Preliminary study findings show that water soluble and solvent free Paclical(R), and US-market approved Abraxane(R) have nearly identical concentration curves of both total and unbound paclitaxel following intravenous infusion of 260mg/m2 suggesting the same efficacy of the two drugs.
Oasmia Pharmaceutical AB, developer of a new generation of drugs within human and veterinary oncology, announced today the topline findings from a head-to-head comparison study of its lead human cancer product candidate Paclical(R) and Celgene’s Abraxane(R), which show similar pharmacokinetic (PK) profiles of the two products. The study was conducted in women with metastatic breast cancer.
“We believe our technology is superior to Abraxane(R) because it increases the solubility of paclitaxel in water,” commented Margareta Eriksson, Vice President of Clinical Development at Oasmia Pharmaceutical. “The benefits of using our treatment over those currently available on the market are simple: Paclical(R) enables higher doses, shortens infusion time, eliminates the need for pre-medication and improves the safety profile for patients.”
About the Head-to-Head Comparison Study of Paclical(R) and Abraxane(R)
The cross-over, 2 cycle study with 3 weeks between treatments was designed to compare the pharmacokinetics of Paclical(R) and Abraxane(R) in 28 patients.
Differences Between Paclical(R) and Abraxane(R)
Paclical(R) 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(R) 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(R) 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.
Abraxane(R) was developed as a Cremophor-free product containing paclitaxel suspended in human albumin. Like Abraxane(R), Paclical(R) is free of Cremophor EL, but unlike Abraxane(R), Paclical(R) does not contain human albumin.
