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Cerulean Provides Update on Clinical Trial Exploring Dose-Intensive Schedule for CRLX101 Nanoparticle-Drug Conjugate

Cerulean Pharma Inc., a clinical stage company developing nanoparticle-drug conjugates (NDCs), today announced that the first patient has been dosed in a trial exploring a dose-intensive schedule for its lead NDC, CRLX101, in patients with advanced solid tumor malignancies.

The trial will explore safety and tolerability of CRLX101 when administered in a weekly dosing regimen. This trial is expected to complete enrollment in the second half of 2016.

“I joined Cerulean because I believe that CRLX101 has the potential to be approved in multiple indications, and I am excited to lead that effort. CRLX101 has been studied in over 300 patients, and I am encouraged by the data generated to date with bi-weekly dosing in multiple tumor types when given as monotherapy and in combination with other therapies,” said Adrian Senderowicz, M.D., Senior Vice President and Chief Medical Officer of Cerulean. “The tolerability we have seen with CRLX101 allows us to explore whether an increase in intensity with a weekly dosing regimen may enhance the therapeutic index, enabling additional registration strategies using this novel regimen.”

This is an open-label, dose-escalation study in patients with advanced solid tumor malignancies with up to 18 patients receiving weekly CRLX101 alone, and up to 18 patients receiving weekly CRLX101 in combination with bi-weekly Avastin®. The trial is designed to determine the maximum tolerated dose for potential indications of CRLX101. Preliminary evidence of anti-tumor activity also will be evaluated.

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 300 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 currently in Phase 1/2a clinical development.

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