Study to utilize DNA sequencing to determine the ovarian cancer
patients most likely to benefit from rucaparib
BOULDER, Colo.--(BUSINESS WIRE)--Oct. 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.
Source: Clovis Oncology, Inc.
Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com