OXiGENE Receives Regulatory Clearance to Commence Phase III Clinical Trial for Advanced, Inoperable Non-Small Cell Lung Cancer (NSCLC).

WALTHAM, Mass. -- OXiGENE, Inc.

--Phase III Study to Evaluate CA4P in Combination with Radiotherapy and Chemotherapy; Trial Endpoint Targets an Increase in Median Survival Benefit

--First Vascular Disrupting Agent to Enter a Phase III Clinical Trial 

OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases, today announced it received regulatory clearance in the United Kingdom to commence its first Phase III clinical trial with its lead product candidate, Combretastatin A4P (CA4P). The Company will evaluate CA4P in combination with radiotherapy and chemotherapy for the treatment of unresectable Stage IIIb/IV NSCLC.

"We believe that this notice of acceptance to commence a Phase III trial represents an important step forward for OXiGENE's clinical program as it represents the achievement of another significant clinical landmark for the Company in 2005," stated Frederick Driscoll, President and Chief Executive Officer at OXiGENE. "OXiGENE's clinical progress this year, which includes the initiation of this Phase III trial, as well as the initiation of a Phase II clinical trial in platinum resistant ovarian cancer and the commencement of a Phase Ib trial evaluating CA4P in combination with Avastin(R), demonstrates our clinical focus on oncology and reflects our roadmap for our intended clinical development path. We believe that these clinical achievements support OXiGENE's position as the leading developer of novel, small molecule Vascular Disrupting Agents."

Trial Design and Targeted Endpoint

The Phase III study of CA4P in combination with radiotherapy and chemotherapy will be a randomized, double blind, placebo-controlled trial. The trial is expected to enroll approximately 370 patients who have not had prior treatment for NSCLC and who will be randomized into either a control group or a treatment group. The primary objective of this trial is to compare median survival time of patients in the treatment group versus the control group. Tumor response will be evaluated using the international standard for oncology clinical trials, known as Response Evaluation Criteria In Solid Tumors (RECIST). The trial will also further define the safety profile in the treatment group.

This Phase III clinical trial is designed to have a pre-planned, interim data analysis that will occur after approximately half of the patients have completed treatment, to evaluate preliminary safety and patient response. The data analysis will be performed by an independent third party review board that will establish whether the trial should proceed to its completion or be concluded for overwhelming efficacy, for safety concerns, or for futility.

The Phase III trial has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom and is subject to ethics approval by the Medical Research Advisory Committee (MRAC). Clinical trial site selection is currently ongoing in the United Kingdom. OXiGENE is planning to file for regulatory clearance to commence this trial in several additional countries.

About Inoperable, Late Stage Non-Small Cell Lung Cancer 

Non-small cell lung cancer accounts for 75 percent of all lung cancer(1) making it the most widespread form of lung cancer. Approximately 350,000 cases are expected to be diagnosed globally each year(2) and approximately half of those people afflicted with NSCLC will have the most advanced stages of the disease (Stage IIIb or Stage IV), that are not treatable with surgery alone.(2,3) Stage IIIb/IV inoperable lung cancer yields a poor prognosis with median survival estimated at 6.7 months.(4)

On October 5, 2005, interim data for a Phase Ib clinical trial evaluating CA4P in combination with radiotherapy for the treatment of NSCLC was presented at the National Cancer Research Institute's Cancer Conference held in Birmingham, United Kingdom. The clinical trial included two cohorts of patients with NSCLC who received radiotherapy and either a single dose of CA4P at the end of the first week of radiotherapy treatment or once weekly doses of CA4P for three weeks. The investigator noted that those patients who received weekly CA4P for three weeks, as compared to those patients who received a single dose of CA4P, showed a trend to increase the median survival to 11.6 months versus 6.8 months, respectively. The investigator also reported that increased radiation toxicities had not been observed when CA4P was administered, and that the side effects of CA4P observed to date were mild and self-limiting.

Dai Chaplin, Ph.D., Chief Scientific Officer and Head of Research and Development for OXiGENE commented on OXiGENE's clinical programs, "We are encouraged by the data from this Phase Ib trial evaluating CA4P in combination with radiotherapy, and we look forward to seeing if the preliminary results are borne out in the trial we are about to begin. We are hopeful that this combination therapy will ultimately result in a treatment that is both effective and well-tolerated by patients with NSCLC."

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 depolymerizing agent that causes newly formed endothelial cells that line blood vessels 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 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 growth, CA4P has been shown in preclinical studies to suppress development and induce regression of these unnecessary blood vessels.

The initiation of this Phase III clinical trial brings to eight the total number of clinical studies evaluating CA4P in oncology that are open or soon-to-be open for enrollment. These clinical trials involve the use of CA4P in both single-agent and combination therapies, including a Phase II trial evaluating CA4P in combination with carboplatin/paclitaxel for the treatment of platinum-resistant ovarian cancer, as well as a Phase Ib trial studying CA4P in combination with Avastin(R) (Bevacizumab). CA4P is also being studied in a Phase II clinical trial in myopic macular degeneration.

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.

(1) Journal of Clinical Oncology, Vol. 22:801-810, March 2004

(2) Globocan 2000: Cancer Incidence

(3) Datamonitor 2004, DaVinci HealthCare Partners, 2004.

(4) Decision Resources, Inc., Non Small Cell Lung Cancer, May 2002.

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 may turn out to be wrong, including statements regarding OXiGENE's ability to enroll patients in the Phase III clinical trial of CA4P in combination with radiotherapy and chemotherapy; the therapeutic efficacy and future success of CA4P either in single-agent therapy or in combined therapy with chemotherapy and/or radiotherapy or other compounds or therapies in treating cancer; CA4P's mechanisms of action; and the ability of CA4P to cause anti-tumor effects in combination with other therapies. 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, 2004 for a description of these risks.

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