Onconova Announces Five Presentations on Rigosertib in Myelodysplastic Syndromes (MDS) at the ASH 2019 Annual Meeting & Expos...
November 07 2019 - 7:30AM
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage
biopharmaceutical company discovering and developing novel products
to treat cancer, with a focus on Myelodysplastic Syndromes (MDS),
today announced that five abstracts relating to the Company's lead
product candidate, rigosertib, were accepted for presentation at
the 61st American Society of Hematology (ASH) Annual Meeting &
Exposition in Orlando, FL, which takes place December 7-10, 2019.
Oral Presentation:
1. |
Phase II Study of Oral Rigosertib Combined with Azacitidine
(AZA) As First Line Therapy in Patients (Pts) with Higher-Risk
Myelodysplastic Syndromes (HR-MDS) |
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Session Name: 637. Myelodysplastic Syndromes –
Clinical Studies: Combination Therapies |
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Abstract: 566 |
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Date: Monday, December 9, 2019 |
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Presentation Time: 7:00 AM - 8:30 AM |
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Location: W311 EFGH (Orange County Convention
Center) |
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Presenter: Shyamala C. Navada, MD, Division of
Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New
York, NY |
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Poster Presentations:
2. |
Genomic Profiling in Patients with Higher-Risk
Myelodysplastic Syndrome (HR-MDS) Following HMA Failure: Baseline
Results from the INSPIRE Study (04-30) |
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Session Name: 637. Myelodysplastic Syndromes –
Clinical Studies: Poster II |
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Abstract: 3015 |
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Date: Sunday, December 8, 2019 |
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Session Time: 6:00 PM – 8:00 PM |
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Location: Hall B (Orange County Convention
Center) |
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Presenter: Guillermo Garcia-Manero, MD,
Department of Leukemia, The University of Texas MD Anderson Cancer
Center, Houston, TX |
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3. |
The INSPIRE Study in Higher-Risk Myelodysplastic Syndrome
(HR-MDS): A Novel Phase 3 Study Adaptive Design for Hematological
Malignancies in Adults |
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Session Name: 637. Myelodysplastic Syndromes –
Clinical Studies: Poster III |
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Abstract: 4249 |
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Date: Monday, December 9, 2019 |
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Presentation Time: 6:00 PM - 8:00 PM |
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Location: Hall B (Orange County Convention
Center) |
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Presenter: Anna Jonasova, MD, General
University Hospital in Prague, 1st Internal Clinic - Clinic of
Hematology, Prague, Czech Republic |
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4. |
Phase 3, Multi-Center, International, Randomized,
Double-Blind, Placebo Controlled Study of Oral Rigosertib +
Injectable Azacitidine (AZA) Versus Injectable Azacitidine in
Treatment-Naïve Patients with Higher-Risk Myelodysplastic Syndrome
(HR-MDS) |
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Session Name: 637. Myelodysplastic Syndromes –
Clinical Studies: Poster III |
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Abstract: 4268 |
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Session Time: 6:00 PM – 8:00 PM |
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Location: Hall B (Orange County Convention
Center) |
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Presenter: Guillermo Garcia-Manero, MD,
Department of Leukemia, The University of Texas MD Anderson Cancer
Center, Houston, TX |
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5. |
The Sequenced Combination of Rigosertib and Azacitidine Has
Modulatory Effects on CXCL8, RIG-I like Receptor (RLR) and
Wnt/β-Catenin Signaling and Downstream Hematopoiesis Pathways in an
in Vitro Model of the Myelodysplastic Syndrome |
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Session Name: 636. Myelodysplastic Syndromes –
Basic and Translational Studies: Poster III |
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Abstract: 4231 |
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Date: Monday, December 9, 2019 |
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Session Time: 6:00 PM – 8:00 PM |
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Location: Hall B (Orange County Convention
Center) |
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Presenter: Richa Rai, Tisch Cancer Institute,
Icahn School of Medicine at Mount Sinai, New York, NY |
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage
biopharmaceutical company discovering and developing novel small
molecule drug candidates to treat cancer, with a focus on
Myelodysplastic Syndromes (MDS). Using a proprietary
chemistry platform, Onconova has created a pipeline of 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
http://www.onconova.com.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are conditions
that can occur when the blood-forming cells in the bone marrow
become dysfunctional and thus produce an inadequate number of
circulating blood cells. It is frequently associated with the
presence of blasts or leukemic cells in the marrow. This
leads to low numbers of one or more types of circulating blood
cells, and to the need for blood transfusions. In MDS, some of the
cells in the bone marrow are abnormal (dysplastic) and may have
genetic abnormalities associated with them. Different cell
types can be affected, although the most common finding in MDS is a
shortage of red blood cells (anemia). Patients with
higher-risk MDS may progress to the development of acute
leukemia.
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a
proprietary Phase 3 small molecule. A key publication in a
preclinical model demonstrated 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 first-line 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 the INSPIRE Phase 3 Clinical Trial
The clinical trial
INternational Study of
Phase 3 IV
RigosErtib, or
INSPIRE, was finalized following guidance received
from the U.S. Food and Drug Administration and European Medicines
Agency. INSPIRE is a global, multi-center, randomized,
controlled study to assess the efficacy and safety of IV rigosertib
in higher-risk MDS (HR-MDS) patients who had progressed on, failed
to respond to, or relapsed after previous treatment with a
hypomethylating agent (HMA) within nine cycles over the course of
one year after initiation of HMA treatment. This time frame
optimizes the opportunity to respond to treatment with an HMA prior
to declaring treatment failure, as per NCCN Guidelines.
Patients are randomized at a 2:1 ratio into two study arms: IV
rigosertib plus Best Supportive Care versus Physician's Choice plus
Best Supportive Care. The primary endpoint of INSPIRE is
overall survival. The trial continued beyond the
pre-specified interim analysis and is nearing its conclusion. Full
details of the INSPIRE trial, such as inclusion and exclusion
criteria, as well as secondary endpoints, can be found on
clinicaltrials.gov (NCT02562443).
About IV Rigosertib
The intravenous form of rigosertib has been
studied in Phase 1, 2, and 3 clinical trials involving more than
1000 patients, and is currently being evaluated in a randomized
Phase 3 international INSPIRE trial for patients with HR-MDS after
failure of HMA therapy.
About Oral Rigosertib
The oral form of rigosertib was developed to
provide a potentially more convenient dosage form for use where the
duration of treatment may extend to multiple years. This dosage
form may also support combination therapy modalities. To date,
over 400 patients have been dosed with the oral formulation of
rigosertib in clinical trials. Combination therapy of oral
rigosertib with azacitidine, the standard of care in HR-MDS, has
also been studied. Currently, oral rigosertib is being developed as
a combination therapy together with azacitidine for patients with
higher-risk MDS who require HMA therapy. A Phase 1/2 trial of the
combination therapy has been fully enrolled, and the preliminary
efficacy and safety data was presented at The American Society of
Hematology (ASH) Annual Meeting in December 2018 and will be
updated at the upcoming ASH Meeting in December 2019.
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, the need for additional financing, the success and timing
of Onconova's clinical trials and regulatory approval of protocols,
our collaborations, 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.
General Contact
Avi Oler Onconova Therapeutics, Inc.
267-759-3680 ir@onconova.us
http://www.onconova.com/contact/
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