Date: 2015-11-05
Type of information: Results
phase:
Announcement: results
Company: Oasmia Pharmaceutical (Sweden)
Product: Paclical® (paclitaxel)
Action
mechanism: taxane derivative. Paclical® is a water-soluble formulation of Oasmia's patented non-toxic XR-17 technology and paclitaxel, one of the most widely used anti-cancer substances which is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Paclical® consists of a freeze-dried powder that is dissolved in conventional solution for infusion and it has orphan drug designation in the EU and the U.S. Oasmia has completed a Phase-III study with Paclical® for ovarian cancer, which included 790 patients. Submission for marketing authorization in Europe will take place later this fall and the U.S. submission is planned for next year, depending on the availability of overall survival data. The product was authorized for treatment of ovarian cancer in the Russian Federation in April of 2015.
Disease: metastatic breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 5, 2015, Oasmia Pharmaceutical, a developer of a new generation of drugs within human and veterinary oncology, confirmed the previously published findings from a head-to-head comparison study of its lead human cancer product Paclical® and Celgene’s Abraxane®, demonstrated superimposable paclitaxel PK profiles. The study was conducted in women with metastatic breast cancer. Patients were randomized to receive a sequence of either Paclical->Abraxane or Abraxane->Paclical both as one hour infusion at 260 mg/m2, respectively. There were no reported serious adverse events in the study. There were eleven grade 3 adverse events reported for Paclical and ten for Abraxane, with the most common event being neutropenia for both drugs. * On August 4, 2015, Oasmia Pharmaceutical announced the topline findings from a head-to-head comparison study of its lead human cancer product candidate Paclical® and Celgene's Abraxane®, which show similar pharmacokinetic (PK) profiles of the two products. The study was conducted in women with metastatic breast cancer. The cross-over, 2 cycle study with 3 weeks between treatments was designed to compare the pharmacokinetics of Paclical® and Abraxane® in 28 patients with metastatic breast cancer.
