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View the ICX-PRO
animation |
 ICX-PRO (cyzact®) is a
topical woundcare product designed to actively stimulate wound
healing and closure in persistent
chronic wounds. It comprises active,
allogeneic human
dermal fibroblasts embedded in a
human fibrin gel matrix which is
applied to the wound at regular intervals until healing has
occurred.
Once approved, ICX-PRO will be used by
primary care physicians, surgeons, specialist woundcare physicians
and plastic surgeons to treat a variety of chronic wounds including
venous leg ulcers (VLUs) and
diabetic foot ulcers (DFUs). ICX-PRO will
be supplied directly from Intercytex' manufacturing facility
in a specially designed proprietary holder to protect the gel
during transportation.
ICX-PRO was designed from feedback from
woundcare physicians and will be differentiated from other active
wound stimulants as a result of its long shelf life (21 days),
easy storage (standard refrigeration) and ease of
handling.
Background
 VLUs are caused by chronic
venous insufficiency which is a prolonged condition of inadequate
circulation often associated with partial vein blockage or valve
leakage. The tissue becomes poorly nourished and fragile
resulting in stasis,
dermatitis and breakdown or ulceration of
the surrounding tissues. Whilst the majority of VLUs can be
adequately treated in the clinic with compression therapy,
approximately 30% remain recalcitrant and may persist for several
years.
DFUs are the
most common cause of non-traumatic lower extremity amputations in
the western world. Foot complications are the most frequent
reason for hospitalisation in patients with
diabetes and account for up to 25% of all
diabetic admissions in the US and UK. The majority of diabetic foot
complications begin with the formation of skin ulcers. Early
clinical intervention combined with appropriate treatment of these
ulcers may prevent up to 85% of amputations.
Market
opportunity
The prevalence
of VLUs in the adult population is estimated at 1% - 2% equating to
over 587,000 patients suffering from VLUs in the US alone.* The
prevalence of DFUs is estimated at over 635,000 patients in the US.
This number is increasing at approximately 5% per annum due to the
increased incidence of
diabetes.* There is
estimated to be an $800 million annual addressable market in the US
alone for the treatment of chronic VLUs and DFUs.*
ICX-PRO
clinical and commercial development
In a recently
completed Phase IIb trial in patients with VLUs
that had failed to respond to conventional therapy, 80% of
subjects showed a measurable reduction in wound size. In
addition, 41% of subjects with baseline wounds of up to 20 square
cm in size achieved complete wound closure during the study
period.
A
multi-centre, double blind, randomised,
placebo-controlled
Phase III trial is currently underway in
the UK, US and Canada. Initially, 216 patients
suffering from VLUs of at least three months duration that had been
non-responsive to conventional therapy were enrolled. Patients were
randomised and half received ICX-PRO in association with
standard four-layer
compression bandaging, a
quarter received fibrin gel with no cells also with
standard four-layer compression bandaging and a further
quarter received standard four-layer compression bandaging
alone. The primary endpoint is to show the incidence of 100%
complete wound closure at 12 weeks. Following
DSMB advice and discussions with the
FDA, patient numbers have been increased
to 396 patients with recruitment to complete in the
second quarter of 2008. Data will be available during the
first half of 2009 and a
BLA filed during the second half of 2009
with a potential launch at the end of 2010.
Intercytex has
also completed an open label
Phase II trial to investigate the safety and
efficacy of ICX-PRO in patients with chronic DFUs that have failed
to heal despite conventional
treatment. Nine
subjects whose ulcers had not responded to conventional therapy
were treated with ICX-PRO over a 20 week period in association with
standard of care. No product related serious adverse events have
been reported to date. Two patients have withdrawn from
the study and four out of the remaining six had either complete or
almost complete closure at around 24 weeks. One patient is
still to be assessed.
Manufacturing
Intercytex
will manufacture ICX-PRO for Europe and the United States at
its own GMP compliant manufacturing facilities for the
early years following launch.
*Source: Krog
Associates (Market Research)
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