Sunesis Pharmaceuticals Announces European Medicines Agency Acceptance of Pediatric Investigation Plan for QINPREZO™ (Vosaroxin) for AML
A PIP is part of the EMA approval process and must be accepted prior to submission of a Marketing Authorization Application (MAA) for the drug in the
"We are pleased with the acceptance of our PIP by the EMA, an important step leading into a potential filing of our Marketing Authorization Application for QINPREZO in
About QINPREZOTM (vosaroxin)
QINPREZOTM (vosaroxin) is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that QINPREZO both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the
The trademark name QINPREZO is conditionally accepted by the
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, QINPREZO, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of
This press release contains forward-looking statements, including statements related to Sunesis' overall strategy, the design, conduct, progress, timing and results of the VALOR trial and Sunesis' other clinical trials and the commercial potential for QINPREZO™ (vosaroxin). Words such as "anticipate," "approximately," "believe," "could," "estimate," "expect," "potential," "remain," "transform," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of QINPREZO, risks related to whether outstanding warrants will be exercised in the future, risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of QINPREZO, the risk that raising funds through lending arrangements may restrict our operations or produce other adverse results, the risk that Sunesis' development activities for QINPREZO could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for QINPREZO may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717