Healthcare Industry News: non-small-cell lung cancer
News Release - February 3, 2006
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)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
WALTHAM, Mass.--(HSMN NewsFeed)--Feb. 3, 2006--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 in the United States for the treatment of Stage IIIa/IIIb Non Small Cell Lung Cancer (NSCLC). 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.
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, 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 (RECIST).
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 (MHRA) to commence a Phase III clinical trial of CA4P in the United Kingdom in patients with inoperable 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 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 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.
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
(5)Choy H et al.: Multi-institutional phase II trial of paclitaxel, 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 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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