GlobeNewswire
2012-06-22 Potential to Expand Commercial Opportunity and Intellectual
Property Protection for ZYBRESTAT(R)
SOUTH SAN FRANCISCO, Calif., June 21, 2012 (GLOBE NEWSWIRE) -- OXiGENE,
Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company
developing novel therapeutics to treat cancer, announced the
establishment of an exclusive, worldwide licensing agreement with
Angiogene Pharmaceuticals Ltd., a U.K.-based drug development company,
for data, development plans, know-how, patents and other intellectual
property rights relative to their vascular disrupting agent (VDA)
program for neuroendocrine cancers, focused specifically on carcinoid
syndrome. OXiGENE plans to leverage these assets for the development
and potential commercialization of ZYBRESTAT to treat carcinoid
syndrome associated with metastatic carcinoid and neuroendocrine
tumors, which represents a large and growing market opportunity with
significant unmet medical need.
Combined with OXiGENE's previous research and development work in this
indication, the Company believes that these in-licensed assets provide
a compelling therapeutic rationale to conduct a Phase 2 clinical study
in persistent carcinoid syndrome, potentially to be followed by
advancing to a registration clinical program.
"According to the American Cancer Society, there are approximately
5,000 new carcinoid tumors diagnosed in the US each year. An additional
3,000 neuroendocrine tumors (NETs) are diagnosed annually. Assuming
similar incidence rates, this translates to 16,000 new cases of
carcinoid and NETs annually in the combined markets of Europe and
Japan. Although the underlying cause is unclear, there is a strong
consensus that the incidence of carcinoid tumors is increasing.
In-licensing these intellectual property and other assets from
Angiogene is strategically important for OXiGENE, providing the
potential to significantly expand the commercial opportunity and patent
protection for ZYBRESTAT," said Peter Langecker, M.D., PhD., OXiGENE's
Chief Executive Officer. "OXiGENE has contemplated developing ZYBRESTAT
in carcinoid syndrome for some time, given the compelling scientific
basis for using a VDA to disrupt blood flow to induce tumor necrosis
and reduce production of well-validated biologic mediators, such as
serotonin, which are associated with the most severe, debilitating
symptoms of this disease."
Added Dr. Langecker: "Embolization is a well-established method for the
treatment of carcinoid tumors, but it is limited to those tumors that
have readily accessible blood vessels. The use of a systemic treatment
with a VDA to achieve a comparable effect on more disseminated tumors,
especially outside the gut or the liver, may open up new treatment
paradigms for carcinoid patients. The preclinical data acquired with
this license demonstrate that administration of a VDA to a rat
suffering from a hormone-producing neuroendocrine tumor can lead to
lower circulating hormone levels. Neuroendocrine tumors, including
carcinoid, are increasing in incidence more rapidly than other cancers,
but treatment, including, drugs, surgery, or embolization techniques,
are not successful for all patients or may provide only temporary
relief. The medical need for additional therapeutic options for
patients and doctors remains open, and we believe this provides an
excellent opportunity for OXiGENE to utilize its technology and
experience in developing drugs in the VDA arena for the benefit of
those patients."
Carcinoid Syndrome and VDAs
Carcinoid syndrome is rare and is caused by carcinoid tumors--small,
malignant or benign tumors that most commonly arise in the submucosa of
the gastrointestinal tract. Carcinoid syndrome is the set of symptoms
that may occur in patients who have carcinoid tumors. The syndrome
occurs when carcinoid tumors overproduce substances such as serotonin
that normally circulate throughout the body. The serotonin produced by
the carcinoid tumor is further metabolized to the most important
serotonin metabolite, 5-HIAA (5-hydroxyindoleacetic acid).
This overproduction of serotonin and other hormones causes the symptoms
of carcinoid syndrome, which include episodic flushing, diarrhea,
wheezing, and potentially, the eventual development of carcinoid heart
disease. Carcinoid tumors often do not produce noticeable symptoms
until they spread to the liver.
Patients with a carcinoid primary tumor, particularly a mid-gut primary
tumor that has metastasised to the liver, have raised levels of
tumor-derived hormones and mediators, which impact morbidity and
survival. Many patients develop overt and debilitating symptoms from
the mediator release, referred to as carcinoid syndrome. Longer-term
consequences of such mediator release are life threatening. Carcinoid
tumors have been described as being largely resistant to chemotherapy.
Apart from surgery or direct embolization, the only effective treatment
is chronic administration of somatostatin analogues, which, while
having little impact on tumor growth, reduce the hormonal burden and
relieve symptoms. The U.S. Food and Drug Administration (FDA) has
approved the usage of a salt form of this peptide, octreotide acetate
(Sandostatin(R)), as an injectable depot formulation for the treatment
of acromegaly, diarrhea and flushing episodes associated with carcinoid
syndrome, and diarrhea in patients with vasoactive intestinal
peptide-secreting tumors (VIPomas).
While the majority of patients initially respond to somatostatin
analogue therapy with reduced levels of serotonin, many of these
patients subsequently develop resistance to these treatments, leading
to a resurgence of symptoms, and leaving few further treatment options.
The Company believes that metastatic carcinoid and metastatic
neuroendocrine tumors are particularly well suited for treatment with
VDAs since disruption of blood flow to liver metastases using localised
invasive techniques has been observed to have immediate and clinically
significant patient benefit by reducing the size or eliminating
completely the serotonin-producing tumors and thus addressing the
symptoms of carcinoid syndrome. It is possible that ZYBRESTAT may be
shown to provide clinical benefit in reducing circulating levels of
serotonin or 5-HIAA, either by itself or in conjunction with drugs like
Sandostatin(R). If successful in subsequent clinical testing, ZYBRESTAT
may prove to be more effective with the possibility of a beneficial
effect on the course of the disease rather than just the symptoms.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel
therapeutics to treat cancer. The Company's major focus is developing
vascular disrupting agents (VDAs) that selectively disrupt abnormal
blood vessels associated with solid tumor progression. 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, which
include the timing of advancement, outcomes, and regulatory guidance
relative to our clinical programs, achievement of our business and
financing objectives, and the outcome of any clinical development of
ZYBRESTAT for the treatment of carcinoid syndrome and neuroendocrine
cancers, 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
inherent risks of drug development and regulatory review, and the
availability of additional financing to continue development of our
programs.
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, 2011.
CONTACT: Investor and Media Contact:
ir@oxigene.com
650-635-7000