Onconova Therapeutics Inc. (NASDAQ: ONTX) led the bulls early in Tuesday’s trading session on positive data from an ongoing Phase 1/2 clinical trial. The company announced the presentation of data from an ongoing Phase 1/2 clinical trial of oral rigosertib and azacitidine in higher-risk myelodysplastic syndromes (HR-MDS) at the 57th American Society of Hematology (ASH) Annual Meeting.
So far the combination of oral rigosertib and azacitidine has been well tolerated to date. However there were adverse events of Grade ≥3 experienced across all cycles. It’s worth noting that these side effects were similar to the side effects previously reported for azacitidine administered alone.
The combination achieved a 77% overall response rate in all MDS patients, and an overall response rate of 84% in treatment-naïve MDS patients.
Lewis R. Silverman, M.D., investigator in the trial and Associate Professor of Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai, said:
The high response rate observed in the 09-08 combination trial is impressive. Furthermore, the tolerability profile of oral rigosertib and azacitidine suggests that this combination could be used in HR-MDS. These results provide strong support for the advancement of oral rigosertib into late-stage clinical trials.
Onconova intends to seek an end of Phase 2 meeting with U.S. and European regulators in order to discuss next steps for the combination program.
Ramesh Kumar, Ph.D., president and CEO of Onconova, added:
The results for oral rigosertib in combination with azacitidine support moving this novel therapy towards pivotal trials for patients with MDS and myeloid malignancies. We intend to provide clarity related to timing of further development for oral rigosertib at our upcoming investor event on December 16th.
Shares of Onconova were trading up over 40% at $1.84 just after the markets opened on Tuesday but pulled back afterward. The stock has a consensus analyst price target of $5.00 and a 52-week trading range of $1.12 to $4.47.