INTERCYTEX REFORMS AS U.S. DEPARTMENT OF DEFENSE FUNDS VAVELTA® SCAR THERAPY TRIALS FOR INJURED SOLDIERS
Manchester, UK, 11 November 2010…..Intercytex, the regenerative medicine company, announces that it has reformed as a private enterprise and that its lead product, the cell therapy (VAVELTA®) will be evaluated by the US military to help treat injured soldiers.
Battlefield mortality has decreased from 30% in World War II to less than 10% in present day conflicts, partly as a result of better medical care. Sadly, this increased survival has been associated with a rise in the number of patients with chronic disabilities including burn and trauma scars. Burns account for approximately 10% of all combat casualties* and Improvised Explosive Devices (IEDs), which are an increasingly common feature of today’s conflicts, are associated with extensive traumatic skin loss. As a result, burn and trauma scar contractures (where skin around the wound contracts, thickens and becomes inelastic) are a significant and growing problem for injured war heroes.
‘I am really delighted to announce the relaunch of Intercytex on Armistice Day since our lead product, VAVELTA®has the potential to make a real difference to the lives of injured troops’ commented Dr Kemp, Intercytex’ new Chief Executive Officer. VAVELTA® has already been used in a small number of patients suffering from scar contractures and the outcome of these treatments has led to this Phase II trial in military personnel with burn scars. The work is funded by a significant agreement from the US Department of Defence and the clinical trial is scheduled to begin at Pittsburgh University Hospital, US, in 2011 in partnership with the McGowan Institute for Regenerative Medicine.
In addition to the US trial, a grant from the UK Technology Strategy Board has been awarded to Intercytex in collaboration with Lt COL Steve Jeffery, a consultant plastic surgeon, to develop a clinical trial application to examine VAVELTA® in scar patients in the UK. The intention is to begin this trial at Queen Elizabeth Hospital, Birmingham, UK, later in 2011.
As well as developing treatments for burn and trauma scars, Intercytex is also planning to evaluate VAVELTA® in patients with a rare genetic skin disorder called Dystrophic Epidermolysis Bullosa (DEB). In DEB the skin and internal body linings blister at the slightest impact, causing painful open wounds. This devastating and often fatal disease affects approximately 1,000 patients in the UK alone. The clinical trial is expected to start in London at the end of the year and is funded jointly by The Technology Strategy Board and the patient charity DebRA.
VAVELTA® is designated as one of the first Advanced Therapy Medicinal Products (ATMP) by the European Medical Agency and has already been used in compassionate use programmes and via hospital exemption schemes in over 100 patients in a variety of indications.