SOUTH SAN FRANCISCO, Calif., June 10, 2013 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer, announced the publication in the peer-reviewed journal Thyroid of the final results of a randomized controlled global trial in anaplastic thyroid cancer (ATC) which suggests a survival benefit in patients who received ZYBRESTAT and chemotherapy versus chemotherapy alone.
The results of the FACT study ( Fosbretabulin in Anaplastic Cancer of the Thyroid) form the basis of the company's ongoing efforts to pursue a Marketing Application Authorization (MAA) with the European Medicine Agency (EMA) under the Exceptional Circumstances process which is specifically designated for very rare diseases that have limited or no available therapeutic options and a significant unmet medical need.
"ATC affects 800 to 1,000 patients each year in the U.S. and a similar number in the European Union with a reported median survival around 3-4 months, with fewer than 10 percent of patients surviving one year," said Julie A. Sosa, M.D., Duke University School of Medicine, Durham NC, who was the Principal Clinical Investigator of the study. "This final publication of the FACT study data, suggests there might be clinically meaningful increases in both overall survival and one-year survival with ZYBRESTAT. It may represent a potential new therapeutic option for patients with ATC, who to this day have limited treatment options and generally dismal outcomes."The online publication, ahead of print, titled "Randomized safety and efficacy study of fosbretabulin with paclitaxel/carboplatin against anaplastic thyroid carcinoma," by Sosa et al., is available at: http://0-www.ncbi.nlm.nih.gov.elis.tmu.edu.tw/pubmed/23721245 . The preliminary results of the FACT study were previously presented as an oral presentation at American Society of Clinical Oncology (ASCO) meeting and named "Best of ASCO" in 2011. In this randomized 80-patient study, the observed median overall survival (OS) was 5.2 months for patients who received a combination of ZYBRESTAT and chemotherapy compared with 4.0 months for patients receiving chemotherapy alone (Hazard Ratio (95% CI) of 0.73 (0.44, 1.21) NS), indicating a 27% reduction in the risk of death. For patients treated with ZYBRESTAT and chemotherapy, the likelihood of being alive at one year was 26% compared with 9% for patients treated with chemotherapy alone. The treatment on both arms of the study was well tolerated and, as seen in previous studies, the most clinically relevant side effects associated with the use of ZYBRESTAT in this study were neutropenia, transient hypertension, and tumor pain. There were no significant adverse cardiovascular side effects.
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