Oasmia Pharmaceutical AB (STO:OASM), a developer of a new generation of drugs within human and veterinary oncology, announced on Monday that it has finalised the treatment of all 228 patients at 17 clinical sites in five countries under its Docecol programme for treatment of metastatic breast cancer.
Since 2016, the company said it has been conducting a pharmacokinetic cross-over clinical phase I study and a randomised clinical study in the indication metastatic breast cancer. Both studies compare Docecal and Taxotere. This treatment has now been finalised and 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.
According to the company, positive results from the study programme will be sufficient to apply for sales approval and marketing approval in Russia, which is a fast growing oncology markets. Oasmia has planned to submit for approval during the second half of 2018.
Also, the company intends to initiate discussions regarding possible registration of Docecal based on the current programme with EMA for the EU and with the FDA for the US.
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