Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,516.27 98.74 0.68%
TOPIX 1,173.37 6.78 0.58%
HANG SENG 22,760.24 64.23 0.28%

Clovis Oncology Announces First Patient Enrolled in ARIEL2 Study of Rucaparib in Ovarian Cancer



  Clovis Oncology Announces First Patient Enrolled in ARIEL2 Study of
  Rucaparib in Ovarian Cancer

Study to utilize DNA sequencing to determine the ovarian cancer patients most
                       likely to benefit from rucaparib

Business Wire

BOULDER, Colo. -- October 30, 2013

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the global ARIEL2
(Assessment of Rucaparib in Ovarian Cancer Phase 2 Trial) study of rucaparib
has commenced with the dosing of the first patient at a U.S. study site.
Rucaparib is the Company’s oral, potent, small molecule poly (ADP-ribose)
polymerase (PARP) inhibitor being developed for the treatment of platinum
sensitive, relapsed ovarian cancer.

“I am delighted to be starting this important and timely trial,” said
Professor Iain Mcneish, Professor of Gynecological Oncology, Institute of
Cancer Sciences, University of Glasgow and one of the two chief investigators
of the ARIEL2 study. “We have found there are many ovarian cancer patients who
do not carry germline BRCA mutations yet still benefit from PARP inhibitor
therapy. This study is designed specifically to help identify these women
using tumor DNA sequencing, which is a viable approach since nearly all
ovarian cancer patients have plentiful tumor tissue samples following
de-bulking surgery. Platinum sensitivity alone may not be the best predictor
of PARP inhibitor outcome and I am confident we can do much better for
patients using tumor genetic analysis.”

“We are pleased to move forward with the international ARIEL clinical program,
beginning with ARIEL2 today, and followed closely by our ARIEL3 pivotal study
which will initiate by the end of this year,” said Patrick J. Mahaffy,
president and CEO of Clovis Oncology. “PARP inhibitors have the potential to
provide meaningful clinical benefit to many women with ovarian cancer, and
ARIEL2 is designed to identify the broader population of patients who likely
benefit from rucaparib therapy, beyond the germline BRCA mutation carrier
population.”

ARIEL2 is a single-arm, open-label, Phase 2 study designed to identify tumor
characteristics that predict sensitivity to rucaparib using DNA sequencing to
evaluate each patient’s tumor. Tumor samples from study participants will be
tested for BRCA1 and BRCA2 mutations (genes that are linked to hereditary
breast and ovarian cancers), as well as other biomarkers that are expected to
confer sensitivity to PARP inhibitor therapy. All patients in the study will
receive both rucaparib and their molecular test results (including tumor BRCA
status), and be treated until their disease progresses or until they withdraw
from the study.

In late 2013, the Company intends to initiate its pivotal study, ARIEL3, a
randomized, double-blind, Phase 3 study that will compare the effects of
rucaparib versus placebo. The study will evaluate whether rucaparib in
platinum-sensitive, ovarian, fallopian tube or primary peritoneal high-grade
cancer patients can extend the period of time for which the disease is
controlled. The study will also prospectively test whether a patient’s BRCA
mutation status or other biomarkers predict their response to rucaparib.

If the trial is successful, the Company intends to use data generated from the
ARIEL studies to submit an application to the U.S. Food and Drug
Administration (FDA) and other Health Authorities requesting an approval for
rucaparib in all genetically-appropriate patients with relapsed,
platinum-sensitive ovarian, fallopian tube or primary peritoneal high-grade
cancer in a maintenance setting.

About Rucaparib

Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 in development for
the treatment of ovarian cancer. Rucaparib is currently the subject of two
largely complete Company-sponsored Phase I clinical studies: one to determine
the MTD of oral rucaparib administered on a daily basis as monotherapy; and a
second trial to determine the MTD of oral rucaparib that can be combined with
intravenous platinum chemotherapy for the treatment of solid tumors. Now that
the optimal dose and schedule of 600 mg BID have been established in the Phase
I portion of the monotherapy study, the Company intends to initiate a Phase II
expansion cohort to assess efficacy in germline BRCA ovarian cancer patients.

About Ovarian Cancer

Over 90% of ovarian cancer arises from the uncontrolled growth and replication
of epithelial cells which form the surface of the ovary. Cancer involving this
type of cell is known as epithelial ovarian cancer. High grade serous and
endometrioid ovarian cancers are biologically related and common, accounting
for approximately 75% of cases. If detected at a very early stage, ovarian
cancers can usually be removed surgically and this can be potentially
curative. However, there are often no clearly identifiable initial symptoms
and in approximately 90% of high grade serous ovarian cancer cases, the cancer
has spread to other parts of the body before a person is diagnosed.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring,
developing and commercializing innovative anti-cancer agents in the U.S.,
Europe and additional international markets. Clovis Oncology targets
development programs at specific subsets of cancer populations, and
simultaneously develops diagnostic tools that direct a compound in development
to the population that is most likely to benefit from its use. Clovis Oncology
is headquartered in Boulder, Colorado, and has additional offices in San
Francisco, California and Cambridge, UK.

To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements
involve substantial risks and uncertainties that could cause our clinical
development programs, future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the
uncertainties inherent in the initiation of future clinical trials,
availability of data from ongoing clinical trials, expectations for regulatory
approvals, and other matters that could affect the availability or commercial
potential of our drug candidates. Clovis Oncology undertakes no obligation to
update or revise any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as risks relating
to the business of the company in general, see Clovis Oncology’s Annual Report
on Form 10-K for the year ended December 31, 2012 and its other reports filed
with the Securities and Exchange Commission.

Contact:

Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement