This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

Identification

Generic Name
GI-5005
DrugBank Accession Number
DB05942
Background

GI-5005 is GlobeImmune's lead infectious disease product from its proprietary Tarmogen active immunotherapy platform for the treatment of chronic hepatitis C infection. GI-5005 is whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets. Tarmogens are believed to activate both an innate immune response via Toll-like receptors (TLRs), as well as an adaptive, antigen specific cellular immune response.

Type
Biotech
Groups
Investigational
Biologic Classification
Vaccines
Recombinant
Synonyms
Not Available
External IDs
  • GI 5005
  • GI-5005

Pharmacology

Indication

Investigated for use/treatment in hepatitis (viral, C).

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Contraindications & Blackbox Warnings
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Pharmacodynamics

Not Available

Mechanism of action

The mechanism of action for GI-5005 (i.e. immune elimination of infected hepatic cells) may work synergistically in combination with the current or emerging standard of care, which directly inhibits viral replication, to more effectively eradicate hepatitis C virus from the liver. Additionally, this mechanism of action may offer an option for interferon-intolerant or interferon-contraindicated patients as a long term monotherapy.

GI-5005 is designed to elicit a cellular immune response against cells infected with the HCV virus. The yeast vector is designed not only to stimulate an innate immune response mediated by Toll-like receptors (TLRs), but also to deliver target protein directly to antigen presenting cells, eliciting an antigen-specific helper T cell (CD4) and killer T cells (CD8) cellular immune response to eliminate diseased cells.

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbataceptThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of GI-5005 can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of GI-5005 can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of GI-5005 can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
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Food Interactions
Not Available

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
Not Available
CAS number
1001913-27-4

References

General References
  1. Haller AA, Lauer GM, King TH, Kemmler C, Fiolkoski V, Lu Y, Bellgrau D, Rodell TC, Apelian D, Franzusoff A, Duke RC: Whole recombinant yeast-based immunotherapy induces potent T cell responses targeting HCV NS3 and Core proteins. Vaccine. 2007 Feb 9;25(8):1452-63. Epub 2006 Nov 10. [Article]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2CompletedTreatmentChronic Hepatitis C Genotype 11
1CompletedTreatmentHepatitis C Virus (HCV) Infection1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
Not Available
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created at November 18, 2007 18:28 / Updated at June 12, 2020 16:52