OXiGENE Announces Initiation of Phase 1b/2 Clinical Trial of OXi4503 in Acute Myeloid Leukemia
October 21 2015 - 4:15PM
- First patient dosed in OXiGENE-sponsored expansion of
investigator trial
- Phase 1b/2 dose-escalation study of OXi4503 as a single agent
and in combination with cytarabine
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing
vascular disrupting agents (VDAs) for the treatment of cancer,
today announced that it has initiated a phase 1b/2 clinical trial
(Study OX1222) of its investigational drug OXi4503 for treatment of
acute myeloid leukemia (AML). OXi4503, which has shown significant
activity in preclinical studies of AML, is a novel VDA that is
designed to reduce blood flow to tumors and to prevent cancer cells
from replicating.
Study OX1222 is a continuation and expansion of a phase 1 single
site clinical trial of OXi4503 conducted by the University of
Florida (UF) with support from the Leukemia & Lymphoma Society.
OXiGENE is expanding upon the UF study to speed collection of
additional safety and efficacy data and to obtain clinical data for
OXi4503 in combination with cytarabine, which is an approved
treatment for AML.
"OXi4503 is a promising new investigational drug for patients
with Myelodysplastic Syndromes and Acute Myeloid Leukemia," stated
Christopher R. Cogle, M.D., Associate Professor of Medicine,
University of Florida, and the principal investigator of the study.
"Blood vessels are hiding spots for these diseases. OXi4503 is a
first-in-class drug that rouses sleeping leukemia cells from
vascular beds and primes leukemia cells to cytarabine
chemotherapy."
The American Cancer Society estimates that there are
approximately 21,000 patients diagnosed with AML each year.
About Study OX1222
Study OX1222 is currently enrolling patients with relapsed or
refractory AML or with Myelodysplastic Syndromes (MDS), and will
study the safety and efficacy of OXi4503 administered weekly. The
study is designed to enroll up to 27 patients in phase 1b and up to
78 patients in phase 2 stage. The objectives of the study are to
determine the maximum tolerated dose of OXi4503 both as a single
agent and as part of combination therapy with intermediate-dose
cytarabine chemotherapy, and to collect efficacy data as determined
by the overall response rate. Data from both the open-label
monotherapy and combination stages of the study are expected in
2016.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing
vascular disrupting agents (VDAs) to treat cancer. VDAs selectively
disrupt abnormal blood vessels that sustain tumors. The company's
investigational drugs include CA4P (fosbretabulin), which is in
development as a treatment for solid tumors, and OXi4503, which 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, data
and regulatory guidance relative to our clinical programs and
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, manufacturing and regulatory
review, and the availability of additional financing to pursue and
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