JCEM Publishes Data from OXiGENE-sponsored Preclinical Study of Combretastatin A4 phosphate / CA4P Triple-Drug Combinations in Anaplastic Thyroid Cancer
In a paper published Monday, August 6, 2007, in the Journal of Clinical Endocrinology and Metabolism, lead author Sai-Ching J. Yueng, of the University of Texas M.D. Anderson Cancer Center in Houston, TX and colleagues report that both triple-drug combinations incorporating CA4P showed positive results, as determined by tumor volume and weight assessments, in mouse xenograft models of ATC utilizing two human ATC cell lines. In addition, correlative studies undertaken by the authors corroborated vascular disruption / tumor blood-flow shut-down as the primary mechanism by which CA4P exerted its anti-tumor activity in these models.
"We believe that these results add to the body of data, including Phase I and II human clinical trial results, indicating that CA4P - or ZYBRESTAT(TM) - has both biological and clinical activity against anaplastic thyroid cancer," commented Dai Chaplin, Ph.D., OXiGENE's Chief Scientific Officer, also an author on the paper.
"Importantly, these data indicate that the combination of CA4P (ZYBRESTAT) and chemotherapy has enhanced anti-tumor activity, and we believe this animal data provide support for the use of the triple combination comprising ZYBRESTAT, paclitaxel and carboplatin in the ongoing pivotal registration human clinical study of ZYBRESTAT in ATC," Dr. Chaplin indicated.
OXiGENE announced on July 9, 2007 that it had initiated a 180-patient pivotal registration study of ZYBRESTAT in anaplastic thyroid cancer under a Special Protocol Assessment agreement with the FDA. Two-thirds of the patients enrolled in this study will receive the triple-drug combination comprising intravenous ZYBRESTAT, carboplatin and paclitaxel, and the other third will receive carboplatin and paclitaxel alone. The primary endpoint will be a statistically significant difference in the overall survival rate between the two treatment arms, as determined by a log-rank analysis of Kaplan-Meier survival curves at times when pre-determined numbers of study events (patient deaths) are reached. The study design incorporates a planned interim analysis for efficacy and safety, which will be overseen by an Independent Data Monitoring Committee. Approximately 40-45 clinical trial sites in North America, Europe, the Middle East and India are expected to participate in the study. ZYBRESTAT for treatment of ATC has been granted Fast Track status by the FDA and Orphan Drug status by both the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA).
About ZYBRESTAT / Combretastatin A4P (CA4P)
The Company believes that ZYBRESTAT is poised to become the first therapeutic product in a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). 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. ZYBRESTAT has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against ATC and other solid tumors in clinical studies.
Information for Physicians, Patients and Caregivers
Further information on the ZYBRESTAT pivotal registration study is available at www.clinicaltrials.gov (http://clinicaltrials.gov/ct/show/NCT00507429?order=1). If you are a patient or a caregiver and would like further information about anaplastic thyroid cancer and/or enrollment in OXiGENE's ongoing pivotal registration study of ZYBRESTAT in anaplastic thyroid cancer, please contact ThyCa, the Thyroid Cancer Survivors' Association, Inc.: -0-
ThyCa www.ThyCa.org (877) 588-7904 firstname.lastname@example.org
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.
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, including those relating to the future clinical development of ZYBRESTAT, approval by the FDA, timing of patient enrollment, the effective combination of ZYBRESTAT with other drugs, and ZYBRESTAT leading a novel class of small-molecule drug candidates 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. 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 Form 10-K, 10-Q and 8-K reports. 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, 2006.
Shari Annes, 650-888-0902
Investor Relations, 781-547-5900
Posted: August 2007