NEW YORK, April 27, 2016 /PRNewswire/ --
Overall Survival data from the Phase III study meets endpoint and demonstrates non-inferiority favoring Paclical/Apealea; will form basis for application seeking marketing approval in the United States anticipated for the end of 2016/2017.
Oasmia Pharmaceutical AB (NASDAQ: OASM), a developer of a new generation of drugs within human and veterinary oncology, today announced positive overall survival results for Paclical/Apealea in the Phase III study that included a total of 789 patients with epithelial ovarian cancer. These preliminary results showed non-inferiority between the two treatment groups: Paclical/Apealea in combination with carboplatin versus Taxol in combination with carboplatin. In fact, the overall survival in patients completing 6 treatment cycles was 25.7 months in patients that had received the Paclical/Apealea combination compared to 24.8 months in patients that had received the Taxol combination.
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The results from the evaluation of the OS data confirm previous findings from June 2014, that the study had met the primary endpoint of Progression Free Survival (PFS) favoring Paclical/Apealea, and strengthens the positive risk/benefit profile for Paclical/Apealea published in October 2014. Earlier this year, Oasmia applied for marketing approval of Apealea (the alternatively branded name for Paclical) in the EU for treatment of ovarian cancer. This overall survival data will be added to the EMA application and will form the basis of the marketing application to the FDA in the US.
"It was expected that the analysis would show non-inferiority and confirmation of the PFS results, two key factors for why we believe Apealea is an alternative to the treatment of ovarian cancer," said Margareta Eriksson, Vice President of Clinical Development at Oasmia Pharmaceutical.
"These results are very important for the further development of Oasmia's product pipeline. This new data will add value to Apealea's application for marketing approval in the EU, and facilitate the marketing approval process in the United States," said Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical. "With recent reports forecasting the global market for drugs treating ovarian cancer will reach $1.71 billion in 2019, there exists a largely unmet need for novel therapies in oncology. We believe that Paclical/Apealea has tremendous potential to take significant market share in all major markets as we continue to commercialize and distribute the product."
For more information, visit the Oasmia website, http://www.oasmia.com
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