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AVEO Stops AML Study on Ficlatuzumab Amid Coronavirus Pandemic

Zacks Equity Research

AVEO Pharmaceuticals, Inc. AVEO and partner Biodesix, Inc. announced that they discontinued the phase II CyFi-2 study evaluating ficlatuzumab in combination with high-dose cytarabine versus high-dose cytarabine alone in patients with relapsed/refractory acute myeloid leukemia (AML).

The decision was prompted by the urgent shift in focus of clinical sites on making efforts to combat the coronavirus disease, COVID-19.

Notably, in November 2019, AVEO and Biodesix initiated the phase II CyFi-2 study on ficlatuzumab for the given indication. The study is yet to begin patient enrollment.

AVEO and Biodesix share a worldwide agreement to develop and commercialize ficlatuzumab.

Meanwhile, in January 2020, AVEO and Biodesix presented data from a phase Ib study evaluating ficlatuzumab in combination with nab-paclitaxel and Eli Lilly’s LLY Gemzar (gemcitabine) to address the previously-untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer.

This early-stage study was designed to find the maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel for treating the given patient population.

Ficlatuzumab is a potent hepatocyte growth factor (HGF) inhibitory antibody product candidate. AVEO is also developing ficlatuzumab for treating squamous cell carcinoma of the head and neck (SCCHN).

Shares of AVEO have plunged 61.5% in the past year compared with the industry’s decrease of 10%.

We note that many companies are closely monitoring the current situation related to the COVID-19 outbreak and are implementing plans to stay prepared for the protection of their employees and business as well as communities.

Large-pharma companies like Pfizer PFE and Lilly decided to delay the initiation of most of their new clinical studies and stop enrollment in the ongoing ones. Bristol-Myers BMY is also deferring its new clinical studies and decided to postpone the launch of its recently-approved multiple sclerosis drug, Zeposia. Several other smaller drug/biotech companies plan to push back recruitment in their ongoing clinical studies post the pandemic outbreak.

COVID-19 has so far affected more than 700,000 people across countries, claiming more than 34,000 lives. The death toll in the United States crossed the 2000-mark. Several countries are on lockdown to stop the spread of this deadly virus, which is also adversely impacting their economies.

Zacks Rank

AVEO currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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