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crudeoil24

04/28/15 9:27 AM

#87611 RE: BioHunter #87385

CERU >>>> 15 minutes ago - DJNF

CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 28, 2015--
Cerulean Pharma Inc. (Nasdaq: CERU), a leader in Dynamic Tumor Targeting(TM), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Cerulean's lead nanoparticle-drug conjugate, CRLX101, in combination with Avastin(R) (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy. The FDA's Fast Track Program is designed to facilitate the development and expedite the review of drugs that are intended to treat serious conditions and fulfill an unmet medical need.

"The Fast Track designation recognizes the serious unmet medical need of patients with metastatic renal cell carcinoma and the potential of CRLX101 to address this disease," said Christopher D. T. Guiffre, Cerulean's President and Chief Executive Officer. "We will continue to work closely with the FDA with the goal of bringing CRLX101 to people living with cancer as quickly as possible."

CRLX101 is currently being evaluated in combination with Avastin as a treatment of relapsed renal cell carcinoma in a randomized Phase 2 trial.