CRLX101 plus Avastin Does Not Show Improvement Compared to Standard of Care in this Setting
Company to Host Conference Call Today at
The trial was conducted at 43 sites in the US and
The study demonstrated no statistically significant difference in median PFS and objective response rate for the CRLX101 combination compared to SOC. Median PFS was 3.7 months for the CRLX101 combination compared with a median PFS of 3.9 months for SOC (hazard ratio: 1.25, p=0.822). The 95% confidence interval for PFS for the CRLX101 combination was 2.0 months to 4.3 months and for SOC was 2.2 months to 5.4 months. Objective response rate by independent radiological review for patients who received the CRLX101 combination was 5% (2/42) compared to 14% (6/43) for SOC (p=0.836). The CRLX101 and Avastin combination appeared to be safe and well-tolerated and the safety and tolerability profile of the combination was consistent with that observed in previous studies. The full data set from the trial are expected to be submitted for presentation at an upcoming medical conference.
"We are disappointed with this outcome and will undertake a thorough
analysis of the data to understand why CRLX101 plus Avastin
underperformed compared to the results we saw in an earlier
investigator-sponsored trial," said
Conference Call Details
Cerulean will host a conference call today at
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. CRLX101 has shown activity in multiple
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 400 patients. The
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 Phase 2a clinical development. 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
LYNPARZA is a trademark of the AstraZeneca group of companies.
Director, Investor Relations and Corporate Communications
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