About Onconova Therapeutics
Onconova Therapeutics, Inc. is a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer. Using a proprietary chemistry platform, Onconova has created a pipeline of targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova has three product candidates in clinical trials and several active pre-clinical programs.
Advanced clinical trials with our lead compound, rigosertib, are aimed at unmet medical needs of patients with myelodysplastic syndromes (MDS). MDS is a hematological malignancy resulting in bone marrow failure which leads to acute myeloid leukemia (AML) in 30% of high-risk patients. There have been no advancements in this indication in more than a decade. Current therapeutic options are not curative and often cause serious side effects. More than 10,000 patients suffer from MDS in the USA, representing a significant unmet medical need.
Onconova Therapeutics was incorporated in 1998 in Delaware and began trading on the NASDAQ stock exchange under the ticker symbol ONTX in July, 2013.
Broad pipeline includes novel drug candidates in
phase 3, early stage clinical and pre-clinical trials
Onconova’s lead product candidate, rigosertib, a small molecule drug candidate, is currently in a pivotal phase 3 study (“INSPIRE”) for the treatment of high-risk MDS after failure of a hypomethylating agent. Rigosertib has a unique mechanism of action that targets the Ras cancer gene product, one of the most sought after targets in oncology involved in more than 30% of human cancers.
The INSPIRE trial design is informed by prior studies which identified a sub-population in patients where the drug was highly effective. This trial is designed to enroll approximately 360 patients in the United States, Europe, Japan and Australia. An oral form of rigosertib has also been tested in combination with azacitidine in a Phase 1/2 trial for higher-risk MDS (HR-MDS) which showed promising interim data, setting the stage for a pivotal, Phase 3 study. Rigosertib is protected by issued patents and has been awarded Orphan Designation for MDS in the United States, Europe and Japan.
Using a proprietary chemistry platform, Onconova has created a pipeline of targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova has a broad pipeline with three products in clinical trials including rigosertib, briciclib (in advanced solid tumors refractory to current therapies), and recilisib (to treat effects of advanced radiation syndromes, specifically cytopenias), as well as active pre-clinical programs.
Dr. James Holland
We were deeply saddened by the passing of Dr. James Holland, a distinguished member of our advisory board since 2004. Dr. Holland passed away on March 22, 2018.