Healthcare Industry News: paclitaxel
News Release - May 31, 2007
OXiGENE Reaches Agreement with FDA on Special Protocol Assessment for ZYBRESTAT(TM) (CA4P) Phase II/III Pivotal Trial in Anaplastic Thyroid CancerPhase II/III Pivotal Trial Expected to Begin Enrolling Patients in June 2007
Conference Call Scheduled for 9 a.m. EST on Friday, June 1, 2007
WALTHAM, Mass.--(HSMN NewsFeed)--OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase II/III pivotal trial of its potential first-in-class vascular disrupting agent, ZYBRESTAT(TM) (combretastatin-A4 phosphate / CA4P) in anaplastic thyroid cancer (ATC). The FDA's agreement to the SPA means that, if OXiGENE follows the agreed-upon protocol, the results of the trial support the safety and effectiveness of ZYBRESTAT, and no substantive scientific issues are identified after the trial begins, much of the uncertainty associated with the design of a pivotal clinical trial should be removed.
"Despite advances in the management of cancer, there are no approved treatments for anaplastic thyroid cancer. By working closely with the FDA to reach agreement on an SPA for this trial, and given our promising Phase II data in ATC, we believe that we have moved closer to our goal of providing an effective treatment for patients suffering from this highly lethal form of cancer," commented Dr. Richard Chin, Chief Executive Officer and President of OXiGENE.
The randomized and controlled Phase II/III clinical trial is expected to enroll approximately 180 patients with ATC, two-thirds of whom will receive intravenous ZYBRESTAT plus carboplatin and paclitaxel, and the other third of whom 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. The Company currently plans to begin enrolling patients in this trial in June 2007. Approximately 45 clinical trial sites worldwide are expected to participate in the study.
The trial will be conducted under OXiGENE's Investigational New Drug (IND) application on file with the FDA. ZYBRESTAT has received fast-track designation by the FDA and has also been granted Orphan Drug status in both the United States and Europe for thyroid cancer. Additional information regarding the study design, enrollment criteria, and participating centers will be available at http://www.clinicaltrials.gov (keyword: anaplastic thyroid cancer).
Conference Call Scheduled for 9 a.m. EST on Friday, June 1, 2007
On Friday, June 1, 2007 at 9 a.m. EST a conference call will be webcast to discuss the SPA. OXiGENE's President and Chief Executive Officer, Dr. Richard Chin, will host the call. Chief Scientific Officer, Dr. David Chaplin, Chief Business Officer, John Kollins and Chief Financial Officer, James Murphy, will also participate.
To listen to a live or an archived version of the audio webcast, please log on to the Company's website, www.oxigene.com. Under the "Investor Center" tab, click on the link to "Presentations & Conference Calls."
OXiGENE's conference call can also be heard live by dialing (800) 811-8845 (U.S. and Canada) or (913) 981-4905 (international) five minutes prior to the call. A replay will be available starting at 12:00 p.m. EST on June 1, 2007 and ending at midnight EST on June 8, 2007. To access the replay, please dial (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (international) and refer to reservation number 5735734.
About Special Protocol Assessments
A Special Protocol Assessment (SPA) is an agreement with the U.S. Food and Drug Administration that the Company's Phase II/III clinical trial design is acceptable and is robust enough to form the basis of a regulatory approval based on the protocol design, clinical endpoints, and statistical analyses, if pre-specified efficacy results are achieved. The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a New Drug Application (NDA). For more information on Special Protocol Assessments, go to http://www.fda.gov/cber/gdlns/protocol.htm#ii.
About Anaplastic Thyroid Cancer
Anaplastic Thyroid Cancer (ATC) is one of the most lethal cancers known in humans. There are no approved treatments for this disease. ATC is a high-grade neoplasm, characterized by an aggressive clinical course with brief survival, and refractoriness to currently available local and systemic modalities of treatment. ATC comprises 1-2% of all primary thyroid malignancies, and patients are often elderly (between 60-70 years of age). While ATC epidemiology has not been extensively studied and documented, it is estimated that there are approximately 1,000 to 4,000 new cases per year in the U.S. and in Europe combined. Newly-diagnosed ATC patients have a median life expectancy of approximately 3 months, and only a very limited number of patients survive for longer than one year.
Information for Patients and Caregivers
For further information about anaplastic thyroid cancer and the OXiGENE Phase II/III ZYBRESTAT(TM) clinical trial, please contact ThyCa: Thyroid Cancer Survivors' Association, Inc.:
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 to date. Our strategy for optimizing the antitumor activity of ZYBRESTAT is to combine it with other types of therapeutic modalities, including cytotoxic drugs, anti-angiogenesis drugs, and radiation therapy. Our rationale for combining ZYBRESTAT with other therapeutic modalities stems from the hypothesis that agents with different and potentially complementary mechanisms of action and with a non-overlapping toxicity profile may achieve synergistic antitumor activity when administered concurrently. In animal studies, ZYBRESTAT has been shown to enhance the anti-tumor effects of several chemotherapeutic agents, several anti-angiogenic drugs, and radiation.
About OXiGENE, Inc.
OXiGENE is a clinical-stage biopharmaceutical 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 successful completion of the planned Phase II/III trial, approval by the FDA, enrollment of the first patient by June 2007 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-Q, 8-K and 10-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.
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