Intercytex Group plc – Interim results for the six months ended 30 June 2008
18th September 2008
Intercytex Group plc (LSE: ICX), the regenerative medicine
company developing innovative products to restore skin and hair,
announces its interim results for the six months ended 30 June
2008.
PRODUCT HIGHLIGHTS
Cyzact® (ICX-PRO) - healing chronic
wounds
- Phase III trial in venous leg ulcers fully recruited; data
expected to be announced around the end of Q1/2009 with filing of
the BLA in the second half of that year
- Final positive Phase II data from diabetic foot ulcer trial of
Cyzact® presented at EWMA conference in Lisbon
VAVELTA® - natural repair for
damaged skin
- First commercial sales of VAVELTA® commenced in June;
rollout of distribution network underway with over 15 clinics now
accredited
- Positive final data from two Phase II trials of VAVELTA®
presented in June at FACE congress in London, UK
- Further positive responses being generated from field trials of
VAVELTA® conducted by the Clinical Practice Group with around
50 patients treated by this group to date
- Treatment commenced in a third Phase II trial for burns scars
(including contractures); trial extended to up to 30 patients with
additional centres being enrolled
ICX-SKN - skin grafts for acute wounds
- Phase I study showed integration of graft in all 12 patients
persisting for up to 6 months
- Product being reformulated for trauma and burns applications
for US Phase II clinical trial as part of the AFIRM award
ICX-TRC - hair regeneration
- Data from the Phase II trial shows increase in hair count in 11
out of 14 (79%) evaluable subjects at 24
weeks
CORPORATE AND FINANCIAL HIGHLIGHTS
- Placing of new shares to existing shareholders completed on 8th
September 2008 raising £2.75m gross
- Intercytex the only non-US participant in a group awarded
substantial funding to establish US Armed Forces Institute of
Regenerative Medicine (AFIRM); initial funding available to support
development of ICX-SKN for burns in the US
- 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
- Positive report received from Human Tissue Authority following
inspection of our Manchester GMP facility
- Loss before tax for the six months ended 30 June 2008 of
£6.59m (H1 2007: £6.04m)
- Cash and cash equivalents and liquid investments at 30 June
2008 of £6.36m (H1 2007: £17.55m)
BOARD
- Max Herrmann, ACA appointed as CFO replacing Richard
Moulson
Nick Higgins, CEO of Intercytex, commented: "Intercytex
continues to make excellent progress in becoming a significant
player in the rapidly expanding field of regenerative medicine.
During the period, the Company continued to achieve its milestones
and has broadened the applications of its products under
development. With a rich, late-stage pipeline, a marketed product
and backing from the US Department of Defence, we are very
confident of our future prospects."
There will be an analyst meeting to discuss the interim results
today at 10.30am at the offices of Financial Dynamics at Holborn
Gate, 26 Southampton Buildings, WC2A 1PB. For those unable to
attend, there will be a live audio conference call. Please call
Claire Rowell on 0207 269 7285 for details.
Enquiries
For more information, contact:
| Intercytex Group plc |
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|
| Nick Higgins, Chief Executive |
Tel: |
0161 904 4500 |
| |
|
|
| Financial Dynamics |
|
|
| David Yates |
Tel: |
0207 269 7156 |
| Lara Mott |
Tel: |
0207 269 7182 |
| |
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| Piper Jaffray Ltd |
|
|
| Will Carnwath |
Tel: |
0203 142 8700 |
Notes for Editors
Intercytex is a healthcare company developing regenerative
medicine products for the woundcare and aesthetic medicine markets.
It uses its expertise in cell therapy technology to develop
innovative products that harness the innate ability of human cells
to regenerate and repair the body. Intercytex has 4 products in
development:
- Cyzact®, designed to stimulate active repair in chronic
wounds - in a Phase III trial
- VAVELTA® (ICX-RHY), a facial rejuvenation product already
introduced to the UK market.
- ICX-SKN, being developed as a durable and robust skin
replacement - recently completed a Phase I trial
- 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 a GMP clinical production facility with research and
development laboratories in Manchester, UK. Additional laboratories
are located in Boston, USA.
Intercytex' shares trade on AIM, a 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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