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OXiGENE Reports Positive Phase 2 Interim Results in Platinum-Resistant Ovarian
Cancer for Lead Vascular Disrupting Agent, ZYBRESTAT™
Data Showing Clinical Activity and Tolerability Presented at 12th Biennial
Meeting of the International Gynecologic Cancer Society
WALTHAM, MA -- October 27, 2008 -- OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a
clinical-stage, biopharmaceutical company developing novel therapeutics to treat
cancer and eye diseases, reported positive interim results from an ongoing phase
2 study of ZYBRESTAT in patients with platinum-resistant ovarian cancer. Ten of
34 evaluable patients (29%) enrolled to date in the ongoing, single-arm, Simon
two-stage design study evaluating the combination of ZYBRESTAT and chemotherapy
(carboplatin and paclitaxel) had partial responses as measured by tumor imaging
(RECIST) and/or ovarian cancer biomarker (CA-125) criteria. An additional
unconfirmed partial response was observed in a patient lost to follow up, and
stable disease responses were observed in an additional nine patients. The
combination regimen of ZYBRESTAT and chemotherapy was observed to be well
tolerated.
“The results of this study in patients resistant to platinum-based therapy are
highly encouraging and support further evaluation of ZYBRESTAT in patients with
ovarian cancer,” commented Professor Gordon Rustin, of Cancer Research UK.
Professor Rustin, who presented the data at the 12th Biennial Meeting of the
International Gynecologic Cancer Society in Bangkok, Thailand, is the principal
investigator of the study and an internationally recognized expert in the
management of gynecological malignancies.
“The data presented are consistent with the overall results we have seen in
approximately 350 patients to date indicating that ZYBRESTAT appears to be
well-tolerated and has clinical activity against a variety of tumor types,
including difficult-to-treat malignancies such as platinum-resistant ovarian
cancer and anaplastic thyroid cancer,” commented Patricia Walicke, M.D., Ph.D.,
Chief Medical Officer at OXiGENE. “Moreover, the results presented are
consistent with preclinical data from ovarian cancer xenograft models suggesting
ZYBRESTAT may restore platinum-sensitivity to platinum-resistant tumors by
necrosing the tumor core, an area within a tumor thought to become most
resistant to chemotherapeutic agents such as platinum therapeutics.”
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ZYBRESTAT Phase 2 Platinum-Resistant Ovarian Cancer Study
Data reported are based on a preliminary analysis of 34 evaluable patients
enrolled to date in the phase 2 trial. Per the study design, total enrollment
in the trial is anticipated to be 43 patients. Patients in the study had
received between one and seven prior lines of chemotherapy and were confirmed to
have platinum-resistant ovarian cancer. Platinum resistance is defined as
disease relapse within six months of completing treatment with platinum-based
therapy, and the patients enrolled in the study would therefore not be expected
to respond to further treatment with platinum-based therapy.
Patients in the study were given a 10-minute infusion of ZYBRESTAT, followed by
standard doses of carboplatin and paclitaxel within 18-22 hours. This
combination was repeated every 3 weeks for up to 6 cycles. The combination
regimen of ZYBRESTAT, carboplatin and paclitaxel appeared to be well-tolerated,
with the most frequently reported side-effects being transient nausea, fatigue
and tumor pain (predominately grade 1 and 2).
In December 2007, OXiGENE reported that the study met the primary efficacy
endpoint of Stage 1 of the Simon two-stage study. In the first stage, 5 of the
18 patients responded to ZYBRESTAT (i.e., achieved a partial response per RECIST
and/or ovarian cancer biomarker (CA-125) criteria). Twenty-five patients are
expected to be enrolled in the second stage of the study. The company expects
final data from this study in the first half of 2009.
About ZYBRESTAT
ZYBRESTAT (fosbretabulin) is currently being evaluated in a pivotal registration
study as a potential treatment for anaplastic thyroid cancer (ATC) under a
Special Protocol Assessment agreement with the U.S. Food and Drug Administration
(FDA). Phase II studies in platinum-resistant ovarian cancer and non-small cell
lung cancer are also ongoing. OXiGENE believes that ZYBRESTAT is poised to
become the first therapeutic product in a novel class of small-molecule drug
candidates called vascular disrupting agents (VDAs). Through interaction with
vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively targets
and collapses tumor vasculature, thereby depriving the tumor of oxygen and
causing death of tumor cells. In clinical studies in solid tumors, ZYBRESTAT
has demonstrated potent and selective activity against tumor vasculature, as
well as clinical activity against ATC, ovarian cancer, and various other solid
tumors. In clinical studies in patients with forms of macular degeneration,
intravenously-administered ZYBRESTAT has demonstrated clinical activity, and the
Company is working to develop a convenient and patient-friendly topical
formulation of ZYBRESTAT for ophthalmological indications.
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About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel
therapeutics to treat cancer and eye diseases. The company's major focus is
developing VDAs that selectively disrupt abnormal blood vessels associated with
solid tumor progression and visual impairment. OXiGENE is dedicated to
leveraging its intellectual property and
therapeutic development expertise to bring life-extending and -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 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, enrollment rate for patients in the ZYBRESTAT pivotal trial for
anaplastic thyroid cancer, interim analysis of the same, timing of the IND
filing and Phase I trial initiation for topical ZYBRESTAT, timing of a Phase II
clinical trial of ZYBRESTAT and bevacizumab in NSCLC, timing or execution of a
strategic collaboration on any product or indication, and cash utilization rates
for 2008. 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, 2007.
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OXiGENE Reports Positive Phase 2 Interim Results in Platinum-Resistant Ovarian Cancer for Lead Vascular Disrupting Agent, ZYBRESTAT™
| Source: Oxigene, Inc.