OXIGENE Announces Publication of Final FACT Study Data
OXIGENE Announces Publication of Final FACT Study Data in Journal Thyroid Suggest Survival Benefit of ZYBRESTAT(R) in Patients With Anaplastic Thyroid Cancer
Data From 80-Patient Randomized Study Indicates 27% Reduction
in Risk of Death With ZYBRESTAT Plus Chemotherapy
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.
Peter J. Langecker, M.D., Ph.D., OXiGENE Chief Executive Officer,
commented: "In the past several months, we have made significant progress in pursuit of the MAA and are optimistic that we may be in a position to submit an application for marketing approval to the EMA in 2015, pending additional input from the Scientific Advice Working Party of the EMA, expected in the coming months. We believe that the MAA strategy in the EU will best leverage the investment we have made in ATC and is in the best interest of all our stakeholders. We are also continuing to explore a path in the U.S. for registration of ZYBRESTAT in ovarian cancer which we believe represents a significant commercial opportunity for OXiGENE."
ZYBRESTAT (fosbretabulin tromethamine) is a novel small-molecule, vascular disrupting agent. Through interaction with vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively targets and collapses tumor vasculature, thereby depriving the tumor of oxygen and causing death of tumor cells. In clinical trials in solid tumors, ZYBRESTAT has shown potent and selective activity against tumor vasculature, as well as possible clinical activity against anaplastic thyroid cancer, ovarian cancer and various other solid tumors.
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, and regulatory guidance relative to our clinical programs, achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development and regulatory review, and the availability of additional financing to continue development of our programs.
Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2012.
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Posted: June 2013