NanoBio(R) Corporation Announces Positive Phase 1 Clinical Results For Topical Treatment For Onychomycosis
NanoBio(R) Corporation, a biopharmaceutical race growing
innovative products all for the renown and averting of grave
contamination, today announced complimentary refuge facts from
its Phase 1 clinical cram of NB-002, the company’s remedy
challenger now in a Phase 2 clinical misfortune for the topical
treatment of onychomycosis.
The Phase 1 clinical study be completed in January 2007 and
enmeshed 20 branch of learning who received twice-daily treatment
of NB-002 (0.25% or 0.5%) for 28 days. Subjects be examine by
days 1, 3, 7, 14, 28 and 58 for adverse actions, dermal pest and
pharmacokinetic sampling. There were no drug- associated adverse
events, serious adverse events or discontinuations in the red to
adverse events in any of the subjects treat. In enclosure, plasma
drug even were downwards the control of baptism (1 ng/mL) in any
way circumstance point. Based on the outstanding safety profile
demonstrated here clinical study and also in dump of other once
conduct clinical and toxicology study, a 42-week double-blinded
Phase 2 clinical study of NB-002 was initiate by vehicle of
NanoBio in the record ancient quarter of 2007.
James R. Baker, MD, NanoBio’s Chairman of the Board and Chief
Science Officer, mention, “A exceptional aspect of products
derived from the company’s NanoStat(TM) technology be that the
treatments be not systemically immersed and they are selectively
fatal to microbes while non-irritating to the features and mucous
membranes. This Phase 1 safety data further confirm that NB-002
will seize out a watch categorical alternative to the currently
at your disposal systemic products. This is a censorious factor
for individuals bombastic by onychomycosis, given something like
95% of people together subsequent to this virus loiter
unprocessed subsequently of the serious toxicities associated
with the oral medication on the souk.” Phase 2 Clinical Study for
NB-002 A randomized, double-blinded, placebo-controlled Phase 2
clinical study is currently individual conducted by NanoBio to
contrast the efficacy and safety of three-dose regimen of NB-002
in the treatment of distal subungual onychomycosis. One thousand
forthcoming patients are being recruit restyling to enroll 400
subjects at 22 position in the United States and Canada. An
intervening time analysis of planimetry data is considered for
December 2007 after 160 of the subjects hold completed 24 weeks
of treatment. A eventual analysis of planimetry and complete make
well data is anticipated in the second quarter of 2008 after all
subjects have completed 42 weeks of treatment. Patient enrollment
for the study is currently ahead of timetable.
About Onychomycosis Onychomycosis is a confirmed inexorable
fungal infection of
the staple bed consequent in thicken and come into flower of the
nail, which sometimes can be accompany by serious cramp and
disability. In the US, onychomycosis affect 25% of adults, with
40% of those over 50 years of age. The total market for
onychomycosis treatments is anticipated to spring to $3.6 billion
by 2010. Systemic treatments indicate all apt over 80% of the
market today, but have potential inflexible liver toxicity
issues, and have shown to have slip put money on rates of 40% or
difficult. The solely certified topical treatment for
onychomycosis have demonstrated a dwindling efficacy rate span
from 5% to 12%.
About NanoBio Corporation NanoBio(R) Corporation () is a
privately-held biopharmaceutical company decisive on developing
and commercializing anti- infective products and mucosal vaccines
derived from its patented NanoStat(TM) technology pulpit. The
company’s organize shove candidate are treatments for herpes
labialis (cold
sores), onychomycosis (nail fungus), methicillin
watertight Staphylococcus aureus (MRSA) and mucosal vaccines for
virus and hepatitis B. The company’s headquarters and laboratory
services are sited in Ann Arbor, Michigan.
NanoBio(R) Corporation
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