)

6 . The composition of claim 1 , wherein the cyclodextrin is selected from the group consisting of SAE-CD derivatives, SBE-α-CD, SBE-β-CD, SBE1-β-CD, SBE4-β-CD, SBE7-β-CD, SBE-γ-CD, hydroxypropyl-β-cyclodextrin, 2-HP-β-CD, hydroxyethyl-β-cyclodextrin, hydroxypropyl-γ-cyclodextrin, hydroxyethyl-γ-cyclodextrin, dihydroxypropyl-β-cyclodextrin, glucosyl-α-cyclodextrin, glucosyl-β-cyclodextrin, diglucosyl-β-cyclodextrin, maltosyl-α-cyclodextrin, maltosyl-β-cyclodextrin, maltosyl-γ-cyclodextrin, maltotriosyl-β-cyclodextrin, maltotriosyl-γ-cyclodextrin, dimaltosyl-β-cyclodextrin, methyl-β-cyclodextrin, and derivatives and/or combinations thereof.

7 . The composition of claim 1 , wherein the cyclodextrin is SBE7-β-CD.

8 . The composition of claim 1 , wherein the cyclodextrin has a concentration (w/v) ranging from about 0.001% to about 50%.

9 . The composition of claim 1 , wherein the cyclodextrin has a concentration (w/v) ranging from about 28% to about 32%.

10 . The composition of claim 1 , wherein the composition further comprises one or more of lactose, dextrose, mannitol, a pH buffering agent, an antioxidant agent, a preservative agent, a tonicity adjuster, or a combination thereof.

11 . The composition of claim 1 , wherein the composition comprises d-cis-3-(4-hydroxyphenyl)-4-(4-hydroxyphenyl)-8-methylchroman-7-ol in an amount of about 0.2-50 mg/mL.

12 . The composition of claim 1 , wherein the composition further comprises a chemotherapeutic agent selected from the group comprising cisplatin, carboplatin, paclitaxel, gemcitabine or doxorubicin.

13 . The composition of claim 1 , wherein the liquid vehicle comprises water, Ringer's solution, phosphate buffered saline solution, isotonic sodium chloride solution, ethanol or 1,3-butanediol.

14 . The composition of claim 1 , wherein the liquid vehicle comprises water.

15 - 19 . (canceled)

20 . A method of treating cancer in an individual in need thereof, the method comprising administering to the individual a pharmaceutical composition comprising:
i) d-cis-3-(4-hydroxyphenyl)-4-(4-hydroxyphenyl)-8-methylchroman-7-ol provided in at least 95% enantiomeric excess; ii) a cyclodextrin; and iii) a liquid vehicle.

21 . The method of claim 20 , wherein the cancer has lost sensitivity to a chemotherapeutic agent, an anti-cancer agent, or a radiation therapy.

22 . The method of claim 21 , wherein the composition increases or induces sensitivity of the cancer to the chemotherapeutic agent, the anti-cancer agent, or the radiation therapy.

23 . The method of claim 20 , wherein the cancer is selected from the group comprising bladder cancer, breast cancer, colon cancer, rectal cancer, endometrial cancer, kidney cancer, leukemia, lung cancer, melanoma, non-Hodgkin lymphoma, ovarian cancer, pancreatic cancer, prostate cancer, thyroid cancer, and cancers of the brain.

24 . The method of claim 20 , wherein the cancer is breast cancer or ovarian cancer.

25 . The method of claim 20 , further comprising administering to the individual a chemotherapeutic agent selected from the group comprising cisplatin, carboplatin, paclitaxel, gemcitabine, and doxorubicin.

26 . A kit comprising:
i a sealable, plastic infusion bag; and ii) a pharmaceutical composition comprising:
a) d-cis-3-(4-hydroxyphenyl)-4-(4-hydroxyphenyl)-8-methylchroman-7-ol provided in at least 95% enantiomeric excess;
b) a cyclodextrin; and
c) a liquid vehicle.

Assignees

• Mei Pharma Inc

Inventors

• Moreno Ofir

Classifications

• A61K31/353 Primary

  3,4-Dihydrobenzopyrans, e.g. chroman, catechin · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K9/5161

  Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin · CPC title

• A61K31/337

  having four-membered rings, e.g. taxol · CPC title

• A61K31/555

  containing heavy metals, e.g. hemin, hematin, melarsoprol · CPC title