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VAVELTA® is a skin repair and
rejuvenation product. It has been designed to
improve the structure, function and appearance of skin
damaged by scarring or the aging process .
VAVELTA® is a suspension
of human dermal fibroblasts (HDFs) in cell
storage medium, for injection into the skin. When
injected into the skin, HDFs are believed to lay down collagen
within the dermis which restructures and repairs the
extracellular matrix. An improvement
should be apparent once the HDFs have begun to produce
collagen and in this way, VAVELTA® provides a
gradual improvement in the structure, function and appearance of
the skin. Repeat procedures may be given as
necessary.
Market
opportunity
The market for
cosmetic procedures is growing strongly
with around 11.5 million carried out in 2006 in the
US alone at a cost of $12.2 billion. (Source: American Society
for Aesthetic Plastic Surgery)
The
procedure
 VAVELTA® is injected
directly into the target area using a fine gauge needle. It is
a straightforward and minimally invasive procedure. The number
of injections given will be determined by the nature of
the skin and indication and a local anaesthetic such as
lidocaine gel may be administered before the procedure to
minimise any discomfort being experienced.
VAVELTA® must
be administered by experienced physicians, well-trained in
intra-dermal injection e.g. plastic surgeons, dermatologists and
other doctors who specialise in aesthetic medicine. VAVELTA® is
now available from a number of accredited clinics in the
UK.
Regulatory
status
 Under current European Union
regulation, the production of VAVELTA® is regulated under
the European Human Tissue Directive (Directive 2004/23/EC) on
setting the standards of quality and safety for the donation,
procurement, testing, processing, preservation, storage and
distribution of human tissues and cells. As such, Intercytex
is licensed by the UK Human Tissue Authority.
Intercytex has a number of clinical studies ongoing to evaluate the
products within its portfolio. These studies are designed
to ensure patient and clinician confidence and have been
developed in anticipation of the new legislation relating to
products such as VAVELTA®.
VAVELTA® clinical and commercial
development
A Phase I trial,
conducted in collaboration with Professor Nicholas Lowe MD, FRCP at
the Cranley Clinic, London, consisting of a
placebo-controlled safety and tolerability
study in ten healthy volunteers, has been completed. Each
volunteer received a course of three injections given into the
skin of the upper arm. VAVELTA® was shown to be very well
tolerated; no serious adverse events were reported and all adverse
events were transient and resolved without treatment.
A Phase II dose-escalation trial of VAVELTA® in
nasolabial
folds, also conducted at the Cranley Clinic,
London has been completed. In this trial, six subjects received a
low dose of VAVELTA® and a second group of ten subjects
was treated with a higher dose. All subjects have
been being followed out to six months post-treatment. The
average satisfaction scores for both groups, as assessed separately
by both patients and the investigator on a scale of one to ten (ten
being the highest), were 7.8 and 7.6 eight respectively. In
addition, the investigator measured an improvement in wrinkle
severity in 12 subjects (75%) .
A second Phase II trial, for the use of
VAVELTA in acne scarring, conducted by Dr David Eccleston
MB, ChB at the MediZen clinic in Birmingham, has been
completed. Subjects were followed out to six months
post-treatment. The average satisfaction scores for
the treatment, as assessed separately by both subjects and the
investigator on a scale of one to ten (ten being the
highest), were 6.8 and 6.3 respectively.
No
serious adverse events have been observed and the product has been
well tolerated in both Phase II trials.
Intercytex has established a Clinical Practice Group (CPG)
of specialist clinicians which has been conducting
field evaluations using VAVELTA® in a commercial setting.
To date, over 50 patients have been treated for a variety
of skin damage including acne scarring and wrinkles.
Feedback from clinicians and patients has been
so positive that commercial sales have now commenced
through a number of accredited clinics in the UK.
To
view the list of accredited clinics, please click on the link
below:
Accredited clinics in the UK offering
VAVELTA®
Intercytex is also exploring the use of VAVELTA® for the
treatment of recessive dystrophic epidermolysis bullosa, a
seriously debilitating and ultimately fatal skin disease affecting
young children, characterised by blister formation after minor
trauma to the skin.
Manufacturing
VAVELTA®
is manufactured by Intercytex at its
GMP compliant manufacturing facilities in
Manchester, UK.
 Glossary
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