Cerulean Announces Oral Presentation of CRLX101 Clinical Data at Gynecologic Oncology 2016 Conference

WALTHAM, Mass.–(BUSINESS WIRE)–Cerulean
Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing
nanoparticle-drug conjugates (NDCs), today announced that Carolyn N.
Krasner, M.D., of the Massachusetts General Hospital Cancer Center, will
give an oral presentation on the Phase 1b results of an ongoing clinical
trial of CRLX101 in combination with weekly paclitaxel in patients with
relapsed ovarian cancer at the Gynecologic Oncology 2016 Conference to
be held on May 19-21 in San Antonio, Texas. This trial is being
conducted by Cerulean in collaboration with the GOG Foundation, Inc.
under the direction of Dr. Krasner, GOG Study Chair.
“Thus far, the combination of CRLX101 and weekly paclitaxel in
platinum-resistant ovarian cancer patients appears to be well tolerated.
Moreover, in the first nine patients enrolled in this Phase 1b trial, we
have observed that a majority have objective responses,” said Dr.
Krasner. “I am eager to present these results to the gynecologic
oncology community at the Gynecologic Oncology 2016 Conference in May
and to further discuss them with my colleagues at the GOG Foundation,
Inc. Meeting in July.”
As of March 11, 2016, three patients received 12 mg/m² of
CRLX101 and six patients received 15 mg/m² of CRLX101, in
each case on a once every other week schedule, in combination with 80
mg/m² of weekly paclitaxel. The maximum tolerated dose and
recommended Phase 2 dose for this combination is 15 mg/m² for
CRLX101 (every other week) and 80 mg/m² for weekly paclitaxel
(3 weeks on/1 week off). No dose limiting toxicities were observed.
Partial response and stable disease rates were 56% (5/9), and 11% (1/9),
respectively. To date, the only Grade ≥3 treatment-related adverse event
was neutropenia, which occurred in two patients (one Grade 3 and one
Grade 4). The most common adverse events (>30%) were fatigue, neutrophil
count decreased, and nausea.
“We are rapidly accruing additional patients at the recommended Phase 2
dose,” said Adrian Senderowicz, M.D., Senior Vice President and Chief
Medical Officer of Cerulean. “These additional patients will deepen our
understanding of this combination and supplement our available knowledge
of the combination of CRLX101 and Avastin^® (bevacizumab)
before launching a pivotal study in relapsed ovarian cancer.”
In a human ovarian xenograft model, the combination of CRLX101 and
paclitaxel was synergistic. In this preclinical study, tumor growth
delay and survival were greater for the combination than either
treatment alone or the sum of both individual treatments, and the
combination appeared to be well tolerated in mice.
About GOG Foundation, Inc. (GOG Foundation)
The GOG Foundation, Inc. (GOG Foundation) is an independent
international non-profit organization with the purpose of promoting
excellence in the quality and integrity of clinical and basic scientific
research in the field of gynecologic malignancies. The GOG Foundation is
committed to maintaining the highest standards in clinical trials
development, execution, analysis and distribution of results. Continuous
evaluation of our processes is utilized in order to constantly improve
the quality of patient care. The GOG Foundation conducts clinical trials
for patients with a variety of gynecologic malignancies, including
cancers that arise from the ovaries, uterus, cervix, vagina, and vulva.
The GOG Foundation is a separate entity from the National Clinical
Trials Network groups that are funded by the National Cancer Institute.
About CRLX101
CRLX101 is a nanoparticle-drug conjugate (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 also inhibits hypoxia-inducible
factor-1α (HIF-1α), which research suggests is a master regulator of
cancer cell survival mechanisms. CRLX101 has shown activity in four
different tumor types, both as monotherapy and in combination with other
cancer treatments. CRLX101 is in Phase 2 clinical development and has
been dosed in more than 350 patients. The U.S. FDA has granted CRLX101
Orphan Drug designation for the treatment of ovarian cancer and Fast
Track designation in combination with Avastin in metastatic renal cell
carcinoma.
About CRLX301
CRLX301 is a dynamically tumor-targeted 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 similar to or better than
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. CRLX301 is
in Phase 1/2a clinical development.
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 NDC clinical 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 NDC clinical candidate, CRLX301, is in a
Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.
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.
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Avastin is a registered trademark of Genentech, Inc.