OXiGENE to Present Data Showing Importance of Local Site Pathology Confirmation in Phase 2/3 Clinical Trial of Zybrestat in Anaplastic Thyroid Cancer

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."

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.

 


About OXiGENE

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.

The OXiGENE, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4969

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 and 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, 2011.


CONTACT: Investor and Media Contact:
ir@oxigene.com
650-635-7000

 

Posted: September 2012

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