VAVELTA® Phase II data presented at FACE
30th June 2008
Intercytex Group plc (LSE: ICX) the leading developer of
regenerative medicine products to restore skin and hair, today
announces that positive 6 month follow-up data from two Phase II
trials of VAVELTA®, its cell therapy product for damaged skin,
were presented at the FACE congress on 28th June, 2008.
The first Phase II clinical trial, focused on nasolabial folds,
was conducted at the Cranley Clinic for Dermatology in London with
Professor Nicholas Lowe MD FRCP. In this trial 6 subjects received
a low dose of product. A second group of 10 subjects was then
injected with a higher dose. All subjects were followed out to 6
months post-treatment with the following results:
- The average satisfaction scores for both groups at 6 months for
the treatment as assessed separately by both subjects and the
investigator on a scale of 1-10 (10 being the highest), were 7.8
and 7.6 respectively. In addition, the investigator measured an
improvement in wrinkle severity in 12 (75%) subjects
- No serious adverse events have been observed and the product
has been well tolerated
The second Phase II study involved the use of the product in
acne scarring in a study conducted by Dr David Eccleston MB ChB, at
the MediZen Clinic in Birmingham. Subjects were followed out to 6
months post-treatment with the following results:
- The average satisfaction scores for the treatment at 6 months
as assessed separately by both subjects and the investigator on a
scale of 1 -10 (10 being the highest) were 6.8 and 6.3
respectively
- No serious adverse events have been observed and the product
has been well tolerated
Treatment has commenced in a third Phase II trial investigating
use of the product for burns scars (including contractures). It is
intended to recruit up to 30 patients in this open label study.
Over the last 9 months a Clinical Practice Group (CPG) of 5
specialist clinicians has been conducting field evaluations in a
commercial setting. To date, over 30 patients have been treated for
a variety of different skin imperfections including acne scarring
and wrinkle reduction. Feedback from clinicians and patients on the
product has been sufficiently positive that commercial sales have
now commenced through a limited number of accredited centres in the
UK.
Nick Higgins, CEO of Intercytex, commented:
“We have made very substantial progress with VAVELTA
over the last 12 months. Since introducing the product in 2007 we
have completed two clinical trials, begun a third trial and treated
over 30 patients in a commercial setting. We are encouraged by the
high satisfaction scores achieved and from the very favourable
reaction from aesthetic specialists.”
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
FACE (the Facial Aesthetic Conference and Exhibition), held in
London, is the largest medical aesthetic conference in the UK,
aimed at practitioners and clinics providing predominantly
non-surgical medical aesthetic treatments.
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
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actual financial condition, results of operations and business
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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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