Controlled release of antibodies to modulate cytokines
AssigneeFlow Pharma, Inc.
InventorsReid M. Rubsamen, Scott Burkholtz, Charles V. Herst, Tom Hodge, Lu Wang
Life of this patent
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Abstract
An injectable formulation, comprising: poly(lactic-co-glycolic (PLGA) microsphere encapsulating siltuximab, wherein microspheres are sized to release siltuximab over a period of hours, days and weeks, where the biocompatible polymer releases antibody at an absorption rate which is characterized by an absorption rate constant (Ka (h−1) in the range of (0.001 to 2.048)+/−20%, or +/−10%, or +/−5% . . . for use and treating human patients with infections. The invention includes treating patients with viral infections of SARS-Cov-2 using siltuximab.
Claims8
A method of treating, comprising:
- diagnosing a patient with an infection of Ebola;
- measuring a level of IL-6 in the patient to obtain an initial level;
- administering to the patient by intramuscular injection a therapeutically effective amount of an injectable formulation of a therapeutically effective amount of siltuximab anti-IL-6 antibody encapsulated in a biocompatible polymer;
- and
- allowing the anti-IL-6 antibody to bind IL-6 cytokines in the patient and reduce cytokine release syndrome effects while allowing a level of free IL-6 cytokine to remain in the patient.
A method of treating, comprising:
- diagnosing a patient with an Ebola infection;
- administering to the patient at a first point in time a therapeutically effective amount of a first injectable formulation comprising a pharmaceutically acceptable carrier with free anti-IL-6 antibody, and
- allowing the free anti-IL-6 antibodies to bind IL-6 cytokines in the patient and provide for an initial phase of reducing cytokine release syndrome effects in the patient while leaving an amount of free IL-6 cytokines, and
- administering to the patient at a second point in time a therapeutically effective amount of a second injectable formulation comprising a pharmaceutically acceptable carrier with free anti-IL-6R antibody wherein the second point in time is at least one hour after the first point in time.
A method of treating, comprising:
- diagnosing a patient with an Ebola infection;
- administering to the patient by injection at a first point in time a therapeutically effective amount of a first injectable formulation comprising a pharmaceutically acceptable carrier and free siltuximab, and
- allowing the free siltuximab to bind IL-6 cytokines in the patient and provide for an initial phase of reducing cytokine release syndrome effects in the patient while leaving a level of free IL-6 cytokines, and
- administering to the patient at a second point in time a therapeutically effective amount of a second injectable formulation comprising a pharmaceutically acceptable carrier with free anti-IL-6R antibody selected from the group consisting of sarilumab and tocilizumab, wherein the second point in time is at least one hour after the first point in time;
- wherein the first and second injectable formulations are administered by a type of injection selected from the group consisting of subcutaneous and intramuscular and both formulations comprise free unencapsulated antibodies and antibodies encapsulated in a biocompatible polymer.
A method of treating, comprising:
- diagnosing a patient with an Ebola infection;
- administering to the patient by intravenous injection a therapeutically effective amount of an injectable formulation comprising a pharmaceutically acceptable carrier, and at least one anti-IL-6 antibody selected from siltuximab, wherein the formulation is injected at a rate so as to reduce cytokine release syndrome effects;
- measuring the IL-6 cytokine blood level in the patient;
- and
- adjusting the dose and frequency of injection based on the measured cytokine level to allow for a level of IL-6 cytokines of about 5 to 7 μg/ml, thereby avoiding cytokine release syndrome while allowing for a level of circulating IL-6 cytokines.
Dependencies are inferred from the claim text.