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news.OxiGENE has joined forces with US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of Zybrestat, designed for the treatment of anaplastic thyroid cancer (ATC).
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The randomized placebo-controlled, double-blinded FACT 2 study has enrolled 300 subjects who will be randomized 1:1 to administer carboplatin and paclitaxel plus fosbretabulin versus carboplatin and paclitaxel plus placebo.
The study will compare the median overall survival between the two arms.
OxiGENE president and chief executive officer Pete Langecker said OxiGENE appreciates the FDA’s granting of the SPA for the pivotal FACT 2 trial of Zybrestat in patients with anaplastic thyroid cancer.
”ATC is a tough disease — tough for patients who are faced with dire prospects, tough for doctors who have very little to offer in terms of therapy to their patients, tough for the company trying to develop a novel treatment and even tough for regulators who see the need but who also have to see certain criteria met to be able to approve a drug.” Langecker added.
"ATC is the indication for which we have the most compelling data, suggesting an overall survival benefit for patients who receive ZYBRESTAT along with carboplatin and paclitaxel chemotherapy and that is the reason for our continued pursuit of this indication.
”We believe that vascular disrupting agents can make a valuable contribution to anticancer therapeutic regimens, and we look forward to advancing our VDA programs not only in ATC, but also in ovarian cancer, carcinoid syndrome, myeloid leukemia and other potential indications."