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01/30/14 - $16.22
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onconova therapeutics inc (ONTX) Details

Onconova Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on discovering and developing small molecule drug candidates to treat cancer. Its clinical-stage product candidates include rigosertib intravenous that is in Phase III trials for higher risk myelodysplastic syndromes (MDS); rigosertib Oral, which is Phase II clinical trials for patients with transfusion-dependent lower risk MDS and in patients with head and neck cancers; and a combination of rigosertib Oral and azacitidine in a Phase 1/2 study of first-line MDS patients. The company’s clinical-stage product candidates also comprise ON 013105, a small molecule targeting an important regulatory protein, cyclin D1, which is found at elevated levels in cancer cells; and recilisib, a molecule with radiation protection properties has completed four Phase I clinical trials. In addition, its preclinical products consist of ON 1231320, an inhibitor of polo-like kinase 2; ON 123300, an inhibitor of the cell cycle and cancer cell metabolism; ON 108600, an inhibitor of cyclin-dependent kinase 9 and casein kinase 2; ON 044580, a dual inhibitor of janus kinase 2 and Bcr-Abl kinase; ON 24 series of compounds that are oral anti-tubulin agents; and ON 146 series, which are selective inhibitors of PI3K alpha/delta isoforms. It has a development and license agreement with Baxter Healthcare SA; and a license agreement with SymBio Pharmaceuticals Limited. The company was founded in 1998 and is headquartered in Newtown, Pennsylvania.

64 Employees
Last Reported Date: 03/20/14
Founded in 1998

onconova therapeutics inc (ONTX) Top Compensated Officers

Co-Founder, Chief Executive Officer, Presiden...
Total Annual Compensation: $742.8K
Chief Financial Officer and Secretary
Total Annual Compensation: $347.9K
President of Research and Development
Total Annual Compensation: $359.0K
Compensation as of Fiscal Year 2013.

onconova therapeutics inc (ONTX) Key Developments

Onconova Therapeutics, Inc. Appoints Steven M. Fruchtman as Chief Medical Officer and Senior Vice President, Research and Development

Onconova Therapeutics, Inc. announced the appointment of Steven M. Fruchtman, M.D., as Chief Medical Officer and Senior Vice President, Research and Development. Dr. Fruchtman is a board certified hematologist with extensive industry experience in clinical research for myelodysplastic syndromes (MDS), hematologic malignancies and solid tumors. He will report to Thomas J. McKearn, M.D., Ph.D., the Company's President, Research and Development, and will provide worldwide strategic planning and leadership for the clinical development and registration of rigosertib and other pipeline product candidates. Dr. Fruchtman joins Onconova after a distinguished career in both academia and the industry. Most recently he was the Chief Medical Officer of Syndax Pharmaceuticals, where he led the clinical development of entinostat for breast cancer.

Onconova Therapeutics, Inc.(NasdaqGS:ONTX) dropped from NASDAQ Biotechnology Index

Onconova Therapeutics, Inc. will be removed from the NASDAQ Biotechnology Index.

Onconova Therapeutics, Inc. Announces Data from Clinical Trials of Rigosertib in Myelodysplastic Syndromes and Non-Proliferative Acute Myeloid Leukemia

Onconova Therapeutics, Inc. announced the presentation of data from clinical trials of rigosertib in myelodysplastic syndromes (MDS) and non-proliferative acute myeloid leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting. Based on synergistic anti-leukemic activity of the combination of rigosertib and azacitidine demonstrated in non-clinical studies, an exploratory, dose-range finding study was conducted at Mount Sinai Medical Center and the MD Anderson Cancer Center. A total of 18 patients with MDS or non-proliferative AML, who were either previously untreated with hypomethylating agents (HMAs), or who had failed or progressed on an HMA, were included in this study. The indicated dose of azacitidine (75 mg/m2/day) was given in combination with escalating doses of oral rigosertib in three successive cohorts (140-560 mg given two times daily). Oral rigosertib was administered from day one through day 21 of a 28-day cycle. Azacitidine was administered for seven days starting on day eight of the 28-day cycle. Nine patients with MDS, eight patients with AML and one patient with CMML received the combination.  Responses according to International Working Group (IWG) criteria were observed. Marrow complete remission (mCR) was achieved in five patients (2 AML; 3 MDS). Complete remission with incomplete recovery of blood counts (CRi) was observed in four patients (1 AML; 3 MDS), and stable disease (SD) was observed in two patients (1 MDS; 1 CMML). Measures of hematological improvement, including increases in platelet (1 AML; 2 MDS patients), erythroid (2 MDS patients) and neutrophil (2 MDS patients) counts were observed with the combination. Notably, two MDS patients who responded had previously failed treatment with a hypomethylating agent. The most frequently reported adverse events in cycle 1 included constipation, diarrhea, nausea, fatigue, hypotension, and pneumonia. The adverse events did not differ significantly among the three dosing cohorts. The only adverse events of Grade 3 or greater that occurred in more than one patient were pneumonia (4), neutropenia, (3), febrile neutropenia (2) and thrombocytopenia (2). Elevation in creatinine in one patient in the first cohort was deemed as a possible treatment-related Grade 3 dose-limiting toxicity that required subsequent expansion of the cohort. Overall, the adverse event profile did not appear to differ significantly from that reported for azacitidine alone. The Phase 2 segment of the study is underway in multiple centers to further assess the response to the combination.


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