Mateon Announces Presentation of OXi4503 AML Study Data at 58th Annual Meeting of American Society of Hematology
December 06 2016 - 7:00AM
- Completed enrollment in the two
lowest dose cohorts, third cohort now in progress
-
Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical
company developing vascular disrupting agents (VDAs) for the
treatment of orphan oncology indications, today announced the
poster presentation of data from its on-going phase 1b OX1222 study
of OXi4503 in combination with cytarabine in patients with Acute
Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
OXi4503 is one of Mateon’s two VDAs currently in clinical
development. OX1222 is a dose-ranging study of OXi4503 combined
with cytarabine in relapsed/refractory AML and MDS. The poster
presented at the 58th Annual Meeting of the American Society of
Hematology (ASH) describes results from the initial two cohorts of
OX1222, which represent the lowest doses of OXi4503 in the
study.
The first cohort enrolled 6 patients at a dose of 3.75 mg/m2 of
OXi4503 in combination with an intermediate dose (1g/m2/day x 5
days) of cytarabine. The second cohort enrolled 4 patients at a
dose of 4.68 mg/m2 of OXi4503 in combination with the same
intermediate dose of cytarabine. Patients enrolled into OX1222 were
treatment-resistant, end-stage AML/MDS patients who had on average
four prior therapy failures before entering the study.
In total 2 of 10 (20%) patients achieved a complete remission
(CR) on treatment and currently remain in CR without further
treatment – one at 6 months and the other at 3 months. One patient
of six (17%) responded in the 3.75 mg/m2 dose cohort, and one
patient of four (25%) responded in the 4.68 mg/m2 dose cohort. The
study is currently enrolling patients in the third cohort at 6.25
mg/m2 of OXi4503.
OXi4503 was generally well tolerated in the first two cohorts of
the study. The adverse event profile remains similar to that
seen in the monotherapy Phase 1b portion of the trial, with
coagulopathies and hematological adverse events the most
significant events. The most common drug-related SAEs were
anemia (30%), neutropenia (30%), D-dimer increase (20%),
thrombocytopenia (20%), and AST increase (20%). One patient
in the 3.75 mg/m2 cohort experienced a dose-limiting toxicity of
hypofibrinogenemia with no clinical evidence of bleeding, which
resolved with treatment.
“I am very excited to see two complete remissions out of the ten
patients treated to date, as these were heavily pre-treated
patients,” stated Tara L. Lin, MD, Associate Professor, Division of
Hematologic Malignancies & Cellular Therapeutics, University of
Kansas Cancer Center. “Our poster presentation at ASH concluded
that OXi4503 in combination with cytarabine demonstrated
preliminary evidence of activity in heavily pretreated
relapsed/refractory AML patients and that this combination was
generally well tolerated through cohorts 1 and 2. I greatly look
forward to seeing the results from additional cohorts as the
optimal dose of OXi4503 in combination with cytarabine has yet to
be determined.”
The poster presentation was entitled “A Phase 1b (OX1222)
Dose-Finding Study of OXi4503 Combined with Cytarabine in Patients
with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic
Syndrome” and was presented by Justin M. Watts, MD, Assistant
Professor of Clinical Medicine at the University of Miami.
About MateonMateon Therapeutics, Inc. is a biopharmaceutical
company seeking to realize the full potential of vascular targeted
therapy (VTT) in oncology. VTT includes vascular disrupting agents
(VDAs) such as the investigational drugs that Mateon is developing,
and anti-angiogenic agents (AAs), a number of which are
FDA-approved and widely used in cancer treatment. These two
approaches have distinct yet complementary mechanisms of
action.
At Mateon, we believe that we can significantly improve cancer
therapy by employing these two complementary approaches
simultaneously. When utilized this way, VDAs obstruct existing
blood vessels in the tumor leading to significant central tumor
cell death while AAs prevent the formation of new tumor blood
vessels.
Mateon is committed to leveraging our intellectual property and
the product development expertise of our highly skilled management
team to enable VTT to realize its true potential and to bring
much-needed new therapies to cancer patients worldwide.
Safe Harbor StatementThis 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 Mateon 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
Mateon’s reports to the Securities and Exchange Commission,
including Mateon’s reports on Form 10-K, 10-Q and 8-K. However,
Mateon 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, 2015.
CONTACTS
Investors:
ir@mateon.com
650-635-7000
Media:
JPA Health Communications
Nic DiBella
nic@jpa.com
617-945-5183