Onconova Therapeutics Announces Presentation on Rigosertib at the RAS-Targeted Drug Discovery Summit
September 16 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),
will present at the RAS-Targeted Drug Discovery Summit being held
September 17-19 in Boston, Massachusetts. Dr. Steven
Fruchtman, President & CEO, will be presenting. Also
attending the conference will be Avi Oler, VP Corporate
Development.
ABOUT RAS AND RIGOSERTIB:
There is a high frequency of Ras mutations in
cancer that leads to the belief that mutations of the Ras Pathway
provide a proliferative advantage and thus is involved in the
pathogenesis of cancer. As a result, targeting the Ras
pathway has been the objective of scientific research for decades.
As published in the journal Cell in 2016, and now under
investigation in a pivotal Phase 3 Trial, rigosertib targets the
mutated RAS pathway by its interaction with Ras effector proteins
containing the Ras Binding Domain. The RAS-Targeted Drug
Discovery Summit provides an opportunity to showcase the potential
for rigosertib in MDS and in other RAS-driven cancers, such as
KRAS-mutated lung cancer and colorectal cancer, and Ras- driven
pediatric cancers as well. Onconova will review its INSPIRE Trial
for which the Company anticipates reporting top-line data for
second-line, higher-risk MDS patients in the first half of 2020
following full enrollment and 288 death events. Onconova’s
representatives look forward to joining colleagues at the Summit to
discuss advancements in rigosertib’s development and the progress
the Company and others have made in targeting RAS.
DETAILS OF THE PRESENTATION:
Title: |
Rigosertib: Targeting the Ras+ Pathway and Clinical Trials in MDS
and Beyond |
Date/Time: |
Thursday, September 19th, 10:30 a.m. |
Presenter: |
Steven M. Fruchtman, M.D. |
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. 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 higher-risk MDS patients (pivotal
Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in
first-line 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 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 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 higher-risk MDS (HR-MDS), after
failure of hypomethylating agent, or HMA, therapy.
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 new
pivotal Phase 3 study design is under discussion with the FDA.
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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