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 required
number of survival events for the pivotal Phase 3 INSPIRE has been
reached. The Company anticipates announcing topline data by the end
of the third quarter of 2020.
“Consistent with previous guidance for topline
data disclosure, we anticipate providing preliminary efficacy and
safety data from the pivotal Phase 3 INSPIRE trial during the third
quarter of this year,” said Steven M. Fruchtman, M.D., President
and Chief Executive Officer. “Onconova is not currently in
possession of topline data. However, we estimate the timing of this
data readout based on having achieved the required number of
survival events, the continued progress for source verification
needed for the data set, and our experience in navigating the
challenges of conducting clinical trials in the COVID pandemic
environment. We plan to disclose the initial topline data results
when available, via press release and subsequent conference call,
with a full data presentation anticipated at a major medical
conference later this year.”
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 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
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
naive 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 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. Preclinical studies with IV rigosertib is
underway in COVID-19 as well.
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.
About SARS-CoV-2 and
COVID-19
Severe 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 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, the timing for data read outs 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
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