Methods of treatment of cancer by continuous infusion of coenzyme Q10

Inventors

Narain, Niven RajinSarangarajan, RangaprasadGray, Thomas MitchellMcCook, John PatrickJimenez, Joaquin J.

Assignees

BPGbio Inc

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Publication Number

US-11298313-B2

Patent

Publication Date

2022-04-12

Expiration Date


Abstract

The invention provides regimens and methods for the treatment of cancer comprising continuous infusion of coenzyme Q10. The coenzyme Q10 may be administered as a monotherapy, or in combination with an additional agent, such as an anticancer agent, a chemotherapeutic agent, or an anti-angiogenic agent. The coenzyme Q10 may be administered at two or more different rates.

Core Innovation

The invention relates to treating cancer in a subject by administering a composition comprising from 0.001% to 20% (w/w) of coenzyme Q10 by continuous intravenous infusion for at least 48 hours. The approach is anchored in extended continuous administration rather than shorter intravenous administration.

The same coenzyme Q10 continuous intravenous infusion approach is also used to prevent or limit the severity of an adverse event associated with treatment of cancer. The severity of an adverse event in the subject is reduced as compared to intravenous administration of the same dose of coenzyme Q10 over a period of 6 hours or less.

The disclosed continuous infusion may include multi-stage infusion rates, including three sequential infusion rates, and subject selection or monitoring criteria tied to coagulation, including platelet thresholds and International Normalized Ratio (INR) values within normal limits. The claims further characterize selection of infusion rates using mg/kg/hour values and upper-limit thresholds.

Claims Coverage

The document includes two independent methods. The first covers treating cancer by continuous intravenous infusion of a coenzyme Q10 composition for at least 48 hours. The second covers preventing or limiting the severity of an adverse event by reducing adverse event severity compared to the same dose given over 6 hours or less, while also using continuous intravenous infusion for at least 48 hours.

Continuous intravenous coenzyme Q10 cancer treatment for at least 48 hours

Administering a composition comprising from 0.001% to 20% (w/w) of coenzyme Q10 by continuous intravenous infusion for at least 48 hours to treat the cancer in the subject.

Reducing adverse event severity versus ≤6-hour intravenous coenzyme Q10 dosing

Preventing or limiting severity of an adverse event associated with treatment of cancer with intravenously administered coenzyme Q10 by administering to a subject having cancer a composition comprising from 0.001% to 20% (w/w) of coenzyme Q10 by continuous intravenous infusion for at least 48 hours, where the severity of the adverse event is reduced as compared to intravenous administration of the same dose of coenzyme Q10 over a period of 6 hours or less.

Overall claim coverage centers on continuous intravenous infusion administration of coenzyme Q10 at specified concentration limits for at least 48 hours, with an adverse-event framework that requires reduced severity versus an intravenous dosing period of 6 hours or less. Dependent claim refinements address infusion-rate scheduling with sequential rates and coagulation-based criteria including platelet and INR measures.

Stated Advantages

Treats the cancer in the subject.

Reduces the severity of an adverse event compared to intravenous administration of the same dose over a period of 6 hours or less.

Documented Applications

Treating cancer in a subject using coenzyme Q10 administered by continuous intravenous infusion for at least 48 hours.

Preventing or limiting severity of an adverse event associated with cancer treatment with intravenously administered coenzyme Q10 by using continuous intravenous infusion for at least 48 hours.

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