UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 1, 2015
OXiGENE, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
0-21990 |
13-3679168 |
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| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
701 Gateway Boulevard, Suite 210, South San Francisco, CA |
94080 |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (650) 635-7000
________________________________________________________________________________
(Former name or former address, if changed since last report)
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |
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| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |
Item 8.01. Other Events.
On June 1, 2015 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit 99.1. Press release dated June 1, 2015
SIGNATURES
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 hereunto duly authorized.
| OXiGENE, Inc. |
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| Date: June 1, 2015 | By: | /s/ DR. WILLIAM D. SCHWIETERMAN Dr. William D. Schwieterman Chief Executive Officer |
EXHIBIT 99.1
SOUTH SAN FRANCISCO, Calif., June 1, 2015 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing novel therapies for the treatment of cancer, today provided an update on recent discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a proposed Phase 3 trial of fosbretabulin in combination with bevacizumab in patients with platinum-resistant ovarian cancer.
"We are extremely pleased by the agency's support for advancing to a Phase 3 trial and their guidance in defining a registration pathway for fosbretabulin in platinum-resistant ovarian cancer," said Bill Schwieterman, M.D., OXiGENE's President and CEO. "Patients with this advanced form of ovarian cancer have limited treatment options, and there are no currently approved treatment regimens that avoid the adverse effects associated with standard chemotherapy. We believe that an anti-vascular regimen could offer a new paradigm of treatment and an important addition to the available therapies for advanced ovarian cancer. Our strategy is now to prepare a full protocol for a three-arm Phase 3 trial and to pursue a SPA while we simultaneously explore funding and partnering opportunities for this promising program."
The proposed Phase 3 trial is based on the results of the GOG186I study in which the anti-vascular combination of fosbretabulin and bevacizumab showed statistically significant improvements in PFS compared to bevacizumab alone as defined by the statistical analysis plan. The benefits appeared to be particularly robust in a subset of patients with platinum-resistant disease where a post-hoc subgroup analysis of the study showed that patients who were platinum-resistant had a median PFS of 6.7 months when treated with bevacizumab and fosbretabulin compared to 3.4 months for those receiving bevacizumab alone.
In the U.S., approximately 22,000 women are diagnosed with ovarian cancer each year, of which 4,300 are resistant to platinum-based therapies. Many patients who are platinum-resistant have already experienced multiple cycles of conventional chemotherapy, and suffer from significant side effects. As the first potential non-chemotherapeutic regimen for platinum-resistant ovarian cancer, OXiGENE believes the combination of fosbretabulin and bevacizumab has the potential to avoid the side effects of standard chemotherapy and provide a more convenient dosing regimen.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapies for treatment of cancer. The company is focused on developing vascular disrupting agents (VDAs), which are compounds that selectively disrupt abnormal blood vessels associated with tumor survival and progression. The company's lead clinical product candidate, fosbretabulin, is in development as a potential treatment for solid tumors. OXi4503, its second product candidate, is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
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 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, 2014.
CONTACT: Investor and Media Contact:
ir@oxigene.com
650-635-7000