Compositions and methods for treatment of inflammation

Inventors

McDonald, Thomas • Drescher, Kristen

Assignees

Creighton University • Vireo Systems Inc

Abstract

The present invention is directed to novel anti-inflammatory immunomodulators including creatinine or a creatinine salt, for example, creatinine hydrochloride. The present invention is also directed to methods for treating inflammation and inducing an immunomodulatory response. In particular, the anti-inflammatory immunomodulators are useful for treating an inflammatory condition or an autoimmune disease.

Core Innovation

The invention relates to anti-inflammatory immunomodulators comprising creatinine and creatinine salts, including creatinine hydrochloride. It is directed to a method of inducing an immunomodulatory response in a patient identified with rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, inflammatory myopathy, pancreatitis, lupus, or a combination thereof. The method includes administering a composition containing an immunomodulating agent effective to produce an immunomodulatory effect, where the immunomodulating agent comprises a creatinine salt.

A central mechanism asserted is the downregulation or suppression of pro-inflammatory TNF-α and, in certain embodiments, IL-6. The document describes suppression at both mRNA and protein levels, including real-time RT-PCR and immunohistochemical staining to support the mechanism. It reports that creatinine hydrochloride reduces TNF-α mRNA signal and decreases TNF-α protein signal following a treatment period. The document also describes creatine monohydrate as showing similar TNF-α suppression, attributed in the document to hydrolysis to creatinine.

The invention further encompasses composition and administration embodiments, including specific creatinine salt species and optional blending, and it describes topical and transdermal administration forms. The compositions are described to include different creatinine salt derivatives such as creatinine hydrochloride and other creatinine salts (e.g., nitrate, malate, gluconate, zinc chloride, citrate). Administration is described in topical formats such as ointment, lotion, cream, gel, adhesive patch, and wrap, including embodiments that incorporate penetrating agents. The overall disclosure ties these formulation forms to inducing the claimed immunomodulatory response in the identified inflammatory or autoimmune settings.

Claims Coverage

The partial content identifies three independent claims, each covering a method of inducing an immunomodulatory response using a creatinine-salt-based immunomodulating agent, with claim 10 focused on topical formulations and claim 17 focused on suppressing TNF-α and/or IL-6 at an inflamed area. Across the independent claims, the inventive features concentrate on patient identification, administration of a creatinine-salt-containing composition or formulation, and—depending on the claim—specified immunomodulatory targets (TNF-α and/or IL-6) and route (topical or inflamed-area formulation).

Overall, the independent claims are directed to administering creatinine-salt-containing compositions/formulations to patients with specified inflammatory or autoimmune diseases to induce an immunomodulatory response. Claim scope includes topical formulation embodiments, and also explicitly ties the immunomodulatory effect to suppression of TNF-α and/or IL-6 at an inflamed area.

Stated Advantages

Documented Applications