OXiGENE Begins Phase 1b/2a Trial of OXi4503, a Novel Second-Generation Vascular
Disrupting Agent
WALTHAM, Mass., April 6, 2009 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN),
a clinical-stage biopharmaceutical company developing novel therapeutics to
treat cancer and eye diseases, announced that the company has initiated a Phase
1b/2a study of its dual-mechanism, second-generation vascular disrupting agent
(VDA), OXi4503, in patients with solid tumors with hepatic involvement.
The multi-center study is being conducted in Australia and is expected to
enroll approximately 63 patients at up to 11 sites. The study is open to
patients with primary hepatocellular carcinoma, as well as patients with
secondary hepatic tumor involvement. Patients participating in this
dose-escalating study will be administered intravenous OXi4503 on days 1, 8 and
15 of a 28-day cycle. The open-label, dose-escalation study is designed to
evaluate safety, tolerability and maximum tolerated dose (MTD), and is expected
to conclude in the fourth quarter of 2009. The company expects to announce
top-line data in the first half of 2010. Once MTD is determined, and depending
upon the results of the Phase 1b portion of the trial, a subsequent Phase 2a
portion of the trial would evaluate overall response rate to OXi4503 in
patients with hepatocellular carcinoma or other advanced cancers with hepatic
tumor involvement.
"We believe that Vascular Disrupting Agents are a promising new weapon in the
fight against cancer. Based on preclinical animal models evaluating OXi4503 in
hepatocellular carcinoma and liver metastases, and initial data from the
ongoing Phase 1 study of OXi4503 in patients with advanced solid tumors, tumors
in the liver may be particularly responsive to OXi4503's combination of
vascular disruption and cytotoxic therapy to effect tumor death. I am pleased
to be working with OXiGENE in the clinical evaluation of OXi4503, which may one
day be an important therapy for patients with liver cancers," said Christopher
Sweeney, M.B.B.S., Director of Cancer Clinical Department of Medical Oncology,
Royal Adelaide Hospital Cancer Centre, Professor of Medicine, Discipline of
Medicine, Faculty of Health Sciences, University of Adelaide and the principal
investigator for this study.
"Initiating this Phase 1b/2a trial of OXi4503 represents an important step for
vascular disrupting agents, and for OXiGENE," said Patricia Walicke, M.D.,
Ph.D., Chief Medical Officer for OXiGENE, Inc. "The trial is designed to build
on the interesting data gathered from the Phase 1 study of OXi4503 in patients
with advanced solid tumors, as well as from preclinical studies that
demonstrated OXi4503's single-agent activity in xenograft tumor models and
synergistic or additive effects in combination with chemotherapy and other
treatment modalities. We expect that additional patient data will help us to
further elucidate the safety and activity profile of OXi4503 and significantly
advance our understanding of this promising new compound."
Clinicians and other medical professionals who would like more information
about this study may contact OXiGENE at 781-547-7900.
About OXi4503
OXi4503 (combretastatin A1 di-phosphate / CA1P) is a dual-mechanism vascular
disrupting agent (VDA) that is being developed in clinical trials for the
treatment of solid tumors. Like its structural analog, ZYBRESTAT(TM)
(fosbretabulin / CA4P), OXi4503 has been observed to block and destroy tumor
vasculature, resulting in extensive tumor cell death and necrosis. In addition,
preclinical data indicate that OXi4503 is metabolized by oxidative enzymes
(e.g., tyrosinase and peroxidases), which are elevated in many solid tumors and
tumor white blood cell infiltrates, to an orthoquinone chemical species that
has direct cytotoxic effects on tumor cells. Preclinical studies have shown
that OXi4503 has (i) single-agent activity against a range of xenograft tumor
models; and (ii) synergistic or additive effects when incorporated in various
combination regimens with chemotherapy, molecularly-targeted therapies
(including tumor-angiogenesis inhibitors), and radiation therapy. OXi4503 is
currently being evaluated as a monotherapy in a Phase 1 dose-escalation trial
in patients with advanced solid tumors and in a Phase 1b/2a study in patients
with solid tumors with hepatic involvement. OXiGENE is developing OXi4503 under
the strategic drug development partnership it established with Symphony Capital
in October 2008.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel
therapeutics to treat cancer and eye diseases. The Company's major focus is
developing vascular disrupting agents (VDAs) that selectively disrupt abnormal
blood vessels associated with solid tumor progression and visual impairment.
OXiGENE is dedicated to leveraging its intellectual property and therapeutic
development expertise to bring life-extending and life-enhancing medicines to
patients.
The OXiGENE, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4969
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.
Forward-looking statements can be affected by inaccurate assumptions OXiGENE
might make or by known or unknown risks and uncertainties, including, but not
limited to, timing for results from the Phase 1b/2a study of OXi4503 in
patients with solid tumors with hepatic involvement, and timing or execution of
a potential strategic collaboration on any product or indication or any other
transaction. 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 reports on Form 10-K, 10-Q and 8-K. 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, 2008.
CONTACT: OXiGENE, Inc.
Investor and Media Contact:
Michelle Edwards
650-635-7006
medwards@oxigene.com
OXiGENE Begins Phase 1b/2a Trial of OXi4503, a Novel Second-Generation Vascular Disrupting Agent
| Source: Oxigene, Inc.