Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, with a focus on myelodysplastic
syndromes (MDS), announced that the Company believes it remains on
target to report top-line data from the global Phase 3 INSPIRE
Trial with intravenous (IV) rigosertib in second-line, higher-risk
MDS patients in the first half of 2020 following full enrollment
and 288 death events. The Company anticipates completion of
the INSPIRE Trial in the first half of 2020 based on approaching 90
percent or 324 randomized patients of the required 360 randomized
patients, and the number of confirmed death events reached to
date.
Steven M. Fruchtman, M.D., President and Chief
Executive Officer, stated, “Enrollment in our global Phase 3
INSPIRE Trial with IV rigosertib in second-line, higher-risk MDS
patients is progressing. We are approaching 90 percent of
planned enrollment. Based on enrollment and the number of
reported events reached, which exceeded 75% of the required 288
events at end of September 2019, we continue to anticipate
reporting top-line data in the first half of 2020 following full
enrollment and 288 death events. Enrollment in Brazil is
expected to begin in November, and we look forward to the Brazilian
Association of Hematology, Hemotherapy and Cellular Therapy
Congress in Rio de Janeiro, November 6-9.”
Dr. Richard Woodman, Chief Medical Officer of
Onconova, continued, “Prior to readout of the INSPIRE trial, the
Company plans to focus Onconova’s research and development
activities on completing the INSPIRE trial. After completion
of the INSPIRE trial, based on recent feedback from the FDA, we
plan to conduct a randomized Phase 2 Trial with a control arm of
single agent azacitidine for the continued development of oral
rigosertib plus azacitidine in first-line higher-risk MDS
patients. We also plan to consult with key opinion
leaders on the design of a Phase 2 controlled study for submission
to the FDA as the next step in the development of oral rigosertib.
The proposed Phase 2 Study does not require a Special Protocol
Assessment (SPA).”
In addition to the pivotal Phase 3 INSPIRE
study, a Phase 1 study of rigosertib in combination with a PD-1
inhibitor for patients with progressive K-Ras mutated non-small
cell lung cancer is expected to commence by early 2020 as an
investigator-initiated study. Ras-mutated cancers represent
about a third of all human cancers. We recently participated
in the RAS Drug Discovery Summit in Boston and plan to participate
in the next RAS Drug Discovery Summit in Vienna, Austria in
February 2020. We are also working toward filing an IND for a
Phase 1 trial of ON 123300, our investigational dual inhibitor of
CDK4/6 + ARK5, which we believe has the potential to treat various
cancers including refractory metastatic breast cancer. The IND has
been submitted in China by our corporate partner Han X.
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 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. 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 INternational
Study of Phase 3
IV RigosErtib,
or INSPIRE, clinical trial 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 preliminary
efficacy and safety data was presented at The American Society of
Hematology (ASH) Annual Meeting in December 2018 and will be
updated at the upcoming ASH 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, 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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