Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage
biopharmaceutical company discovering and developing novel products
to treat cancer, with an initial focus on myelodysplastic syndromes
(MDS), today announced that the Company will be
participating in two upcoming international conferences:
1. RAS-Targeted Drug Discovery
Summit/Europe |
February
25-27 |
|
Vienna, Austria |
Presentation Details:
Title:
Rigosertib is a Unique Small Molecule RAS Antagonist:
Scientific & Clinical
StudiesDate/Time:
Thursday, February 27th, 9:00 AM Central European
TimeVenue:
Hilton Vienna
PlazaPresenter:
Steven M. Fruchtman, M.D., President & CEO of Onconova
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 are 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 this
year, following full enrollment and 288 death events. Dr. Fruchtman
looks forward to joining colleagues at the Summit to discuss
advancements in rigosertib’s development as well as the progress
the Company and others have made in targeting RAS.
2. 2nd Regional Symposium on MDS |
March 5-6 |
|
Tel Aviv, Israel |
“We are pleased to participate in the MDS
Conference in Tel Aviv where experts from around the globe will be
presenting new data on the diagnosis and management of MDS,” said
Dr. Steven Fruchtman.
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). 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 updated
efficacy and safety data was presented at the ASH 2019 Annual
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, 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.
General Contact:
Avi Oler Onconova Therapeutics, Inc. 267-759-3680
ir@onconova.us
http://www.onconova.com/contact/
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