Onconova Therapeutics, Inc. to Provide Corporate Update and Second Quarter 2018 Financial Results
August 07 2018 - 8:00AM
Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage
biopharmaceutical company focused on discovering and developing
novel products to treat cancer, with a primary focus on
myelodysplastic syndromes, today announced that the Company will
release its second quarter 2018 financial results on August 14,
2018 before the market opens. The Company will host a conference
call on August 14, 2018 at 9:00 a.m. Eastern Time to discuss these
results.
Interested parties may access the call by dialing toll-free
(855) 428-5741 from the US or (210) 229-8823 internationally, and
using conference ID 5287175.
The call will also be webcast live. Please click here to access
the webcast. A replay will be available at this link until
November 30, 2018.
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 primary focus on
Myelodysplastic Syndromes (MDS). Rigosertib, Onconova's lead
candidate, is a proprietary Phase 3 small molecule agent, which the
Company believes blocks cellular signaling by targeting RAS
effector pathways. 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. Onconova has three product candidates in the clinical
stage and several pre-clinical programs. 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. For more information, please visit
http://www.onconova.com.
About IV Rigosertib
The intravenous form of rigosertib has been employed in Phase 1,
2, and 3 clinical trials involving more than 800 patients, and is
currently being evaluated in a randomized Phase 3 international
INSPIRE trial for patients with higher-risk MDS, after failure of
hypomethylating agent, or HMA, therapy.
About INSPIRE
The INternational Study of
Phase III IV
RigosErtib, or INSPIRE, was
finalized following guidance received from the U.S. Food and
Drug Administration and European Medicines Agency and derives from
the findings of the ONTIME Phase 3 trial. INSPIRE is a
multi-center, randomized controlled study to assess the efficacy
and safety of IV rigosertib in HR-MDS patients who had progressed
on, failed to respond to, or relapsed after previous treatment with
an HMA within the first 9 months or 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.
Following interim analysis in early 2018, the independent Data
Monitoring Committee recommended that the trial continue with an
expansion in enrollment to 360 patients based on a pre-planned
sample size re-estimation. Patients are randomized at a 2:1
ratio into two treatment arms: IV rigosertib plus Best Supportive
Care versus Physician's Choice plus Best Supportive Care. The
primary endpoint of INSPIRE is overall survival. 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 Oral Rigosertib
The oral form of rigosertib was developed to provide more
convenient dosing for use where the duration of treatment may
extend to multiple years. This dosage form may also support many
combination therapy modalities. To date, 368 patients have
been treated with the oral formulation of rigosertib. Initial
studies with single-agent oral rigosertib were conducted in
hematological malignancies, lower-risk MDS, and solid tumors.
Combination therapy of oral rigosertib with azacitidine and
chemoradiotherapy has also been explored. 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 results were presented in
2016. This novel combination is the subject of an issued US patent
with earliest expiration in 2028.
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,
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.
General Contact:
http://www.onconova.com/contact/ Mark GuerinOnconova
Therapeutics, Inc.267 759 3680
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