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: April 5, 2000
(Date of earliest event reported)
OXiGENE, INC.
(Exact name of registrant as specified in its charter)
Delaware 000-21990 13-3679168
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(State or other jurisdiction Commission File Number) (IRS Employer
of incorporation) 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 April 5, 2000, the Registrant issued a press release, a copy of
which is attached hereto as Exhibit 99.1, announcing clinical results regarding
its lead tumor vascular targeting agent, Combretastatin A4 Prodrug, as presented
at the 91st Annual meeting of the Amercian Association for Cancer Research.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(c) Exhibits.
99.1 Press release of the Registrant, dated April 5, 2000.
<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: April 6, 2000 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 April 5, 2000.
OXIGENE ANNOUNCES PROMISING CLINICAL RESULTS FOR LEAD TUMOR VASCULAR
TARGETING AGENT, COMBRETASTATIN A4 PRODRUG
Presentation at American Association for Cancer Research
Boston, MA and Stockholm, Sweden, April 5, 2000 -- OXiGENE, Inc. (Nasdaq: OXGN,
SSE: OXGN) announced at the 91st Annual meeting of the American Association for
Cancer Research (AACR), promising preliminary results of its University of
Pennsylvania Cancer Center Phase I clinical trial of the Company's lead tumor
vascular targeting anti-angiogenic product candidate, Combretastatin A4 Prodrug
(CA4P), currently being evaluated for the treatment of patients with advanced
cancer. CA4P, licensed to Bristol-Myers Squibb Company in December of last year,
is the first of a new class of anti-cancer therapies that acts by directly
reducing tumor blood supply. CA4P is different from angiogenic inhibitors now in
clinical development in that it attacks existent tumor vasculature as well as
inhibits the formation of new tumor vasculature.
The clinical trial reported on today is the third in a series of three Phase I
evaluations conducted to examine the safety and dosing profile of CA4P in
patients with advanced solid tumors. This most recent trial highlights the
results of 27 evaluable patients with advanced solid tumors. Under the trial
protocol, all patients were given CA4P daily for five days, every 21 days.
Results show that CA4P was well tolerated at all dose levels up to at least 56
mg/m2. At dose levels above 42 mg/m2, reduction in tumor blood flow was observed
through serial MRI measurement, similar for observations seen in the other Phase
I clinical trials. In addition, 10 out of 27 patients showed stable disease for
3-8 cycles (1 cycle = 21 days). Two of these patients have shown stable disease
for at least 7 cycles.
Preliminary data was previously reported for the first two trials in this
evaluation series. Previous preliminary data sets showed that CA4P had an
acceptable safety profile and was able to significantly reduce blood to tumors.
This result was observed when the drug was given either once a month, as carried
out at the Ireland Cancer Center at Case Western Reserve University and
University Hospitals of Cleveland, Cleveland, Ohio, or three times a month as
carried out at the Cancer Research Campaign, London England.
"We believe this drug shows promise in treating cancer and we look forward to
Phase II clinical investigation," said Peter J. O'Dwyer, M.D., Professor of
Medicine at the University of Pennsylvania Cancer Center, Department of
Medicine, Division of Hematology/Oncology, Philadelphia, PA, the study's
principal investigator. Based on these results, and those of OXiGENE's other two
Phase I clinical trials for CA4P, OXiGENE and its development partner,
Bristol-Myers Squibb, plan to initiate further clinical trials to advance the
commercial development of CA4P.
"Results from this clinical trial show that CA4P can also be safely administered
to patients on a daily schedule at a dose which has previously been shown to
exert clinical effect," said Bjorn Nordenvall, M.D., Ph.D., Chairman and Chief
Executive Officer of OXiGENE, Inc. "Based on these, and other positive clinical
data, OXiGENE and Bristol-Myers Squibb will work together in the continued
evaluation of this promising drug candidate in an effort to ensure that its
therapeutic potential is realized as soon as possible."
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 be a world leader in
vascular targeting for cancer and other diseases involving aberrant
neovasculature. OXiGENE has offices in Stockholm, Sweden and Boston, MA.
Certain statements made in this press release related to ongoing clinical
studies, efficacy of the Company's CA4P and the possible commercialization
thereof, as well as the possible success of the Company's business and its
technology goals 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 cause the Company's actual results or
outcomes to be materially different from those anticipated and discussed in this
press release. Factors that may cause such a difference include, but are not
limited to, those risks and uncertainties associated with the regulatory
approval of the Company's proprietary drugs, and other risks included in the
Company's Annual Report on Form 10-K and in the Company's other filings with the
Securities and Exchange Commission during the past 12 months.
Visit OXiGENE's website at: http://www.oxigene.com
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