NEWTOWN, Pa., May 18, 2017 (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 (MDS), today announced details relating to a poster presentation addressing Intravenous Rigosertib in
Second-line Higher Risk MDS at the upcoming American Society of Clinical Oncology Annual Meeting taking place June
2nd-6th in Chicago.
Further Rationale for Rigosertib in a Second-line HR-MDS Setting
Abstract Number: 7056
Title: Relationship of Bone Marrow Blast (BMBL) response to Overall Survival (OS) in a Multicenter
study of Rigosertib (Rigo) in Patients with Myelodysplastic Syndromes (MDS) with Excess Blasts Progressing on or After Treatment
with a Hypomethylating Agent (HMA).
Date: Monday, June 5,
2017
Time and Location: 8:00 AM — 11:30 AM, McCormick Place, Hall
A
Presenter: Aref Al-Kali, MD, Mayo Clinic - Rochester, Minnesota
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, while causing minimal damage to normal
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 the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS,
after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease,
provides long duration of exposure, and ensures dosing under a controlled setting.
About INSPIRE
The INternational Study of Phase III IV
RigosErtib, or INSPIRE, is based on 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. The trial will enroll approximately 225 patients 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 and an interim analysis is anticipated. 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 also supports 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 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 future events or Onconova
Therapeutics, Inc.'s future operations, clinical development of Onconova's product candidates and presentation of data with respect
thereto, regulatory approvals, expectations regarding the sufficiency of Onconova's cash and other resources to fund operating
expenses and capital expenditures, Onconova's anticipated milestones and future expectations and plans and prospects. 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/ INVESTOR RELATIONS CONTACT: Lisa Sher, MBS Value Partners on behalf of Onconova Therapeutics Lisa.Sher@mbsvalue.com / (212) 750-5800
