NEWTOWN, Pa., June 01, 2016 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced it filed a registration statement on Form S-1 with the Securities and Exchange Commission for a rights offering to its existing stockholders.
Under the proposed rights offering, Onconova would distribute non-transferable subscription rights to purchase units to its stockholders and participating warrant holders on the record date. Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other shareholders. The Company has not yet announced the composition of the units, a subscription price, record date or subscription period.
Onconova plans to use the proceeds from the rights offering to continue funding INSPIRE, the Company’s ongoing global Phase 3 clinical trial of rigosertib IV in a population of patients with higher-risk myelodysplastic syndromes (MDS) after failure of hypomethylating agent (HMA) therapy. INSPIRE was initiated in the fourth quarter of 2015, and is now enrolling patients in the U.S. and Europe at 57 sites. The Company also plans to use a portion of the proceeds for other development of the Company’s clinical and preclinical programs, other research and development activities, business development and general corporate purposes, which may include capital expenditures and funding working capital needs.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About INSPIRE
The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first nine months of initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer. Onconova's clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. In addition to rigosertib, the Company's most advanced product candidate, two other candidates are clinical stage, and several candidates are in pre-clinical stages. For more information, please visit http://www.onconova.com
