Exhibit 99.1

 

 

Onconova Therapeutics, Inc. Reports Recent Business Highlights and First Quarter 2017 Financial Results

 

NEWTOWN, Pa., May 15, 2017 (GLOBE NEWSWIRE) —

Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes, today provided a corporate update and reported financial results for the first quarter ended March 31, 2017.

 

“We had a productive start to 2017, advancing the Phase 3 trial for our lead clinical candidate and securing funding to support ongoing clinical stage trials for patients with Myelodysplastic Syndromes (MDS). The presentation of positive data on two preclinical candidates representing potentially novel approaches for the treatment of Solid Tumors and Acute Myeloid Leukemia, Multiple Myeloma, and Lymphoma has resulted in increased interest from partners, and underscores the depth of our pipeline,” said Dr. Ramesh Kumar, President and Chief Executive Officer.

 

“The INSPIRE Phase 3 trial for our lead clinical candidate, rigosertib, for the second-line treatment of patients with higher-risk (HR) MDS continues to advance as planned, with interim analysis and key enrollment milestones ahead. While we design our global Phase 3 trial of oral rigosertib in combination with azacitidine for first line HR MDS patients, we are expanding our Phase 2 combination trial to obtain additional efficacy and tolerability data across a larger number of trial sites. We plan to seek a Special Protocol Assessment in the United States after first obtaining Scientific Advice from the European regulatory authorities during the third quarter of this year. Thus, we are well-positioned for multiple key milestones as we seek to address the underserved needs of patients with MDS.”

 

Enrollment Progressing for INSPIRE Trial of IV Rigosertib in 2nd Line HR-MDS

 

INSPIRE Trial Update

 

·                  172 trial sites selected globally

 

·                  18 countries with regulatory and IRB/ethics approvals

 

·                  Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Poland, Spain, Sweden, UK & USA

 

·                  Sites expected to initiate in May or June in Switzerland

 

·                  Clinical trial applications are underway for 3 countries (Estonia, Hungry and Russia)

 

·                  163 sites opened to date (44 North America, 86 ROW, 33 Japan)

 

·                  As of April 30, 60 sites in 14 countries have enrolled patients

 

·                  First patients in Belgium, Ireland, Israel and Italy were enrolled in March or April

 


The following information was filed by Onconova Therapeutics, Inc. (ONTX) on Monday, May 15, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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