Final Data Presentation Shows 25% Confirmed Response Rate in Relapsed Patient
Population
WALTHAM, Mass., June 1, 2009 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN)
(Stockholm:OXGN), a clinical-stage, biopharmaceutical company developing novel
therapeutics to treat cancer and eye diseases, announced today that Professor
Gordon Rustin and colleagues from the Mount Vernon Cancer Research Centre, UK
and other institutions in the United Kingdom, reported positive final data from
the investigator-sponsored Phase 2 study, conducted in collaboration with
OXiGENE, of ZYBRESTAT in patients with platinum-resistant ovarian cancer at the
2009 Annual Meeting of the American Society of Clinical Oncology (ASCO). Of 44
patients enrolled in the study, 11 (25%) had confirmed partial responses as
determined by the Gynecological Cancer InterGroup (GCIG) response criteria,
i.e., response by tumor imaging (RECIST) and/or ovarian cancer biomarker
(CA-125) criteria. An additional 4 patients had unconfirmed partial responses,
and stable disease responses were reported in an additional 16 patients. The
combination regimen of ZYBRESTAT and carboplatin plus paclitaxel chemotherapy
was observed to be well-tolerated with approximately half of the patients
completing all 6 cycles of therapy. The Phase 2 trial was a single-arm, Simon
two-stage design study evaluating the safety and efficacy of the combination of
ZYBRESTAT and chemotherapy (carboplatin and paclitaxel). Dr. Martin Zweifel of
the Mount Vernon Cancer Centre, UK, who presented the study results, was
awarded a Merit Award by the ASCO Scientific Program Committee in recognition
of an outstanding abstract submission.
"The results of this Phase 2 study suggest clinical benefit to women with
ovarian cancer who had been pretreated with chemotherapy, and whose disease was
resistant to platinum-based therapy. The overall response rate of 25%, plus an
additional 11% of patients with unconfirmed RECIST responses, and the
observation of clinical benefit in additional patients who were not evaluable
by RECIST or CA-125 criteria, are highly encouraging results in a patient
population with few remaining therapeutic alternatives. These data appear to
strongly support further evaluation of ZYBRESTAT in patients with ovarian
cancer in randomized-controlled trials," commented Professor Rustin the
principal investigator of the study and an internationally recognized expert in
the management of gynecological malignancies.
"We believe that these favorable Phase 2 data, taken together with previously
reported results from clinical studies in anaplastic thyroid cancer and other
solid tumor types, provide further support for ZYBRESTAT as a highly-active
anti-vascular therapy with potentially broad therapeutic utility against a
variety of cancers," commented John A. Kollins, Chief Executive Officer at
OXiGENE. "We believe these results further strengthen the position of ZYBRESTAT
as a leading drug candidate in the vascular disrupting agent field."
ZYBRESTAT Phase 2 Platinum-Resistant Ovarian Cancer Study
The data reported today were presented in an oral session titled,
"Combretastatin A4 phosphate (CA4P, fosbretabulin) carboplatin and paclitaxel
in patients with platinum-resistant ovarian cancer: final phase II trial
results." The results are based on analysis of 44 patients enrolled in the
Phase 2 trial. Prior to enrollment in the study, patients had received between
1 and 7 prior lines of chemotherapy and were confirmed to have
platinum-resistant ovarian cancer. Platinum resistance was defined as disease
relapse within 6 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 administered 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. In contrast
with other ongoing ZYBRESTAT clinical studies, in this study ZYBRESTAT was not
administered to patients as a maintenance therapy following completion of the
chemotherapy regimen.
Results showed that, of those patients that had either a partial response per
GCIG criteria or stable disease:
* 5 patients had partial responses confirmed by both RECIST and
CA-125;
* 1 patient had a partial response by RECIST, but could not be
evaluated by CA-125;
* 2 patients had stable disease by RECIST and partial response by
CA-125;
* 3 patients had a partial response by CA-125 but were not evaluable
by CT;
* 4 patients had a partial response by CT, but were not confirmed
by repeat scan or CA-125;
* 16 patients had stable disease as a best response.
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).
Conclusions of the study were:
* The infusion of ZYBRESTAT at least 18 hours prior to standard
doses of paclitaxel and carboplatin was well tolerated;
* Myelosuppression was within the range expected from chemotherapy
with paclitaxel and carboplatin alone;
* Cardiac toxicity was minimal with hypertension of short duration
being easily controlled by glyceryl trinitrate or premedication
with amlodipine;
* A response rate of 25% (11/44) in a platinum resistant population
is encouraging;
* An additional 11% (5/44) of patients had unconfirmed responses on
CT (RECIST) or dramatic clinical benefit, and
* The results of the study suggest randomized trials including
ZYBRESTAT should be performed in patients with ovarian cancer.
A copy of the ASCO presentation is available on OXiGENE's website at
www.oxigene.com.
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). A Phase II study in platinum-resistant ovarian cancer has
been completed and a non-small cell lung cancer study combining fosbretabulin
with bevacizumab and platinum based chemotherapy is 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.
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.
The OXiGENE, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4969
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 2009. 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, 2008.
CONTACT: OXiGENE, Inc.
Investor and Media Contact:
Investor Relations
Michelle Edwards
650-635-7006
medwards@oxigene.com
OXiGENE Reports Positive Data From Phase 2 Trial of ZYBRESTAT in Platinum Resistant Ovarian Cancer At the 2009 ASCO Annual Meeting
| Source: Oxigene, Inc.