APL-1702 Cevira is a photodynamic drug-device combination product. It consists of a convenient, fully integrated drug delivery and light device which is being developed for non-surgical treatment of high-grade cervical dysplasia.
Asieris has world-wide development and commercialization license of Cevira®
Introduction of Cevira®
Drug: Ointment. Drugs are more effectively absorbed by precancerous lesions or cancer cells and metabolized into a molecule (photosensitizer) for photodynamic therapy.
Instruments: Small medical instruments made of medical grade silicone rubber, about the size of tampons, with a cup and light source at the end.
The treatment is based on photodynamic therapy combining a photosensitizer with activation by light of a specific wavelength.
Usages of Cevira®
Results of Phase II Clinical Trial
Cevira has completed a randomized, double-blind, placebo-controlled multicenter clinical trial in Europe and the United States. 262 patients with CIN confirmed by biopsy were enrolled. Biopsy, cytology and HPV were used to evaluate the response rate after 3-6 months.
Efficacy: A clear dose-dependent effect. In the CIN2 population, the response rate was 95% in HAL 5% group and 57% in placebo group at 3 months after treatment, 95% in HAL 5% group and 62% in placebo group at 6 months after treatment (P < 0.001).
Safety: No systemic adverse reactions, Three subjects reported serious adverse events, none of which were considered related to study treatment. Mainly local and self-limiting adverse reactions, such as vaginal discharge local discomfort and spotting. Five patients became pregnant within 3 months of last PDT and all women delivered healthy full-term infants.
Advantages of Cevira®
Cevira® has demonstrated statistically significant efficacy and safety in patients with HSIL with below potential advantages: