SOUTH SAN FRANCISCO, Calif., Sept. 7, 2012 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced the presentation of data from the Phase 2/3 trial (FACT) of ZYBRESTAT in patients with anaplastic thyroid cancer (ATC), showing that patients enrolled in the trial had confirmed histologic diagnoses of ATC as indicated by site selected local pathology confirmation and a high rate of reliability and concordance with a second, independent central pathology review conducted prior to patient enrollment. These findings underscore the feasibility of utilizing local pathology confirmation of ATC in future clinical studies in ATC without the need for central pathology confirmation prior to patient enrollment, and indicate that a post-enrollment central review would provide the same degree of assurance. This should allow a more rapid enrollment of patients into future clinical trials in this indication. These data also confirm that patients with more favorable histologies were not enrolled in the study.
The poster will be presented on Sunday, September 9th at the 36th Annual Meeting of the European Thyroid Association in Pisa, Italy, and is titled, "Central Pathology Confirmation of Anaplastic Thyroid Cancer (ATC) in a Large Randomized Controlled Trial (FACT) Shows High Concordance with Site Designated Local Pathologist Confirmation," by Balkissoon et al.
Commented Jai Balkissoon, M.D., F.A.C.S., OXiGENE's Vice President of Clinical Development: "With a cancer as lethal and fast-progressing as ATC, it is critically important to ensure that patients are enrolled in the clinical trial as quickly as possible. The data to be presented from the Phase 2/3 FACT study on Sunday show the acceptability of using site selected local pathology confirmation to establish the diagnosis of ATC instead of mandating a pre-enrollment central pathology confirmation, which not only can cause enrollment delays but may prevent patients from entering the study altogether due to rapid disease progression or death. These data provide valuable insights that may be of significant value as we advance plans to conduct a pivotal registration trial in this indication."