BOULDER, Colo.--(BUSINESS WIRE)--May. 16, 2013--
Clovis Oncology (NASDAQ:CLVS) announced that three abstracts (ASCO
Abstracts #2524, #2585, #2586) highlighting results from three Phase I
studies of the company’s two lead compounds will be presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting 2013 in
Chicago.
Data contained in the published abstracts was current as of the
submission deadline of February 5th, 2013. Data to be presented in the
poster sessions will include data from the trials as of early May.
Clovis is developing CO-1686, a novel, oral, targeted covalent
(irreversible) inhibitor of the epidermal growth factor receptor (EGFR),
for the treatment of non-small cell lung cancer (NSCLC), in patients
with initial activating EGFR mutations as well as the T790M primary
resistance mutation. Rucaparib,
an oral, potent, small molecule poly (ADP-ribose) polymerase (PARP)
inhibitor, is being developed for ovarian cancer. Both compounds are in
the Phase I dose-escalation portion of Phase I/II clinical trials.
The abstracts accepted for poster presentation, all as part of the
Developmental Therapeutics – Clinical Pharmacology & Experimental
Therapeutics Session, are as follows:
(Abstract #2524) First in-human evaluation of CO-1686, an
irreversible, selective, and potent tyrosine kinase inhibitor of EGFR
T790M.
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Dr. Lecia V. Sequist, Massachusetts General Hospital, Boston
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Tuesday, June 4, 8:00 a.m. - 12:00 p.m. CDT
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Location: E450a
The poster will be discussed at the associated discussion session:
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Dr. David Carbone, Ohio State’s Comprehensive Cancer Center – James
Cancer Hospital and Solove Research Institute.
-
Tuesday, June 4, 11:30 a.m. - 12:30 p.m. CDT (Dr. Carbone is scheduled
to speak from 11:54 a.m. – 12:06 p.m.)
-
Location: E354b, Poster #12
(Abstract #2585) A phase I dose escalation and PK study of continuous
oral rucaparib in patients with advanced solid tumors.
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Dr. Rebecca Kristeleit, University College of London Cancer Institute,
London
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Monday, June 3, 8:00 a.m. – 11:45 a.m.
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Location: S Hall A2, Poster Board: 7E
(Abstract #2586) A phase I study of oral rucaparib in combination
with carboplatin.
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Dr. L. Rhoda Molife, The Royal Marsden and Institute of Cancer
Research, Surrey, UK
-
Monday, June 3, 8:00 a.m. – 11:45 a.m.
-
Location: S Hall A2, Poster Board: 7F
About CO-1686
CO-1686 is a novel, oral, targeted covalent (irreversible) inhibitor of
the cancer-causing mutant forms of epidermal growth factor receptor
(EGFR) currently being studied for the treatment of non-small cell lung
cancer (NSCLC). CO-1686 was designed to selectively target both the
initial activating EGFR mutations as well as the T790M resistance
mutation, while sparing wild-type, or “normal” EGFR at anticipated
therapeutic doses. Accordingly, it has the potential to treat NSCLC
patients with EGFR mutations both as a first-line or second-line
treatment with a reduced toxicity profile compared to current EGFR
inhibitor therapies. The Phase I/II study is currently in the dose
escalation phase, being conducted at six sites in the U.S. and Europe.
Following the establishment of an appropriate dose, the Company intends
to study CO-1686 in a Phase II expansion cohort of NSCLC patients with
activating EGFR mutations who have failed initial EGFR-directed therapy
and have developed the T790M mutation, as well as a second expansion
cohort of first-line mutant EGFR NSCLC patients.
About Rucaparib
Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 in development
for the treatment of ovarian cancer. Rucaparib is currently in two
Company-sponsored Phase I clinical studies; one to determine the maximum
tolerated dose (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. Once the optimal dose and schedule have been
established in the monotherapy study, the Company will initiate a Phase
II expansion cohort to assess efficacy in selected ovarian cancer
patients. The Company expects to initiate a biomarker study in
platinum-sensitive ovarian cancer patients in the third quarter of 2013,
as well as the pivotal Phase III study in platinum-sensitive ovarian
cancer patients in late 2013.
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
Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com