NEWTOWN, Pa., Dec. 9, 2013 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced two presentations relating to clinical trials of its most advanced product candidate, rigosertib, at the 55th American Society of Hematology (ASH) Annual Meeting in New Orleans, Louisiana, December 7-10, 2013. The presentations included data on efficacy, tolerability, and dosing regimen from the Phase 2 ONTARGET study of oral rigosertib in transfusion-dependent, lower risk MDS patients and response, overall survival, and longer-term follow-up data from a Phase 1/2 trial of intravenous (IV) rigosertib in higher risk post-hypomethylating agent-treated MDS and acute myeloid leukemia (AML) patients.
"The presentations at ASH reinforce the emerging therapeutic and safety/tolerability profiles of rigosertib, our small-molecule inhibitor of PI3K and PLK pathways, and underscore our commitment to develop rigosertib as a novel treatment for patients with MDS," commented Ramesh Kumar, Ph.D., President and Chief Executive Officer of Onconova. "We look forward to the design of an approval-track trial of oral rigosertib in transfusion-dependent, lower risk MDS and top-line data from our Phase 3 pivotal trial in higher risk MDS."
Data from oral rigosertib trials in lower risk MDS patients:
Azra Raza, M.D., Director, MDS Center, Columbia University Medical Center et al., presented a poster entitled "Oral Rigosertib (ON 01910.Na) Treatment Produces An Encouraging Rate Of Transfusion Independence In Lower Risk Myelodysplastic Syndromes (MDS) Patients; A Genomic Methylation Profile Is Associated With Responses." The poster summarized data from the Phase 2 ONTARGET trial of oral rigosertib in transfusion-dependent, lower risk MDS patients.
A second Phase 2 clinical trial, the 09-07 study, is open to further explore the safety and the possible effects of oral rigosertib in transfusion-dependent, lower risk MDS patients who have failed ESA treatment.
Data from IV rigosertib trials in higher risk MDS patients:
Shyamala Navada, M.D., Assistant Professor, Icahn School of Medicine at Mount Sinai et al., presented a poster entitled, "Predictors of Response to Rigosertib In Patients with a Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Relapsed or Refractory to Hypomethylating Agents." The poster summarized results from a Phase 1/2 study of IV rigosertib in patients with MDS and AML who had failed treatment with hypomethylating agents.
Onconova recently completed enrollment in the Phase 3 ONTIME study in higher risk MDS patients who have failed treatment with hypomethylating agents. Top-line survival results from this trial are anticipated in the first quarter of 2014.
ASH 2012 Presentations Relating to Rigosertib
Abstract #2745
Oral Rigosertib (ON 01910.Na) Treatment Produces An Encouraging Rate Of Transfusion Independence In Lower Risk Myelodysplastic Syndromes (MDS) Patients; A Genomic Methylation Profile Is Associated With Responses
Date: Sunday, December 8, 2013 |
Time: 6:30 PM - 8:30 PM |
Session: 633. Myelodysplastic Syndromes: Poster II |
Location: Ernest N. Morial Convention Center, Hall E |
Presenter: Azra Raza, M.D., MDS Center, Columbia University Medical Center, New York, NY |
Abstract #1527
Predictors Of Response To Rigosertib In Patients With a Myelodysplastic Syndrome (MDS) Or Acute Myeloid Leukemia (AML) Relapsing After Or Refractory To Hypomethylating Agents
Date: Saturday, December 7, 2013 |
Time: 5:30 PM - 7:30 PM |
Session: 633. Myelodysplastic Syndromes: Poster I |
Location: Ernest N. Morial Convention Center, Hall E |
Presenter: Shyamala C. Navada, M.D., Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY |
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer. Onconova's clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. In addition to rigosertib, the Company's most advanced product candidate, two other candidates are in clinical trials, and several candidates are in pre-clinical stages. For more information, please visit http://www.onconova.com.
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, which 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, 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 those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on June 14, 2013, as amended (Registration No. 333-189358).
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