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Cerulean begins Phase 1b/2a study of CRLX101

Cerulean Pharma has begun dosing patients in Phase 1b/2a study of CRLX101 in combination with Avastin in metastatic renal cell carcinoma (mRCC) patients whose disease has progressed following treatment with at least one prior molecularly targeted therapy.

The study, which incorporates a rapid dose escalation stage and a subsequent efficacy stage, is being conducted at the Abramson Cancer Center of the University of Pennsylvania, according to the company.

Cerulean chief medical officer Edward Garmey said the company has observed that the intratumor pharmacokinetic properties of nanopharmaceuticals can lead to novel pharmacodynamic effects.

"We will be collaborating with Dr. Keefe and his colleagues to assess the impact of CRLX101 on HIF-1 alpha, an exciting oncology drug target that appears to be widely upregulated in hypoxic conditions and in RCC," Garmey added.

CRLX101, a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1 alpha, is a dynamically tumor-targeted nanopharmaceutical designed to concentrate in tumors, prolonging drug exposure at the site of action.