Oxigene’s antitumor drug meets end point in Phase II cancer trial

The clinical trial utilized an open-label, Simon two-stage design to evaluate the combination of Zybrestat, carboplatin and paclitaxel in patients with advanced, platinum-resistant ovarian cancer, a refractory form of ovarian cancer. Having met the Stage 1 primary efficacy endpoint, the clinical trial will proceed to its second stage, in which an additional 25 patients will be enrolled.

In the ongoing study, in order to advance to the second stage of the trial, a minimum of three out of the first 18 patients treated with the Zybrestat-chemotherapy combination needed to achieve a partial response or better. Response was determined by the investigators based upon tumor imaging (RECIST) and ovarian cancer response biomarker (CA-125) criteria. In addition to the three patients with confirmed partial responses, preliminary results indicated that stable disease was observed in seven of the first 11 evaluable subjects in the clinical trial. The combination regimen of Zybrestat, carboplatin and paclitaxel appeared to be well-tolerated, with no observations of colon perforations that had been reported previously with anti-VEGF therapy in this patient population.

Gordon Rustin, the principal investigator on the study, said: “The encouraging initial results with the Zybrestat-chemotherapy combination in this refractory patient population support further testing and development of the drug for ovarian carcinoma and other solid tumors.”