–Rigosertib plus Azacitidine Combination Phase 2 Trial Results Featured–
NEWTOWN, Pa., Nov. 04, 2016 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that three abstracts relating to the Company’s lead product candidate, rigosertib were accepted for presentation at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, California, which takes place December 3-6, 2016.
Details for the presentations are listed below.
Combination Therapy Phase 2 Data
Abstract Number: 3167
Title: Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster II
Date: Sunday, December 4, 2016
Presentation Time: 6:00 – 8:00 PM PST
Location: Hall GH (San Diego Convention Center)
Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Safety Analysis Summary for >500 Patients Treated with Rigosertib in Clinical Trials
Abstract Number: 2011
Title: Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster I
Date: Saturday, December 3, 2016
Presentation Time: 5:30 – 7:30 PM PST
Location: Hall GH (San Diego Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
Computational Analysis of Subgroup Data from Previous Clinical Trials
Abstract Number: 4324
Title: Computational Analysis of Genomic Abnormalities from a Phase 3 Trial of Rigosertib in Higher-Risk MDS: Simulation of a Predictive Signature for Clinical Response
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III
Date: Monday, December 5, 2016
Presentation Time: 6:00 – 8:00 PM PST
Location: Hall GH (San Diego Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a Phase 3 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. The Company’s most advanced product candidate, rigosertib, is a small molecule inhibitor of cellular signaling and acts as a RAS mimetic. These effects of rigosertib appear to be mediated by direct binding of the compound to the RAS-binding domain (RBD) found in many RAS effector proteins, including the Raf and PI3 kinases. Rigosertib is protected by issued patents (earliest expiry in 2026) and has been awarded Orphan Designation for MDS in the United States, Europe and Japan. In addition to rigosertib, two other candidates are in the clinical stage, and several candidates are in pre-clinical stages. For more information, please visit http://www.onconova.com.
About Oral Rigosertib
The oral form of rigosertib provides a more convenient dosing for use where the duration of treatment may extend to multiple years. To date, more than 350 patients have been treated with the oral formulation of rigosertib, either as a single agent or in combination with other drugs. Phase 1 studies with 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.
About Trial 09-08 (NCT01926587): Combination therapy with oral rigosertib and azacitidine
The current standard of care for higher-risk MDS patients is one of two approved hypomethylating agents (Azacitidine and Decitabine, approved by the FDA in 2004 and 2006). Although these drugs are currently the mainstays in HR-MDS therapy, their overall response rate and duration of benefit is limited to a subset of eligible patients and all responding patients ultimately progress. Therefore, there is an urgent need for developing therapeutic options for newly diagnosed MDS patients. The 09-08 Phase 1/2 trial tested oral rigosertib in combination with injectable azacitidine in a dose ranging study (Phase 1), followed by an expansion cohort (Phase 2) to evaluate the efficacy and safety of the combination. Interim results from this trial were presented at the 2015 ASH conference indicating that the combination was generally well tolerated and that clinical responses were observed in 23 of 30 MDS patients evaluable for efficacy assessment.1 Both 1st-line and 2nd-line patients were included in this study.
The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trial involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 global INSPIRE trial as 2nd-line treatment for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is suited for patients with advanced disease and provides long duration of exposure and ensures adequate dosing under a controlled setting.
References
1Navada S, et al. A phase 2 study of the combination of oral rigosertib and azacitidine in patients with myelodysplastic syndrome (MDS). ASH 2015; Abstract 910.
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,” “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 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.
CONTACT: CONTACT: Onconova Therapeutics
Benjamin Hoffman, 267-759-3036
bhoffman@onconova.us
