BOULDER, Colo.--(BUSINESS WIRE)--Aug. 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 2nd line
T790M+ non-small cell lung cancer (NSCLC) patients and in 1st
line EGFR NSCLC patients. The 2nd line cohort is expected to
initiate by year-end and the 1st line cohort in early 2014.
Additionally, the Company expects to initiate the registration study in 2nd
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 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