Onconova: Enrollment in Phase 3 IV rigosertib trial in HR-MDS is 'top priority'
"As we progress through 2019, we are advancing the clinical development of our pipeline and executing on our collaboration strategy, as highlighted by the recently announced license agreement for investigational rigosertib in Greater China with HanX Biopharmaceuticals," said Steven M. Fruchtman, M.D., President and CEO. "2019 is an important year for Onconova and we are working diligently to execute on our objectives. If successful, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years." Dr. Fruchtman added, "Enrollment in our Phase 3 intravenous rigosertib trial in second-line HR-MDS patients is continuing and is our top priority. We exceeded 75 percent enrollment of the study during the first quarter and are focused on completing enrollment in the second half of 2019 and reporting top-line data following full enrollment and 288 death events. We believe the addition of sites in Brazil and China later this year could contribute significantly to achieving our goal of completing enrollment by year end. We also look forward in the future to initiating a Phase 3 trial with oral rigosertib in combination with azacitidine in first-line HR-MDS patients and to filing an IND in the U.S. for ON 123300, a first-in-class CDK4/6 + ARK5 inhibitor for the treatment of a variety of advanced tumors." Cash and cash equivalents as of March 31, 2019, totaled $10.4M compared to $17M at December 31, 2018. The company expects that cash and cash equivalents at March 31, 2019 will be sufficient to fund ongoing trials and operations into the fourth quarter of 2019. After receiving the upfront proceeds from the HanX rigosertib transaction, the company expects that its cash and cash equivalents will be sufficient to fund ongoing trials and operations into the first quarter of 2020. Net loss was $7.6M for the quarter ended March 31, 2019, compared to $5.1M for the first quarter ended March 31, 2018. Research and development expenses were $4.1M for the quarter ended March 31, 2019, and $4.6M for the comparable period in 2018. General and administrative expenses were $3.2M for the quarter ended March 31, 2019, and $1.9M for the comparable period in 2018.