Onconova Therapeutics Announces Publication of Phase 1 Results in Leukemia Research Exploring Oral Rigosertib in Combination ...
July 07 2020 - 8:00AM
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, with an initial focus on
myelodysplastic syndromes (MDS), today announced the e-publication
of results from a Phase 1 company-sponsored study of oral
rigosertib in combination with standard dose azacitidine in the
treatment of patients diagnosed with either higher-risk
myelodysplastic syndrome (HR-MDS) or acute myeloid leukemia (AML)
in the international hematological malignancy journal Leukemia
Research.
“A key strategy emerging in the treatment of MDS
is the identification of safe and effective combinations,
particularly those involving oral agents. The results from this
Phase 1 study represent Onconova’s first efforts to explore oral
rigosertib in combination with azacitidine to address the unmet
medical need in patients with MDS and AML. We anticipate meeting
with the FDA, in conjunction with the pivotal data readout from the
INSPIRE Trial, for alignment with the agency on a registration
trial for the combination of oral rigosertib plus azacitidine in
HMA-naïve HR-MDS,“ said Steven M. Fruchtman, M.D., President and
CEO of Onconova.
“These results coupled with preliminary data
from the phase II studies, support further clinical development of
this novel combination with a manageable safety profile and
efficacy in patients with MDS both those HMA naïve and after HMA
failure,” said study principal investigator Lewis R. Silverman,
M.D., Director, Translational Research Center for the
Myelodysplastic Syndrome, Associate Professor, Medicine,
Hematology, and Medical Oncology, The Tisch Cancer Institute at the
Icahn School of Medicine at Mount Sinai. “The oral administration
of rigosertib is not just more convenient for patients, but may
improve treatment compliance, leading to improved clinical
outcomes.”
This publication reports the results of an
open-label, dose-escalating Phase 1 study with the combination oral
of rigosertib and standard dose azacitidine administered
sequentially to patients diagnosed with HR-MDS following
HMA-failure, or relapsed/refractory AML. The study objectives were
to assess safety and determine the recommended Phase 2 dose (RP2D)
for future studies. The study evaluated three dose cohorts of oral
rigosertib with no dose-limiting toxicities reported. In addition,
the oral rigosertib/azacitidine combination demonstrated an overall
response rate of 7/9 (78%) in patients with HR-MDS and 2/7 (29%) in
patients with AML. The Phase 2 part of the study is ongoing.
Additional details are available on www.clinicaltrials.gov
(NCT01926587).
“We believe this combination could eventually
prove very beneficial for patients with higher-risk MDS. In
addition to its oral formulation and thus ease of administration,
rigosertib is potentially an attractive partner for a variety of
combination approaches due to its novel mechanism of action as a
RAS mimetic that differentiates it from other MDS therapies,” said
Richard C. Woodman, M.D., Chief Medical Officer of Onconova.
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication in a
preclinical model reported rigosertib’s ability to block cellular
signaling by targeting RAS effector pathways (Divakar, S.K., et
al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association
with Effector Proteins to Block Signaling." Cell 165, 643).
Onconova is currently in the clinical development stage with oral
and IV rigosertib, including clinical trials studying single agent
IV rigosertib in second-line higher-risk MDS patients (pivotal
Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in HMA
naive and refractory higher-risk MDS patients (Phase 2). Patents
covering oral and injectable rigosertib have been issued in the US
and are expected to provide coverage until at least 2037.
About Onconova Therapeutics,
Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel drugs to treat cancer, with an initial focus on
myelodysplastic syndromes (MDS). Onconova has a pipeline of
proprietary targeted agents designed to work against specific
cellular pathways that are important in cancer cells. Advanced
clinical trials with the Company’s lead compound, rigosertib, are
aimed at what the Company believes are unmet medical needs of
patients with MDS. Onconova has conducted trials with two other
research compounds and has a pre-clinical program with a CDK4/6 and
ARK5 inhibitor, ON 123300.
For more information, please visit
https://www.onconova.com.
Forward-Looking Statements
Some of the statements in this release are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, and involve risks and uncertainties.
These statements relate to Onconova expectations regarding the
INSPIRE Trial and Onconova’s other development plans. Onconova has
attempted to identify forward-looking statements by terminology
including "believes," "estimates," "anticipates," "expects,"
"plans," "intends," "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future
events or outcomes. Although Onconova believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, including Onconova's ability to continue as a going
concern, maintain its Nasdaq listing, the need for additional
financing, the success and timing of Onconova's clinical trials and
regulatory approval of protocols, our collaborations including the
effective termination of the HanX license and securities purchase
agreements and plans for partnering certain territories, and those
discussed under the heading "Risk Factors" in Onconova's most
recent Annual Report on Form 10-K and quarterly reports on Form
10-Q. Any forward-looking statements contained in this release
speak only as of its date. Onconova undertakes no obligation to
update any forward-looking statements contained in this release to
reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
Press release contact information
Company Contact:Avi OlerOnconova Therapeutics,
Inc.267-759-3680
ir@onconova.ushttps://www.onconova.com/contact/
MediaDavid Schull, Russo Partners LLC: (212)
845-4271Nic Johnson, Russo Partners LLC: (212) 845-4242
InvestorsJan Medina, CFA, Russo Partners LLC:
(646) 942-5632
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