Last $2.29 USD
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Volume 22.2K
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onconova therapeutics inc (ONTX) Snapshot

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02/27/14 - $8.89
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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 Announces Clinical Development Plan for Rigosertib in Higher Risk Myelodysplastic Syndrome (HR-MDS) Patients

Onconova Therapeutics, Inc. announced that following discussions regarding the future development of rigosertib with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and several European national regulatory agencies, the Company has solidified its plans for a Phase 3 clinical trial for rigosertib in HR-MDS patients after failure of treatment with HMAs. Pending regulatory approvals and appropriate financing, Onconova hopes to initiate trial enrollment during the second half of 2015. Based on subgroup analyses and the current lack of any approved second-line therapies for HR-MDS patients, Onconova explored various approval pathways with the regulatory agencies. An unmet medical need exists for MDS patients who do not benefit from HMA therapies. The potential for refining the clinical indication was discussed with both the FDA and EMA, based on the demonstration of heterogeneity in the ONTIME trial patient population and the consequent definition of subgroups with high prognostic risk that appear to derive a greater benefit from rigosertib treatment. Both the FDA and EMA have expressed a preference for a randomized controlled trial with overall survival and overall response as clinically meaningful endpoints. Therefore, based on the feedback from the FDA and the EMA, and utilizing the results of the ONTIME trial, a randomized controlled trial in a more homogeneous patient population is being developed for regulatory review.

Onconova Therapeutics, Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 01:00 PM

Onconova Therapeutics, Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 01:00 PM. Venue: Waldorf Astoria New York, New York, New York, United States. Speakers: Ramesh Kumar, Co-Founder, Chief Executive Officer, President and Director.

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.


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