Methods of treatment of cancer by continuous infusion of coenzyme Q10
Inventors
Narain, Niven Rajin • Sarangarajan, Rangaprasad • Gray, Thomas Mitchell • McCook, John Patrick • Jimenez, Joaquin J.
Assignees
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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 provides methods of treating cancer with a composition comprising coenzyme Q10 administered by continuous intravenous infusion [procedural detail omitted for safety]. The description encompasses nanosuspension formulations, monotherapy, and combinations with additional anticancer agents. Furthermore, the disclosure includes monitoring coagulation status during treatment and managing decreased coagulation through treatment discontinuation or corrective intervention and resumption when normal coagulation is confirmed.
The disclosure details clinical and preclinical evaluations across solid tumors and leukemias, evaluating safety, dose-limiting toxicity, pharmacokinetics, and treatment response. Coagulation abnormalities are addressed through clinical monitoring and treatment management, reporting reduced adverse-event severity compared with shorter infusion schedules. Preclinical survival findings and interim clinical tumor responses are documented, while the underlying technical problem being solved is not explicitly described in patent.
Claims Coverage
The claims include four independent claims directed to treating cancer using continuous intravenous coenzyme Q10 infusion, presenting four inventive features covering treatment administration and distinct coagulation-monitoring decisions.
Cancer treatment with continuous intravenous coenzyme Q10 infusion
Independent claim 1 covers treating cancer by administering a composition comprising coenzyme Q10 through continuous intravenous infusion [procedural detail omitted for safety]. Dependent claims specify an agent to increase coagulation, including vitamin K, as well as infusion duration and frequency.
Coagulation monitoring with treatment discontinuation
Independent claim 7 covers treating cancer with continuous intravenous coenzyme Q10 infusion, monitoring the subject for decreased coagulation, and discontinuing coenzyme Q10 treatment when decreased coagulation is identified [procedural detail omitted for safety].
Coagulation management followed by continued treatment
Independent claim 8 covers monitoring for decreased coagulation, administering an agent to increase coagulation when decreased coagulation is identified, confirming normal coagulation, and continuing coenzyme Q10 treatment. A dependent claim identifies vitamin K as part of the coagulation-increasing agent.
Treatment continuation with normal coagulation
Independent claim 9 covers monitoring for decreased coagulation during continuous intravenous coenzyme Q10 treatment and continuing treatment when the subject is identified as having normal coagulation [procedural detail omitted for safety].
Together, the four independent claims cover continuous intravenous coenzyme Q10 infusion for cancer treatment and coagulation-status management involving discontinuation, corrective intervention followed by continuation, or continuation when normal coagulation is confirmed.
Stated Advantages
Preclinical studies report improved survival trends with continuous coenzyme Q10 infusion across cancer models.
Interim clinical results describe early tumor responses and patient outcomes.
Prolonged coenzyme Q10 infusion is described as safe and well tolerated in monotherapy and combination therapy, with reduced adverse-event severity and reduced coagulation abnormalities compared with shorter infusion schedules.
Documented Applications
Cancer treatment for solid tumors as well as leukemias, including relapsed or refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).
Administration of coenzyme Q10 as monotherapy or in combination with anticancer agents, including gemcitabine, 5-fluorouracil and leucovorin, docetaxel, or fludarabine and cytarabine.
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