AVEO Oncology Announces Completion of a CHMP Oral Explanation for Tivozanib as a Treatment of First-Line Renal Cell Carcinoma
May 19 2017 - 7:00AM
Business Wire
AVEO Oncology (NASDAQ:AVEO) today announced its European
licensee for tivozanib, EUSA Pharma, has completed an oral
explanation to the Committee for Medicinal Products for Human Use
(CHMP), the scientific committee of the European Medicines Agency
(EMA), as part of the Marketing Authorization Application (MAA)
review process for tivozanib as a treatment for patients with
first-line renal cell carcinoma (RCC). It is expected that with the
oral explanation complete, the CHMP will proceed to an opinion
which they will submit to the European Commission (EC), which has
the authority to approve medicines for use in the 28 countries in
the European Union. The opinion is expected to be announced at a
future CHMP meeting.
“We are pleased that the file continues to progress through the
CHMP review process with EUSA having completed an oral explanation
for tivozanib,” said Michael Bailey, president and chief executive
officer of AVEO. “We believe tivozanib’s unique tolerability
profile, together with the longest progression free survival from a
Phase 3 first line RCC study, demonstrates its potential to enhance
treatment options for RCC patients.”
RCC is the most common form of kidney cancer,i which accounts
for an estimated 49,000 deaths in Europe each year.ii It is
expected to be one of the fastest increasing cancers over the next
ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial
growth factor (VEGF) inhibitors are the gold standard treatment for
advanced RCC in Europe, however, patients on current treatments can
often experience significant side effects.iv,v
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth
factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent,
selective and long half-life inhibitor of all three VEGF receptors
and is designed to optimize VEGF blockade while minimizing
off-target toxicities, potentially resulting in improved efficacy
and minimal dose modifications. Tivozanib has been investigated in
several tumors types, including renal cell, colorectal and breast
cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology
and other areas of unmet medical need. The Company is focused on
seeking to develop and commercialize its lead candidate tivozanib,
a potent, selective, long half-life inhibitor of vascular
endothelial growth factor 1, 2 and 3 receptors, in North America as
a treatment for renal cell carcinoma and other cancers. AVEO is
leveraging multiple partnerships aimed at developing and
commercializing tivozanib in oncology indications outside of North
America, and at progressing its pipeline of novel therapeutic
candidates in cancer and cachexia (wasting syndrome). 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
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,” “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: the Company’s expectation that the CHMP
will proceed to an opinion in connection with its review process
for tivozanib as a treatment for RCC, that they will announce such
opinion at a future CHMP meeting and will submit such opinion to
the EC; AVEO’s beliefs about the potential therapeutic benefits of
tivozanib as a treatment, including for RCC; AVEO’s strategy,
prospects, plans and objectives, including those that relate to
advancing therapeutics, including tivozanib, and for leveraging
collaborations. 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: whether the
tivozanib file will continue to progress through the CHMP on the
time frame and manner currently expected; AVEO’s ability to enter
into and maintain its third party collaboration agreements; the
ability of AVEO and its licensees and other partners to achieve
development and commercialization objectives under these
arrangements, including, in the case of EUSA’s, its plans to
advance the development and commercialization of tivozanib in the
European Union; AVEO’s ability, and the ability of its licensees,
to demonstrate to the satisfaction of applicable regulatory
agencies the safety, efficacy and clinically meaningful benefit of
AVEO’s product candidates, including without limitation risks
relating to the ability of EUSA to successfully obtain approval of
its MMA for tivozanib in the European Union. AVEO faces other risks
relating to its business as well, including its ability to
successfully enroll and complete clinical trials, including the
TIVO-3 and TiNivo studies; 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, expenses and outcomes
related to AVEO’s ongoing shareholder litigation; 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; unplanned capital requirements;
adverse general economic and industry conditions; competitive
factors; and those risks discussed in the section titled “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital
Resources” included in AVEO’s Annual Report on Form 10-K for the
year ended December 31, 2016, its quarterly reports on Form 10-Q
and in other filings that AVEO may make with the SEC in the future.
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 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.
____________________________
i Cancer Research UK. Kidney Cancer, Types
and Grades. Available at:
http://www.cancerresearchuk.org/about-cancer/kidney-cancer/stages-types-grades/types-grades.
Last accessed May 2017.
ii Cancer Research UK. Kidney Cancer
Statistics. Available at:
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/mortality#heading-Five.
Last accessed May 2017.
iii Cancer Research UK. Kidney cancer
rates are increasing, so what’s fuelling the surge? Available at:
http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/.
Last accessed May 2017.
iv Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As Initial
Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma:
Results From a Phase III Trial. Journal of Clinical Oncology.
Volume 31. 2013: 30:3791 v Wong MKK, Mohamed AF et al. Selecting
renal cell carcinoma therapy: Ranking of patient perspective on
toxicities. J Clin Oncol 30: 303s, 2012 (suppl; abstr 4608)
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AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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