AVEO Oncology & Biodesix to Discontinue CyFi-2 Study of Ficlatuzumab in Relapsed & Refractory AML in Response to Public Healt...
March 27 2020 - 4:40PM
Business Wire
AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced
the discontinuation of their CyFi-2 study, a randomized Phase 2
clinical study evaluating ficlatuzumab, AVEO’s potent hepatocyte
growth factor (HGF) inhibitory antibody product candidate, in
combination with high-dose cytarabine vs. high-dose cytarabine
alone in patients with relapsed and refractory acute myeloid
leukemia (AML). This decision is being taken due to the urgent
shift among clinical sites toward efforts to combat the COVID-19
pandemic, which has impacted the feasibility of completing the
study within the shelf-life of the current ficlatuzumab clinical
trial supply. The study has not yet begun patient enrollment.
“While this is a difficult decision, as we remain optimistic
about the potential of ficlatuzumab in AML, we believe it is
necessary in light of the COVID-19 pandemic and its effect on the
states where the CyFi-2 study was to take place,” said Michael
Bailey, president and chief executive officer of AVEO. “Our
investigators have been informed of the closure, and we greatly
appreciate their enthusiasm for the study. We remain committed to
the practice of scientific discovery and will focus our resources
and efforts on our ongoing initiatives.”
About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte
growth factor (HGF) inhibitory antibody that binds to the HGF
ligand with high affinity and specificity to inhibit HGF/c-Met
biological activities. AVEO and Biodesix, Inc. have a worldwide
agreement to develop and commercialize ficlatuzumab. Ficlatuzumab
is currently being evaluated in a clinical study of patients with
squamous cell carcinoma of the head and neck (HNSCC).
About AVEO
AVEO is developing an oncology pipeline designed to provide a
better life for patients with cancer. AVEO’s strategy is to focus
its resources toward development and commercialization of its
product candidates in North America, while leveraging partnerships
to support development and commercialization in other geographies.
AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the
European Union, the United Kingdom, Norway, New Zealand and Iceland
for the treatment of adult patients with advanced renal cell
carcinoma. AVEO is working to develop and commercialize tivozanib
in North America as a treatment for renal cell carcinoma,
hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb)
is in a Phase 2 clinical trial in head and neck cancer and has
reported early clinical data in pancreatic cancer. AVEO’s
earlier-stage pipeline includes several monoclonal antibodies in
oncology development, including AV-203 (anti-ErbB3 MAb), AV-380
(GDF15 MAb) and AV-353 (Notch 3 MAb). For more information, please
visit the Company’s website at www.aveooncology.com.
About Biodesix
Biodesix is a lung cancer diagnostic solutions company covering
the continuum of patient care from early risk classification of
lung nodules through treatment guidance in late stage cancer. The
Company develops blood-based diagnostic tests addressing important
clinical questions by combining multi-omics through the power of
artificial intelligence. Biodesix is the first company to offer
four approved, non-invasive tests for patients with lung cancer or
suspicious lung nodules. The Biodesix Lung Reflex® strategy for
lung cancer patients integrates the GeneStrat® and VeriStrat® tests
to support treatment decisions with results in 72 hours, expediting
time to treatment. The Nodify XL2TM test and the Nodify CDTTM test
evaluate the risk of malignancy in incidental pulmonary nodules,
enabling physicians to better triage patients to the most
appropriate course of action. Biodesix also collaborates with many
of the world’s leading biotechnology and pharmaceutical companies
to solve complex diagnostic challenges. For more information about
Biodesix, please visit www.biodesix.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 fact, contained in
this press release are forward-looking statements. The words
“anticipate,” “believe,” “designed to,” “expect,” “intend,” “may,”
“plan,” “potential,” “could,” “should,” “would,” “seek,” “look
forward,” “advance,” “goal,” “strategy,” 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
strategy, prospects, plans and objectives for ficlatuzumab and its
other product candidates and for the Company generally. AVEO has
based its expectations and estimates on assumptions that may prove
to be incorrect. As a result, readers are cautioned not to place
undue reliance on these expectations and estimates. 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, and the ability of its licensees, to
demonstrate to the satisfaction of applicable regulatory agencies
such as the FDA the safety, efficacy and clinically meaningful
benefit of AVEO’s product candidates, including, in particular,
tivozanib and ficlatuzumab; AVEO’s ability to successfully file an
NDA for tivozanib; and AVEO’s ability to enter into and maintain
its third party collaboration and license agreements, and its
ability, and the ability of its strategic partners, to achieve
development and commercialization objectives under these
arrangements. AVEO faces other risks relating to its business as
well, including risks relating to the impact of the novel
coronavirus (COVID-19) outbreak on AVEO’s clinical trials and other
business operations; the timing and costs of seeking and obtaining
regulatory approval; AVEO’s and its collaborators’ ability to
successfully enroll and complete clinical trials; AVEO’s ability to
maintain compliance with 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; AVEO’s ability to successfully implement its strategic
plans; AVEO’s ability to raise the substantial additional funds
required to achieve its goals, including those goals pertaining to
the development and commercialization of tivozanib; the outcome of
litigation; unplanned capital requirements; adverse general
economic and industry conditions; competitive factors; and those
risks discussed in the sections titled “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Liquidity and Capital Resources” included in
AVEO’s quarterly and annual reports on file with the Securities and
Exchange Commission (SEC) and in other filings that AVEO makes with
the SEC. The forward-looking statements in this press release
represent AVEO’s views as of the date of this press release, and
subsequent events and developments may cause its views to change.
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 other than
the date of this press release. Any reference to AVEO’s website
address or a third-party website address in this press release is
intended to be an inactive textual reference only and not an active
hyperlink.
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version on businesswire.com: https://www.businesswire.com/news/home/20200327005510/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
BIODESIX: Jordona Jackson Smith for Biodesix (805)
674-7347 Jordona@jacksonbio.com
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