Press Release
Cerulean Reports First Quarter 2016 Corporate Highlights and Financial Results
Conference Call Today at
"During the first quarter, we announced groundbreaking clinical data for
CRLX101 in the Proceedings of the
First Quarter 2016 Corporate Highlights
-
Announced publication of clinical data for CRLX101 in PNAS
showing CRLX101 localizes selectively in human tumors, sparing
adjacent healthy tissue
- Data represent first human proof of mechanism for Cerulean's platform technology
-
Reported clinical data from the ongoing Phase 1/2a trial of CRLX301 in
patients with refractory solid tumors at the 14th
International Congress on Targeted Anticancer Therapies - Determined the maximum tolerated dose on a once-every-three-weeks (Q3W) dosing schedule
First Quarter 2016 Financial Summary
Cash Position - As of
R&D Expenses - Research and development expenses for the first quarter
were
G&A Expenses - General and administrative expenses for the first quarter
were
Net Loss Attributable to Common Stockholders - Net loss attributable to
common stockholders for the first quarter was
More detailed financial information and analysis may be found in our
Quarterly Report on Form 10-Q, which was filed with the
Key Developments Subsequent to the End of the First Quarter
-
Reported top-line data from ongoing trial with the
GOG Foundation, Inc. of CRLX101 in combination with weekly paclitaxel in relapsed ovarian cancer-
Full data to be presented in an oral presentation at the
Gynecologic Oncology 2016 Conference on
May 19
-
Full data to be presented in an oral presentation at the
Gynecologic Oncology 2016 Conference on
-
Presented data for both CRLX101 and CRLX301 developments via five
poster presentations at the
American Association for Cancer Research (AACR) annual meeting- Phase 2 trial of the NDC CRLX101 in combination with Avastin in patients with platinum-resistant ovarian cancer (MGH poster)
- Tumor selective localization of CRLX101, an investigational nanoparticle-drug conjugate of camptothecin
- CRLX101, an investigational nanoparticle-drug conjugate of camptothecin, demonstrates synergy with immunotherapy agents in preclinical models
- A camptothecin-containing nanoparticle-drug conjugate combination with DDR agents provides a novel approach to increasing therapeutic index (AstraZeneca poster)
- Pharmacokinetics of CRLX301, a novel nanoparticle-drug conjugate containing the payload docetaxel, in patients with refractory solid tumors
Anticipated Upcoming Milestones
During the remainder of the first half of 2016, Cerulean expects to:
-
Announce first patient dosed in Phase 1b/2 trial for the
Cerulean-AstraZeneca-National Cancer Institute collaboration to study potential synergy between CRLX101 and LYNPARZA™ (olaparib) - Announce first patient dosed in Phase 2a trial of CRLX301 in solid tumors
-
Report additional CRLX301 data from Phase 1 trial at
American Society of Clinical Oncology (ASCO)
During the second half of 2016, Cerulean expects to:
- Report primary and secondary endpoint top-line data (PFS and ORR) from randomized Phase 2 RCC trial of CRLX101 in combination with Avastin
- Report results from an ongoing clinical trial evaluating weekly dosing of CRLX101 alone and in combination with Avastin
- Report additional interim data from investigator-sponsored trials with CRLX101 in combination with Avastin in relapsed ovarian cancer and CRLX101 in combination with chemoradiotherapy in locally advanced rectal cancer
Conference Call Information
Management will conduct a conference call at
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
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
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.
About
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 the sufficiency of our cash
and cash equivalents to fund our operations, debt service and other
scheduled expenditures and other statements containing the words
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"hypothesize," "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 and completion 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
Avastin is a registered trademark of
LYNPARZA is a trademark of the AstraZeneca group of companies.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160502006208/en/
Director,
Investor Relations and Corporate Communications
njones@ceruleanrx.com
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