On November 14, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported a corporate update and reported financial results for the third quarter ended September 30, 2016 (Press release, Onconova, NOV 14, 2016, View Source [SID1234516681]).
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"Onconova continues to reach important milestones in the development of rigosertib for patients with myelodysplastic syndromes (MDS). In July, our partner SymBio Pharmaceuticals announced the enrollment of the first patient in Japan for our INSPIRE pivotal trial for rigosertib in 2nd-line higher-risk MDS (HR-MDS). In September, we announced the results of a successful End-of-Phase 2 meeting with the FDA for oral rigosertib in combination with azacitidine for 1st-line HR-MDS patients," said Ramesh Kumar, Ph.D., President and CEO of Onconova. "We are pleased with the progress of our oral rigosertib development program, as well as the INSPIRE trial that is now running on four continents with more than 150 trial-sites in 15 countries."
Recent Business Highlights:
Progress in Oral Rigosertib Combination with Azacitidine for 1st-line HR-MDS
Following evaluation of 54 enrolled patients in the Phase 2 Trial 09-08 of oral rigosertib plus azacitidine, Onconova conducted an End-of-Phase 2 meeting during which updated results from this trial were discussed with the FDA. Based on these discussions, and guidance from the Agency, Onconova will design a randomized, controlled Phase 3 clinical trial comparing the combination of oral rigosertib plus azacitidine to azacitidine plus placebo in hypomethylating agent (HMA) naïve HR-MDS patients. This sizable population of MDS patients not previously treated with HMAs is a poorly met medical need where the front-line treatments (HMAs) are effective for only a fraction of the indicated patients. Notably, in contrast to the INSPIRE trial, where the primary efficacy endpoint was Overall Survival (OS), the new pivotal trial will employ Response Rate (RR) as the approval endpoint, permitting more rapid completion and evaluation of the study. The RR will be a composite of complete remission (CR) and partial remission (PR).
Progress in INSPIRE Pivotal Trial of IV Rigosertib in 2nd-line HR-MDS
The global Phase 3 INSPIRE trial of IV rigosertib in patients who have failed to respond to or progressed with an HMA therapy is now enrolling in the United States, Europe, Australia, and Japan. As of October 3, 2016, 157 sites were open for the INSPIRE trial to recruit patients.
The INSPIRE trial was recently reviewed in a pre-planned first meeting of the Drug Safety Monitoring Board. Following a review of the safety data of enrolled patients, the Board recommended continuation of the trial without any modifications.
Key Opinion Leader Meeting on Novel Approaches to Targeting RAS
Onconova hosted an investor event featuring two pioneers in the area of RAS biology, Dr. Channing J. Der of the University of North Carolina, and Dr. E. Premkumar Reddy of Mount Sinai School of Medicine. The meeting focused on novel approaches for targeting the RAS pathway and highlighted the therapeutic potential for rigosertib as a novel RAS-directed therapy. A replay of the webcast for this event can be found by clicking the following link: View Source
Recent Rigosertib Publications
Two peer-reviewed articles describing clinical and non-clinical studies with rigosertib in MDS were published in Expert Review of Anticancer Therapy (link to article) and Expert Opinion on Orphan Drugs (link to article).
Upcoming Events
Presentation of updated data from 09-08 combination therapy trial at ASH (Free ASH Whitepaper) Annual Meeting: December 2016
Presentations highlighting safety and tolerability in more than 500 patients, and analysis of previously completed randomized clinical trial of rigosertib at ASH (Free ASH Whitepaper) Annual Meeting: December 2016
Completion of site activation for INSPIRE trial: 1Q2017
Third Quarter 2016 Financial Results
Cash, cash equivalents and marketable securities as of September 30, 2016, totaled $25.8 million, compared to $19.8 million as of December 31, 2015.
Total net revenue was $1.7 million for the third quarter of 2016 and $5.4 million for the nine months ended September 30, 2016, compared to $1.6 million and $1.9 million, respectively, for the comparable periods in 2015.
Research and development expenses were $4.0 million for the third quarter of 2016 and $15.4 million for the nine months ended September 30, 2016, compared to $5.3 million and $21.3 million, respectively, for the comparable periods in 2015.
General and administrative expenses were $2.0 million for the third quarter of 2016 and $7.2 million for the nine months ended September 30, 2016, compared to $2.2 million and $7.8 million, respectively, for the comparable periods in 2015.