Clinical and Regulatory information
Summary
Under current European Union regulation, VAVELTA® is not classified as a medicinal product. The product is however 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 Human Tissue Authority.
Although not required to undertake clinical trials, Intercytex believes that it is the appropriate and responsible course to clinically evaluate its product. This will ensure patient and clinician confidence ahead of the proposed Advanced Tissue Medicinal Product legislation relating to products such as VAVELTA®.
Clinical trial information
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 subject 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 was also conducted at the Cranley Clinic with Professor Lowe. In this trial six subjects received a low dose of VAVELTA®. A second group of ten subjects was treated with a higher dose.
All subjects were followed out to six months post-treatment. The average satisfaction scores for both groups, as assessed separately by both subjects and the investigator on a scale of one to ten (ten being the highest), were 7.8 and 7.6 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 was conducted by Dr David Eccleston at the MediZen clinic, Birmingham. Subjects were followed out to six months post-treatment. The average satisfaction scores, as assessed as above, were 6.8 and 6.3 respectively. No serious adverse events were observed and the product has been well tolerated in both Phase II trials.
Treatment has commenced in a third Phase II trial investigating the use of VAVELTA® in burns scars (including contractures). It is intended that 30 patients will be recruited for this open label trial.
Intercytex has established a Clinical Practice Group (CPG) of five specialist clinicians who have been conducting field evaluations in a commercial setting. To date, over 30 patients have been treated for a variety of different types of skin damage including acne scarring and wrinkles. Feedback from clinicians and patients on VAVELTA® has been sufficiently positive that commercial sales have now commenced in a number of accredited centres in the UK.
The optimal Phase III trial design will be based on the results of these Phase II trials and discussions with the FDA next year.
VAVELTA®is manufactured by Intercytex at its Good Manufacturing Practice (GMP) compliant facilities in Manchester, UK. Intercytex is a publicly quoted British company that develops regenerative medicine products that restore skin and hair.
