Oasmia Pharmaceutical AB, a Swedish developer of a new generation of cancer drugs, have been conducting a pharmacokinetic cross-over clinical phase I study and a randomized clinical study in the indication metastatic breast cancer.
Both studies compare Docecal and Taxotere (chemotherapy drug). The treatment of 228 patients at 17 clinical sites in five countries has now been finalized. The work to compile the results is ongoing. Docecal is a nanoparticular and water-soluble formulation of docetaxel combined with Oasmia’s proprietary XR17 technology. Docecal is solvent free and does not require pre-medication.
Breast cancer is a serious disease and one of the most common causes of death among women in the western world. Metastatic breast cancer is an increasingly common disease however, novel diagnostics and treatment methods have resulted in increased quality of life and survival among the affected women. The total market for oncological treatments exceeds $100 billion.
Positive results from the study program will be sufficient to apply for sales- and marketing approval in Russia, which is one of the world’s fastest growing oncology markets. Oasmia plans to submit for approval during the second half of 2018. The company intends to initiate discussions regarding possible registration of Docecal based on the current program with EMA for the EU and with the FDA for the USA.