Troubled Aveo hit with another setback as investigators shutter PhII
Aveo Oncology may be under new management, but it’s still afflicted by a long-running pattern of trouble in the clinic. Usually, that trouble has been focused on its lead drug tivozanib. This time, though, the setback is for its number two drug in the clinic.
In a filing with the SEC Monday morning, the biotech $AVEO says that it was forced to discontinue a mid-stage study for ficlatuzumab due to a high discontinuation rate among a group of patients in the drug arm. The drug is a hepatocyte growth factor (HGF) inhibitory antibody.
After experiencing slower than expected enrollment, a blinded interim analysis of the FOCAL study was conducted and found that patients who were positive for both VSP and EGFR mutations, who were known to be selected for poor prognosis, experienced materially higher discontinuation rates than observed in both the general ITT population and retrospective exploratory subgroup population of Study P06162, which was the basis for the FOCAL study design. This observation significantly compromised the feasibility of the trial. The parties have mutually agreed to discontinue the study. The parties intend to further discuss the details for the discontinuation of the study and future development of ficlatuzumab.
Back in March, Aveo agreed to pay a $4 million SEC fine to settle its end of a probe into the way the biotech’s top execs kept an agency demand for a new study of tivozanib secret, failing to tell its investors about the agency’s deep concerns over patient deaths. Three of those execs — including former CEO Tuan Ha-Ngoc, who stepped down in 2015 as most of the staff was laid off — are still under investigation.
The fine sent the company’s shares back into penny stock territory, where it still resides today. Aveo has a market cap of $66 million.
Aveo has had to endure a series of setbacks for tivozanib, failing a study in 2013 and then forced to close a Phase II in 2014 in another failure to enroll enough patients. More recently, though, Bristol-Myers agreed to supply Opdivo for an early stage combo study, matching the checkpoint drug with tivozanib for renal cell carcinoma.