Onconova Therapeutics Announces Presentation at BIO Digital 2020
June 08 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 that Avi Oler,
Senior Vice President, Corporate Development, will present at BIO
Digital 2020, being held virtually June 8 - 12, 2020.
Mr. Oler will provide an overview of the
Company’s corporate development objectives and upcoming milestones
for its lead candidate rigosertib and its oncology product
candidate pipeline. The presentation will be available here for
viewing on-demand.
Mr. Oler will be available for virtual meetings
throughout BIO Digital. To arrange a meeting, please visit the BIO
One-on-One Partnering webpage.
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/.
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 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-naïve 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
(INSPIRE) was finalized following guidance
received from the U.S. Food and Drug Administration and the
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).
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.us
Media David Schull, Russo Partners
LLC: (212) 845-4271Nic Johnson, Russo Partners LLC: (212)
845-4242
Investors Jan Medina, CFA, Russo Partners LLC:
(646) 942-5632
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