NEWTOWN, Pa., May 1, 2015 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that nine abstracts are being presented at the 13th International Symposium on Myelodysplastic Syndromes in Washington, DC, April 29 – May 2, 2015.
Collaborators from leading institutions, including Dr. Guillermo Garcia-Manero (MD Anderson Cancer Center), Dr. Lewis R. Silverman, Dr. Shyamala C. Navada, and Dr. Stephen Cosenza (Mount Sinai School of Medicine), are presenting results from multiple clinical and mechanism of action studies of rigosertib. These presentations highlight:
- Data from the ONTIME study of IV rigosertib in higher-risk MDS – three presentations
- Updated safety and efficacy results from the Phase 1 combination trial of oral rigosertib and azacitidine in MDS and AML
- Translational non-clinical data demonstrating the synergistic activity of the rigosertib/azacitidine combination
- Epidemiological and health outcomes studies in MDS – four presentations
Phase 3 ONTIME Trial Presentations:
Title: Randomized Phase III Study of IV Rigosertib versus Best Supportive Care (BSC) in Patients with Higher-risk MDS (HR-MDS) After Failure of Hypomethylating Agents (HMAs)
Date: Thursday, April 30, 2015
Presenter: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center, Houston, TX
Title: Mutational Profile and Karyotypic Abnormalities of a Cohort of Clinical Trial Patients with Higher-risk Myelodysplastic Syndromes (MDS) Following Failure of Hypomethylating Agents (HMAs): Impact on Response to Rigosertib Therapy
Date: Thursday, April 30, 2015
Presenter: Ghulam J. Mufti, MD, Department of Haematological Medicine, King's College London, London, United Kingdom
Title: Bone Marrow Blast (BMBL) Response Correlates with Overall Survival in Rigosertib-treated Patients with Higher-risk Myelodysplastic Syndrome After Failure of Hypomethylating Agents (HMAs): A New Response Criterion?
Date: Thursday, April 30, 2015
Presenter: Lewis R. Silverman, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Oral Rigosertib/Azacitidine Combination Presentations:
Title: A Phase I/II Study of the Combination of Oral Rigosertib and Azacitidine (AZA) in Patients with Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
Date: Thursday, April 30, 2015
Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Title: Rigosertib, a Novel Inhibitor of Ras Signaling, Overcomes Azacitidine Resistance in Acute Myeloid Leukemia Cell Lines
Date: Thursday, April 30, 2015
Presenter: Stephen Cosenza, PhD, Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY
MDS Epidemiology and Health Economics Presentations:
Title: Incidence and Treatment of Myelodysplastic Syndrome in the US: Optimization or Disappointing Care?
Date: Friday, May 1, 2015
Presenter: Erin P. Demakos, RN, CCRN, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Title: Patterns of Care for Hypomethylating Agents (HMAs) in MDS Patients (pts) in the US: A Disturbing Lack of Optimal Treatment Translates to a Recipe for Failure
Date: Friday, May 1, 2015
Presenter: Erin P. Demakos, RN, CCRN, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Title: Population Incidence of MDS Following Hypomethylating Agent (HMA) Treatment Failure: Analysis of US Commercial Claims Data
Date: Friday, May 1, 2015
Presenter: Christopher R. Cogle, MD, University of Florida, Gainesville, FL
Title: MDS Conceptual Framework Identifies Unmet Need for HMA-Unresponsive and Transplant-Ineligible Patients
Date: Friday, May 1, 2015
Presenter: Sandra Kurtin, RN, MS, AOCN, ANP-C, University of Arizona Cancer Center, Tucson, AZ
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 clinical stage, and several candidates are in pre-clinical stages. For more information, please visit http://www.onconova.com.
About Rigosertib
Rigosertib is a small molecule that inhibits cellular signaling by acting as a Ras mimetic. This is believed to be mediated by direct binding of rigosertib to the Ras-binding domain (RBD) found in many Ras effector proteins, including the Raf kinases and PI3K. The initial therapeutic focus for rigosertib is myelodysplastic syndromes (MDS), a group of bone marrow disorders characterized by ineffective formation of blood cells that often converts into acute myeloid leukemia (AML). Clinical trials with intravenous (IV) and oral formulations of rigosertib are being conducted at leading institutions in the U.S. and Europe.
About the ONTIME Trial
The ONTIME Trial, a Phase 3 multi-center, randomized, controlled study assessed the efficacy and safety of rigosertib 72-hour continuous intravenous infusion plus best supportive care (BSC) compared to BSC alone, in higher-risk MDS patients with excess blasts (5% to 30% bone marrow blasts), who had progressed on, failed or relapsed after treatment with HMAs. Results of stratified and exploratory subgroup analyses, demonstrating heterogeneity in the study population, were presented at the 2014 American Society of Hematology Annual Meeting (Garcia-Manero et al., Abstract 163). The ONTIME trial did not meet its primary endpoint in the intent-to-treat population, but improvements in median overall survival (mOS) were observed in various pre-specified and exploratory subgroups of patients, including "primary HMA failure" patients (those who had progressed on or failed to respond to previous treatment with HMAs) and patients in the Revised International Prognostic Scoring System (IPSS-R) Very High Risk category (IPSS-R calculates a risk score for MDS patients based on the location and type of chromosome abnormalities, number and degree of cytopenias, and percentage of bone marrow blasts observed at diagnosis). Among the 184 patients (62% of patients in the trial) with primary HMA failure, mOS was 8.6 months in the rigosertib arm (127 patients) compared to 5.3 months in the best supportive care arm (57 patients), with a hazard ratio of 0.69 and a p value of 0.040. Among the 134 patients (45% of patients in the trial) who were in the IPSS-R Very High Risk category, mOS was 7.6 months in the rigosertib arm (93 patients) compared to 3.2 months in the best supportive care arm (41 patients), with a hazard ratio of 0.56 and a p value of 0.005. Further, the safety and tolerability of rigosertib IV in the ONTIME trial was acceptable.
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, 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 those discussed under the heading "Risk Factors" in our most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q.
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