OXiGENE Reports First Quarter Operational and Financial Results
-- Company Continues to Achieve Regulatory and Clinical Milestones On or Ahead
of Planned Timelines
-- Company Continues to Work with the U.S. Food and Drug Administration to Come
to Agreement on Phase III Protocol for Anaplastic Thyroid Cancer
-- Company In-Licenses Preclinical Molecule Targeting B-Cells
WALTHAM, Mass.--(BUSINESS WIRE)--April 25, 2007--Regulatory News:
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a clinical-stage
biotechnology company developing novel therapeutics to treat cancer
and eye diseases, today reported operational and financial results for
the first quarter ended March 31, 2007.
Dr. Richard Chin, President and Chief Executive Officer of OXiGENE
commented that, "Vascular disrupting agents (VDAs) are an important
and valuable new class of drug in development for the treatment of
cancer and certain ophthalmologic conditions. We believe our lead drug
candidate, ZYBRESTAT(TM), which we previously referred to as CA4P, has
the potential to become the first VDA to reach the market. We are
making very good progress on our studies and are working to initiate
what we expect to be our pivotal Phase III registration study in
anaplastic thyroid cancer later this quarter."
Accomplishments for Q1 2007
The Company indicated that it has achieved many of its set
milestones on or ahead of schedule:
Clinical:
-- Positive results from Phase II ZYBRESTAT(TM) (CA4P) clinical
trial in myopic macular degeneration (MMD-213); and
-- Positive discussions with the U.S. Food and Drug
Administration regarding a protocol for ZYBRESTAT(TM) in a
Phase III Pivotal Trial in Anaplastic Thyroid Cancer.
Ophthalmology Formulation Development:
-- Initiated studies of ZYBRESTAT(TM) evaluating topical
formulations with results expected in the second half of 2007.
Business:
-- Executed a license for worldwide development and
commercialization of a preclinical molecule targeting B-cells
from Intracel, a privately-held company.
Organizational:
-- Appointment of John Kollins as Senior Vice President and Chief
Business Officer.
Financial Results
The net loss for the three months ended March 31, 2007 was $3.9
million, or $0.14 per share, compared with a net loss of $3.3 million,
or $0.12 per share, in the first quarter of 2006.
At March 31, 2007, OXiGENE had cash, cash equivalents and
marketable securities of approximately $42.2 million compared with
approximately $45.8 million at December 31, 2006.
Cash utilization from operations for the first quarter of 2007 was
approximately $3.6 million.
Clinical Update - ZYBRESTAT(TM)
Oncology
Anaplastic Thyroid Cancer
The Company is currently working closely with the FDA to come to
agreement on the Phase III protocol in anaplastic thyroid cancer. The
Company is currently planning a randomized, Phase III clinical trial
that is expected to enroll approximately 180 patients with ATC,
two-thirds of whom will receive intravenous ZYBRESTAT(TM) plus
carboplatin and paclitaxel, and the other third of whom 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 will be
overseen by an Independent Data Monitoring Committee. The Company
currently anticipates enrollment of the first patients later this
quarter. Approximately 45 clinical trial sites worldwide are expected
to participate in the study. ZYBRESTAT(TM) has received fast-track
designation by the FDA and has also been granted orphan drug status in
both the United States and Europe for ATC.
Non-small Cell Lung Cancer
The Company is planning to initiate a Phase II study with
ZYBRESTAT(TM) in combination with an antiangiogenic agent in the
second half of 2007. This study will include bevacizumab (Avastin(R))
based, in part, on OXiGENE's preclinical research in this area. The
detailed design of the protocol is under review with various lung
cancer key opinion leaders.
Ovarian Cancer
The Company has a Phase II study in platinum-resistant ovarian
cancer, running in the United Kingdom at a number of sites. This study
is a modified Simon two-stage design which hopes to capture a specific
number of responses in the first 18 patients. With an adequate number
of responses, the study allows for an expanded phase to further
evaluate the efficacy. It is likely that the first part will complete
recruitment in the second half of this year.
Ophthalmology
The Company also noted the results of its MMD-213 study in which
100% of the twenty-three patients receiving ZYBRESTAT(TM) in this
study achieved the primary endpoint, maintenance of vision at 3
months. Dr. Chin commented that, "We believe these results provide
evidence of human proof-of-concept for the application of
ZYBRESTAT(TM) in macular degeneration, since it has been observed that
drugs that work in AMD appear to work in MMD and vice versa. Our
ophthalmology program continues to progress well, and we are working
to develop a topical eye drop formulation of ZYBRESTAT(TM)." The
Company anticipates an IND filing for ZYBRESTAT(TM) in the treatment
of AMD by the first quarter of 2008.
Clinical Update - OXi4503
The Company is progressing in the development of its protocol to
study its product candidate OXi4503 in combination with bevacizumab in
solid tumors. This study is expected to be an open-label dose
escalation study with a two arm dose expansion phase to assess the
safety, tolerability, biological and antitumor activity of the
combination in subjects with advanced solid tumors. OXiGENE expects to
finalize the protocol soon and to submit the protocol for IRB and
regulatory approval this quarter. The Company anticipates having the
first patient enrolled shortly after mid-year 2007.
Pre-Clinical Update - ZYBRESTAT(TM)
Ophthalmology
OXiGENE has initiated studies evaluating topical formulations of
ZYBRESTAT(TM) with results expected in the second half of 2007.
Pre-Clinical Update - OXi4503
The Company continues to further investigate the dual mechanism of
action of OXi4503 and how to optimize its therapeutic potential.
Studies are underway and have provided very encouraging data
particularly in combination with already approved antiangiogenic
approaches. Dr. Dai Chaplin, Chief Scientific Officer, commented, "We
anticipate more presentations on this exciting treatment combination
as we move through 2007. We are also supporting our clinical programs
by determining the most relevant biomarkers of treatment response. A
central part of the biomarker research is focused around the release
of circulating endothelial cell progenitor cells observed following
OXi4503 treatment."
Baylor Collaboration
OXiGENE is continuing its drug discovery collaboration with Baylor
University. The Company intends to have one early development
candidate out of the Baylor initiative by year end and is already
encouraged by the early data emerging from this program.
Antibody
The Company has executed a license agreement with Intracel, a
privately-held company, for worldwide development and
commercialization of a preclinical molecule targeting B-cells. This is
a fully human antibody that the Company believes has the potential to
be a best-in-class molecule. OXiGENE has already initiated development
of this molecule, with the goal of filing an IND by the end of 2009.
Planned Events for 2007
-- Presentation of MMD-213 results at the 47th Annual Meeting of
the Association of Research in Vision and Ophthalmology (ARVO)
in Fort Lauderdale, FL on May 7, 2007 by David M. Brown MD
FACS, MS Benz and Tien P. Wong MD of The Methodist Hospital,
Houston, TX. The abstract may be viewed at www.arvo.org;
-- Enrollment of the first ATC patient into Phase III
ZYBRESTAT(TM) trial later this quarter;
-- Initiate a Phase II ZYBRESTAT(TM) study in combination with
bevacizumab in non-small cell lung cancer;
-- Presentation of data from ongoing Phase I study of OXi4503 at
the American Society of Clinical Oncology in Chicago in June
2007;
-- Initiate a study with OXi4503 in solid tumors in combination
with bevacizumab in third quarter, 2007; and
-- Initiate Phase I study with ZYBRESTAT(TM) (CA4P) for
age-related macular degeneration by early 2008.
Dr. Peter Harris, Chief Medical Officer, commented that, "OXiGENE
will continue to build on our successful pre-IND meetings for both our
oncology program in anaplastic thyroid cancer and new formulations for
ZYBRESTAT(TM). We shall continue to learn more about our compounds
mechanistically to ensure that the clinical development program has
the best possible chance for success."
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 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.
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in 000's)
(Unaudited)
March 31, December 31,
2007 2006
---------- -------------
Assets
Cash, cash equivalents and marketable
securities $42,229 $45,839
Licensing agreement 752 777
Other assets 951 1,026
---------- -------------
Total assets $43,932 $47,642
========== =============
Liabilities and stockholders' equity
Accounts payable and accrued liabilities $3,907 $4,222
Total stockholders' equity 40,025 43,420
---------- -------------
Total liabilities and stockholders' equity $43,932 $47,642
========== =============
OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in 000's except per share amounts)
(Unaudited)
Three months ended
-------------------
March 31,
-------------------
2007 2006
---------- --------
Costs and expenses:
Research and development $2,389 $2,321
General and administrative 2,124 1,621
---------- --------
Total costs and expenses: 4,513 3,942
Operating loss (4,513) (3,942)
---------- --------
Investment income 572 612
Other expense, net (8) (6)
---------- --------
Net loss $(3,949) $(3,336)
========== ========
Basic and diluted net loss per common share $ (0.14) $(0.12)
Weighted average number of common shares
outstanding 27,875 27,517
CONTACT:
OXiGENE, Inc.
Investor Relations, 781-547-5900
OXiGENE Reports First Quarter Operational and Financial Results
| Source: Oxigene, Inc.
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