CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced that it has received written feedback from the U.S. Food and Drug Administration regarding a potential pivotal study for tivozanib in the treatment of NRP-1 low colorectal cancer (CRC). Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor (VEGF) with a long half-life and activity against all three VEGF receptors.
AVEO recently presented results from the BATON-CRC study, a 265 patient randomized trial exploring the combination of mFOLFOX6 and tivozanib or bevacizumab as first-line treatment in patients with advanced metastatic CRC, at the 2015 American Association for Cancer Research (AACR) Tumor Angiogenesis and Vascular Normalization Conference. Among the predefined biomarkers explored in this study, neuropilin-1 (NRP-1), a signaling protein known to bind to VEGF-A in serum, was found to be a potential prognostic marker for angiogenesis inhibitor activity and may be predictive of tivozanib activity relative to bevacizumab.
Results from this study and the Company’s ongoing assay development efforts were presented to the FDA. Updated analyses from the Company’s assay development efforts, which are similar to those presented at the AACR conference, will be presented at the upcoming European Society of Medical Oncology 17th World Congress on Gastrointestinal Cancer taking place July 1-4, 2015 in Barcelona Spain.
In response to questions from AVEO regarding a proposed pivotal phase 3 trial of tivozanib in CRC, the FDA suggested that the Company continue work on the development of its biomarker assay to address variability between assays presented, and that, at present, “insufficient data exists to determine the appropriateness of this [NRP-1 low] subgroup” for the proposed phase 3 study. This feedback is consistent with the Company’s current clinical strategy and discussions with cancer research cooperative groups. As such, AVEO plans to evaluate options to confirm the activity of tivozanib and FOLFOX in NRP-1 low CRC through a prospectively defined, randomized Phase 2 study, while continuing to work on the development of a commercially viable assay.
“NRP-1 expression is a biomarker of growing interest for malignancies treated with angiogenesis inhibitors,” said Michael Bailey, president and chief executive officer of AVEO. “As part of our effort to develop a commercial companion diagnostic, we continue to evaluate alternative NRP-1 assays. Feedback from the FDA reinforces the importance of these ongoing efforts prior to embarking on a pivotal trial. We look forward to continuing our dialogue with the Agency and cooperative groups toward the design and potential conduct of an appropriate confirmatory study and the development of a companion diagnostic.”
AVEO Oncology (AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words “anticipate,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward looking statements include among others statements about AVEO's clinical development plans for tivozanib in CRC. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to demonstrate to the satisfaction of the FDA, EMA or other equivalent foreign regulatory agencies, include the Rapporteurs in Europe, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO’s ability to successfully implement its restructuring and strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise the substantial additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” included in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date subsequent to the date of this press release.