The results of the Phase I single centre, randomised, single-blind, placebo-controlled study confirmed the excipient’s safety and tolerability, and was described as a milestone by the Swedish biotech which develops and markets the cancer drug Paclical (paclitaxel).
The XR17 excipient is derived from Vitamin A and consists of a polar head and long hydrophobic tail which – when in liquid – forms spherical micelles of approximately 20 to 60nm in diameter.
These micelles can be used to encapsulate insoluble active pharmaceutical ingredients (APIs), rendering them water soluble.
According to the firm, this can improve solubility, facilitate administration, enhance the bioavailability, and allow for dual encapsulation of water-soluble and water-insoluble APIs into one nanoparticle.
XR17 is the basis of the delivery mechanism for five of Oasmia’s cancer candidates, including Doxophos (doxorubicin) and Docecal (docetaxel), a potential rival to Sanofi’s blockbuster drug Taxotere.
But confirmation of the excipient as a drug delivery system could lead the firm to license out the technology to other drug developers, the firm said.
This would be “mainly drugs for intravenous use,” the firm’s CEO Julian Aleksov told in-Pharmatechnologist.com, adding the potential for licensing is huge. “[This is] around 75 % of all insoluble novel molecules as well as already approved drugs.”
He said Oasmia has seen interest from other pharma firms for the use of the platform, but could not divulge details.
The excipient is manufactured by Oasmia at its facilities in Sweden, and other potential benefits include lower production costs, and lower toxicity, the firm said.