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Enrollment Complete in Cerulean CRLX101 NDC-Avastin Combination Phase 2 Trial in RCC

Cerulean Pharma Inc., a clinical stage company developing nanoparticle-drug conjugates (NDCs), today announced completion of enrollment of a randomized Phase 2 trial of its lead NDC, CRLX101, in combination with Avastin®, in third- and fourth-line relapsed renal cell carcinoma (RCC). The trial has enrolled all 110 patients and the company expects to announce top-line data in the first half of 2016.

“This is an exciting time in the evolution of RCC treatments,” said Martin H. Voss, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center and Principal Investigator for the trial. “Currently approved treatment options provide limited benefit to heavily pretreated patients, and the therapeutic approach in the third- and fourth-line setting is poorly defined. There remains a clear need for a different mechanistic approach, so I am pleased that we have completed enrollment and look forward to the results.”

“Completing enrollment in this Phase 2 trial marks a significant milestone for the company,” stated Christopher D. T. Guiffre, President & Chief Executive Officer of Cerulean. “We are grateful for the dedication demonstrated by the patients and the clinical investigators that are participating in this trial.”

The Phase 2 trial compares CRLX101 in combination with Avastin to investigator’s choice of standard of care in patients with RCC who have received two or three prior lines of therapy. The primary endpoint is investigator-assessed progression free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. PFS also will be evaluated by blinded independent radiological review. Other secondary endpoints include overall response rate, duration of response and overall survival. The trial is sized to show a 2.3 month improvement over an expected 3.5 month median PFS for standard of care with a hazard ratio of 0.6, meaning that the trial is expected to show whether CRLX101 plus Avastin provides a 40% improvement in PFS over available third- and fourth-line treatments.

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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