OXiGENE Presents Data Confirming Survival Benefit of ZYBRESTAT in Patients With Anaplastic Thyroid Cancer
SOUTH SAN FRANCISCO, Calif., Sept. 14, 2011 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, today presented data from a retrospective comparative analysis suggesting that treatment with ZYBRESTAT (fosbretabulin, or CA4P) confers a one-year survival benefit in patients with anaplastic thyroid cancer (ATC) compared to treatment with chemotherapy alone. The data derive from a comparison between the results of the company's aggregate data from five independent prospective Phase 1 and Phase 2 trials using ZYBRESTAT to treat patients with ATC, including the FACT trial, and data from the 50-year experience in treating ATC patients at the Mayo Clinic, Rochester, MN (Mayo Group) from 1949-1999, published by Dr. Bryan McIver, one of the world's leading experts in treating patients with ATC. OXiGENE's FACT trial is the largest single, randomized, controlled, multi-center clinical trial ever conducted in ATC, and the Mayo studies comprise the largest retrospective review of the treatment outcomes in ATC conducted at a single institution. The FACT data were originally presented at the 2011 ASCO meeting by Dr. Julie Sosa from Yale Medical School, New Haven, CT.
The data were presented at the 35th Meeting of the European Thyroid Association, in Krakow, Poland, in a presentation titled, "Comparison of 1-year Survival between Patients with Anaplastic Thyroid Cancer (ATC) treated with Fosbretabulin (CA4P) in 5 Independent Prospective Studies and a Large Single Institution Historical Series." The presenter was Rossella Elisei, M.D., Department of Endocrinology, University of Pisa, Italy.
Key findings and conclusions from the retrospective analysis presented today were:
13 patients or 9.7% of all 134 ATC patients treated at the Mayo Clinic survived one year or more.
19 patients or 23% of all 84 ATC patients treated with ZYBRESTAT either alone or in combination with chemotherapy survived more than one year. The longest survival is 13+ years in a patient with a complete response.
The 9% rate of patients in the control arm of the FACT study surviving one year is almost identical to the observed 9% in the much larger Mayo cohort, underscoring the meaningfulness of the 24% rate in the FACT study in terms of a suggested survival benefit.
As is often the case with historical data, direct comparisons between the FACT trial and the Mayo Group have to be interpreted with the caveat that there were changes in standard-of-care treatment over the past 50 years, as well as differences in staging, sample size, and time-to-death analysis (i.e., survival time was computed from the time of randomization in FACT while Mayo group used time of diagnosis as the starting point). This slight imbalance in the calculation of time to death, however, would favor the Mayo group in terms of a slightly longer calculated survival.
The increased one-year survival rate with ZYBRESTAT was seen in patients with larger tumors.
Peter J. Langecker, M.D., Ph.D., OXiGENE's CEO, commented on the importance of the comparative analysis: "We undertook this retrospective analysis to further elucidate the clinical relevance of the survival benefit with ZYBRESTAT shown in the FACT trial, with particular focus on comparing the control group's outcomes on chemotherapy alone with the Mayo Clinic's group. Despite some of the different characteristics in the two sets of studies, the one-year survival benefit for patients in the control group and the patients in the cohort treated at the Mayo Clinic is nearly identical, with fewer than 10% of patients alive after one year.
"The 24% of patients treated with ZYBRESTAT in the FACT study surviving one year or longer remains striking in its significance. Patients treated with ZYBRESTAT essentially had a one-in-four chance of being alive after one year compared to only a one-in-10 chance in the control group, which corresponds to the survival outcome in the Mayo Clinic treated group.
"Sadly, one must conclude that over the past 50 years, as reflected in the Mayo study, treatment outcomes have remained poor for patients with ATC in spite of general advances in diagnosis, surgical techniques, available chemotherapeutic agents and supportive care, underscoring the critical need for new, improved therapeutic options beyond standard chemotherapy. This is the reason why the FACT survival data, even without a p-value due to the 80-patient sample size, have been so favorably received by the ATC community. We are working closely with many of the clinicians and experts who see ATC patients in the U.S. and abroad, and we remain hopeful that we will be able to advance ZYBRESTAT to a registration trial and potentially make a meaningful contribution to the treatment paradigm for this highly lethal tumor."
A copy of the data presented today is available on the OXiGENE website: www.oxigene.com.
ZYBRESTAT is being evaluated in a Phase 2 study of patients with non-squamous non-small cell lung cancer and other clinical trials, including a recently completed Phase 2 study of ZYBRESTAT plus chemotherapy in patients with anaplastic thyroid cancer (ATC). OXiGENE believes that ZYBRESTAT is poised to become an important product in a novel class of small-molecule drug candidates called vascular disrupting agents. 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 demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against anaplastic thyroid cancer, ovarian cancer and various other
About OXiGENE, Inc.
OXiGENE is a clinical-stage biotechnology company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life-saving and enhancing medicines to patients.
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Safe Harbor Statement
This press release contains forward-looking statements that reflect management's current views regarding OXiGENE's continued product development operations and the value and potential of OXiGENE's product candidates in development 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 outcome of clinical studies and the availability of additional financing to continue development of ZYBRESTAT. 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, 2010.
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