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Press Release: Innocoll Receives FDA Approval to Commence a Phase 2 Clinical Trial for the Topical Treatment of Infected Diabetic Foot Ulcers with Its CollaRx(R) GENTAMICIN
ASHBURN, Va., Jan. 22 -- Innocoll, Inc., a privately-held
specialty pharmaceutical company, announced that the U.S. Food and Drug
Administration (FDA) has approved its Investigational New Drug (IND)
application to conduct a Phase 2 study for CollaRx(R) GENTAMICIN as a
topical antibiotic treatment for mildly infected diabetic foot ulcers.
CollaRx GENTAMICIN is a biodegradable and fully resorbable
Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's
proprietary CollaRx technology. Upon application to a wound, the product
releases gentamicin, a broad- spectrum, concentration-dependent
aminoglycoside antibiotic, for local action. This achieves a high
concentration of drug at the target tissue, while maintaining low systemic
levels well below the toxicity threshold.
CollaRx GENTAMICIN, as a surgical implant, is already approved and
marketed in Europe and other non-US territories as an adjunct to systemic
therapy for the treatment and prevention of post-surgical site acquired
infection. Published clinical case studies and anecdotal reports from
clinicians using the marketed product suggest its effectiveness in the
treatment and cure of infected chronic wounds, including diabetic foot
Practically all ulcers are colonized with pathogenic bacteria, and a
high proportion become clinically infected requiring treatment with
antibiotics. Orally administered and injected antibiotics are often
associated with systemic side effects and widespread use leads to
development of bacterial resistance. Furthermore, diabetic ulcers are often
associated with vascular disease and restricted peripheral blood flow
(ischemia), which may render systemically acting antibiotics less
effective. Infection can also spread to the bone (osteomyelitis), which is
less well vascularised than soft tissue.
There are no topically applied antibiotics currently marketed in the US
that are specifically indicated for the treatment of infected diabetic foot
ulcers. Innocoll plans to study the treatment of diabetic foot infections
of varying severities, as defined according to the clinical classification
in the IDSA Guidelines, in a series of phase 2 trials. The lead indication
is for the treatment of mild infection where CollaRx GENTAMICIN will be
compared to an orally administered antibiotic, the current standard of
care. In future trials, Innocoll plans to investigate the product as an
adjunct to systemic therapy for treating infections of higher severity and
also as a method to prevent ulcers from becoming clinically infected.
Commenting on the approval, Dr. Michael Myers, President and CEO of
Innocoll Inc., said, "We strongly believe that CollaRx GENTAMICIN has the
potential to become the standard of care for the treatment and prevention
of infected diabetic foot ulcers and are committed to undertaking the
necessary clinical trials to prove its safety, efficacy, and clinical
advantages. This product opportunity will be a major investment for the
Company and we expect it to become the platform for expanding our direct
sales and marketing from Europe into the US and an important growth driver
for the business as a whole. We are currently in the process of securing
the necessary finance to fund this and other near term clinical programs to
progress our development pipeline."