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Cerulean Announces CRLX101 Advances to Second Stage of Phase 2 Clinical Trial of CRLX101 in Combination with Avastin® in Relapsed Ovarian Cancer

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Cerulean Pharma Inc. (Nasdaq: CERU), a clinical stage company developing nanoparticle-drug conjugates (NDCs), today announced that CRLX101 has achieved the pre-defined, gating criterion for advancement into stage two of an open label, single-arm Phase 2 investigator-sponsored trial (IST) of CRLX101 in combination with Avastin® in patients with recurrent cisplatin-resistant ovarian, tubal and peritoneal cancer. Eighteen patients were enrolled in stage one of the trial. To date, 8 of 15 (53%) patients have achieved at least six months of progression free survival, with three patients still ongoing. Historical data in this setting have indicated that approximately 20% of patients are progression free at six months.

The trial is investigating the rate of progression free survival at six months using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in recurrent cisplatin-resistant ovarian, tubal and peritoneal cancer patients. The IST is being conducted by Massachusetts General Hospital and the affiliated Harvard teaching hospitals under the direction of the principal investigator, Carolyn Krasner, M.D.

"Ovarian cancer is the eighth most common cancer for women in the United States and remains the leading cause of death among gynecologic cancers in the United States," said Dr. Krasner. "There is a clear need for more treatment options for these patients. I am encouraged by the synergies observed with the combination of CRLX101 and Avastin thus far, and am pleased that our trial has advanced into stage two."

Posted-In: News FDA Press Releases


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