# US 12,005,089 B2 · CVS transplantation for treatment of bacterial vaginosis

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- Number: US 12,005,089 B2
- Document ID: US12005089B2
- Status: Granted
- Kind: B2
- Application number: 15/174,540
- Filed: 2016-06-06
- Published: 2016-09-29
- Granted: 2024-06-11
- Earliest claimed: 2014-12-15
- Assignees: The Johns Hopkins University
- Applicants: The Johns Hopkins University
- Inventors: Laura Ensign; Richard Cone; Justin Hanes
- Web page: https://patentgrep.com/patent/US12005089B2

## CPC

- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61P 15/02: for disorders of the vagina
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Methods and materials for treating bacterial vaginosis (“BV”) are provided. Cervicovaginal secretions (“CVS”) from a woman with vaginal microbiota dominated (>50%) by one of the species of lactobacillus typically found in the human vagina, e.g. Lactobacillus crispatus, L. iners, L. gasseri, L jensenii, is transplanted to women with BV as a method for restoring beneficial vaginal microbial communities and/or increasing resistance to sexually transmitted disease. Efficacy can be enhanced, or the properties of the endogenous CVS improved, through administration of an acidifying agent such as lactic acid. The examples demonstrate the role of healthy CVS in disease resistance, and the effect of pH on CVS properties. The examples also describe the collection and transplantation of healthy beneficial CVS into women at risk for, or after treatment for, BV.

## Claims

### Claim 1

A formulation for vaginal administration to restore normal cervicovaginal microflora in a recipient in need thereof, the formulation comprising:
an isolated lyophilized cervicovaginal secretion,
healthy vaginal microbiota, wherein at least 50% of the healthy vaginal microbiota is a Lactobacillus species typically found in the human vagina, the secretion having no evidence of sexually transmitted disease or bacterial vaginosis,
a dissolution agent comprising between about 0.5 and 1.5% lactic acid to promote growth of the healthy vaginal microbiota, and
between about 1% and 15% of a cryoprotectant to enhance the viability of the healthy vaginal microbiota relative to the viability of the healthy vaginal microbiota in the absence of the cryoprotectant,
wherein the formulation is formulated for administration to the vagina of a recipient.

### Claim 2 (depends on 1)

The formulation of claim 1, wherein the isolated cervicovaginal secretion has been sterile filtered and pH adjusted prior to addition of healthy vaginal microbiota.

### Claim 3 (depends on 1)

The formulation of claim 1, wherein the microbiota comprises Lactobacillus bacteria isolated or cultured in vitro.

### Claim 4 (depends on 1)

The formulation of claim 1 packaged into a dosage unit in an applicator for administration to a woman.

### Claim 5 (depends on 1)

The formulation of claim 1, wherein the formulation has been frozen and thawed for administration to a woman.

### Claim 6 (depends on 1)

The formulation of claim 1, wherein the cryoprotectant is selected from the group of cryoprotectants consisting of glycerol, sucrose, dextrose, polyvinylpyrrolidone (PVP), and dimethylsulfoxide (DMSO).

### Claim 7 (depends on 1)

The formulation of claim 1, wherein the formulation has been spray dried or lyophilized, optionally in combination with a resuspending agent.

### Claim 8 (depends on 1)

The formulation of claim 1, wherein the lactic acid is D-lactic acid.

### Claim 9 (depends on 1)

The formulation of claim 1, wherein the cervicovaginal secretion comprises cervicovaginal secretions from more than one donor with vaginal microbiota dominated by Lactobacillus.

### Claim 10 (depends on 1)

The formulation of claim 1, wherein the vaginal microbiota is dominated by Lactobacillus crispatus species.

### Claim 11 (depends on 1)

The formulation of claim 1, wherein the dissolution agent comprises about 1% lactic acid.