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Research programme: topical microbicides - Osel

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Drug Profile

Research programme: topical microbicides - Osel

Alternative Names: Genetically-modified LBPs - Osel; MucoCept - Osel; MucoCept LBPs - Osel

Latest Information Update: 04 Nov 2017

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At a glance

  • Originator Osel Inc
  • Class Anti-infectives; Antivirals; Bacteria
  • Mechanism of Action HIV fusion inhibitors; Virus attachment inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • No development reported Bacterial vaginosis; HIV infections

Most Recent Events

  • 04 Nov 2017 No recent reports of development identified for preclinical development in Bacterial-vaginosis in USA (Vaginal, Suppository)
  • 04 Nov 2017 No recent reports of development identified for preclinical development in HIV-infections(Prevention) in USA (Vaginal, Suppository)
  • 22 Jul 2011 Preclinical development is ongoing USA

Development Overview

Introduction

A modified strain of Lactobacillus, is being developed by Osel using the proprietary MucoCept platform technology, for the therapeutic prevention of bacterial vaginosis (BV) and HIV infection. MucoCept utilises non-pathogenic commensal Lactobacillus flora, commonly found in the reproductive tract, to neutralise bacteria and HIV particles before infection can occur. The MucoCept bacterium, a genetically enhanced human vaginal isolate of Lactobacillus jensenii, is designed to colonise the vaginal mucosa and produce high levels of the potent HIV-binding protein cyanovirin-N (CV-N) as either secreted or surface-displayed molecules. These molecules sequester HIV virus particles that can then be inactivated by microbicidal compounds such as lactic acid and hydrogen peroxide, which are also secreted by the Lactobacilli. Preclinical development is ongoing in the US.

As at November 2017, no recent reports of development had been identified for preclinical development in Bacterial-vaginosis in USA (Vaginal, Suppository), preclinical development in HIV-infections (Prevention) in USA (Vaginal, Suppository).

Key Development Milestones

In July 2011, preclinical results were published that showed Osel's MucoCept product, Lactobacillus jensenii expressing CN-V, could reduce the transmission of SHIV (human HIV virus modified to infect monkeys) by 63% when introduced to rhesus macaques [1] .

In June 2005, Osel received a multiple-year grant from the US National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to further develop a MucoCept Lactobacillus strain for the prevention of bacterial vaginosis and HIV infection, under support from the Partnerships for Topical Microbicides [2] . The MucoCept project has also been supported by CONRAD-GMP, IPM, USAID, and the Bill and Melinda Gates Foundation.

Patent Information

Osel currently has four patents covering the use of genetically modified vaginal lactobacilli against viral infections through mucosal membranes (Osel's MucoCept platform technology).

Drug Properties & Chemical Synopsis

  • Route of administration Vaginal
  • Formulation Suppository
  • Class Anti-infectives, Antivirals, Bacteria
  • Target HIV fusion; Virus attachment
  • Mechanism of Action HIV fusion inhibitors; Virus attachment inhibitors
  • WHO ATC code

    G01 (Gynecological Antiinfectives and Antiseptics)

  • EPhMRA code

    G1C (Gynaecological Antibacterials)

    J5C4 (HIV antivirals, entry inhibitors)

Development Status

Summary Table

Download Data (CSV)
Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Bacterial vaginosis - - No development reported (Preclinical) USA Vaginal / Suppository Osel Inc 04 Nov 2017
HIV infections - Prevention No development reported (Preclinical) USA Vaginal / Suppository Osel Inc 04 Nov 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Osel Inc Originator USA
Osel Inc Owner USA

Development History

Event Date Update Type Comment
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for preclinical development in Bacterial-vaginosis in USA (Vaginal, Suppository) Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for preclinical development in HIV-infections(Prevention) in USA (Vaginal, Suppository) Updated 04 Nov 2017
22 Jul 2011 Active Status Review Preclinical development is ongoing USA Updated 22 Jul 2011
21 Nov 2005 Phase Change - Preclinical Preclinical trials in Bacterial vaginosis in USA (Vaginal) Updated 21 Nov 2005
09 Jun 2005 Phase Change - Preclinical Preclinical trials in HIV infections prevention in USA (Vaginal) Updated 20 Jul 2011

References

  1. Scientists Use Live Bacteria to Fight HIV.

    Media Release

  2. Osel Receives NIH Award Under Partnerships for Topical Microbicides.

    Media Release
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