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 the Company
intends to release its second quarter financial results on
Wednesday, August 12, 2020. Management plans to host a conference
call and live webcast at 4:30 p.m. ET on that day to discuss these
results and provide an update on its pipeline programs.
Conference Call and Webcast
InformationInterested parties who wish to participate in
the conference call may do so by dialing (855) 428-5741 for
domestic and (210) 229-8823 for international callers and using
conference ID 2875654.
To facilitate an on-time conference call start,
Onconova recommends that participants dial in 15 minutes before the
4:30 p.m. ET start time.
Those interested in listening to the conference
call via the internet may do so by visiting the investors and media
page on the company's website at www.onconova.com and clicking on
the webcast link. In addition to the live webcast, a replay will be
available on the Onconova website for 90 days following the
call.
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 additional
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
SyndromesMyelodysplastic 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 RigosertibRigosertib,
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 naive and refractory higher-risk
MDS patients (Phase 2). Preclinical work with rigosertib is
underway in COVID-19 as well. 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
TrialThe 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 RigosertibThe
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 RigosertibThe 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.
About SARS-CoV-2 and
COVID-19Severe acute respiratory syndrome due to
SARS-CoV-2 has impacted millions of people worldwide and has led to
the death of hundreds of thousands of individuals. Collaborative
efforts to test many experimental and health authority approved
agents are ongoing worldwide to address the global pandemic through
the development of therapeutic antiviral drugs to treat COVID-19
infection, and with vaccines to prevent infection with
SARS-CoV-2.
Forward-Looking StatementsSome
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.ushttps://www.onconova.com/contact/
MediaDavid Schull, Russo Partners LLC: (212)
845-4271Nic Johnson, Russo Partners LLC: (212) 845-4242
InvestorsJan Medina, CFA, Russo Partners LLC:
(646) 942-5632
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Feb 2024 to Mar 2024
Onconova Therapeutics (NASDAQ:ONTX)
Historical Stock Chart
From Mar 2023 to Mar 2024