Oasmia boasts good interim results of Paclical
Uppsala - After good interim results Oasmia wastes no time and starts the approval process for its ovarian cancer drug Paclical. The interim analysis, based on data from approximately 400 patients, showed the expected efficacy of Paclical compared to the comparator, Taxol. The results pointed towards a favorable efficacy for Paclical, the Swedish drug developer said. Oasmia uses its retinoid based platform XR-17 to wrap up the cancer drug Paclitaxel to develop a water soluble formulation that does not require premedication: Paclical. The result from the interim analysis shows that Paclical is reducing a certain biomarker, CA 125, to the same level as Taxol. CA 125 (Cancer Antigen 125) is a protein, often elevated in women with ovarian cancer. An increased value in a woman previously diagnosed with ovarian cancer is usually an indication of progression.
Oasmia will apply for marketing authorization for Paclical within the European Union and some countries within the emerging markets, for the indication ovarian cancer. The filing process will start immediately, Oasmia said in a statement. Furthermore, Osmia ended the agreement it had with Finnish Orion Corporation regarding distribution of Paclical® in the Nordic region. Oasmia will take care of the distribution itself.