Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, announced that the first patient has been dosed in a Phase 1b/2a 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 2 study in advanced non-small cell lung cancer.

Having completed enrollment of a 150-patient randomized Phase 2 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 molecularly targeted therapy. This 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 and is led by principal investigator Stephen Keefe, M.D.

“We have observed that the unique intratumor pharmacokinetic properties of our nanopharmaceuticals can lead to novel pharmacodynamic effects,” said Edward Garmey, M.D., 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’ tumors, 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.”

First CRLX101 Patient Dosed | News | Drug Discovery and Development Magazine


Mark E. Davis, a successful chemical engineer, never dreamed that he would reinvent his career and create a revolutionary kind of cancer drug. But everything changed when his wife was diagnosed with breast cancer. 10 years later, IT-101, the nanoparticle drug he engineered, was approved for a six-month trial in humans. Also, meet a group of young, hopeful scientists who are setting their sights on a resource that provides enough energy in one hour to power the entire globe for one year-the sun. They believe they can create an “artificial leaf” that uses sunlight to split water into hydrogen and oxygen.


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