Biomedical Engineering Reference
In-Depth Information
7.5 AdditionalProperties
Preliminary.safety.studies,.including.organ.histology,.blood.pathology,.and.clinical.exam-
ination,.have.shown.the.various.nanoviricides.to.be.safe.at.the.levels.tested,.which.have.
been.both.at.and.above.levels.shown.to.be.therapeutic..Some.of.the.chemical.components.
of. the. nanoviricides. are. currently. incorporated. into. some. biological. therapeutic. agents.
in. order. to. prolong. circulating. half-life. and. reduce. immunogenicity.. Our. nanoviricides.
exploit.this.property.and.should.allow.a.half-life.suficient.to.enable.optimal.therapeutic.
dosing.intervals..Our.preclinical.pharmacodynamic.studies.indicate.that.we.can.achieve.
eficacy.with.a.medically.acceptable.dosing.frequency.
The.nanoviricide.technology.can.be.employed.to.produce.distinctly.different.classes.of.
nanoviricide.antiviral.therapeutic.agents,.as.described.below:
.
1.. Fixed.antiviral.therapeutics..To.make.a.“ixed”.nanoviricide,.one.would.simply.develop.
a.speciic.ligand.to.which.a.virus.binds.and.attach.the.ligand.to.the.backbone.
.
2.. Broad-spectrum. therapeutics.. If. the. selected. ligand. binds. to. not. one. but. many.
virus.strains,.types,.or.classes,.one.would.obtain.a.broad-spectrum.nanoviricide.
.
3.. Accurate.Drug.in.Field.(ADIF™).platform.therapeutics..A.backbone.nanoviricide.
material. can. be. made. with. a. chemically. reactive. functional. group. preattached.
along. the. polymer. chain.. We. have. developed. such. groups. that. enable. storage.
at. room. temperature,. possibly. for. several. years.. When. a. novel,. emerging,. or.
advanced.pathogen.occurs,.puriied.antibodies.can.be.fragmented.and.the.isolated.
fragments,.devoid.of.the.Fc.fragment,.can.simply.be.mixed.in.with.the.backbone.
nanoviricide.material,.resulting.in.a.facile.reaction.leading.to.covalent.attachment.
of.the.fragments.to.the.nanoviricide.backbone.material,.to.make.an.accurate,.effec-
tive,.nanoviricide.drug.that.is.speciic.to.the.threat..Thus,.this.is.an.ideal.platform.
for.novel,.emerging,.or.advanced.agent.biothreat.scenarios.
As.mentioned.previously,.the.development.of.virulent,.readily.transmissible,.drug-resis-
tant.mutants.continues.to.be.a.signiicant.challenge.with.antiviral.therapeutics.and.has.led.
to.the.use.of.cocktail.therapies.with.their.associated.side.effect.and.drug.interaction.con-
cerns.. The.polyvalent. nature.of.the.nanoviricide.technology. addresses.the.development.
of.drug-resistant.mutants..Polyvalency.has.been.shown.to.improve.the.potency.of.mono-
meric.inhibitors.100-.to.1,000-fold.
19-21
.In.a.nanoviricide,.this.could.result.in.considerable.
tolerance. for. mutants. that. arise. with. decreased. binding. afinity. in. the. viral. monomeric.
ligand.binding.site..Moreover,.if.multiple.ligands.that.bind.to.different.sites.on.the.virus.
coat. are. attached. to. the. same. nanoviricide,. this. can. produce. synergistic. effects,. leading.
to. even. higher. potency. than. the. parent. ligands,. with. the. polyvalent. multiple. different.
ligands.likely.precluding.the.development.of.mutants.resistant.to.the.nanoviricide.
7.6 Summary
NanoViricides,. Inc.. believes. that. by. employing. its. technology. of. proprietary. self-assem-
bling.amphiphilic.polymers.that.form.nanoscopic,.targeted.polymeric.micelles,.it.has.devel-
oped.antiviral.therapeutics.that.can.have.a.clinically.signiicant.impact.on.the.treatment.
