On December 17, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Pint Pharma, a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market, reported the receipt of approval from the Brazilian Health authority to initiate the INSPIRE Trial in Brazil with intravenous rigosertib in Higher-Risk MDS (HR-MDS) (Press release, Onconova, DEC 17, 2019, View Source [SID1234552438]). In November 2019 enrollment in the INSPIRE Trial surpassed 90% percent of the required enrollment, and the Company continues to anticipate reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events.

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"As we enter the final stage of enrollment of the INSPIRE Trial, we thank our corporate partner Pint Pharma for their collaboration in opening the study in Brazil," said Dr. Steven Fruchtman, President and CEO of Onconova Therapeutics, Inc. "The INSPIRE Trial surpassed 90% percent of the required enrollment in November 2019 and we expect the addition of up to 16 clinical trial sites in Brazil will provide further momentum to our anticipated reporting of topline data in the first half of 2020, following full enrollment and reaching the number of required survival events."

"We are excited to collaborate with Onconova in opening new clinical sites and look forward to the recruitment of eligible patients for the INSPIRE Trial in Brazil," said David Munoz, Chief Executive Officer of Pint Pharma. He added, "We are also pleased that local physicians will gain invaluable experience with rigosertib by their participation on the INSPIRE Trial."

Dr. Ric Woodman, Chief Medical Officer of Onconova, is working closely with Dr. Valnei Canutti, Chief Scientific Officer of Pint. Dr. Woodman commented, "There is a great unmet medical need and interest to conduct studies in patients with HR-MDS in this geographical region. I look forward to a productive collaboration with Pint Pharma and working with Dr. Canutti, an expert in conducting trials in Brazil as well as an expert in MDS."

Dr. Canutti added, "We anticipate meaningful contributions from Brazil to accrual to the INSPIRE Trial and are excited about receiving health authority approval to initiate INSPIRE in Brazil. There are significant numbers of patients with HR-MDS in Brazil with no approved approach following failure of the standard of care azacitidine. We at Pint, in collaboration with our partner Onconova, look forward to Brazil’s contributions to complete accrual to this important pivotal global trial."

About Pint Pharma

Pint Pharma is devoted to the development, registration, and commercialization of specialty-based treatments. Pint Pharma benefits from leaders with extensive experience in the pharmaceutical sector and who are based strategically throughout Latin America and Europe. Pint Pharma has a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma strives to be the first Pan-Latin American provider of innovative and high value-added treatments within Rare Diseases, Specialty Care, and Oncology.