Oasmia Pharmaceutical AB (STO: OASM, DE: OMAX) announced interim analysis from a Phase III study with Paclical® in ovarian cancer. The company says that the interim analysis based on 400 or so patients points toward a favourable efficacy of Paclical® compared to Taxol® (active compound in both is paclitaxel). Both drugs are given in a combination with Carboplatin.
Dose for Paclital is 250 mg/m2 and no pre-medication is needed. The dose for Taxol is 175 mg/m2 and the patients received the recommended pre-treatment. Oasmia says the lack of intensive pre-treatment stemming from the fact that Paclical is water-soluble is a great advantage for Paclical. The study plans to recruit 650 patients.
Oasmia’s method of evaluating efficacy involves the use of a biomarker CA 125, which is a novel method. The company says that study design is in accordance with the scientific advice received from the European Medicines Agency, EMA, in 2008. According to the company’s analysis Paclical reduces the level of CA 125 to the same level as Taxol. The study continues to collect data on time to progression and on overall survival.
Oasmia says it will apply for MA within the European Union and in some emerging markets for the indication. It also says the study will form a basis for the company application for market authorization in the USA. The stock is up 15% for the day.
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