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: September 21, 1998
(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 September 21, 1998, the Registrant issued a press release, a copy of
which is attached hereto as Exhibit 99.1, providing a clinical development
update on Neu-Sensamide(TM).
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(c) Exhibits.
99.1 Press release of the Registrant, dated September 21, 1998.
<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: September 24, 1998 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 September 21, 1998.
OXiGENE PROVIDES CLINICAL DEVELOPMENT UPDATE ON NEU-SENSAMIDE(TM)
-Phase III NSCLC Protocol Amended to Focus on Squamous Cell Carcinoma-
Boston, MA and Lund, Sweden, September 21, 1998 - OXiGENE, Inc. (Nasdaq:
OXGN, SSE: OXGN), an international biopharmaceutical company, today announced
clinical development plans for Neu-Sensamide(TM), including an amendment of the
Company's Phase III clinical trial protocol in non-small cell lung cancer
(NSCLC). Neu-Sensamide, a potential radiosensitizer for the treatment of cancer,
is currently undergoing clinical trials in the U.S. and Europe.
The Phase III clinical trial was designed to study the efficacy of
Neu-Sensamide in combination with radiation therapy in patients with NSCLC. The
Company, in cooperation with its clinical investigators, has now amended the
Phase III protocol to reflect findings from a Phase II/III study of
Sensamide(TM), a prototype compound. This data showed that on an intention to
treat basis, there was no difference in survival or tumor response between
patients receiving radiation alone and those receiving radiation and Sensamide.
However, as previously reported, investigators identified a patient
sub-group--those with squamous cell carcinoma, a common form of lung cancer--for
whom Neu-Sensamide in combination with radiation is expected to have efficacy.
Based on these findings, future patient enrollment in the Phase III
Neu-Sensamide trial will now target NSCLC patients with squamous cell carcinoma,
and the total number of patients enrolled in the trial will be expanded from 220
to 350 to accommodate this new focus. In addition, due to the fact that today's
standard therapy in the U.S. for NSCLC combines radiation and chemotherapy, the
Company has decided not to continue recruiting patients in the U.S. for the
Phase III trial and to focus instead on the Company's ongoing Phase II studies
where radiation is combined with chemotherapy and Neu-Sensamide.
Bjorn Nordenvall, Chairman, President and Chief Executive Officer of
OXiGENE, commented, "Our decision to focus our Neu-Sensamide Phase III trial on
the patient sub-group that is expected to benefit most from this treatment will
put us in a better position to move the clinical development of our product
forward."
He continued, "In addition to the ongoing Phase III trial, we are advancing
three other Neu-Sensamide clinical trials--two Phase II trials in NSCLC, and a
Phase I trial in glioblastoma, a highly malignant form of brain cancer. Our new
generation sensitizer, OXi-104, is progressing positively through our Phase I/II
clinical trials, in combination with chemotherapy in patients with advanced
stage cancers."
Clinical investigators will present fully analyzed data from the Phase
II/III study of Sensamide at the European Society for Therapeutic Radiology and
Oncology (ESTRO) meeting in Edinburgh, Scotland this week.
OXiGENE is an international biopharmaceutical company developing a diverse
portfolio of innovative products to combat cancer and other major diseases. The
Company currently has four products in clinical development, including
Neu-Sensamide, being tested as a radiosensitizer in Phase II and III studies in
patients with non-small cell lung cancer and in a Phase I study in patients with
glioblastoma; OXi-104 (declopramide), being tested as a chemosensitizer in Phase
I/II studies in patients with advanced stage cancers; Cordycepin, which is in a
Phase I/II study in patients with TdT-positive leukemia; and Combretastatin A-4
prodrug, a tumor vascular targeting agent expected to enter Phase I/II studies
in the second half of 1998.
This press release contains forward-looking statements that 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.
