OXiGENE Completes Patient Enrollment in a Phase II Clinical Trial Evaluating CA4P with Chemotherapy in Imageable Solid Tumors; With Individuals Still Receiving Therapy, Company Anticipates Presentation of Data Later in 2006.WALTHAM, Mass. -- OXiGENE, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases, today announced that the Company has successfully completed patient enrollment in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II for the treatment of imageable solid tumors. The trial, which is being conducted in the United States under OXiGENE's Investigational New Drug (IND) application on file with the Food and Drug Administration, is designed to evaluate the safety and anti-cancer activity of the triple combination of Combretastatin A4P (CA4P)--OXiGENE's lead therapeutic candidate--together with widely-used chemotherapy agents, carboplatin and paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); . OXiGENE expects the presentation of top line data later in 2006, as patients enrolled in this trial are continuing to receive prolonged therapy. "We believe that the completion of patient accrual in this Phase II clinical trial is another significant milestone in the clinical advancement of Combretastatin A4P," commented Frederick Driscoll, President and Chief Executive Officer at OXiGENE. "We continue to be encouraged by the safety profile to date of the combination of CA4P and chemotherapy, as well as by the patient benefit that has been observed in early safety trials." The Phase II clinical trial, which received clearance to commence in December 2004, is a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , open-label trial open-label trial Clinical research A trial in which doctors and participants know which therapy is being administered. See Blinding. designed to evaluate the triple combination of Combretastatin A4P, carboplatin and paclitaxel in patients with solid tumors. The objectives of the trial are to assess the safety of several doses of CA4P in combination with the two chemotherapeutic agents, gather data on anti-tumor activity and establish a recommended Phase II/III dose. Additionally, the study will assess, by Magnetic Resonance Imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ), changes in tumor blood flow, which may provide additional insight into the biological activity of CA4P. An Overview of the Clinical Advancement of CA4P plus Chemotherapy After completing several early safety trials with CA4P as a monotherapy, as well as preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. in animals showing synergistic effects when CA4P was paired with carboplatin, OXiGENE completed a Phase Ib clinical trial to evaluate the safety and tolerability in man of the CA4P-carboplatin combination. This first combination trial led to the commencement of a Phase I/II clinical trial (at centers in the United Kingdom and the United States) to evaluate the pairing of CA4P with carboplatin or paclitaxel or both chemotherapeutic agents combined. The trial, which is now closed for patient enrollment, was designed to establish the optimal dose and the maximum tolerated dose, to recommend a Phase II dose, and to assess the safety and tolerability of the combination in patients with ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast , as well as other solid tumors. Based on the presentation of positive interim data by the investigators leading this Phase I/II trial, OXiGENE, in December 2004 and ahead of its anticipated clinical timeline, initiated a randomized, open-label Phase II clinical trial in the United States to evaluate the therapeutic combination in imageable solid tumors. This trial has now completed patient enrollment, but patients are still receiving therapy. During 2005, investigators provided several positive interim updates to the Phase I/II combination trial; data which supported OXiGENE's decision to progress with the above-mentioned Phase II clinical trial in imageable tumors. Most recently, in November 2005 at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics, investigators presented data that indicated a 67 per cent response rate among evaluable patients with advanced, inoperable inoperable /in·op·er·a·ble/ (in-op´er-ah-b'l) not susceptible to treatment by surgery. in·op·er·a·ble adj. Unsuitable for a surgical procedure. ovarian cancer who were treated with the combination of CA4P and chemotherapy. All of these patients had failed previous, alternate cancer treatments. The investigator also reported that four additional ovarian cancer patients had disease stabilization during treatment, and partial responses were seen in patients with esophageal cancer Esophageal Cancer Definition Esophageal cancer is a malignancy that develops in tissues of the hollow, muscular canal (esophagus) along which food and liquid travel from the throat to the stomach. and small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. . This interim update again reinforced OXiGENE's strategic decision to initiate a Phase II clinical trial, ahead of schedule, evaluating CA4P in combination therapy with carboplatin and paclitaxel for the treatment of relapsed, advanced platinum-resistant ovarian cancer. This trial is currently underway. About Combretastatin A4P (CA4P) CA4P leads a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). CA4P works via two potentially synergistic processes that selectively target pericyte-depleted neovessels, which lack ensheathment from smooth muscle support cells. CA4P is a potent and reversible tubulin tubulin /tu·bu·lin/ (too´bu-lin) the constituent protein of microtubules. tu·bu·lin n. A globular protein that is the structural constituent of microtubules. depolymerizing agent that causes newly formed endothelial cells Endothelial cells The cells lining the inner walls of the blood vessels. Mentioned in: Von Willebrand Disease that line blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. to change shape, round up and detach from the vessel wall. Recent preclinical research has also shown that CA4P disrupts the molecular engagement of VE-cadherin, a junction protein important for endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium. Endothelial A layer of cells that lines the inside of certain body cavities, for example, blood vessels. cell survival and function, and inhibits the associated (beta)-catenin/AKT signaling pathway, leading to rapid vascular collapse and tumor cell death, or necrosis. These complementary mechanisms block the flow of blood to a tumor and deprive it of oxygen and nutrients essential to its survival. Similarly, in eye diseases that are characterized by abnormal blood vessel blood vessel n. An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates. blood vessel(s), n the network of muscular tubes that carry blood. growth, CA4P has been shown in preclinical studies to suppress development and induce regression of these unnecessary blood vessels. About OXiGENE, Inc. OXiGENE is an emerging pharmaceutical 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Any or all of the forward-looking statements in this press release may turn out to be wrong, including statements regarding the presentation of data from a Phase II clinical trial in imageable tumors; that the data will continue to support the anti-cancer activity observed to date in previous and ongoing clinical trials; OXiGENE's ability to enroll patients in a Phase II clinical trial of CA4P with chemotherapy for platinum resistant ovarian cancer; the therapeutic efficacy and future success of CA4P either in single-agent therapy or in combined therapy with chemotherapy in treating cancer; and, the potential commercialization of CA4P. 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, 2005 for a description of these risks. |
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