Ex. 99-1
OXiGENE Announces Successful Completion of its Phase I U.S. Trial of
Combretastatin A4P for the Treatment of Solid Tumor Cancers
Researchers Report Statistically Significant Findings Demonstrating Drug's
Ability to Reduce Blood Flow to Malignant Tumors
Watertown, Massachusetts, October 31, 2001 - OXiGENE, Inc. (Nasdaq: OXGN, SSE:
OXGN), The Vascular Targeting Company, today announced the completion of the
Phase I U.S. clinical trial of its novel anti-tumor vascular targeting agent,
Combretastatin A4 Prodrug (CA4P). The trial generated statistically significant
findings demonstrating CA4P's ability to successfully reduce blood flow that
feeds malignant tumors. CA4P is the first vascular targeting drug to be tested
in a human trial in the United States.
Results will be detailed in a poster presentation this afternoon at the 2001
AACR-NCI-EORTC (American Association for Cancer Research/National Cancer
Institute/European Organization for Research and Treatment of Cancer)
International Conference on Molecular Targets and Cancer Therapeutics in Miami,
Florida. The data show that CA4P can be given safely at doses that significantly
diminish the blood flow to malignant tumors, as evidenced by MRI (magnetic
resonance imaging).
Researchers confirmed a significant reduction in the tumor blood flow in
patients studied 4-6 hours following infusion of CA4P. "We believe that this
Phase I trial provides further evidence of the role that our vascular targeting
agents can play in causing death of existing tumor cells," said Dai Chaplin,
Ph.D., OXiGENE's chief operating officer and head of research and development.
The study, led by Scot Remick, M.D, associate professor of medicine at the
Ireland Cancer Center, University Hospitals of Cleveland, Case Western Reserve
University School of Medicine in Cleveland, Ohio, marked the first completed
U.S. clinical assessment in humans of a vascular targeting agent as an
anti-cancer modality.
A total of 25 patients participated in the Ireland Cancer Center trial. Some
highlights include:
|X| One patient, a 55-year-old man with anaplastic thyroid carcinoma, had a
"pathological complete remission" after undergoing CA4P treatment and has been
disease free for more than two years. |X| Two other patients experienced
"prolonged periods of freedom from progression of their disease," according to
the research.
|X| A patient with colon cancer remained stable for 19 months, while
another with medullary thyroid cancer remained stable for 12 months.
Clinically significant toxicities included tumor pain (two patients) and acute
coronary syndrome (two patients) at the highest dosage levels.
"The drug appears to produce a statistically significant reduction in tumor
blood flow in the patients we studied," Dr. Remick said. "It is certainly rare
to see a `complete responder' in a Phase I clinical trial. Given the absence of
cytotoxic side effects normally seen with traditional chemotherapy drugs, the
research team is enthusiastic about the potential of combining CA4P therapy with
other anti-cancer treatments.
"Additional indication of vascular effect was also noted in this study by the
observation of acute changes in the release of an endothelial cell specific
marker in the blood known as soluble intercellular adhesion molecule-1
(sICAM-1). The changes in sICAM-1 levels that we saw in this study may reflect
rapid endothelial damage and or cell death due to infusion of CA4P. These
results imply that serial measurement of endothelial specific markers such as
sICAM-1 may provide further insight into the effects of vascular targeting
agents on endothelial cell targets," Dr. Remick continued. "We were able to
demonstrate the ability to reduce tumor blood supply at tolerable dosage levels,
without traditional cytotoxic side effects. In short, we were able to
demonstrate the concept of tumor vasculature targeting."
In May, OXiGENE announced final data from its Phase I U.K. clinical trial of
CA4P at the annual meeting of the American Society of Clinical Oncologists. In
that study, which involved 34 patients, CA4P demonstrated a reduction in
malignant tumor blood flow. The dose-limiting toxicity in the U.K. study was
reversible ataxia.
Another Phase I trial, involving 30 patients, also has been conducted at the
University of Pennsylvania. One patient in that study, a 19-year-old with
medullary thyroid cancer, has seen disease stabilization for 19 months. Five
other patients, including two with medullary thyroid cancer, also exhibited
clinically relevant degrees of disease stabilization. The dose-limiting toxicity
in the University Pennsylvania trial was tumor pain.
In both the U.K. and University of Pennsylvania trials, no dose-limiting cardiac
toxicity was observed.
"The findings from OXiGENE's three Phase I trials are very encouraging," said
Dr. Chaplin. "We have demonstrated the drug's proof of principle in that the
drug can interfere with the blood flow in malignant tumors at doses that are
well tolerated and, moreover, we actually have seen clinical responses in
several patients."
Combretastatin A4P is derived from the African bush willow Combretum caffrum.
Unlike their therapeutic counterparts, anti-angiogenesis agents, which inhibit
the formation of new blood vessels in a tumor, vascular targeting agents attack
existing tumor vasculature that supports the primary tumor mass.
Company to Host Conference Call In conjunction with this announcement, OXiGENE
will host a conference call at 10 a.m. (ET) Thursday, November 1. Participating
on the call will be Bjorn Nordenvall, M.D., Ph.D., OXiGENE's chairman and chief
executive officer, Dr. Chaplin and Dr. Remick.
To access the conference call, please dial (800) 354-6885 (domestic) and (212)
346-0123 (international) five minutes prior to the scheduled start time. A
48-hour replay of the call will be available by calling (800) 633-8284
(domestic) and 858-812-6440 (international). Please refer to reservation number
19938507.
The conference call also is available by logging on to:
http://web.servicebureau.net/conf
/meta?i=1112300747&c=2343&m=was&u=/w_ccbn.xsl&date_ticker=11_1_2001_OXGN
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About OXiGENE
OXiGENE, an international biopharmaceutical company, is the world leader in
vascular targeting agents that destroy existing blood vessels associated with
cancerous tumors, and which may have an application in the treatment of
restenosis and certain forms of ocular disease. With its flagship family of
Combretastatin-based vascular targeting agents, OXiGENE is developing a diverse
portfolio of innovative products to combat these conditions. The Company's
mission is to in-license new therapeutics from academic partners, and develop
new drugs that will enhance the effectiveness of traditional cancer treatments
and to introduce innovative therapies that attack cancer and other diseases.
This news release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. These statements include,:
the efficacy, safety and other findings of the Phase I trials of Combretastatin
A4P conducted in the United States and abroad; the potential benefits of
OXiGENE's vascular targeting agents in cancer treatment and other diseases
including certain forms of ocular disease and, restenosis; and the benefits of
combining CA4P with other forms of cancer treatment. Any or all of the
forward-looking statements in this press release may turn out to be wrong. They
can be affected by inaccurate assumptions we might make or by known or unknown
risks and uncertainties including but not limited to, the early stage of our
product development and the unproven efficacy of our technology and at
acceptable dosage levels; our ability to raise capital when needed and on
reasonable terms; uncertainties as to the future success of ongoing and planned
clinical trials; our dependence on others for much of the clinical development
of our technology, as well as for obtaining regulatory approvals and conducting
manufacturing and marketing of any products that might successfully reach the
end of the development process; competition from other companies and other
institutions pursuing alternative technologies; and uncertainties related to our
ability to obtain adequate intellectual property protection for our technology
and products. Consequently, no forward-looking statement can be guaranteed and
actual results may vary materially. Additional information concerning factors
that could cause actual results to materially differ from those in the
forward-looking statements are contained in our reports to the Securities and
Exchange Commission including our 10-Q, 8-K and 10-K reports. We undertake no
obligation to publicly update forward-looking statements, whether as a result of
new information, future events or otherwise, except as may be required by law.
Contact:
OXiGENE, Inc. or Sharon Merrill Associates, Inc.
Tammy Bishop David Calusdian (Investors)
Director of Investor Relations and Scott Solomon (Media)
Corporate Communications (617) 542-5300
(617) 673-7826 dcalusdian@investorrelations.com
tbishop@oxigene.com ssolomon@investorrelations.com