Broad pipeline includes novel drug candidates in
phase III, early stage clinical and pre-clinical trials
Onconova’s lead product candidate, a small molecule drug candidate, rigosertib, is currently in a pivotal phase III study (“INSPIRE”) for the treatment of MDS after failure of a hypomethylating agent. Rigosertib has a unique mechanism of action that targets the Ras cancer gene, one of the most sought after genes in oncology accounting for more than 30% of human cancers. To date, more than 1,100 patients have been treated with rigosertib.
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 funded through 2017 and is designed to enroll approximately 225 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 lll study in 2017. 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 work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. Onconova has a broad pipeline with three products in clinical trials including rigosertib, briciclib (in advanced solid tumors refractory to current therapies), reclisib (to treat effects of advanced radiation syndromes, specifically cytopenia) and active pre-clinical programs.
Onconova Therapeutics was incorporated in 1998 in Delaware and began trading on the NASDAQ stock exchange under the ticker symbol ONTX in July, 2013.