Cerulean
Pharma Inc. (Nasdaq: CERU), a leader in Dynamic Tumor Targeting™,
today announced that the first patient has been dosed with CRLX301 in
Cerulean’s Phase 1/2a trial in patients with advanced solid tumor
malignancies. CRLX301 is a nanoparticle-drug conjugate, or NDC, with a
docetaxel payload, and it is the second clinical candidate from
Cerulean’s Dynamic Tumor Targeting Platform.
“CRLX301 was superior to docetaxel in seven of seven animal models, with
a statistically significant survival benefit in five of those
preclinical models,” said Paul Friedman, M.D., Executive Chairman of
Cerulean. “We also saw preclinical tolerability that is consistent with
our expectations of the platform -- specifically, improved tolerability
relative to published data with docetaxel. We look forward to learning
if these preclinical results will translate in the clinic.”
Edward Garmey, M.D., Chief Medical Officer of Cerulean added, “During
the course of the CRLX301 clinical development program, we will
carefully assess the investigational spaces in which currently approved
taxanes can be improved through the targeted delivery of the cytotoxic
payload to tumor cells and the relative sparing of healthy cells. We
also are interested in those settings where taxanes haven’t been
approved but where our NDC technology might facilitate their use, either
alone or in combination.”
This is the first clinical trial of CRLX301. The Phase 1/2a trial is
commencing in Australia and is expected to expand to the U.S. The Phase
1 portion is a single-arm, open-label, dose-escalation study of CRLX301
in up to 36 patients with advanced solid tumor malignancies that is
designed to identify the maximum tolerated dose and establish the
recommended Phase 2 dose of CRLX301 when administered by intravenous
infusion once every three weeks. The Phase 2a portion will be an
expansion cohort that will enroll an additional 24 patients. The primary
endpoints are pharmacokinetics, safety and tolerability of CRLX301.
Preliminary evidence of efficacy also will be evaluated.
About CRLX301
CRLX301 is a dynamically tumor-targeted nanoparticle-drug conjugate
(NDC) designed to concentrate in tumors and slowly release its
anti-cancer payload, docetaxel, inside tumor cells. In preclinical
studies, CRLX301 delivers up to 10 times more docetaxel into tumors,
compared to an equivalent milligram dose of commercially available
docetaxel and was superior to docetaxel in seven of seven animal models,
with a statistically significant survival benefit seen in five of those
seven models. In addition, preclinical data show that CRLX301 had lower
toxicity than has been reported with docetaxel in similar preclinical
studies.
About CRLX101
CRLX101 is a dynamically tumor-targeted NDC designed to concentrate in
tumors and slowly release its anti-cancer payload, camptothecin, inside
tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is
involved in cellular replication, and hypoxia-inducible factor-1α
(HIF-1α), which research suggests is a master regulator of cancer cell
survival mechanisms thought to promote drug and radiation resistance.
CRLX101 has shown activity in late-stage disease in three different
tumor types, both as monotherapy and in combination with Avastin®.
CRLX101 is currently in Phase 2 clinical development and has been dosed
in more than 250 patients.
About Cerulean’s Dynamic Tumor Targeting™ Platform
Cerulean’s Dynamic Tumor Targeting Platform creates NDCs that are
designed to provide safer and more effective cancer treatments. We
believe our NDCs concentrate their anti-cancer payloads inside tumors
while sparing normal tissue because they are small enough to pass
through the “leaky” vasculature present in tumors but are too large to
pass through the wall of healthy blood vessels. Once inside tumors, our
NDCs enter tumor cells where they slowly release anti-cancer payloads
from within the tumor cells.
About Cerulean Pharma
The Cerulean team is committed to improving treatment for people living
with cancer. We apply our Dynamic Tumor Targeting Platform to create a
portfolio of NDCs designed to selectively attack tumor cells, reduce
toxicity by sparing the body’s normal cells, and enable therapeutic
combinations. Our first platform-generated candidate, CRLX101, is in
multiple clinical trials in combination with other cancer treatments,
all of which aim to unlock the power of combination therapy. Our second
platform-generated candidate, CRLX301, is in a Phase 1/2a clinical
trial. For more information, please visit www.ceruleanrx.com.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about the clinical development
of our product candidates, statements about our estimated research and
development expenses and sufficiency of cash to fund specified use of
cash and other statements containing the words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “would,” and
similar expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important factors,
including: the uncertainties inherent in the initiation of clinical
trials, availability and timing of data from ongoing and future clinical
trials and the results of such trials, whether preliminary results from
a clinical trial will be predictive of the final results of that trial
or whether results of early clinical trials will be indicative of the
results of later clinical trials, expectations for regulatory approvals,
availability of funding sufficient for our foreseeable and unforeseeable
operating expenses and capital expenditure requirements and other
factors discussed in the “Risk Factors” section of our Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on
November 13, 2014 and in other filings that we make with the Securities
and Exchange Commission. In addition, any forward-looking statements
included in this press release represent our views only as of the date
of this release and should not be relied upon as representing our views
as of any subsequent date. We specifically disclaim any obligation to
update any forward-looking statements included in this press release.
Avastin® is a trademark of Genentech Inc.
Copyright Business Wire 2014