SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES AND EXCHANGE ACT OF 1934
Date of Report: October 4, 1999
(Date of earliest event reported)
OXiGENE, INC.
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(Exact name of registrant as specified in its charter)
Delaware 000-21990 13-3679168
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(State or other jurisdiction (Commission File (IRS Employer
of incorporation) Number) Identification Number)
One Copley Place, Suite 602, Boston, Massachusetts 02116
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 536-9500
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Item 5. Other Materially Important Events
On October 4, 1999, the Registrant issued a press release, a copy of which
is attached hereto as Exhibit 99.1, announcing interim results of a Phase I
clinical trial for its Combretastatin A4 Prodrug.
Certain statements made in this press release that may relate to clinical
trial outcomes, therapeutic applications and outcomes, governmental approvals,
potential market size and commercialization are forward-looking and are made
pursuant to the safe harbor provisions of the Securities Litigation Reform Act
of 1995. Such statements involve risks and uncertainties that may differ
materially from those set forth in these statements. As described elsewhere in
the Registrant's filings with the Securities and Exchange Commission, Phase I
clinical trials represent the first use of a drug in humans and include only a
small number of patients for the purpose of determining the preliminary safety
profile of a drug. The results of early stage clinical testing of drugs are not
necessarily predictive of results that will be obtained from subsequent testing,
and the FDA may require modification, suspension or termination of subsequent
clinical trials. There can be no assurance that future clinical trials will
demonstrate the safety and efficacy of a drug or the ability to obtain necessary
regulatory approvals of such drugs. In addition, the economic, competitive,
governmental, technological and other factors identified in the Registrant's
filings with the Securities and Exchange Commission could affect the results
reflected in such forward-looking statements.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(c) Exhibits.
99.1 Press release of the Registrant, dated October 4, 1999.
<PAGE>
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned herewith duly authorized.
Date: October 5, 1999 OXiGENE, INC.
(Registrant)
By: /s/ Bo Haglund
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Bo Haglund
Chief Financial Officer
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EXHIBIT INDEX
Exhibit
99.1 Press release of the Registrant, dated October 4, 1999.
OXIGENE REPORTS INTERIM CLINICAL DATA FOR
COMBRETASTATIN A4 PRODRUG
Phase I Clinical Trial Shows Significant Reduction in Tumor Blood Flow in
Humans
Boston, MA and Stockholm, Sweden, October 4, 1999 - OXiGENE Inc. (NASDAQ: OXGN,
SSE: OXGN) announced today interim results of a Phase I clinical trial for
Combretastatin A4 Prodrug (CA4P). The study is being conducted in collaboration
with the British Charity Organization, The Cancer Research Campaign, (The CRC),
and was presented at the Angiogenesis '99 conference in London by Dr. Gordon
Rustin, Director of the Department of Medical Oncology at Mount Vernon Hospital,
United Kingdom and a co-investigator on the study. Dr. Rustin presented data
showing that cancer patients treated with CA4P had significantly reduced blood
flow in a dose-dependent manner to their tumors as measured by Nuclear Magnetic
Resonance Imaging (MRI). This study is the first demonstration in human clinical
trials of an inhibitor that blocks the flow of blood within tumor-associated
blood vessels. The timing of the blood-flow shutdown in the patients was very
similar to the timing of the shutdown observed in preclinical rodent studies of
CA4P.
These clinical results demonstrate a proof of principle with regard to CA4P's
mode of action.
CA4P is an anti-tumor vascular targeting agent. It is one of a new class of
anti-cancer therapies that act by attacking a tumor's blood supply. In vitro
experiments have demonstrated CA4P's ability to change the shape and
permeability of endothelial cells, cells that line all blood vessels,
particularly those cells that are in an actively proliferating state not unlike
what is observed in tumor vasculature. It is these activities that are thought
to constrict tumor-associated vessels thereby inhibiting blood flow to the
tumor. CA4P is different from angiogenic inhibitors now in development in that
it attacks pre-existent tumor vasculature. This is an activity not seen in
anti-angiogenesis inhibitors currently in clinical trials. CA4P is currently in
three Phase I clinical trials, one in the UK, and two in the US.
"These interim results show that we can administer CA4P to humans safely at
doses that cause a significant decrease in blood flow to tumors. In preclinical
models, we have seen that CA4P displays similar activities as shown here in
human clinical trials, extending to, and confirming its proof of principle in
man as well as in animal models," said Bjorn Nordenvall, Ph.D., MD, President
and CEO of OXiGENE.
Phase I studies are primarily undertaken to evaluate a drug's safety. Clinical
work presented here not only describes CA4P safety data, but due to CA4Ps unique
mechanism of action, additionally shows CA4P's blood flow reduction activity,
i.e. proof of principle. This study, which began at the end of 1998, examined
CA4P in approximately 17 patients over a dose range of 5 to 88 mg/m(2). Blood
flow reduction was seen in all patients evaluated above 52 mg/m(2). Dose
escalation is on-going with no toxic side effects observed in patients to date.
Of interest, pain at the site of the tumor was observed in patients within two
hours of administration at doses of CA4P which clearly induce blood flow
reduction. Tumor pain was not observed in patients administered CA4P at levels
below that which induces blood flow reduction.
Interim results from one of the other two US Phase I studies will be presented
by Dr. Scot Remick, Ireland Cancer Center at Case Western Reserve University and
University Hospitals of Cleveland, on November 3rd at the Chemotherapy
Foundation Symposium in New York.
OXiGENE is an international biopharmaceutical company developing a diverse
portfolio of innovative products to combat cancer and other major diseases. The
Company's mission is to develop new therapeutics that will enhance the
effectiveness of traditional cancer treatments and to introduce therapies that
attack cancer in new ways. OXiGENE has its international corporate headquarters
in Stockholm, Sweden and its United States headquarters in Boston, MA. Please
feel free to visit the Company's Website at:
WWW.OXIGENE.COM.
The Cancer Research Campaign (CRC) is the UK leading cancer charity and is the
European leader in anti-cancer drug development. It funds around a third of all
research into cancer in the UK and is dedicated to bringing new treatments and
cures from the lab bench to the patient's bed side as quickly as possible.
Certain statements made in this press release related to clinical trial
outcomes, therapeutic applications and outcomes, governmental approvals,
potential market size and commercialization are forward-looking and are made
pursuant to the safe harbor provisions of the Securities Litigation Reform Act
of 1995. Such statements involve risks and uncertainties that may differ
materially from those set forth in these statements. In addition, the economic,
competitive, governmental, technological and other factors identified in the
Company's filings with the Securities and Exchange Commission could affect such
results.
A copy of Dr. Rustin's abstract and the Cancer Research Campaign press release
is available upon request. Please call Matthew Knight at Noonan/Russo, (+1)
212-696-4455 Ext 271.
