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Cerulean begins phase I b/II a study of CRLX101 in combo with Avastin in renal cancer

Cambridge, Massachusetts
Friday, July 6, 2012, 18:00 Hrs  [IST]

Cerulean Pharma Inc., a leader in developing dynamically tumour-targeted nanopharmaceuticals, has dosed its first patient in a phase I b/II a study of its lead product candidate, CRLX101, in combination with Avastin in metastatic renal cell carcinoma (mRCC) patients.

The company also announced the completion of enrollment of its randomized phase II study in advanced non-small cell lung cancer.

The company has completed enrollment of a 150-patient randomized phase II study in advanced non-small cell lung cancer, Cerulean is beginning to capitalize on the breadth of the CRLX101 opportunity by expanding its development into additional tumor types with several studies conducted by leading investigators. This newly opened trial is designed to evaluate the activity of CRLX101, a nanopharmaceutical that inhibits both topoisomerase 1 and hypoxia-inducible factor-1 alpha, in combination with Avastin in mRCC patients whose disease has progressed following treatment with at least one prior molecularlytargeted therapy. This study, which incorporates a rapid dose escalation stage and a subsequent efficacy stage, is being conducted at the Abramson Cancer Centre of the University of Pennsylvania and is led by principal investigator Stephen Keefe, MD.

“We have observed that the unique intratumor pharmacokinetic properties of our nanopharmaceuticals can lead to novel pharmacodynamic effects,” said Edward Garmey, MD, chief medical officer of Cerulean. “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.”

“Reaching multiple tumor targets at once may be more efficient at shrinking patients’ tumours, and make them less likely to become resistant to the drugs.  In this new trial for patients with RCC, we will learn if CRLX101 is synergistic with Avastin, the leading VEGF inhibitor,” Dr Keefe said. “We are excited about the potential efficacy of combining these two agents, which mechanistically reinforce each other. The benefit of this approach—attacking multiple targets at once—is not limited to RCC, however, and could be applicable in other cancers as well.”

CRLX101 is an investigational anti-cancer agent that is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1 alpha. CRLX101 is a dynamically tumour-targeted nanopharmaceutical designed to concentrate in tumours, prolonging drug exposure at the site of action. Significant anti-tumour activity has been observed across a wide range of cancers in animal models.  CRLX101 is currently in phase II clinical development.

Cerulean Pharma Inc. is a clinical-stage company specializing in the development of dynamically tumour-targeted nanopharmaceuticals.


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