Zybrestat fosbretabulin regulatory update

OxiGene expanded a named-patient program that provides access to Zybrestat fosbretabulin on a compassionate-use basis to treat anaplastic thyroid cancer (ATC) to include South Korea and Israel. The program already provides access to patients in Canada and the EU, including Nordic countries and Switzerland. Azanta A/S (Hellerup, Denmark) manages the program (see BioCentury, Dec. 19, 2011).

OxiGene said it is seeking an SPA from FDA for the Phase III FACT 2 trial for Zybrestat for ATC, but did not disclose a time frame for the trial start. OxiGene also said it will also continue to seek financing through partnerships and other opportunities to support the Zybrestat development program. Last September, OxiGene restructured and said it would not be able to fund the FACT 2 trial (see BioCentury, Sept. 5, 2011). ...