BOULDER, Colo.--(BUSINESS WIRE)--Jan. 7, 2013--
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced anticipated
development milestones and financial guidance for 2013. Clovis currently
has two clinical development programs and one drug discovery program
underway.
CO-1686
A novel, oral, mutant-selective covalent inhibitor of EGFR mutations in
non-small cell lung cancer (NSCLC), CO-1686 is currently the subject of
an accelerated second-line development program. Clovis anticipates
completing the following milestones in 2013 for CO-1686:
-
Complete dose escalation portion of Phase I/II study to establish the
dose and schedule;
-
Initiate expansion cohorts of Phase I/II study to assess efficacy in
second-line T790M+ NSCLC patients and in first-line mutant EGFR NSCLC;
-
Initiate use of Roche Molecular Systems diagnostic test to identify
T790M+ patients; and
-
Prepare to initiate pivotal study in second-line T790M+ NSCLC patients
in the first half of 2014.
Rucaparib
An oral inhibitor of PARP-1 and PARP-2, rucaparib is being explored in
ovarian and breast cancer patients with BRCA mutations and other DNA
repair deficiencies. Clovis anticipates completing the following
milestones in 2013 for rucaparib:
-
Complete dose escalation portion of Phase I/II study to identify the
monotherapy dose and schedule;
-
Initiate expansion cohort of Phase I/II study to assess efficacy in
selected ovarian cancer patients;
-
Initiate Phase II biomarker validation in selected ovarian cancer
patients to correlate clinical responses with patient genotype and
inform the analysis of the pivotal trial;
-
Advance development of diagnostic test with Foundation Medicine to
identify patients with BRCA mutations and other DNA repair
deficiencies most likely to respond to rucaparib;
-
Initiate pivotal study of rucaparib as maintenance therapy in selected
platinum-sensitive ovarian cancer patients in the second half of 2013.
Mutant c-KIT inhibitor discovery program
During 2012, Clovis entered into a collaboration with Array BioPharma
Inc. to discover a novel KIT inhibitor targeting the resistance
mutations that occur in the majority of gastrointestinal stromal tumor
patients and result in disease progression. This collaboration will
continue in 2013 with a goal of identifying a lead compound in late 2013
or early 2014.
Year-End 2012 Cash Position and 2013 Financial Guidance
Clovis ended 2012 with approximately $144.0 million in cash (these
results are preliminary and unaudited), which should provide sufficient
resources to demonstrate meaningful evidence of efficacy for CO-1686 and
rucaparib. Clovis expects a cash burn of $53.0 to $57.0 million for
2013, ending the year with approximately $90.0 million in cash.
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.
Forward Looking Statements
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 or discovery
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 our clinical development programs for
CO-1686 and rucaparib, our discovery program for the mutant cKIT
inhibitor, the corresponding development pathways of our companion
diagnostics, actions by the FDA, the EMA or other regulatory authorities
regarding whether to approve drug applications that may be filed, as
well as their decisions regarding drug labeling, and other matters that
could affect the availability or commercial potential of our drug
candidates or companion diagnostics, including competitive developments.
Clovis Oncology does not undertake to update or revise any
forward-looking statements. A further description of risks and
uncertainties can be found in Clovis Oncology’s in its reports on Form
10-Q and Form 8-K.
Source: Clovis Oncology
Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com