Facial rejuvenation product (ICX-RHY) successfully completes Phase I Study
20th July 2006
Cambridge, UK, 20 July 2006 – Intercytex (LSE:
ICX), the cell therapy company developing products for the advanced
woundcare and aesthetic medicine markets, today announces the
successful completion of a Phase I study of ICX-RHY, its novel cell
therapy product for facial rejuvenation.
The Phase I study, conducted in collaboration with Prof. Nick
Lowe MD FRCP at the Cranley Clinic, London, consisted of a
placebo-controlled safety and tolerability study in 10 healthy
volunteers. Each subject received a course of three injections
given into the skin of the upper arm.
ICX-RHY was shown to be very well tolerated; no serious adverse
events were reported and all adverse events were transient and
resolved without treatment.
These very encouraging data will allow Intercytex to seek
regulatory approval for a Phase II study, expected to begin during
the second half of this year. The proposed Phase II study will
evaluate the efficacy of ICX-RHY when injected into facial
wrinkles. It is anticipated that preliminary results from this
study will be available around the middle of 2007.
In March of this year, Intercytex received confirmation from the
MHRA (Medicines and Healthcare products Regulatory Agency) that
ICX-RHY was outside the scope of the current legislation covering
the marketing of medicines and devices in the UK. Intercytex plans
to make ICX-RHY available in the UK market once additional clinical
data are available, expected to be in the second half of 2007.
Nick Higgins, Chief Executive Officer, commented: “ICX-RHY
is an exciting product in a high growth field and has the potential
to generate early revenues for the Company. We look forward to
taking the product into Phase II efficacy trials later this
year.”
Enquiries:
Intercytex
Nick Higgins, Chief Executive Officer: +44 (0)1223 421962
Financial Dynamics
David Yates/Anna Keeble: +44 (0)207 831 3113
About ICX-RHY:
ICX-RHY is being developed as a cell therapy approach to the
long-term rejuvenation of rhytids (wrinkles) and skin blemishes
such as scarring. It comprises a suspension of allogeneic human
dermal fibroblasts which are injected into the dermis of the skin
to provide a source of young, collagen-secreting cells. In the UK
the supply or sale of the product is not covered by the licensing
provisions of the Medicines Act and related legislation.
About Intercytex:
Intercytex is an emerging healthcare company developing and
commercialising cell therapy products for the advanced woundcare
and aesthetic medicine markets. Intercytex is using its proprietary
expertise in cell therapy 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 actively to stimulate repair in chronic
wounds in Phase III trials;
- ICX-SKN, being developed as a durable and robust skin
replacement, due to start Phase I trials later this year;
- ICX-RHY, a facial rejuvenation product which has completed a
Phase I clinical trial; and
- ICX-TRC, a hair regeneration product shortly to enter Phase II
clinical trials.
Intercytex commenced operations in 2000 and currently employs
around 70 staff. In addition to its head office in Cambridge, UK,
it has a GMP clinical production facility plus research and
development laboratories in Manchester, UK. Additional laboratories
are located in Boston, USA.
Intercytex’ shares were admitted for trading on the
Alternative Investment Market of the London Stock Exchange on 1
February 2006 under the ticker symbol ICX.L.
For further information on Intercytex, please visit
www.intercytex.com
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