NEWTOWN, Pa., May 09, 2018 (GLOBE NEWSWIRE) -- 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 first quarter 2018 financial results on May 15, 2018
before the market opens. The Company will host a conference call on May 15, 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 2573768.
The call will also be webcast live. Please click here to access the webcast.
A replay will be available at that link until August 31, 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 Therapeutics, Inc.'s expectations regarding the
INSPIRE Trial and the transactions contemplated by the licensing agreement. 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. 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. 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 and current plans and future needs to scale back operations if
adequate financing is not obtained, 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.
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:
http://www.onconova.com/contact/
Mark Guerin
Onconova Therapeutics, Inc.
267 759 3680
