AVEO Falls Over 8% After FDA decision on Tivozanib Print
By Marilyn Mullen   
Friday, 12 June 2015 19:29

AVEO Pharmaceuticals, Inc.(NASDAQ:AVEO) has confirmed receiving written feedback from U.S. Food and Drug Administration for a potential pivotal study for tivozanib in treating NRP-1 low colorectal cancer.  

Tivozanib is a potent and selective inhibitor of vascular endothelial growth factor with long half-life activity against three VEGF receptors.

    

AVEO came out with results BATON-CRC study, 265 patient trial exploring combination of mFOLFOX6 and tivozanib as first-line treatment in patients having advanced metastatic CRC. This was done at the 2015 American Association for Cancer Research Tumor Angiogenesis and Vascular Normalization Conference.

    

Neuropilin-1 (NRP-1) is a signalling protein which is reputed for binding VEGF-A in serum and is said to be potential prognostic marker for angiogenesis inhibitor activity along with being predictive of tivozanib activity relative to bevacizumab.

   

Results from study as well as firm’s ongoing assay development efforts were given to FDA. On the other hand, updated analyses from the firm’s assay development efforts are close to those presented at the AACR conference and would be given at upcoming European Society of Medical Oncology 17th World Congress on Gastrointestinal Cancer that would be happening in Spain.

   

The FDA has suggested that the firm should work on developing the biomarker assay for addressing variability between assays presented and those insufficient data exists for determining appropriateness of subgroup for proposed phase 3 study.

 

Michael Bailey, president and chief executive officer of AVEO, opined that NRP-1 expression is biomarker of growing interest for malignancies. Bailey added that as part of the effort for developing commercial companion diagnostic, the firm would be assessing alternative NRP-1 assays.

 

Bailey also stated that feedback from FDA reinforces importance of ongoing efforts before embarking on pivotal trial.

 

The CEO stated that the firm is looking forward to continue dialogue with Agency and cooperative groups.

 

Shares of the company fell 8.24% to $1.99, off session low of $1.76.




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