BUSINESS WIRE
Key Feasibility Hurdle Overcome in Topical Ophthalmology Program
WALTHAM, Mass.--(BUSINESS WIRE)--Regulatory News:
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a clinical-stage,
biopharmaceutical company developing novel therapeutics to treat cancer
and eye diseases, today reported positive results from preclinical
studies with topical formulations of ZYBRESTAT for ophthalmological
indications. The studies, performed in industry-standard rabbit models,
indicate that two formulations of ZYBRESTAT, when applied topically to
the surface of the eye, are absorbed and result in concentrations of
drug in target tissues in the back of the eye (i.e., the retina and
horoids) that the Company believes will be sufficient for therapeutic
activity in age-related macular degeneration (ARMD) and potentially
other eye diseases in which abnormal neovascularization plays a role.
These results confirm preliminary results seen in earlier preclinical
studies.
“Achieving therapeutic concentrations of
ZYBRESTAT with topical delivery in relevant ocular tissues, such as the
retina, in preclinical models represents a key milestone in OXiGENE’s
ophthalmology program,” commented OXiGENE’s
President and Chief Executive Officer, Richard Chin, M.D. “Having
previously observed in clinical trials that intravenously-administered
ZYBRESTAT has clinical activity in patients suffering from a form of
macular degeneration, we believe a topical formulation of ZYBRESTAT that
delivers sufficient quantities of drug to target tissues in the eye has
a high likelihood of demonstrating activity in the clinic. We now have
results from multiple preclinical studies suggesting that development of
such a formulation is feasible, and we believe that a topical
formulation of ZYBRESTAT could potentially be a major advance for
patients with a variety of ophthalmic diseases and conditions.”
Tolerability of the formulations was favorable in the rabbit studies,
confirming data from earlier rodent studies. Based on these results,
OXiGENE is proceeding with further preclinical studies in non-rodent
models, which, if consistent with results from rabbit and rodent
studies, are expected to provide support for an IND submission,
currently planned for the first half of 2008.
In February 2007, OXiGENE announced positive results from a Phase II
clinical trial of intravenous ZYBRESTAT in 23 patients with myopic
macular degeneration. All patients achieved the primary endpoint of the
trial, stabilization of vision. Results from the trial were reported in
poster form in May 2007 at the 47th Annual
Meeting of the Association of Research in Vision and Ophthalmology, and
a copy of the poster is available on OXiGENE’s
website at http://www.oxigene.com/press/publications.asp
- Posters.
About ZYBRESTAT (combretastatin A4 phosphate / CA4P)
ZYBRESTAT™ is currently being evaluated in a
pivotal registration study in anaplastic thyroid cancer (ATC) under a
Special Protocol Assessment agreement with the U.S. Food and Drug
Administration (FDA). OXiGENE believes that ZYBRESTAT is poised to
become the first therapeutic product in a novel class of small-molecule
drug candidates called vascular disrupting agents (VDAs). Through
interaction with vascular endothelial cell cytoskeletal proteins,
ZYBRESTAT selectively targets and collapses tumor vasculature, thereby
depriving the tumor of oxygen and causing death of tumor cells. In
clinical studies in solid tumors, ZYBRESTAT has demonstrated potent and
selective activity against tumor vasculature, as well as clinical
activity against ATC, ovarian cancer, and various other solid tumors. In
clinical studies in patients with forms of macular degeneration,
intravenously-administered ZYBRESTAT has demonstrated clinical activity,
and the Company is working to develop a convenient and patient-friendly
topical formulation of ZYBRESTAT for ophthalmological indications.
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 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 -enhancing medicines
to patients.
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 the timing and success of
further preclinical studies of topical formulations of ZYBRESTAT for
ophthalmological indications and the timing and ability to submit an IND
for a topical formulation of ZYBRESTAT for ophthalmological indications.
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, 2006.