Results for the year ended 31 December 2008
26th March 2009
--Intercytex reports results and data from
VAVELTA® and ICX-TRC studies--
Intercytex Group plc (LSE: ICX), a developer of regenerative
medicine products, today announces its results for the year ended
31 December 2008. The Company also reports new clinical data
on its regenerative medicine products; VAVELTA® and
ICX-TRC.
On 20 February 2009, Intercytex announced that following the
decision to discontinue the development of Cyzact®, the Board
has determined to evaluate all strategic options for the Company.
Options being considered include the possible merger or sale of the
business.
PRODUCT SUMMARY
VAVELTA® - natural repair for
damaged skin
- VAVELTA® made commercially available to small group
of UK specialists from June 2008
- Over 120 patients treated by Clinical Practice Group (CPG)
since launch and CPG now expanded to 16 clinics
- Positive final data from two Phase II trials of VAVELTA®
presented at the FACE congress in June 2008
- Announced today eight Epidermolysis Bullosa patients treated
with VAVELTA®. Remarkable and rapid healing responses seen in
all of the five patients evaluable to date
- Phase II trial for burns scars (including contractures) on hold
to refocus resources
SHEF-1 - age-related macular degeneration
- Preclinical development programme obtained via the acquisition
of Axordia in December 2008
- SHEF-1 licensed to The London Project to Cure Blindness for
treatment of age-related macular degeneration, the leading cause of
blindness in the elderly
- Development fully funded by The London Project to Cure
Blindness
ICX-TRC - hair regeneration
- Positive data from Phase II trial announced today - increase in
hair count in the majority of evaluable subjects observed at
48 weeks
ICX-SKN - skin grafts for acute wounds
- Phase I study in excisions showed integration of graft in all
12 patients persisting for up to 6 months
- Product being reformulated for burns application as part of the
AFIRM grant award
Cyzact® - chronic
wounds
- Cyzact® discontinued after failure of Phase III venous leg
ulcer trial in February 2009
CORPORATE AND FINANCIAL SUMMARY
- Loss before tax for the year slightly reduced at £11.53m
(2007: £11.63m)
- Cash and cash equivalents and liquid investments at 31 December
2008 of £4.86m (2007: £12.50m)
- Placing of new shares in September 2008 raised £2.75m
gross
- Awarded US$1.5m over 5 years from US Armed Forces Institute of
Regenerative Medicine (AFIRM) to support development of ICX-SKN for
burns
- Awarded grant from the Technology Strategy Board of £285k
over 3 years to assist with development of strategies for
preservation and storage of cell therapy products
- Acquisition of embryonic stem cell company Axordia Limited
(Axordia) for £1.68m in shares in December 2008
- Restructuring announced in January 2009 to significantly reduce
cash burn
- Strategic review announced on 20 February 2009. The Board
continues to explore options to maximise shareholder value, and the
Company is now in discussions with a number of parties which may or
may not lead to an offer being made for the Company
BOARD
- Appointment of Max Herrmann ACA as Chief Financial Officer
replacing Richard Moulson
- Appointment of Lee Woodward ACA as Company Secretary and
Financial Controller (previously Financial Controller)
Nick Higgins, CEO of Intercytex, commented: “Following
the discontinuation of development of Cyzact, all our efforts are
focused on maximising the value of the rest of our broad portfolio
of highly innovative regenerative medicine products. Vavelta®
continues to gain patient and clinician acceptance with more than
120 people having now been treated in a commercial setting.
Today we have announced promising results from use of Vavelta
in the devastating skin condition epidermolysis bullosa, and final
Phase II results of ICX-TRC which have demonstrated good hair
regeneration. The recent acquisition of Axordia has provided
Intercytex with world class stem cell technology and a leading
collaboration with the London Project to Cure Blindness. With
ICX-SKN, our skin graft replacement for burns and acute wounds,
fully funded by the US Armed Forces Institute of Regenerative
Medicine (AFIRM), we have a significant portfolio of regenerative
medicine products.”
Enquiries
For more information, contact:
| Intercytex Group
plc |
|
| Nick Higgins, Chief Executive |
Tel: 0161 904 4500 |
| Max Herrmann, Chief Financial Officer |
Tel: 0161 904
4500 |
|
| |
|
| Financial Dynamics |
|
|
Jonathan Birt |
Tel: 0207 269
7205 |
| Emma Thompson |
Tel: 0207 269
7182 |
| |
|
|
Piper Jaffray Ltd |
|
| Will Carnwath |
Tel: 0203 142
8700 |
Notes for Editors
Intercytex is a 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:
- VAVELTA®, a skin repair and rejuvenation product intended
to improve the feel, function and appearance of skin damaged by
scarring and the aging process, and available from a number of
accredited centres in the UK
- SHEF-1, development of a stem cell line suitable for
differentiation into RPE cells, being carried out in collaboration
with the London Project to Cure Blindness
- ICX-TRC, a hair regeneration product. Phase II trial
completed
- ICX-SKN, being developed as a skin graft replacement for burns
and acute wounds, Phase I trials completed
Intercytex commenced operations in 2000 and currently employs
around 50 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 and Sheffield, UK.
Intercytex’ shares trade on the Alternative Investment
Market of the London Stock Exchange under the ticker symbol
ICX.L.
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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