ICX-RHY (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. It is being developed primarily for medical applications (ICX-RHY) but has also demonstrated utility under the trademark VAVELTA® in aesthetic applications
ICX-RHY (VAVELTA®) is a suspension of human dermal fibroblasts (HDFs) in cell storage medium, for injection into the skin. When injected into the skin, the HDFs are believed to remodel and lay down collagen and other extracellular matrix within the dermis. An improvement should be apparent once the HDFs have begun to produce collagen and in this way,
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®.
ICX-RHY (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.
To date, over 100 patients have been treated for a variety of skin damage including acne scarring and wrinkles.
Manufacturing
VAVELTA® is manufactured by Intercytex at GMP compliant manufacturing facilities in the UK.
