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OXiGENE to Commence a Randomized Clinical Trial in the United States to Evaluate CA4P for the Treatment of Patients with Non Small Cell Lung Cancer (NSCLC).


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)

--Combretastatin A4P (CA4P) will be Evaluated with Concurrent Chemoradiotherapy, a Widely-Accepted Treatment Regimen in the United States--

--Trial Endpoint Targets a One-Year Survival Benefit in Patients with All Histological Types of Unresectable, Stage IIIa/IIIb NSCLC--

--Distinct Clinical Trials in the US and Europe Could Maximize the Market Opportunity for CA4P in Key Oncology Indication--

OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds designed to treat cancer and certain ophthalmologic diseases, today announced that it plans to commence 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
 in the United States for the treatment of Stage IIIa/IIIb Non 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.
 (NSCLC NSCLC non (or cancer).
NSCLC Non-small cell lung cancer, see there
). The Company will evaluate its lead clinical candidate, Combretastatin A4P (CA4P), in combination with concurrent chemoradiotherapy, a widely accepted standard in the United States for the treatment of patients with all histological types of unresectable Stage IIIa/IIIb NSCLC. The trial will be conducted under OXiGENE's Investigational New Drug (IND) application on file with the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
.

The Phase II clinical trial will commence by enrolling approximately 12 patients to assess the tolerability of the protocol and to establish the recommended dose of intravenously administered CA4P. This trial will be the first in which CA4P is administered to patients in combination with concurrent chemoradiotherapy. In other ongoing clinical trials, CA4P has been paired with chemotherapy or radiation therapy with no observed side effects beyond those typically experienced with either treatment.

The Phase II clinical trial will then proceed as 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, multi-center trial that will compare two cohorts of patients -- an investigational group and an active control group. Approximately 66 patients who have not had prior treatment for NSCLC will be randomized 2:1 into the two groups. Patients enrolled in the investigational group will be treated with radiotherapy and seven cycles of chemotherapy plus CA4P, followed by maintenance chemotherapy plus CA4P. The objective of the Phase II clinical trial is to evaluate the survival benefit in patients achieved at one year. The response rate will be evaluated according to Response Evaluation Criteria in Solid Tumors Response Evaluation Criteria In Solid Tumors (RECIST) - is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatments.  (RECIST RECIST Response Evaluation Criteria in Solid Tumors (oncology review criteria) ).

The announcement of this randomized Phase II clinical trial with CA4P in the United States follows OXiGENE's recent announcement of receipt of regulatory clearance from the Medicines and Healthcare Products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.  (MHRA MHRA Medicines and Healthcare Products Regulatory Agency
MHRA Modern Humanities Research Association (United Kingdom)
MHRA Minnesota Human Rights Act
MHRA Malta Hotels and Restaurants Association
) to commence a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  of CA4P in the United Kingdom in patients with 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.
 Stage IIIb/IV NSCLC, a subset of patients not deemed suitable for curative treatment with concurrent radiotherapy.

"We believe this Phase II clinical trial to be a key stepping stone in the path towards potential commercialization of CA4P for the treatment of NSCLC," commented Frederick Driscoll, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of OXiGENE. "We expect that the commencement of this trial in the United States, combined with the Phase III clinical trial which we plan to commence in Europe for the treatment of patients with Stage IIIb/IV NSCLC, may provide a springboard for OXiGENE to maximize its registrational opportunities in a key oncology indication, and with standards of therapy most often selected by oncologists for each subset of patients. Strategically, this is a key clinical achievement for the Company."

About Non Small Cell Lung Cancer

Non small cell lung cancer accounts for 75% 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) Stage IIIa NSCLC is one of the largest growing segments of the disease, due to newer tests that enable earlier detection of the disease.(3), (4) Approximately 56% of patients with Stage IIIa/IIIb live for one year when treated with concurrent radiotherapy.(5)

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 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 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 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.

(1)Journal of Clinical Oncology The Journal of Clinical Oncology is a medical journal published by the American Society of Clinical Oncology. The Journal was founded in 1983 and publishes original research and review articles on topics relating to cancer. It is published 3 times a month. , 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

(5)Choy H et al.: Multi-institutional phase II trial of 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); , carboplatin and concurrent radiation therapy for locally advanced non-small-cell lung cancer. Journal of Clinical Oncology 16:3316, 1998

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 OXiGENE's ability to enroll patients in a Phase II clinical trial of CA4P in combination with chemoradiotherapy in the United States; OXiGENE's ability to enroll patients in a Phase III clinical trial of CA4P in the United Kingdom; 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; potential commercialization of CA4P; 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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Geographic Code:1USA
Date:Feb 3, 2006
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