Clovis Oncology Announces First Patient Treated with Hydrobromide Salt
Tablet Formulation of CO-1686 in its Ongoing Phase I/II Clinical Study
BOULDER, Colo. -- August 28, 2013
Clovis Oncology (NASDAQ:CLVS) announced today that it has dosed the first
patient with its new hydrobromide salt tablet formulation of CO-1686 in its
ongoing Phase I dose-finding portion of its Phase I/II clinical study. CO-1686
is the Company’s novel, oral, targeted covalent (irreversible) inhibitor of
mutant forms of the epidermal growth factor receptor (EGFR) for the treatment
of non-small cell lung cancer (NSCLC) in patients with initial activating
mutations as well as the dominant resistance mutation T790M.
“We believe this is a very important step in the development of CO-1686, given
the improved pharmaceutical qualities of the hydrobromide salt formulation,”
said Patrick Mahaffy, President and CEO of Clovis Oncology. “Over the next
several months we will transition all current patients on the original capsule
form of CO-1686 to this new formulation, and, of course, continue to enroll
new patients as well.”
Data presented at ASCO in June from a Phase I study of CO-1686 in healthy
human volunteers treated with the hydrobromide salt tablet form of CO-1686
showed improved exposures and reduced PK variability compared with the free
base capsule formulation, which has been used to date in the Phase I study in
patients with NSCLC. Specifically, in the Phase I study in healthy volunteers,
the tablet form of CO-1686 demonstrated a 2 to 3-fold improvement in
absorption and a 4-fold reduction in exposure variability relative to the free
base capsule formulation.
With the introduction of the tablet formulation, the Company recommences dose
escalation in the Phase I dose-finding portion of the trial and expects to
identify the recommended Phase II dose (RP2D) by the end of this year. Upon
identification of the RP2D, the Company will initiate the Phase II expansion
cohorts to assess efficacy in 2^nd line T790M+ non-small cell lung cancer
(NSCLC) patients and in 1^st line EGFR NSCLC patients. The 2^nd line cohort is
expected to initiate by year-end and the 1^st line cohort in early 2014.
Additionally, the Company expects to initiate the registration study in 2^nd
line T790M+ NSCLC patients in the second half of 2014 and a Phase I study in
Japan in early 2014.
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 actual
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 the prospectus supplement and related
prospectus for this offering as well as Clovis Oncology’s Annual Report on
Form 10-K for the year ended December31, 2012 and its other reports filed
with the Securities and Exchange Commission.
Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
Breanna Burkart, 303-625-5023
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