Intercytex Group plc (LSE: ICX) the leading developer of regenerative medicine products to restore skin and hair, today announces it has reached its target of 396 patients for enrolment to the pivotal Phase III trial of ICX-PRO in venous leg ulcers. Recruitment to the trial has therefore ceased.
The recruitment target has been achieved within the previous guidance of Q2/2008. The trial, which is being conducted in centres across the USA, Canada and UK, is believed to be the first controlled, double blind trial of a cell therapy for treatment of chronic wounds.
ICX-PRO, which has now been branded as Cyzact®, is a topical woundcare product designed to stimulate active wound healing and closure in persistent chronic wounds. It comprises active, allogeneic human dermal fibroblasts (HDFs) embedded in a human fibrin gel matrix which is applied to the wound at regular intervals until healing has occurred. The units are stored and shipped under refrigerated conditions.
ICX-PRO is a second generation product that has been specifically designed to overcome the shortcomings (storage, preparation and ease of handling) of first generation cell therapy products that have constrained their commercial success. HDFs are the principal cell type found in the human dermis and are responsible for the production of collagen and structural components of skin. It is generally considered that HDFs are responsible for many events required to effect good quality wound repair. The HDFs are trapped in the fibrin scaffold for easy delivery onto the wound bed. The matrix is rapidly broken down by enzymes found in the chronic wound fluid to release the cells from the matrix.
In March this year preliminary data were reported from a Phase II trial of ICX-PRO in diabetic foot ulcers. In this study four out of the seven patients who completed the study showed complete or almost complete closure of the wound by 24 weeks. The results of this trial were presented in a poster at the EWMA conference in Lisbon in mid-May. Data from the Phase III venous leg ulcer trial are expected to be announced around the end of Q1/2009 with filing of the BLA in the second half of that year.
Discussions are continuing with potential partners regarding distribution rights to ICX-PRO.
Nick Higgins, CEO of Intercytex, commented:
“Completion of this multinational Phase III trial will be a significant achievement for Intercytex, especially given that we are supplying all product from our manufacturing facility in Manchester. Having reached our recruitment target, we are now in the final stage of the trial and can look forward to announcing the results early next year.”
Enquiries
For more information, contact:
Intercytex Group plc
Nick Higgins, Chief Executive; Tel: 0161 904 4500
Richard Moulson, Chief Financial Officer; Tel: 0161 904 4500
Financial Dynamics
David Yates; Tel: 0207 269 7156
Lara Mott; Tel: 0207 269 7182
Piper Jaffray Ltd
Will Carnwath; Tel: 0203 142 8700
Intercytex is the leading developer of regenerative medicine products to restore skin and hair. Intercytex uses its fully integrated cell technology platform to develop living, human cell-based products at commercially viable scale in attractive markets.
Intercytex has four products in development:
• ICX-PRO (Cyzact®), designed to stimulate active repair in chronic wounds - in a Phase III trial for venous leg ulcers and a Phase II trial for diabetic foot ulcers
• ICX-SKN, being developed as a skin graft replacement – in a Phase I extension trial
• VAVELTA®, a facial rejuvenation and skin damage repair product in Phase II efficacy trials
• ICX-TRC, a hair regeneration product – in a Phase II trial
All Intercytex’ products are derived from unmodified human cells.
Intercytex commenced operations in 2000 and currently employs around 80 staff. In addition to its head office in Cambridge, UK, it has GMP compliant clinical production facility plus research and development laboratories in Manchester, UK. Additional laboratories are located in Boston, US.
Intercytex’ shares trade on the Alternative Investment Market of the London Stock Exchange under the ticker symbol ICX.L and on the Open Market and the Xetra trading platform of the Frankfurt Stock Exchange under the symbol IGJ.F.
Additional information on the Company can be found at www.intercytex.com
Statements contained within this press release may contain forward-looking information or statements with respect to the financial condition, results of operations and business achievements/performance of Intercytex and certain of the plans and objectives of management of Intercytex with respect thereto. By their nature, forward-looking statements involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as ‘may’, ‘will’, ‘could’, ‘forecasts’, ‘expects’, ‘plans’, ‘anticipates’, ‘believes’, ‘estimates’, ‘predicts’, ‘potential’, ‘continue’ or similar expressions. A number of factors, including the satisfactory progress of research and development, could cause Intercytex’ actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements. Forward projections reflect management’s best estimates based on information available at the time of issue and are not a guarantee of future performance. Other than as required by applicable law, Intercytex does not undertake any obligation to update or revise any forward-looking information or statements to reflect events or circumstances after the date of this release.
The term “Intercytex” refers to Intercytex Group plc and its subsidiary undertakings.
