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Onconova Announces Presentation Of Positive Data From Clinical Trials Of Rigosertib In Myelodysplastic Syndromes (MDS) At The 2013 ASH Annual Meeting

NEWTOWN, Pa., Dec. 9, 2013 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced two presentations relating to clinical trials of its most advanced product candidate, rigosertib, at the 55 th American Society of Hematology (ASH) Annual Meeting in New Orleans, Louisiana, December 7-10, 2013. The presentations included data on efficacy, tolerability, and dosing regimen from the Phase 2 ONTARGET study of oral rigosertib in transfusion-dependent, lower risk MDS patients and response, overall survival, and longer-term follow-up data from a Phase 1/2 trial of intravenous (IV) rigosertib in higher risk post-hypomethylating agent-treated MDS and acute myeloid leukemia (AML) patients.

"The presentations at ASH reinforce the emerging therapeutic and safety/tolerability profiles of rigosertib, our small-molecule inhibitor of PI3K and PLK pathways, and underscore our commitment to develop rigosertib as a novel treatment for patients with MDS," commented Ramesh Kumar, Ph.D., President and Chief Executive Officer of Onconova. "We look forward to the design of an approval-track trial of oral rigosertib in transfusion-dependent, lower risk MDS and top-line data from our Phase 3 pivotal trial in higher risk MDS."

Data from oral rigosertib trials in lower risk MDS patients:

Azra Raza, M.D., Director, MDS Center, Columbia University Medical Center et al., presented a poster entitled "Oral Rigosertib (ON 01910.Na) Treatment Produces An Encouraging Rate Of Transfusion Independence In Lower Risk Myelodysplastic Syndromes (MDS) Patients; A Genomic Methylation Profile Is Associated With Responses." The poster summarized data from the Phase 2 ONTARGET trial of oral rigosertib in transfusion-dependent, lower risk MDS patients.  

  • A combined response rate of 53% according to International Working Group criteria (IWG) was observed in 36 evaluable patients receiving the intermittent dosing schedule.
  • Overall, transfusion independence was observed in 39% (14 of 36) of patients receiving at least eight weeks of intermittent rigosertib. 
  • In these patients, rigosertib induced transfusion independence when employed as a single agent or when used in combination with erythropoiesis-stimulating agents (ESA).
  • The dose of 560 mg twice a day (BID) given for two weeks of a three-week cycle was found to be better tolerated than a continuous BID dosing schedule (three weeks of a three-week cycle). Nine patients received continuous dosing and the remainder (51 patients) received the intermittent dosing. The major adverse events were related to bladder toxicity and included dysuria, frequency of urination, and hematuria/cystitis. No treatment emergent myelosuppression was noted in this study.
  • To address urinary adverse events, a modified dosing regimen with 560 mg in the morning and 280 mg in the afternoon was tested in a cohort. Although the follow-up of this cohort is still limited, of the 13 patients receiving the new regimen only one patient reported a Grade 2+ urinary event (8%).
  • Employing a whole genome scan, a methylation signature comprising 50 loci was identified. This signature helped to relate transfusion independence with methylation profile in the 32 patients analyzed. A confirmation cohort of 20 additional patients is now being enrolled to further explore this potential prognostic tool. 

A second Phase 2 clinical trial, the 09-07 study, is open to further explore the safety and the possible effects of oral rigosertib in transfusion-dependent, lower risk MDS patients who have failed ESA treatment. 

Stock quotes in this article: ONTX 

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