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Intercytex reports positive results from Phase II trials of dermal drug

Intercytex Group has announced the positive six month follow-up data from two Phase II trials of Vavelta, its cell therapy product for damaged skin.

The first Phase II clinical trial, focused on nasolabial folds, was conducted at the Cranley Clinic for Dermatology in London. In this trial six 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 six months post-treatment and the average satisfaction scores for both groups at six 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 at the MediZen Clinic in Birmingham. Subjects were followed out to six months post-treatment and the average satisfaction scores for the treatment at six 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.