Intercytex commences multi-centre Phase II clinical trial of woundcare product ProtoDerm
29th September 2003
Manchester, 29th September 2003: Intercytex today announced commencement of Phase II multi-centre clinical trials to evaluate dose-related efficacy of ProtoDerm, its cell-based wound healing stimulant. Indicated for treatment of chronic skin ulceration, ProtoDerm will be evaluated in approximately 12 trial centres located throughout the UK and Poland.
Within the UK trial centres are based in Manchester, Birmingham, Bradford, Wirral, Southampton and London. Polish centres are located in Gdansk, Warsaw and Krackow. A total of 90 patients will be treated with ProtoDerm, with interim results anticipated mid-year 2004.
ProtoDerm consists of allogeneic fibroblasts seeded into a protein gel. Manufactured to cGMP standards in Intercytex’ Manchester-based clean room facility, two variants of the product will be evaluated in this dose-related study.
Dr Paul Kemp, CEO of Intercytex commented “Commencing Phase II clinical trials of ProtoDerm takes us one step closer towards the goal of commercialising a cost-effective, efficacious solution to the problem of recalcitrant dermal wounds.” He went on to add that “Completion of the study will pave the way for pivotal trials scheduled to commence during 2005.”
Intercytex is a regenerative medicine company with laboratories and offices in Manchester, UK and Boston, US. Employing 45 staff, the Company has raised £17.5 million from venture capital sources since commencing operations in April 2000. Intercytex is developing two lead products to the clinic - ProtoDerm and TrichoCyte, indicated as treatments for chronic dermal wounds and androgenic alopecia respectively.
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