Photocure ASA, a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the conclusion of the Phase 2 program, and FDA clearance to prepare Phase 3 protocol for the clinical development of Cevira, the innovative breakthrough for the treatment of precancerous lesions of the cervix.
The conclusion of a Phase 2 meeting with the FDA confirmed that the Phase 2 data supports the proposed Phase 3 program, and are sufficiently robust to continue the development of Cevira. Following a guidance meeting with FDA in December 2014, Photocure completed the re-analysis of the Phase 2b data as requested by the Agency. The re-analysis included a new panel read pathology assessment and applying new clinical success criteria in the end-point definition. The re-analysis demonstrated that Cevira provides improved treatment efficacy compared to placebo among patients with cervical high grade lesions (HSIL). Photocure discussed the results, including target population and statistical sample size, in the FDA meeting in early December.
Kjetil Hestdal, President and CEO of Photocure, said: “With End of Phase 2 achieved for Cevira in the U.S., together with the support achieved through Scientific Advice in key European markets to progress to Phase 3 in women with HSIL (CIN2), Photocure has reached an important milestone in the development of Cevira.
Cevira has the potential to treat HPV induced cervical high grade disease and prevent the development of cervical cancer which affects more than 500 000 women annually. We will continue discussions with leading companies in women’s healthcare to secure a strategic partnership that will assist in the Phase 3 development and commercialization of Cevira.“
Following the positive outcome of the meeting with the FDA, Photocure plans to submit the proposed Phase 3 protocol for a detailed Special Protocol Assessment (SPA) to the FDA first half 2015.