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ICX-PRO (cyzact®) - chronic wound repair

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10 layers of cell stacks. 'Cell factories' growing fibroblasts used in the manufacture of ICX-PROICX-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

 

cell stacks being loaded into incubatorVLUs 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)

Glossary

 

 
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