Oasmia Pharmaceutical AB (OASM) today announced the positive results for the Paclical/Apealea Phase III study of ovarian cancer treatment.
The study compared Paclical (also branded as Apealea) to Taxol in combination with carboplatin. Both treatments were administered in six three-week cycles.
The results showed that the period from randomization to relapse or death (PFS) was 10.3 months for the Paclical treatment and 10.1 months for the Taxol treatment. The overall survival of the patients that completed the six treatment cycles of Paclical was 25.7 months versus 24.8 month survival of the Taxol patients. The overall survival rate is the time from randomization to death. A total of 789 patients with epithelial ovarian cancer participated in the study.
"It was expected that the analysis of the OS data would show non-inferiority and confirmation of the PFS results, two key factors for why we believe Apealea is an alternative to the presently available treatments of ovarian cancer," VP of Clinical Development Margareta Eriksson said. "Ovarian cancer is a fatal disease, one that is the fifth leading cause of cancer related deaths in women, and of which it is estimated that there will be over 22,000 new cases in the United States in 2016. Today, the treatment is designed to postpone fatality and to improve the quality of life for these patients."