OXiGENE (OXGN) to Update on Phase II/III of ZYBRESTAT
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OXiGENE, Inc. (Nasdaq: OXGN), 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."
The 80-patient FACT trial was the largest prospective, randomized (2:1), controlled trial in patients with ATC treated with the vascular disrupting agent, ZYBRESTAT (CA4P). As previously reported, there was a suggestion of improved overall and one-year survival in this trial. Key study findings to be reported are as follows.
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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."
The 80-patient FACT trial was the largest prospective, randomized (2:1), controlled trial in patients with ATC treated with the vascular disrupting agent, ZYBRESTAT (CA4P). As previously reported, there was a suggestion of improved overall and one-year survival in this trial. Key study findings to be reported are as follows.
- Site selected local pathologists confirmed ATC in all patients enrolled and treated on FACT.
- Central review of all enrolled and treated patients confirmed ATC in 87% and 89% of such patients, respectively.
- Site selected, experienced local pathology confirmation of ATC is acceptable for enrollment and treatment of patients on any large study of ATC, and central pathology review can be done selectively during the study.
- This selective approach has the potential to prevent delays in getting patients on trial and dying while waiting for central review.
- This high concordance rate suggests that patients with more favorable histology were not enrolled on the study.
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