OXiGENE Reports Second Quarter Financial Results and Provides Progress Update
WALTHAM, Mass.--(BUSINESS WIRE)--July 25, 2007--Regulatory News:
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a clinical-stage
biopharmaceutical company developing novel therapeutics to treat
cancer and eye diseases, today reported financial results for the
quarter ended June 30, 2007 and provided an update on its oncology and
ophthalmology drug development programs.
Dr. Richard Chin, President and Chief Executive Officer of
OXiGENE, commented that, "We have made great strides in the second
quarter, including entering into a Special Protocol Assessment (SPA)
agreement with the Food and Drug Administration. This is a major
milestone for OXiGENE, and we believe it significantly enhances the
prospects for approval based on the ongoing pivotal registration study
for ZYBRESTAT(TM) in anaplastic thyroid cancer. In addition, we
executed very well against tight timelines and initiated the pivotal
registration study, with site initiation and initial patient
recruitment and screening underway less than 6 weeks after receiving
the SPA."
Accomplishments for Q2 2007
The Company indicated that it achieved a number of important
milestones during the quarter:
Clinical
Oncology:
-- Formally agreed to a Special Protocol Assessment with the U.S.
Food and Drug Administration for a pivotal registration study
of ZYBRESTAT in anaplastic thyroid cancer.
-- At the June 2007 American Society of Clinical Oncology (ASCO)
annual meeting, reported data from a Phase II study of
ZYBRESTAT in combination with paclitaxel and carboplatin in
patients with advanced imageable malignancies. This
triple-drug combination was well-tolerated and demonstrated
both anti-tumor activity, as determined by RECIST criteria, as
well as significant reductions in tumor blood-flow as assessed
by DCE-MRI imaging.
-- At the ASCO meeting, reported initial results from a Phase I
dose-escalating study of OXi4503, our novel, dual-mechanism,
vascular disrupting agent (VDA). These interim results
demonstrated that OXi4503 is well-tolerated with no
dose-limiting toxicities observed at any dose tested to date,
and that the drug appears to have biological activity, as
evidenced by reductions in tumor blood-flow as measured by PET
and DCE-MRI imaging.
Ophthalmology:
-- At the May 2007 Association for Research in Vision and
Ophthalmology (ARVO) annual meeting, presented positive
results from a Phase II study of ZYBRESTAT in patients with
myopic macular degeneration. The Company believes that these
positive results provide initial human proof-of-concept for
ZYBRESTAT in macular degeneration and other eye diseases, and
also provide support for developing a convenient and
patient-friendly topical ophthalmology formulation of the
drug.
In addition, on July 9, the Company announced the initiation of
the ZYBRESTAT pivotal registration study.
Corporate
-- Added two new Directors with relevant business, health care
and medical / regulatory experience to OXiGENE's Board of
Directors.
Financial Results
The net loss for the three months ended June 30, 2007 was $5.4
million, or $0.19 per share, compared with a net loss of $5.0 million,
or $0.18 per share, in the second quarter of 2006. For the six-month
period ended June 30, 2007, the net loss was $9.3 million, or $0.33
per share, compared to a net loss of $8.3 million, or $0.30 per share,
for the comparable period in 2006.
At June 30, 2007, OXiGENE had cash, cash equivalents and
marketable securities of approximately $38.0 million compared with
approximately $45.8 million at December 31, 2006. Cash utilization
from operations for the first six months of 2007 was approximately
$7.3 million.
Clinical Update - ZYBRESTAT
Oncology:
Anaplastic Thyroid Cancer (ATC)
ZYBRESTAT Pivotal Registration Study Initiated
The Company announced on May 31 that it had reached agreement with
the FDA on a Special Protocol Assessment for its planned pivotal
registration study with ZYBRESTAT in anaplastic thyroid cancer.
Subsequent to the end of the second quarter, the Company announced
initiation of this study, which is expected to enroll approximately
180 patients with ATC. Two-thirds of the patients will receive
intravenous ZYBRESTAT plus carboplatin and paclitaxel, and the other
third will receive carboplatin and paclitaxel alone. The primary
endpoint will be a statistically significant difference in the overall
survival rate between the two treatment arms, as determined by a
log-rank analysis of Kaplan-Meier survival curves at times when
pre-determined numbers of study events (patient deaths) are reached.
The study design incorporates a planned interim analysis for efficacy
and safety, which will be overseen by an Independent Data Monitoring
Committee. Approximately 40 clinical trial sites worldwide are
expected to participate in the study. ZYBRESTAT has been granted Fast
Track status by the FDA and Orphan Drug status by both the FDA and the
European Agency for the Evaluation of Medicinal Products (EMEA).
Non-small Cell Lung Cancer
Randomized, Controlled Phase II Study of ZYBRESTAT In Combination
with Bevacizumab (AVASTIN(R)) On Track to Begin in Fall 2007.
The Company currently plans to initiate a randomized comparative
Phase II study with ZYBRESTAT in combination with the widely utilized
anti-angiogenic drug, bevacizumab (AVASTIN) with chemotherapy, in the
second half of 2007, contingent on the final results from our ongoing
Phase I study with this combination. Scientific support for the
combination of ZYBRESTAT and anti-angiogenic drugs comes, in part,
from (i) work published by the Company's collaborators and published
in the journal Science in September 2006 (See Science 313, 1785, 2006
and the Company's press release dated September 21, 2006); and (ii)
from data emerging from the ongoing Phase Ib study of ZYBRESTAT and
bevacizumab that suggest that this drug combination is safe and
well-tolerated. The Company believes that the Phase II study, the
design of which is under review by the Company and lung cancer key
opinion leaders, will represent the first controlled clinical study of
a vascular disrupting agent in combination with an anti-angiogenic
agent.
Ovarian Cancer
Initial Data From ZYBRESTAT Phase II Ovarian Cancer Study Expected
by Year End
The Company has an ongoing Phase II study of ZYBRESTAT,
administered in combination with carboplatin and paclitaxel, in
patients with platinum-resistant ovarian cancer. This study is a
modified Simon two-stage design, and the primary endpoint is
observance of a specific number of durable responses (as determined by
RECIST criteria) in the first 18 patients. With achievement of an
adequate number of responses in the first stage of the study, the
study design provides for an expanded phase to further evaluate
efficacy. The Company currently anticipates that initial results from
the first stage of this study will be available to report by the end
of 2007.
Ophthalmology
Human Proof-of-Concept Established for ZYBRESTAT in Macular
Degeneration with Intravenous-Route Formulation; Topical Formulation
Development Program Proceeding with IND Anticipated in Q1 2008.
At the May 2007 Association for Research in Vision and
Ophthalmology (ARVO) annual meeting, investigators presented data in
poster form from a Phase II study of ZYBRESTAT in myopic macular
degeneration. All twenty-three patients receiving intravenous-route
ZYBRESTAT in this study achieved the primary endpoint, maintenance of
vision at 3 months. The Company believes these results demonstrate
human proof-of-concept for the application of ZYBRESTAT in age-related
macular degeneration and other ophthalmological diseases which are
characterized by the presence and development of abnormal vasculature
in the eye. Preliminary preclinical data suggest that topical delivery
of ZYBRESTAT to the back of the eye is feasible, and the Company is
currently working to develop a convenient and patient-friendly topical
ophthalmology formulation of ZYBRESTAT suitable for broad use in
age-related macular degeneration (AMD), diabetic retinopathy and other
eye diseases. Importantly, the Company believes a topical formulation
of ZYBRESTAT would be compatible with and complementary to current
intravitreal-route, anti-VEGF therapies and has the potential to
deliver substantial clinical benefits to patients by (i) prolonging
the interval between administration of anti-VEGF drugs via
intravitreal injections; and (ii) providing a prophylactic treatment
alternative for certain AMD patients who may not be candidates for
treatment of intravitreal-route anti-VEGF drugs yet are at risk for
loss of vision. OXiGENE expects to report preclinical biodistribution
and pharmacokinetic data for a potential topical formulation of
ZYBRESTAT in the second half of 2007, and the Company currently
anticipates filing an IND by the first quarter of 2008 for a topical
formulation of ZYBRESTAT for use in the treatment of AMD.
AMD is a leading cause of blindness in people over 55 years of
age. According to the U.S. National Institute of Health's National Eye
Institute, the disease currently affects approximately 1.5% of the
adult population in the U.S. over age 40, or 1.75 million people; this
figure is projected to nearly double to 3 million people by the year
2020 as a result of the population aging.
Clinical Update - OXi4503
The Phase I, dose-escalation study of OXi4503, our novel,
dual-mechanism, vascular disrupting agent (VDA), continues. Interim
results reported at the June ASCO meeting demonstrated that OXi4503 is
well-tolerated, with no dose-limiting toxicities observed to date in
the study. Observed reductions in tumor blood-flow, as measured by PET
and DCE-MRI imaging, provide evidence of biological activity, and
escalation to higher doses will continue, per the protocol, until a
maximum tolerated dose is identified. In collaboration with
investigators and clinical / scientific advisors, the Company is
developing a protocol to evaluate OXi4503 in combination with
bevacizumab in solid tumor patients. The Company anticipates that this
study will be an open-label, dose escalation study with a two-arm dose
expansion phase to assess the safety, tolerability, biological and
anti-tumor activity of the combination in subjects with advanced solid
tumors.
Planned Events for second half of 2007
-- Initiate a Phase II study of ZYBRESTAT in combination with
bevacizumab in non-small cell lung cancer and chemotherapy.
-- Announce initial results from our ongoing Phase I
dose-escalation study of OXi4503 in patients with advanced
solid tumors.
-- Announce initial results from our ongoing Phase Ib study of
ZYBRESTAT in combination with bevacizumab in patients with
advanced solid tumors.
-- Announce initial data from the first stage of Phase II study
of ZYBRESTAT in ovarian cancer.
-- Announce preclinical biodistribution and pharmacokinetic data
for a topical ophthalmological formulation of ZYBRESTAT in
2007.
Planned Events for first half of 2008
-- Initiate Phase I study with ZYBRESTAT for age-related macular
degeneration by early 2008.
About OXiGENE, Inc.
OXiGENE is a clinical-stage biotechnology company developing novel
small-molecule therapeutics to treat cancer and eye diseases. The
Company's major focus is the clinical advancement of drug candidates
that selectively disrupt abnormal blood vessels associated with solid
tumor progression and visual impairment. OXiGENE is dedicated to
leveraging its intellectual property position and therapeutic
development expertise to bring life saving 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,
including with respect to the timing and results of its clinical
trials involving ZYBRESTAT and OXi4503, 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.
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 Form 10-Q, 8-K and 10-K
reports. 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, 2006 for a description of these
risks.
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OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in 000's)
(Unaudited)
June December
30, 31,
2007 2006
------- --------
Assets
Cash, cash equivalents and marketable securities $38,042 $45,839
Licensing agreement 727 777
Other assets 1,886 1,026
------- --------
Total assets $40,655 $47,642 ======= ========
Liabilities and stockholders' equity
Accounts payable and accrued liabilities $ 5,447 $ 4,222
Total stockholders' equity 35,208 43,420
------- --------
Total liabilities and stockholders' equity $40,655 $47,642
======= ========
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OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in 000's except per share amounts)
(Unaudited)
Three months Six months ended
ended
----------------- ------------------
June 30, June 30,
---------------- ------------------
2007 2006 2007 2006
-------- -------- --------- --------
License revenue $ 7 $ - $ 7 $ -
Costs and expenses:
Research and development 3,502 3,275 5,891 5,596
General and administrative 2,380 2,337 4,504 3,958
-------- -------- --------- --------
Total costs and expenses: 5,882 5,612 10,395 9,554
Operating loss (5,875) (5,612) (10,388) (9,554)
-------- -------- --------- --------
Investment income 523 639 1,094 1,250
Other (expense) income, net (17) (22) (24) (28)
-------- -------- --------- --------
Net loss $(5,369) $(4,995) $ (9,318) $(8,332)
======== ======== ========= ========
Basic and diluted net loss per
common share $ (0.19) $ (0.18) $ (0.33) $ (0.30)
Weighted average number of common
shares outstanding 27,875 27,519 27,875 27,518
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CONTACT: OXiGENE, Inc.
Shari Annes, 650-888-0902
or
Investor Relations, 781-547-5900
OXiGENE Reports Second Quarter Financial Results and Provides Progress Update
| Source: Oxigene, Inc.
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