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 two presentations
at the 24th Congress of the European Hematology Association being
held June 13-16, 2019 in Amsterdam, Netherlands. Dr. Steven
Fruchtman, President & CEO, Dr. Ric Woodman, CMO, and Dr.
Ronnee Adesanya, VP Medical Affairs, will be attending the
conference.
DETAILS OF THE PRESENTATIONS:
Title: |
PHASE
II STUDY OF ORAL RIGOSERTIB COMBINED WITH AZACITIDINE IN PATIENTS
WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES (MDS)
|
Format: |
ORAL PRESENTATION: Abstract S839Location – Elicium 1
|
Date/Time: |
Saturday, June 15 / 12:00 – 12:15 |
Presenter: |
Shyamala C. Navada, MDDivision of Hematology/Oncology,
Icahn School of Medicine at Mount Sinai, New York, NY |
Title: |
RIGOSERTIB MODULATES HEMATOPOIESIS GENE SIGNALING PATHWAYS
ALONE OR IN SEQUENCESCOMBINATION WITH AZACITIDINE
ON MDS CELLS IN VITRO |
Format: |
POSTER PRESENTATION: Abstract PS1332Location – Poster
area |
Date/Time: |
Saturday, June 15 / 17:30 – 19:00 |
Presenter: |
Lewis R. Silverman, MDTisch Cancer Institute, Division
of Hematology/Oncology, Icahn School of Medicine at Mount Sinai,
New York, NY |
A copy of the poster and oral presentation slides will be
available immediately following the event by visiting the
Scientific Presentations section of Onconova's website:
https://investor.onconova.com/scientific-presentations
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical
company focused on discovering and developing novel small molecule
drug candidates to treat cancer, with an initial focus on
Myelodysplastic Syndromes (MDS). Rigosertib, Onconova's lead
candidate, is a proprietary Phase 3 small molecule, which the
Company believes blocks cellular signaling by targeting RAS
effector pathways. 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.
Onconova has three product candidates in the clinical stage and
several pre-clinical programs. 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. 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 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 clinic
with oral and IV rigosertib, including single agent IV rigosertib
in second-line high-risk MDS patients (pivotal Phase 3 INSPIRE
trial) and oral rigosertib plus azacitidine in first-line high-risk
MDS patients (Phase 2). Patents covering oral and injectable
rigosertib have been issued in the U.S. and are expected to provide
coverage until at least 2037.
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 high-risk MDS (HR-MDS), after
failure of hypomethylating agent, or HMA, therapy.
About the INSPIRE Phase 3 Clinical Trial
The 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 HR-MDS patients who had
progressed on, failed to respond to, or relapsed after previous
treatment with an 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. An interim
analysis in early 2018 demonstrated a promising survival signal in
the intent-to-treat population as reviewed by the Independent Data
Monitoring Committee. The Committee recommended that the trial
continue with an expansion in enrollment to 360 patients based on a
pre-planned sample size re-estimation. 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. 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 Oral Rigosertib
The oral form of rigosertib was developed to provide more
convenient dosing 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 studied with the oral formulation of rigosertib. 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 Annual Meeting in December 2018. A
pivotal Phase 3 study design is under review by the FDA, and the
Special Protocol Assessment is expected to conclude in the 1H of
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 its products, its
collaboration with HanX, 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, 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 OlerOnconova Therapeutics, Inc.
267-759-3680http://www.onconova.com/contact/
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Apr 2023 to Apr 2024