Oasmia Pharmaceuticals Says Survival Data From A Phase 3 Study Met Endpoint, Shares Gain 5%

Shares of Oasmia Pharmaceutical AB - American Depositary Shares OASM, a Sweden-based developer and manufacturer of drugs in the field of human and veterinary oncology, gained more than 5 percent Wednesday after the company reported results from a Phase 3 clinical trial.

Oasmia Pharmaceutical said overall survival results for its Paclical/Apealea drug in a Phase 3 trial involving 789 patients with epithelial ovarian cancer showed positive overall survival results.

Paclitaxel is a widely used anticancer substance. The company's Paclical/Apealea consists of a freeze-dried powder which has already achieved orphan drug designation in the U.S. and E.U.

Oasmia Pharmaceutical's study consisted of two treatment groups of Paclical/Apealea in combination with carboplatin versus Taxol in combination with carboplatin. The overall survival in patients that had received the Paclical/Apealea combination was 25.7 months versus 24.8 months for patients that had received the Taxol combination. Accordingly, the company announced that the study successfully met its endpoint of demonstrating non-inferiority favoring Paclical/Appealea.

The study's results confirm a prior finding from a June 2014 study that met the primary endpoint of Progression Free Survival (PFS) favoring Paclical/Apealea. The results from the studies will be added to the company's European Medicines Agency (EMA) application and form the basis of the marketing application to the U.S. Food and Drug Administration.

"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," said Margareta Eriksson, Vice President of Clinical Development at Oasmia Pharmaceutical. "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."