# US 11,439,643 B2 · Combination therapy using belinostat and pralatrexate to treat lymphoma

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- Number: US 11,439,643 B2
- Document ID: US11439643B2
- Status: Granted
- Kind: B2
- Application number: 15/736,550
- Filed: 2016-06-14
- Published: 2018-06-28
- Granted: 2022-09-13
- Earliest claimed: 2015-06-16
- Assignees: Acrotech Biopharma Inc.
- Applicants: Spectrum Pharmaceuticals, Inc.
- Inventors: Guru Reddy
- Web page: https://patentgrep.com/patent/US11439643B2

## CPC

- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/18: Sulfonamides (compounds containing a para-N-benzene-sulfonyl-N- group A61K31/63)
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to compositions and methods for treating lymphoma in a subject in need thereof, said methods comprising administering to the patient in need thereof a therapeutically effective amount of a combination of belinostat and pralatrexate, wherein said therapeutically effective amount results in a synergistic antiproliferative effect on cancer cell growth.

## Claims

### Claim 1

A pharmaceutical composition, comprising:
a first amount of belinostat;
a second amount of pralatrexate; and
a pharmaceutical carrier or excipient,
wherein the first amount and the second amount comprise a therapeutically effective amount,
wherein the therapeutically effective amount exhibits a synergistic growth inhibitory effect compared to the first amount alone or the second amount alone when used for the treatment of a mantle cell lymphoma, or a peripheral T-cell lymphoma, wherein the peripheral T-cell lymphoma is an anaplastic large cell lymphoma (ALCL) or a cutaneous T-cell lymphoma,
wherein the therapeutically effective amount has a molar ratio of belinostat to pralatrexate of 8:1 when used for the treatment of the ALCL,
wherein the therapeutically effective amount has a molar ratio of belinostat to pralatrexate of 5:1 when used for the treatment of the mantle cell lymphoma, and
wherein the therapeutically effective amount has a molar ratio of belinostat to pralatrexate of 33:1 when used for the treatment of the cutaneous T-cell lymphoma.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein said composition further comprises a vitamin selected from the group consisting of vitamin B12 and folic acid.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the first amount of belinostat is in a concentration ranging from about 1.0 mg/mL to about 10 mg/mL, and wherein the second amount of pralatrexate is in a concentration ranging from about 1.0 mg/mL to about 30 mg/mL.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein the pharmaceutical carrier or excipient is one or more selected from the group consisting of lactose, starch, sucrose, glucose, methyl cellulose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, dicalcium phosphate, calcium sulfate, mannitol, sorbitol, ethanol, glycerol, water, starch, gelatin, beta-lactose, acacia, tragacanth, sodium aliginate, carboxymethylcellulose, polyethylene glycol, sodium oleate, sodium stearate, magnesium stearate, sodium benzoate, sodium acetate, sodium chloride, agar, bentonite, xanthan gum, glucuronic acid, L-lactic acid, acetic acid, and citric acid.

### Claim 5 (depends on 1)

The pharmaceutical composition of claim 1,
wherein the therapeutically effective amount when used for the treatment of the ALCL is sufficient to deliver from 0.25×IC50 to 0.5×IC50 for each of belinostat and pralatrexate at a target site for the ALCL,
wherein the therapeutically effective amount when used for the treatment of the mantle cell lymphoma is sufficient to deliver from 2×IC50 to 4×IC50 for each of belinostat and pralatrexate at a target site for the mantle cell lymphoma, and
wherein the therapeutically effective amount when used for the treatment of the cutaneous T-cell lymphoma is sufficient to deliver from 0.5×IC50 to 1×IC50 for each of belinostat and pralatrexate at a target site for the cutaneous T-cell lymphoma.