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Last Updated: March 28, 2024

Claims for Patent: 10,420,723


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Summary for Patent: 10,420,723
Title:Milk-derived microvesicle compositions and related methods
Abstract: A composition is provided that comprises a therapeutic agent encapsulated by a milk-derived microvesicle. The compositions can include therapeutic agents such as phytochemical agents or chemotherapeutic agents, while the milk-derived microvesicle can be derived from raw milk or colostrum. Further provided are methods for isolating a microvesicle that includes the steps of obtaining an amount of milk, and subjecting the milk to a series of sequential centrifugations configured to yield greater than about 300 mg of microvesicle protein per 100 ml of milk. Methods of modifying an immune response and treating a cancer in which a milk-derived microvesicle composition is administered are also provided.
Inventor(s): Gupta; Ramesh C. (Prospect, KY), Munagala; Radha (Louisville, KY), Aqil; Farrukh (Louisville, KY), Jeyabalan; Jeyaprakash (Louisville, KY)
Assignee: University of Louisville Research Foundation, Inc. (Louisville, KY)
Application Number:15/910,322
Patent Claims:1. A composition, comprising an effective amount of a therapeutic agent encapsulated by a milk-derived microvesicle, wherein the therapeutic agent is a chemotherapeutic agent selected from, taxane compounds, anti-tumor vinca alkaloids, anti-tumor anthracycline derivatives, HER2 antibodies, DNA methyl transferase inhibitors, actinomycin D, adriamycin, capecitabine, carboplatin, cisplatin, daunorubicin, doxorubicin, 5-fluorouracil, gemcitabine, idarubicin, mitoxantrone, oxaliplatin, retinoids, retinoic acid metabolism blocking agents (RAMBA), taxol, vinblastine, vincristine, vinorelbine, vitamin D, Accutane, and combinations thereof.

2. The composition of claim 1 wherein the chemotherapeutic agent is a taxane compound selected from paclitaxel, docetaxel or combinations thereof.

3. The composition of claim 1 wherein the chemotherapeutic agent is a HER2 antibody selected from trastuzumab, estrogen receptor antagonists, or combinations thereof.

4. The composition of claim 1 wherein the chemotherapeutic agent is a DNA methyl transferase inhibitor selected from azacytidine.

5. The composition of claim 1 wherein the chemotherapeutic agent is a retinoic acid, 5-fluorouracil, vincristine, actinomycin D, adriamycin, cisplatin, docetaxel, doxorubicin, taxol, paclitaxel or a combination thereof.

6. The composition of claim 5 wherein the chemotherapeutic agent is doxorubicin.

7. The composition of claim 5 wherein the chemotherapeutic agent is paclitaxel.

8. The composition of claim 5 wherein the chemotherapeutic agent is docetaxel.

9. The composition of claim 1 wherein the therapeutic agent loading is from 3.8% to 65%.

10. The composition of claim 1 wherein the milk-derived microvesicle is a colostrum-derived microvesicle.

11. The composition of claim 1 further comprising one or more miRNA or siRNA molecules in the milk-derived microvesicle.

12. The composition of claim 11 wherein the one or more miRNA molecules are selected from the group consisting of miR-155 and miR-223.

13. The composition of claim 1 further comprising a pharmaceutically-acceptable vehicle, carrier, or excipient.

14. A composition, comprising a therapeutic agent encapsulated by a milk-derived microvesicle, wherein the milk-derived microvesicle is isolated by obtaining an amount of milk and subjecting the milk to a first centrifugation at 20,000.times.g at 4.degree. C. for 30 min, and then a second centrifugation at 100,000.times.g at 4.degree. C. for 60 min, and then a third centrifugation at 120,000.times.g at 4.degree. C. for 90 min, such that a yield greater than about 50 mg of microvesicle protein per 100 ml of milk is recovered, and wherein the therapeutic agent is a chemotherapeutic agent selected from doxorubicin, paclitaxel, docetaxel, and combinations thereof.

15. The composition of claim 14 wherein the milk is raw milk or colostrum.

16. The composition of claim 14 wherein the therapeutic agent loading is from 3.8% to 65%.

17. The composition of claim 1 wherein the milk-derived microvesicle is derived from raw milk or colostrum.

18. The composition of claim 17 wherein the raw milk is bovine raw milk.

19. The composition of claim 17 wherein the colostrum is bovine colostrum.

Details for Patent 10,420,723

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2033-02-26
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 02/10/2017 ⤷  Try a Trial 2033-02-26
Genentech, Inc. HERCEPTIN HYLECTA trastuzumab and hyaluronidase-oysk Injection 761106 02/28/2019 ⤷  Try a Trial 2033-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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