Combination therapy using belinostat and pralatrexate to treat lymphoma
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11439643-B2
Publication Date
2022-09-13
Expiration Date
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.
Core Innovation
A pharmaceutical composition is provided that includes a therapeutically effective first amount of belinostat and a therapeutically effective second amount of pralatrexate, together with a pharmaceutical carrier or excipient. The therapeutically effective amount exhibits a synergistic growth inhibitory effect compared to using belinostat alone or pralatrexate alone, in the context of treatment of mantle cell lymphoma or peripheral T-cell lymphoma.
The peripheral T-cell lymphoma is specified as anaplastic large cell lymphoma (ALCL) or cutaneous T-cell lymphoma. The therapeutically effective amount is defined to have a molar ratio of belinostat to pralatrexate of 8:1 when used for the treatment of ALCL, 33:1 for cutaneous T-cell lymphoma, and 5:1 for mantle cell lymphoma.
The combination of belinostat and pralatrexate produces synergistic antiproliferative effects in vitro for lymphoma cell lines. Synergy is described using combination index analysis, including Chou-Talalay analysis, and is characterized by CI values indicating synergism.
Claims Coverage
The independent claim is directed to a pharmaceutical composition comprising belinostat and pralatrexate in therapeutically effective amounts that exhibit synergistic growth inhibition for specified lymphomas. The coverage centers on three inventive features: the specific drug combination, the synergy requirement, and lymphoma-type-specific belinostat:pralatrexate molar ratios.
Synergistic belinostat and pralatrexate pharmaceutical composition
A pharmaceutical composition comprising a first amount of belinostat and a second amount of pralatrexate with a pharmaceutical carrier or excipient, wherein the therapeutically effective amounts exhibit a synergistic growth inhibitory effect compared to the first amount alone or the second amount alone.
Synergistic treatment of mantle cell lymphoma or peripheral-t cell lymphoma
Use of the therapeutically effective amounts for the treatment of mantle cell lymphoma or peripheral T-cell lymphoma, wherein the peripheral T-cell lymphoma is anaplastic large cell lymphoma (ALCL) or cutaneous T-cell lymphoma.
Lymphoma-type-specific belinostat:pralatrexate molar ratios
Therapeutically effective amounts having a molar ratio of belinostat to pralatrexate of 8:1 for ALCL, 5:1 for mantle cell lymphoma, and 33:1 for cutaneous T-cell lymphoma.
Overall, the independent claim coverage is anchored by a belinostat plus pralatrexate pharmaceutical composition defined by synergistic growth inhibition and limited to specified lymphoma indications. The claim further constrains treatment by requiring lymphoma-type-specific belinostat:pralatrexate molar ratios for ALCL, mantle cell lymphoma, and cutaneous T-cell lymphoma.
Stated Advantages
Synergistic growth inhibitory effect compared to belinostat alone or pralatrexate alone.
Synergistic antiproliferative effect as characterized by combination index analysis indicating synergism.
Documented Applications
Treatment of mantle cell lymphoma or peripheral T-cell lymphoma, wherein the peripheral T-cell lymphoma is anaplastic large cell lymphoma (ALCL) or cutaneous T-cell lymphoma.
Interested in licensing this patent?