NEW YORK, /PRNewswire/
-- Preliminary study findings
show that water soluble
and
solventfree Paclical®, and US-market
approved Abraxane® 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® and Celgene's Abraxane®, which show
similar pharmacokinetic (PK) profiles of the two products. The
study was conducted in women with metastatic breast cancer.
(Logo: http://photos.prnewswire.com/prnh/20150420/740096)
"We
believe our technology is superior to Abraxane® 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® 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® and Abraxane®
The
cross-over, 2 cycle study with 3 weeks between treatments was
designed to compare the pharmacokinetics of Paclical® and Abraxane®
in 28 patients.
Differences Between
Paclical® and
Abraxane®
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.
Abraxane® was developed as a Cremophor-free product containing
paclitaxel suspended in human albumin. Like Abraxane®, Paclical® is
free of Cremophor EL, but unlike Abraxane®, Paclical® does not
contain human albumin.
The
press release is available in its entirety at http://www.oasmia.com