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

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.

Claims11

Dependent claims

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.

2 more elements

Dependencies are inferred from the claim text.

Facts

Application

15/174,540Filed 6 Jun 2016 · continuation in part

Priority

15 Dec 2014

Published

US 2016/0279182 A129 Sep 2016

Granted

11 Jun 2024

Term ends

Not estimatedThe source records don’t support an estimate.

Classification8 codes

A61K 35/747
Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs: lactobacilli, e.g. L. acidophilus or L. brevis
A61K 9/00
Medicinal preparations characterised by special physical form
A61K 9/0034
Galenical forms characterised by the site of application: urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder;…
A61K 9/0095
Galenical forms not covered by A61K9/02 - A61K9/7023: drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets…

CVS transplantation for treatment of bacterial vaginosis

Life of this patent

CVS transplantation for treatment of bacterial vaginosis

Life of this patent

Abstract

Claims11