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Intercytex part of a group awarded substantial funding to establish US Armed Forces Institute of Regenerative Medicine (AFIRM)


18th April 2008

AFIRM will use regenerative medicine to develop new treatments for battlefield injuries

Intercytex Group plc (LSE: ICX) today announces that it is part of a group that have been selected to establish the United States’ Armed Forces Institute of Regenerative Medicine (AFIRM), supported by a foundation grant from the US Government totalling $85 million. The purpose of AFIRM is to use the science of regenerative medicine to develop new treatments for battlefield injuries. Therapies developed by AFIRM will also be used in trauma and burns patients in the general public.

AFIRM is a multi-institutional, interdisciplinary network developing advanced treatment options for severely wounded soldiers. It is managed and funded through the US Army Medical Research and Materiel Command (MRMC), with additional funding from the Office of Naval Research, the US Air Force Office of the Surgeon General, the National Institutes of Health, the Department of Veterans Affairs, as well as local public and private matching funding.

AFIRM is made up of two civilian research consortia working with the US Army Institute for Surgical Research in Fort Sam Houston, Texas. One consortium is led by the McGowan Institute for Regenerative Medicine and the Wake Forest Institute for Regenerative Medicine and the other is led by Rutgers, the State University of New Jersey, and the Cleveland Clinic. Intercytex is part of the McGowan-Wake Forest consortium and is the only non-US participant in AFIRM, emphasising its leading position in the rapidly emerging and important field of regenerative medicine.

AFIRM has been designed to speed the delivery of regenerative medicine therapies to treat critically injured soldiers from around the world, but in particular those injuries coming from theatres of operation in Iraq and Afghanistan. There are five major programmes: burn repair; wound healing without scarring; craniofacial reconstruction; limb reconstruction, regeneration or transplantation; and compartment syndrome, a condition related to inflammation after injury that can lead to increased pressure, impaired blood flow, nerve damage and muscle death.

In June 2007 Intercytex announced a major breakthrough in regenerative medicine following a clinical trial in which laboratory-made living human skin was fully and consistently integrated into the human body for the first time. Its skin replacement product, ICX-SKN, contrasts with other living skin graft alternatives which biodegrade when implanted in the human body after a matter of weeks - too rapidly to act as skin grafts.

Anthony Atala, co-head of the McGowan-Wake Forest consortium, commented: “For the first time in the history of regenerative medicine, we have the opportunity to work at a national level to bring transformational technologies to wounded soldiers, and to do so in partnership with the armed services. This field has the potential to significantly impact our ability to treat major trauma.

Nick Higgins, CEO of Intercytex, added: “We are immensely proud to be the only non-US company to be involved in this vitally important initiative. Many battlefield injuries involve extensive burns and loss of skin and there is an urgent need for an effective living skin replacement. Intercytex’ breakthrough technology and expertise in developing living skin equivalents should therefore be especially valuable to AFIRM. Our participation in AFIRM will also enable us to accelerate the use of ICX-SKN in burns and trauma applications.

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

Notes for Editors

About Participating AFIRM Institutions

US Army Core Team

  • The US Army Institute of Surgical Research, Fort Sam Houston, TX
  • Brooke Army Medical Center, Fort Sam Houston, TX

McGowan/Wake Forest Consortium

  • McGowan Institute for Regenerative Medicine, University of Pittsburgh
  • Wake Forest Institute for Regenerative Medicine, Wake Forest University Baptist Medical Center
  • Allegheny Singer Research Institute
  • California Institute of Technology
  • Carnegie Mellon University
  • Georgia Institute of Technology
  • Intercytex Group plc
  • Oregon Medical Laser Center at Providence St. Vincent Medical Center
  • Organogenesis Inc.
  • Pittsburgh Tissue Engineering Initiative
  • Rice University
  • Stanford University School of Medicine
  • Tufts University
  • University of California, Santa Barbara
  • University of Texas Health Science Center at Houston
  • University of Wisconsin
  • Vanderbilt University

Rutgers-Cleveland Consortium

  • Rutgers, The State University of New Jersey
  • Cleveland Clinic
  • Carnegie Mellon University
  • Case Western Reserve University
  • Dartmouth Hitchcock Medical Center
  • Massachusetts General Hospital/Harvard Medical School
  • Massachusetts Institute of Technology
  • Mayo Clinic
  • Northwestern University
  • Stony Brook University
  • University of Cincinnati
  • University of Medicine and Dentistry of New Jersey
  • University of Pennsylvania
  • University of Virginia

About ICX-SKN

ICX-SKN comprises a collagen-based matrix produced by the same skin cells - human fibroblasts - that are responsible for laying down the collagen in natural skin. The fibroblasts weave a collagen structure which mimics that found in skin and which shares many of the structural attributes of skin. Intercytex' scientists believe that the combination of living human fibroblasts in a human fibroblast-produced matrix underpins the integration and acceptance of ICX-SKN by the host skin. ICX-SKN is currently in a Phase I extension study prior to entering a Phase II trial in the second half of this year.

About Intercytex

Intercytex is a leading regenerative medicine company developing innovative products to restore skin and hair. Intercytex is using its fully integrated cell technology platform to develop products that harness the innate ability of human cells to regenerate and repair the body.
Intercytex has four products in development:

  • ICX-PRO, 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 durable and robust skin replacement – in a Phase I extension trial
  • VAVELTA®, a facial rejuvenation product already introduced to the UK market
  • 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.

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